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Introduction to STL: Upendra Baxi

Introduction to Science, Technology, and Law by Upendra Baxi

1. Inter-disciplinary Approach: Pursuing multiple disciplines widens mental sweep and depth. Science
represents accumulated knowledge; law is the collected wisdom of ages. "Technics" (use of tools) and a
perfected legal system elevate humans intellectually. Legal system is a synthesis of conflicting interests,
representing organized society's wisdom.

1. Science and Law Similarities: Science and law organized similarly, both based on generalization and
systematization. Precedents in law encapsulate principles, creating a parallel with scientific general
principles. Historical examples show coexistence and enrichment of science and jurisprudence.

1. Progress of Science: 20th-century science is big, complex, and relevant to everyday life. Science integrated
into societal institutions, impacting politics, international relations, and daily affairs. Society must decide if
scientific discoveries are threats or promises. Examples: Computers revolutionizing labor and education,
medical advancements altering life concepts.

1. The March of Law: Legal system complexity increased with industrialization, urbanization, and social
changes. The law adapted to economic, political, and social transformations. Became more complex,
systematized, and rationalized.

1. Classification of Sciences and Impact on Law: Science divided into branches: mathematics, physical,
biological, human and social sciences. Interconnection and overlapping between different branches.
Distinction between "science" and "technology." Sciences developed from "technics" but technical
achievements alone don't produce genuine science.

1. Development of Law: Legal development parallels science; general principles evolve from specific cases.
Enacting universal rules covers a multitude of particular situations.

1. Social Evolution and Legislation: Social evolution, biological progress, and technological advancements
necessitate legislative changes. Changes focus on modernization and reform, affecting political, socio-
economic, family, medico-biological, energy, socio-cultural, and socio-ethical sectors. Social sciences show
significant progress in these aspects.

1. Points of Contact Between Science and Law: Evolution of scientific theory influences law's substance.
Law may need modification in procedure and evidence in response to scientific developments.
Administration by courts can benefit from new scientific techniques. Dialogue between science and law is
not a luxury but a utility, potentially a necessity.

1. Legal Responses to Scientific Developments:

 Bacon's quote emphasizes the need for new remedies to address new problems.
 History shows that law responds to technological changes impacting human life.
 Examples: Legislation on railways, telegraph, telephone, wireless telegraphy, aircraft, and atomic energy.

1. Adjective Law and Science: - Adjective law (law of procedure and evidence) illustrates legal approach to
science. - Section 45 of the Indian Evidence Act recognizes expert opinions, acknowledging expertise in
specific disciplines.
2. Pace of Modern Developments: - Modern times witness an increased number and intensity of points of
contact between science and law. - Scientific discoveries touch individual and social life, necessitating legal
responses. - Legal machinery must reflect a satisfactory response to scientific developments.
3. Recent Scientific Developments: - Recent decades bring scientific developments requiring regulation to
prevent abuse. - Issues like electronic surveillance prompt the need for legislation to protect personal
integrity and privacy. - Growing urbanization and mechanization of transport raise concerns about road
traffic victims. - Society and law need an interdisciplinary study for effective preventive measures.
4. Difficulty of Framing Laws:
 Precision in legislating responses to new scientific developments is challenging.
 Legislation on experimentation may be limited, relying on ethical codes rather than strict laws.
 Challenges include risk-benefit assessment, consent issues, and differentiating patients and volunteers.
 Rigid regulations may impede medical research progress; cautious approaches are taken due to the delicacy
of the subject.
 Ethical value judgments vary among societies, adding complexity to legislation.

1. The Realm of Ideas:

 Increased scientific activities lead to a surge in ideas.


 Legal protection for ideas becomes crucial.
 Existing legal protections include patents, copyright, and literary property.
 Controversies arise on the protection of ideas outside traditional categories, leading to a need for possible
legal responses.

1. Science in the Service of Law and Society:

 Scientific developments should aid legal processes.


 Examples include typewriters, computers in legal research, and interdisciplinary applications of social
sciences.
 Legal recognition of property in ideas reflects a response to expanding intellectual horizons.
 The law should not be blind to beneficial scientific developments.

1. Methodology of Study:

 Interaction of science and law is vast, suggesting the need for focused study areas.
 Principles of selection and adherence are vital in scientific research.
 Comparative methods can be used to study inter-relationships between science and law.
 The importance of interdisciplinary studies is emphasized.
 Future historians may evaluate how society dealt with the interplay of scientific knowledge and public
policy.

Law and Policy of Science and Technology

1. State as the Primary Researcher:


o The state is a major contributor to research, driven by motives beyond profit.
o Nations recognize the potential of science and technology for economic growth and overall
development.
o Policies are formulated to encourage research, innovation, and funding, particularly in areas of
public interest.
2. Societal Progress and Scientific Development:
o The societal progress is intricately linked to advancements in science and technology.
o Developed nations attribute their status to technological and scientific achievements.
o Policies in developed and developing nations differ in terms of fund allocation, infrastructure, and
knowledge pool creation.
3. Ministry of Science and Technology in India:
o India, as a developing nation, established the Ministry of Science and Technology to promote and
regulate scientific endeavors.
o Policies, including the Science and Technology Policy of India (2003), are crafted to support
research and technology development.
o The ministry's role is crucial in providing amenities and incentives for scientific growth in India.
4. Leadership Perspectives:
o Quotes from Indian leaders emphasize the nation's commitment to building a robust science and
technology base.
o Government efforts aim to transform India into a significant player in the global knowledge
economy.
o Recognition of the importance of indigenous technology development for national strength and
independence.
5. Scientific Policy Resolutions:
o Historical perspectives on India's commitment to promoting science and technology.
o Emphasis on principles like self-reliance, sustainable development, and equitable growth.
o A strong infrastructure base, including research labs and skilled human resources, has been
developed.
6. Global Impact of Science and Technology:
o Science and technology's profound impact on economic growth and social development.
o Increased importance of knowledge as a source of economic power.
o Concerns about restrictions on knowledge sharing, intellectual property rights, and global trade
and technology control regimes.
7. Challenges and Changing Dynamics:
o Increasing interdisciplinarity in science, necessitating multi-institutional and multi-country
collaboration.
o Rapid progress in information and communication technology affecting the accessibility and speed
of scientific information.
o Ethical, legal, and social implications arising from scientific and technological developments.
8. National Resolve and Goals:
o India's commitment to supporting science and technology for the well-being of society.
o Recognizing the central role of science and technology in raising the quality of life, creating
wealth, ensuring global competitiveness, and sustainable resource utilization.
9. Advancing Scientific Temper:
o The policy aims to promote scientific temper among citizens, aligning with Article 51A of the
Indian Constitution.
o Citizens are encouraged to have a positive and healthy attitude towards science and technology to
foster an environment conducive to progress.
10. Peoples' Participation:
o The government seeks to promote people's participation in advancing science and technology.
o Integration of universities and industry is envisioned for sustained growth in various fields to
address national needs, including the right to food, health, and work.
11. Development of Indigenous Knowledge:
o The policy aims to develop indigenous knowledge across various fields, positioning India as a hub
of knowledge, information, and technology.
o Emphasis on technology for human welfare and maximum benefit to the population.
12. Objectives of the Policy:
o Spreading the message of science to advance scientific temper and promote a scientifically
progressive society.
o Application of technology in diverse fields for sustainable development.
o Utilizing technology to eradicate poverty, remove regional imbalances, and tap into traditional
knowledge pools.
o Fostering research and development, building centers of excellence, and raising research standards.
o Ensuring freedom and autonomy for academic and research institutions, encouraging creative work
with social responsibility.
o Strengthening research bases, mechanisms for technology evaluation, absorption, and upgradation.
o Encouraging public and private participation and cooperation in key technologies such as
biotechnology and information technology.
o Providing incentives for research and development through intellectual property rights.
o Using technology for forecasting, preventing, and mitigating natural hazards.
o Achieving national development through science and technology progress and promoting
international cooperation.
o Integrating science and technology with other disciplines for a multidisciplinary approach.
o Involvement of scientists and technologists in national governance and policymaking.
13. Globalization and Intellectual Property:
o Acknowledges the trend of emphasizing private property and the need for a strong intellectual
property regime.
o Highlights the global need for incentives and stimulations with private and exclusive monopoly on
research innovations.
14. International Collaborations:
o Recognizes the importance of international collaborations in the era of globalization.
o India actively engages in bilateral and multilateral treaties and compacts to boost development
through collaborations in science and technology.
15. Local and Domestic Cooperation:
o Advocates not only for international cooperation but also emphasizes the importance of local and
domestic cooperation.
o Involvement and contribution from various sectors, including industry, departments, academia,
organizations, people, and local governments, are encouraged.
16. Sensitization Programs:
o States undertake sensitization and orientation programs for stakeholders and the general public to
enhance understanding and cooperation in the use of science and technology.

Module 2

Internet Regulation and Information Technology + Basics of Search Engines

1. Intellectual Property Law and Technology:


o Encourages creativity and innovation in science and technology.
o Grants individual or private monopoly rights as rewards for innovation.
o Technological developments, especially the internet, pose challenges to intellectual property law.
2. Challenges with Internet and Intellectual Property:
o Birth of the internet and World Wide Web is a significant technological development.
o Regulation of the internet poses legal challenges, especially concerning intellectual property.
o E-commerce on the internet raises complex intellectual property issues, including copyright issues
in cyberspace, search engines, and domain names.
3. Copyright Issues on the Internet:
o Digital technologies and the internet have compounded copyright challenges.
o Internet as a battlefield for brands, leading to disputes over reputation and market dominance.
o Various attempts to regulate intellectual property issues on the internet, focusing on copyright.
4. Search Engines, Regulation, and Copyright:
o Paradox in copyright exacerbated by digital technologies and the internet.
o Legal battles between copyright holders and consumer lobbies.
o Exploration of the contemporary angle: search engines and their liability within the copyright
regime.
5. Copyright Owner's Rights and Challenges:
o Copyright owners have economic rights to reproduce, distribute, and communicate their work.
o Challenges arise in the context of the internet, where temporary copies are generated without
permission.
o Search engines, by copying and displaying cached links without permission, raise legal and
copyright issues.
6. Search Engines in India and Global Context:
o Lack of recorded cases on the liability of search engines in India due to nascent legislation and
jurisprudence on digital technologies.
o Controversies in the US and European countries regarding search engine liability.
o Analysis of information technology and copyright regime in India to assess readiness for future
challenges. Overall, the passage discusses the intersection of intellectual property law, technology,
and the internet, with a focus on copyright issues, especially those related to search engines. It
emphasizes the need for regulation and analysis of the copyright regime in the context of evolving
digital technologies.

Internet Search Engines: The Good and the Bad

1. Introduction to Search Engines:


o The widespread and spontaneous use of search engines makes them challenging to define.
o Authors provide tentative definitions; Grimmelmann defines a search engine as a service helping
users locate content on the Internet.
o Larry Page's definition emphasizes a perfect search engine understanding and delivering exactly
what users want.
2. Benefits and Harms of Search Engines:
o Search engines create social benefits by connecting users and content providers, reducing
transaction costs.
o Search engines may cause harms to users, providers, and third parties, as they handle valuable
information.
3. Functionality of Search Engines:
o Four types of information flow in search engine functionality: a. aggregating provider information,
b. matching users with content providers, c. content delivery, and d. ranking.
o Content providers and third parties with copyright interests are concerned about the operation of
search engines.
4. Indexing:
o The primary function is to search out and index content using automated software agents (robots or
crawlers).
o Googlebot, for example, retrieves pages and stores them in Google's index database.
o Content providers object to indexing as it involves making initial copies, considered unauthorized.
5. Search Query:
o Users provide search queries, typically composed of keywords or short phrases.
o Queries help narrow the vast universe of possible results.
6. Delivering Search Results and Ranking:
o Search engines return relevant content to users based on algorithms that summarize and organize
vast amounts of available content.
o Ranking algorithms, such as Google's PageRank, evaluate relevance and overall importance of
web pages.
7. Content, Caching, and Archiving:
o Users often access content directly from the content provider using URLs obtained from search
results.
o Caching and archiving come into play when users are satisfied with the content provided by the
search engine.
o Issues arise when search engines provide content through practices like thumb-nailing, allegedly
making and distributing unauthorized copies.

Nature of the Rights under Copyright Law and their Exploitation

1. Roots and Function of Copyright Law:


o Ambiguous roots in common law, justified by labor and personality theories.
o Evolved to reconcile conflicting interests: Author's rights vs. public access to intellectual works.
o Codified in many countries, each emphasizing different rights in their copyright regime.
2. Understanding Copies under Copyright Law:
o Copyright law aims to protect rights in the context of evolving technologies like the internet.
o §101 of the U.S. Copyright Act defines a copy as, “any material object in which a work is fixed,
and from which the work can be perceived, reproduced, or communicated.”
o UK Copyright Act and Indian Copyright Act define ‘Infringing copy’ without explicit definitions
of ‘copy’.
o International agreements like the Berne Copyright Convention, TRIPS Agreement, and WIPO
treaties outline transferable economic rights.
o §106 of the U.S. Copyright Act grants exclusive rights to reproduce, prepare derivative works,
distribute copies, and perform/display the work publicly.
o CDPA and Indian Copyright Act specify rights to copy, issue copies to the public, perform, show,
play, broadcast, and adapt.
o Different categories of works have specific rights, and jurisdictional differences exist.
3. Nature of Copies and Temporary Copies:
o Examining rights in different jurisdictions sheds light on whether temporary or transitory copies
are protected under copyright laws.
o In the U.S., a copy requires physical permanence for protection under the law, excluding transitory
copies from reproduction rights.
o CDPA in the UK considers transient or incidental copies for reproduction and public distribution
rights, especially when stored electronically.
o Indian Copyright Act grants the exclusive right to authorize reproduction, including storing by
electronic means after the 1994 amendment.
o The nature of the copy and whether temporary copies could be considered for infringement
remains unclear.
4. Temporary Copies in Copyright Laws:
o Most countries do not explicitly include “temporary or transient copies” in the reproduction right
granted to copyright owners.
o WIPO Internet Treaties attempted to address this issue but faced opposition, leading to the deletion
of Article 7.
o An Agreed Statement, forced by the U.S. delegation, clarified that storing a protected work in
digital form constitutes reproduction under the Berne Convention.
5. Volatile Exploitation and Legal Framework:
o Volatile exploitation refers to uses not traditionally falling under copyright, such as web-surfing
and posting materials on the web.
o In the U.S., volatile exploitation falls under the right of reproduction and distribution, creating
challenges like limitless copies due to the first-sale defense.
o The European approach, using the right of communication to the public, treats volatile exploitation
within the performance right.
o The WCT Article 8 adopts the European model, incorporating volatile exploitation under the
performance right, while storage is under the reproduction right.
6. Internet Challenges to Copyright:
o The internet presents unique challenges to copyright due to the nature of copies and ease of
making copies.
o Unlike technologies like VCRs, the internet offers unlimited content and use, with no limits to
copying and distribution.
o Analogy to resolving problems of prior technologies in copyright law is not sufficient for the
internet.
7. Implications of Digital Age on Copyright:
o Increased access to information in the digital age due to zero marginal cost of copying, zero cost of
transmission, and negligible cost of producing/publishing new information.
o Digital transfer over the internet implies copying for every use of works recorded in digital form.
8. Processes with Infringing Qualities on the Internet:
o Browsing: Fundamental activity causing temporary copies in RAM; different from permanent
copies made during downloads.
o Caching: Temporarily storing digital information closer to a requesting computer to speed up
access; local and proxy caching methods.
o Framing: Accessing one website's content while remaining on another site, involving the use of
RAM.
o Linking: Surface linking may not be infringement, but deep linking, providing direct access to
copyrighted content, could be considered infringement. Contributory and vicarious liability may
apply to linking.

Infringement on the Internet

1. Copyright Infringement on the Internet:


o Occurs when a party violates exclusive rights granted by copyright laws.
o Direct infringement occurs when a party performs infringing copying, as per the statutory language
of the 1976 Act.
o Vicarious or contributory liability may be imposed on parties related to the direct infringer,
considering copyright infringement as a tort.
2. Direct Infringement on the Internet:
o The Internet and related technologies place all copyright-protected rights under pressure.
o Vincent J. Roccia identifies three points of copyright infringement on the Internet.
o Infringement during Surfing/Browsing:
 Unintentional and automatic copying generating temporary copies.
 Court decisions vary, with some considering temporary storage as infringement while
others see it as a technical necessity.
 The Fourth Circuit court suggests that a temporary copy made by an ISP might not be an
unlawful copy.
o While Copying Copyrighted Content:
 Intentional copying by the user generating permanent copies, constituting infringement of
the reproduction right.
o While Re-posting Saved Copyrighted Work:
 Infringement of the right of distribution/display when the user reposts copyrighted
information through email, chat, or tweeting.
3. Vicarious and Contributory Infringement:
o Intermediaries often escape direct infringement but can face other liabilities.
o Contributory Infringement:
 Courts specify conditions to prove contributory liability, requiring knowledge and intent.
 "Direct financial interest" is crucial, and activities of intermediaries like search engines
and ISPs are often for commercial benefit.
o Vicarious Infringement:
 Different elements are required, with no need to prove intent and knowledge, but financial
interest is crucial.
 Definition of "direct financial interest" depends on court interpretation.
 Cases like Netcom and Fonovisa set precedents for contributory and vicarious liability,
with contributory liability being more frequently imputed.

Fair use on the Internet

Fair Use Doctrine: ◦ Originating from the Donaldson v. Beckett decision, fair use balances exclusive rights of
authors/publishers with the public interest in free dissemination. ◦ Article 9(2) of the Berne Convention provides
a three-step test for member countries to determine exemptions to the reproduction right. ◦ In the United States,
the fair use clause protects First Amendment principles of free speech and expression. ◦ Four non-exclusive
factors, codified in US law, determine fair use: purpose, nature, amount, and effect. ◦ In India, fair use is
expressed in §52 of the Copyright Act, with a test to determine if unauthorized copying harms the potential
market or value.

Fair Use and Copies on the Internet: ◦ Search Engines and Fair Use: ▪ Kelly v. Arriba Soft established the
fair use doctrine for search engines. ▪ Thumbnail images were considered fair use, but the use of full-size images
was not extended. ◦ Archiving and Caching: Transformative Use: ▪ Cached links in search engine results
qualify as copies, raising infringement concerns. ▪ Field v. Google ruled in favour of Google, emphasizing the
transformative nature of search engine activities and their socially important purposes. ▪ Parker v. Google
dismissed direct, contributory, and vicarious infringement claims, emphasizing the automated and non-volitional
nature of archiving and the lack of knowledge by Google.

Transformative Use in Fair Use Defense: ◦ The transformative use is considered a factor of fair use,
emphasizing the creation of new creative expression containing commentary. ◦ Some commentators argue that
the Ninth Circuit misunderstood the transformative use concept from Campbell v. Acuff Rose Music, Inc.,
potentially impacting the effectiveness of the fair use defense for search engines.

Google’s Universe and Legal Battles: Image Search

Google's Expansion and Mission: ◦ Google's corporate mission is to make the world's information more
accessible and useful. ◦ The discussion focuses on various Google services that extend beyond traditional search
engines, excluding specialized subjects like musical works, sound recordings, videos, P2P sharing/file-
swapping, etc.

Image Search: Legal Battles: ◦ Overview: ▪ Google's image search engine creates a catalog of thumbnails
corresponding to full-sized images found on the web. ▪ Legal challenges arise concerning copyright, trademarks,
and publicity rights. ◦ Perfect 10 v. Google: ▪ Perfect 10 filed a lawsuit against Google, alleging copyright
infringement. ▪ The court adopted the "server" test to define "display" for in-line linking and framing. ▪ Direct
infringement for full-size images was negated based on the server test. ▪ Thumbnail images underwent a fair use
analysis, with a balance against fair use due to factors like Perfect 10's licensing agreement for reduced-size
images. ▪ The Ninth Circuit later overturned the district's judgment, declaring thumbnails as fair use,
emphasizing the transformative nature of search engine use. ▪ Google and Amazon were not held liable for
secondary infringement by their users. ▪ The question of DMCA's safe harbor applicability was remanded back
to the district court. ◦ Ongoing Legal Proceedings: ▪ The legal battle continued in the California Central
District Court, with the last relevant document being Google's response to Perfect 10's motion for partial
summary judgment on Google's entitlement to DMCA's safe harbor.

Book Search/ Library Project and Scholar Project

1. Book Search/Library Project & Scholar Project:


 Google faced legal challenges from Author's Guild and Publishers for
unauthorized scanning and copying of books.
 Google argued fair use, and a settlement was reached, allowing Google to
continue digitization based on rights-holders' choices.
2. Opt-out or Opt-in:
 Debate on whether copyright owners should opt-out or opt-in for inclusion in
Google's Book Search.
 Some argue for economic feasibility and cultural democracy with an opt-out
provision.
 Opt-out considered in conjunction with the fair use doctrine.
3. Fair Use:
 Differing views on whether Google's use of copyrighted material is
transformative.
 Settlement generally hailed as a favorable solution, providing Google access to
works with compensation to rights-holders.
4. News Search:
 Google News faced a lawsuit from AFP, settled out of court with content
withdrawal.
 EU court held Google liable for reproducing headlines and snippets, impacting
newspapers' revenue.
5. Implied Consent and Robot.txt:
 Web Robots use Robot Exclusion Standards; webmasters can exclude their sites.
 Implied consent applied to justify potentially infringing activities like linking
and framing.
 Field v. Google indicated a tentative acceptance of the implied license doctrine.
6. Overall Implications:
 Ongoing discussions on profit-sharing between news publishers and Google.
 Consideration of the Automated Content Access Protocol (ACAP) to address
copyright issues.

Liability under the Indian Copyright Law and fair use

1. Indian Copyright Law: The 1957 Act does not specifically address search
engine liability for copyright infringement. General provisions on direct and
secondary infringement, along with penal provisions, apply. Amendments to the
Copyright Act are under consideration to introduce a more stringent regime for
contributory liability.
2. Intermediary Liability: Search engines can be held liable as intermediaries for
third-party actions, such as user-uploaded content or indexed infringing
websites. Indian law defines intermediaries, including search engines, under the
Information Technology Act (IT Act) after a 2008 amendment. Section 79 of the
IT Act outlines intermediary liability protections with recent amendments
expanding its scope. The amended Section 79 applies to all intermediaries and
adopts a horizontal approach, precluding liability in various legal areas. Notable
features include the removal of the 'knowledge' requirement and conditions
precedent for liability preclusion, including the exercise of due diligence.
Section 79(3)(b) raises debate on its equivalence to the "notice and take down"
provision in the DMCA.
3. Case Example - T-Series vs. YouTube and Google: T-Series filed a lawsuit
against YouTube and Google for allowing users to upload copyrighted material
without permission. The Delhi High Court issued an interim order restraining
YouTube and Google from infringing T-Series' copyrights. YouTube cited the
DMCA's notice and take down provision but faced differences between the US
and Indian regimes. The case was settled out of court, highlighting the potential
applicability of Section 79 of the IT Act for search engine liability.

Conclusion: The discussion has primarily focused on the perspectives of content providers and search engines,
but it is crucial to consider the interests of consumers who seek access to information on the Internet. Here are
some broad-based approaches for the evolving digital landscape:

4. Consumer Willingness to Pay: A global survey by Nielsen indicates that consumers are willing to
pay for online content or accept increased advertising to support costs. A compromise could
involve search engines paying content providers for specific types of content (e.g., music, movies)
while keeping a wide range of information and content free, such as blogs.
5. Public Policy Concerns in Fair Use: Proposals suggest adopting public policy concerns as a fifth
relevant fair use factor in legal considerations. This approach allows courts to apply fair use
exceptions in situations where traditional fair use factors result in a borderline decision, aligning
with the Internet's objective and increasing digitization.
6. Universal Regime for Copyright Infringement: Consideration of a universal regime for
copyright infringement on the Internet is essential, especially for developing countries like India.
Differing rules across countries create conflicts in this seamless jurisdiction, emphasizing the need
for international cooperation and standardization. Institutions like the WTO could play a role in
formulating global rules or regulations.
7. Automated Content Access Protocol (ACAP): There is ongoing debate about updating the Robot
Exclusion Standard to incorporate a more copyright-friendly regime. ACAP, advocated by
institutions like WAN, is proposed as a suitable alternative. International bodies could work
towards formulating rules with global acceptance to address challenges in the digital age.

In conclusion, the evolving digital landscape requires a balance between the interests of content providers,
search engines, and consumers. Addressing copyright concerns, fair use considerations, and international
cooperation can contribute to a more harmonized and effective digital ecosystem.

Liability of Internet Service Providers (ISPs): An Overview: The Internet has become an integral part of our
daily lives, and Internet Service Providers (ISPs) play a crucial role in connecting individuals to the online
world. ISPs offer services such as website building, email services, domain registration, and more. As
intermediaries, they facilitate access to the internet within specific geographical areas through
telecommunication lines and equipment.

Legal Framework in India: In India, the Information Technology Act of 2000 addresses the role and
responsibilities of ISPs. Section 2(w) defines an intermediary as a person who, on behalf of others, receives,
stores, or transmits records and provides related services. This includes various services such as online auction
services, web hosting, online payment services, and network service providers. The proliferation of cyberspace
and the increasing reliance on ISPs in our daily lives necessitate legal frameworks to govern and prevent
potential abuses of power by these intermediaries.

Responsibilities and Services of ISPs:

ISPs primarily offer two major services:

1. Website Hosting and Building: This involves providing individuals and businesses with the tools and
space to build and host websites.
2. Access Provision: ISPs control, monitor, and deliver access to individuals and corporations.

Liability Approaches:

1. Horizontal Approach:
 Definition: This approach applies a single statute to determine ISP liabilities, and the liability is affixed at
one specific place.
 Example: Violations related to defamation will be tried under defamation laws, and copyright violations
will be assessed under copyright laws.
 Adoption: Prevalent in countries like Germany, Japan, Sweden.

2. Non-horizontal Approach:

 Definition: Under this approach, liability may be applied through more than one statute, allowing for
multiple legal avenues.
 Example: Copyright law and defamation laws may both be applied simultaneously for different violations.
 Adoption: Countries like the United States of America, Hungary, Ireland, and Singapore follow this
approach.
Development and Global Considerations:

WIPO Copyright Treaty, 1996: Addressed issues related to internet communication of works. Added the right
to make the work accessible to the public into the Berne Convention. Introduced rights of distribution and
communication to the public.

Digital Millennium Copyright Act (DMCA) of 1998 (USA): First major attempt to address ISP liability.
Provided legal recourse for authors when technological protections for their work were evaded.

Playboy Enterprises v. Frena: Landmark case in the USA where an ISP operator was held accountable for
users' actions in distributing copyrighted images. Emphasized that knowledge or intention are not necessary
elements of infringement. The global community recognized the need to address ISP liability through
international treaties and agreements. However, due to a lack of conclusive agreement, individual countries,
including the USA, have taken steps to formulate laws addressing ISP responsibilities and liabilities. The legal
landscape continues to evolve as technology and the internet play an increasingly vital role in our lives.

Liability of ISPs under Indian Laws: A Legal Analysis: The legal landscape regarding the liability of Internet
Service Providers (ISPs) in India is shaped by provisions in the Copyright Act, 1957, and the Information
Technology Act, 2000.

Copyright Act, 1957:

1. Primary and Secondary Liability:

 ISPs can be held secondarily liable for copyright infringement.


 Section 51(a)(ii) of the Copyright Act details instances of infringement, including "permits for profit" and
"any place."
 ISPs, by facilitating storage through telecommunication facilities, may fall under "any place."
 "Permits for profit" is satisfied as ISPs often charge for their services.

2. Knowledge Requirement:

 Section 51(a)(ii) limits secondary liability based on knowledge of infringement.


 Expressions like "not aware" and "had no reasonable ground for believing" set the standard for secondary
liability.

Information Technology Act, 2000:

1. ISP Classification and Liability:

 ISPs are identified as network service providers under section 79 but lack detailed classification.
 Liability is contingent on the nature of ISP actions within the network of intermediaries.
 Section 79 provides exemptions if ISPs:
o Provide access only to the communication system.
o Are not involved in initiating transmission, selecting the receiver, or modifying transmitted
information.
o Adhere to guidelines and exercise due diligence.

2. Exemptions and Conditions:

 Lack of knowledge and observing due diligence can exempt ISPs from liability.
 Knowledge of illicit content is crucial for liability under Section 79.
 ISPs must take necessary steps upon awareness of infringing material to avoid accountability.

Case Laws:

1. SMC Pneumatics India Pvt Ltd. v. Jogesh Kwatra:

 Asia's first cyber defamation case (2001).


 Accused sent defamatory emails to the employer.
 Delhi High Court issued an injunction, considering a prima facie case.

2. Avnish Bajaj v. State (DPS MMS Scandal):

 Involved lewd and obscene offers posted on baazee.com.


 Delhi Crime Branch took notice, prepared an FIR.
 Avnish Bajaj, Ravi Raj, and Sharat Digumurati were charged.

Conclusion:

The liability of ISPs in India is shaped by a combination of copyright and information technology laws. While
provisions exist, challenges arise in defining specific actions leading to liability. The lack of detailed
classification for ISPs makes it challenging to impose liabilities based on their functions. The evolving nature of
technology and the internet highlights the need for continuous review and revision of laws to address emerging
issues and challenges in this dynamic landscape.

Internet Regulation and Domains Names: Issues relating to Cyber Squatting

The evolution of the internet has brought about a new battleground for brands seeking to establish a reputation.
Cyber-squatting, the deceptive registration of domain names similar to established brands, poses a significant
threat. Companies invest heavily in their trademarks, and when cyber-squatters register confusingly similar
domain names with the intent to profit, it raises concerns. This paper critically analyzes national and
international remedies available to trademark owners, identifies flaws, and proposes measures to enhance their
effectiveness.

Trademark and Intellectual Property:

 Definition: Trademarks, as per the Indian Trademarks Act, 1999, are marks capable of being represented
graphically, distinguishing goods or services of one person from others.
 Purpose: Trademarks aid brand recognition, establishing a reputation for the trademark owner and helping
consumers identify the origin of goods or services.

Impact of Internet and Domain Names:

 The internet's global reach allows companies to market and sell products beyond national boundaries.
 Domain names, similar to trademarks, help consumers identify the source of goods or services offered by a
website.

Domain Names and Cyber-Squatting:


 Definition: Cyber-squatting involves bad-faith registration of domain names, violating trademark rights.
 Issues: Lack of legislation and effective mechanisms to prevent cyber-squatting poses threats to e-
commerce and trademark owners.

Challenges Faced:

 First Come First Served Policy: Registration authorities, such as NSI, operated on a first-come-first-
served basis without verifying the choice of names against existing trademarks.
 Domain Name Disputes: Squatters, parasites, and twins/poachers contribute to domain name disputes.

Categories of Domain Name Disputes:

1. Squatters: Individuals capitalizing on the first-come-first-served policy.


2. Parasites: Exploiting existing trademarks for personal gain.
3. Twins/Poachers: Targeting domain names similar to established trademarks.

Cyber-Squatting Practices:

 Intent of Profit: Cyber-squatters register trademarks as domain names with the intent to profit,
preventing legitimate owners from registering their trademarks.

Legal Landscape:

 Undefined Term: Cyber-squatting lacks a comprehensive legal definition but is generally described as
the abusive registration of domain names violating trademark rights.
 Global Impact: Domain name disputes and cyber-squatting have international implications,
necessitating robust legal measures.

Indian Scenario:

 Dearth of Cyber Laws: India faces a lack of comprehensive cyber laws to effectively combat cyber-
squatting.
 Need for Legislation: The absence of legislation poses a threat to e-commerce and trademark holders.

Proposed Solutions:

1. Legislative Measures: Introduce comprehensive legislation addressing cyber-squatting and domain


name disputes.
2. Verification Mechanism: Implement a verification process for domain name registration, considering
existing trademarks.
3. Global Cooperation: Promote international cooperation to combat cyber-squatting and enforce legal
measures.

Conclusion: The menace of cyber-squatting requires urgent attention and robust legal frameworks. Legislative
measures, a verification mechanism, and global cooperation are essential to safeguard trademarks, promote fair
competition, and maintain the integrity of e-commerce. In an era dominated by the internet, proactive steps are
necessary to address emerging challenges and protect intellectual property rights.

Trademarks on the Internet

Introduction: Traditionally, trademarks served the purpose of identification and certification in commerce.
However, with the evolution of commerce and the internet, the focus of trademark law shifted from
manufacturer-centric proprietary marks to consumer-centric product identification. A trademark is not merely a
symbol of goodwill but a creator of goodwill, influencing consumer choices and guaranteeing satisfaction.

Trademark Evolution:
 Traditional Purpose: Identification for manufacturers (proprietary) and certification (regulatory).
 Evolution: Shift from manufacturer-centric to consumer-centric identification.
 Modern Significance: A product often sells based on the strength of its trademark.

Passing off and Trademarks Infringement:

 Historical Perspective: Trademark protection was based on passing off, preventing misrepresentation that
could harm goodwill.
 Classic Trinity: Misrepresentation leading to confusion and affecting goodwill.
 Source and Quality Misrepresentation: Dilution of goodwill or erosion of uniqueness as forms of
misrepresentation.
 Lord Diplock's Model: Five elements for passing off claim success - misrepresentation, in the course of
trade, to prospective customers, calculated to injure another's trade, and causing or having the potential to
cause injury.

Passing off to Dilution: Beneficial Transformations:

 Extension of Passing Off: Now applies to unconnected businesses, considering loss of licensing
opportunities, expansion potential, and control of reputation.
 Transformation to Dilution: Dilution defined as blurring product identification or erosion of exclusivity.
 Forms of Dilution: Blurring, pure dilution, tarnishment dilution, and generification.
 Claims for Dilution: Primarily related to the erosion of exclusivity or selling power.

Characteristics of Trademark Infringement:

A touchstone to determine trademark infringement, considering the transformation in trademark law, may have
the following characteristics:

1. Misrepresentation of Source: There must be misrepresentation of the source of goods.


2. Potential Detriment: Misrepresentation must have the potential to detrimentally affect goodwill,
reputation, and/or selling power of the mark.
3. Erosion of Exclusivity: There is a possibility of erosion of exclusivity of the mark.

Conclusion: The evolution of trademarks from serving manufacturers to influencing consumer choices signifies
a shift in focus. Passing off has transformed into dilution, protecting against erosion of exclusivity and selling
power. The touchstone for trademark infringement now considers misrepresentation's potential impact on
goodwill, reputation, and exclusivity, ensuring protection for manufacturers and incentivizing the creation of
products that inspire consumer confidence.

Legitimate and Illegitimate Use of Trademarks on the Internet

Introduction: The internet, often likened to a frontier with exclusive areas, involves the use of domain names
for fencing off virtual territories. Domain names, alphanumeric designations assigned to electronic addresses,
play a pivotal role in the online business landscape. Their legitimate and illegitimate use impacts the relationship
between trademarks and the virtual world.

Legitimate Use: Legitimate use of domain names involves scenarios where two companies wish to register
similar business names as domain names. Complications arise in such cases, but both users have legitimate
rights. Another form of legitimacy is when users have a historical connection to the mark but operate in different
industries. Traditionally, trademark law does not grant injunctions in such cases due to historical associations.

Illegitimate Cyber-Squatting:

1. Classic Cyber-Squatting:
o Definition: Registering a trademark as a domain name with the intent to profit, often by selling it
to the trademark owner.
o Impact: Holds domain names hostage until the trademark owner pays a ransom. Courts view it as
trademark dilution and infringement.
2. Derogatory Cyber-Squatting:
o Similarity to Tarnishment Dilution: The registrant does not compete with the trademark owner
but uses the domain name in a manner detrimental to the trademark's reputation, such as for
uploading pornographic material.
3. Typographical Error Cyber-Squatting:
o Description: Free-rider trademark infringement involving the intentional registration of a domain
name substantially similar to a registered trademark, capitalizing on potential consumer errors.
o Outcome: Courts typically strike down such actions.
4. Political Cyber-Squatting:
o Scenario: Registrant registers a domain name substantially similar to an established trademark or
institution with the aim of expressing an opposing opinion.
o Example: Registration of "Nikesucks.com" or a website critiquing political leaders under a
misleading domain name.
5. Linking and Meta-Tagging:
o Description: Involves hyperlinks or meta-tags using a registered trademark on a website without a
genuine connection.
o Concerns: Prohibition based on injurious association; courts decide considering the nature of
injury, effect on reputation, and goodwill.

Conclusion: The interplay between domain names and trademarks on the internet is complex, involving both
legitimate use, where competing rights exist, and illegitimate practices like cyber-squatting. Different forms of
cyber-squatting, such as the classic, derogatory, typographical error, political, and linking/meta-tagging,
showcase the challenges and legal considerations in the virtual landscape. Courts play a crucial role in
determining the legitimacy or illegitimacy of actions, aiming to protect trademarks and prevent unfair practices
in the online domain.

Cyber-Squatting and Trademark Infringement

Introduction: The examination of cyber-squatting cases against the touchstone of trademark infringement
involves understanding how various forms of cyber-squatting impact trademark owners. Selected cases from the
United States and India are scrutinized to evaluate their specific implications.

Classical Cyber-Squatting:

Case Studies: Intermatic v. Toeppen and Panavision v. Toeppen

 Concerns: Misrepresentation: Toeppen's non-commercial use of domain names does not involve
misrepresentation of goods' source. Goodwill/Reputation: No direct use of domain names means no
immediate impact on goodwill, but potential harm to Panavision's web presence. Exclusivity: Marginally
affected as domain names are not actively used.
 Court Rulings: US: Toeppen's intention to arbitrage constituted commercial use. India: Yahoo! Inc. v.
Akash Arora - Ad interim injunction granted based on misrepresentation and potential damage to reputation
and goodwill.

Conclusion: Traditional trademark law has challenges in addressing classic cyber-squatting due to non-
commercial use. Dynamic application of trademark law is needed to tackle innovative forms of infringement.

Derogatory Cyber-Squatting: Case Study: Archdiocese of St. Louis v. Internet Entertainment Group, Inc.

 Scenario: Defendant lured Pope's followers with misleading domain names, leading to a site with
pornographic material.
 Analysis: Misrepresentation: Evident misrepresentation as visitors expected content related to the Pope.
Reputation Damage: Substantial harm to the reputation of both the Pope and the Church.
 Court Ruling:
o Probable harm necessitated a preliminary injunction against the defendants.
Conclusion: Injurious association and reputational damage can be significant factors in determining trademark
infringement in derogatory cyber-squatting cases.

Typographical Error Cyber-Squatting:

Case Study: Rediff Communication v. Cyberbooth

Defendants used the mark 'Radiff.com' to capitalize on typographical errors and create confusion.

Analysis: Misrepresentation: Clear misrepresentation as consumers might associate 'Radiff' with the original
'Rediff.' Injurious Association: Profit misdirection and potential damage to the uniqueness of the original mark.
Court Ruling: Found to be a case of passing off; injunction granted.

Conclusion: Utilizing typographical errors to create confusion constitutes misrepresentation, supporting a


passing-off claim.

Political Cyber-Squatting:

Case Study: Bally Total Fitness Holding Corporation v. Faber: Defendant created www.ballysucks.com for
criticism about Bally's health club business. Analysis:

Likeness with Planned Parenthood Case: Likelihood of confusion and detrimental effect on reputation. Court
Ruling: Rejected claims based on likelihood of confusion, but domain name deemed detrimental to reputation.
Comparison with Planned Parenthood Case: Planned Parenthood's domain name used for criticism was
considered infringement due to its detrimental effect.

Conclusion: Political cyber-squatting, although distinct, may still be analyzed for trademark infringement based
on its impact on reputation and goodwill.

Conclusion: Trademark infringement cases related to cyber-squatting require a nuanced analysis considering
misrepresentation, impact on reputation, and potential harm to goodwill. Courts need to adapt traditional
trademark principles to the evolving nature of online infringement, ensuring the protection of brand value and
consumer trust.

Legal and Regulatory Framework - Remedies Against Trademark Infringement in Cyber-Squatting: The
U.S. Perspective

Introduction: The United States has played a pioneering role in addressing cyber-squatting through dedicated
legislation and legal mechanisms. The Anti-Cyber-Squatting Consumer Protection Act (ACPA) is a key
legislation along with the Federal Lanham Act and the Federal Trademark Dilution Act, providing trademark
owners with various avenues to combat cyber-squatting.

Legal Remedies in the United States:

1. Federal Lanham Act:

 Conditions for Action:


o Requires proving that a domain name, confusingly similar to a famous trademark, is being used
without permission, likely to cause confusion or deception.
o Emphasizes consumer confusion as a touchstone for trademark infringement.
 Limitations:
o Challenges in cases where cyber-squatters reserve domain names without offering goods or
services, thereby causing no consumer confusion.
o Consumer confusion becomes a crucial element to establish trademark infringement.

2. Federal Trademark Dilution Act, 1995:


 Purpose:
o Introduced to address cyber-squatting more effectively.
o Provides tools for protecting well-known trademarks against cyber-squatting, dilution, or
trademark infringement.
 Conditions for Action:
o Requires proving that the mark is famous.
o The mark's usage by another entity diminishes its capacity to distinguish goods or services.
 Considerations:
o Eliminates the need to prove consumer confusion.
o Remedies may not apply if the domain name is not "used in commerce."

3. Anti-Cyber-Squatting Consumer Protection Act (ACPA), 1999:

 Purpose:
o Enacted to address challenges faced under previous acts.
o Specifically targets bad faith and abusive registration of distinctive marks as domain names.
 Key Features:
o Does not require proof of "use in commerce" or "consumer confusion."
o Establishes the concept of "bad faith intent."
o Allows trademark owners to sue cyber-squatters in federal courts.
 Factors Considered in Bad Faith Intent:
o Trademark or intellectual property rights in the domain name.
o Prior use of the domain name in connection with bona fide offerings.
o Intent to divert consumers for commercial gain or to tarnish the mark.
o Offer to transfer the domain name for financial gain.
o Providing false contact information during registration, among others.
 Remedies Under ACPA:
o Forfeiture or cancellation of the domain name.
o Transfer of the domain name to the plaintiff.
o Monetary damages ranging from $1,000 to $100,000.
o Attorney fees and costs.
 Application in Practice:
o Successfully applied in cases like Sporty’s Farm LLC v. Sportsman’s Market Inc.
o Demonstrates the ACPA's effectiveness in stopping commercial misbehavior and transferring
domain names back to legitimate holders.
 In Rem Jurisdiction:
o Allows trademark owners to take action against the domain name itself without suing the domain
owner personally.
o Addresses challenges posed by false contact information provided by cyber-squatters.
 Addressing Typo-Squatting:
o Helps combat typo-squatting, as demonstrated in the Electronics Boutique Holdings case.

Conclusion:

 The U.S. legal framework provides trademark owners with a comprehensive set of tools to combat cyber-
squatting.
 The ACPA, in particular, stands out for its effectiveness in addressing the challenges posed by cyber-
squatters.
 Continuous effectiveness of these laws emphasizes the U.S.'s commitment to protecting trademarks in the
evolving landscape of the internet.

ICANN and UDRP in the Context of Cyber-Squatting: A Comparative Analysis of the United States and
India

ICANN and DNS Management:

 Historical Background:
o Initially under U.S. government control, the domain name system (DNS) faced challenges, leading
to the establishment of ICANN by the U.S. Department of Commerce.
o ICANN took over DNS management, aiming for a more effective and globally inclusive
administration.
 Controversies Surrounding ICANN:
o Some contend that ICANN has a close relationship with the U.S. Department of Commerce,
raising concerns about impartiality.
o Criticisms regarding ICANN's partiality to trademark owners.

Uniform Dispute Resolution Policy (UDRP):

 Origins and Purpose:


o Initiated through the U.S. Government (USG) White Paper in 1998.
o Aimed at resolving trademark/domain name disputes involving cyber piracy.
o Implemented by ICANN based on WIPO's final report in 1999.
 Scope and Limitations:
o Focuses on bad faith and abusive registration of domain names that violate trademark rights
(cyber-squatting).
o Emphasizes a balanced and transparent process, including trademark holders and the broader
Internet community.

UDRP Procedure:

 Conditions for Action:


o Compels registrars to require an agreement, court order, or arbitration award before domain
removal or transfer.
o Mandatory arbitration for disputes.
 Elements Considered in Bad Faith:
o Registration for resale at a profit.
o Preventing trademark owner from using the mark.
o Disrupting a competitor's business.
o Intentionally causing confusion about source affiliation.
 Successes and Limitations:
o Resolves disputes efficiently without extensive paperwork.
o No provision for monetary reimbursement to trademark owners.
o Lack of discovery process may hinder proving "bad faith."
 Legal Status of UDRP Decisions:
o Decisions not binding in subsequent court actions but considered with "appropriate weight."
o Trade names not eligible for relief under UDRP.

Position in India:

 Legal Landscape:
o India lacks specific legislation on cyber-squatting and trademark infringement in cyberspace.
o Information Technology Acts do not comprehensively address IP, domain name disputes, or cyber-
squatting.
 Judicial Role:
o Indian judiciary plays a commendable role in applying existing trademark laws to cyberspace.
o Challenges arise due to territorial nature of trademark laws.
 Case Examples:
o Yahoo Inc. vs. Aakash Arora: Delhi High Court's injunction against a cyber-squatter using a
domain similar to Yahoo's.
o Satyam Infoway Ltd. v. Sifynet Solutions: Supreme Court acknowledging legal protection for
domain names.
 WIPO Arbitration Cases:
o Tata Sons Ltd v. Ramadasoft: WIPO transfer of domain names from a cyber-squatter to Tata Sons
Ltd.
o Titan Industries Ltd. v. Prashanth Koorapati: Granting injunction against a defendant using a
domain similar to the plaintiff's trademark.
 Recent Cases:
o Mahindra & Mahindra Limited vs. Zach Segal: WIPO ruling in favor of M&M in a cyber-
squatting case.

Conclusion: ICANN and UDRP provide a global framework for resolving domain name disputes, particularly
cyber-squatting. The Indian legal landscape, while lacking specific legislation, sees active judicial involvement
in extending trademark concepts to cyberspace. Challenges remain, including the territorial nature of trademark
laws and the absence of provisions for monetary reimbursement in UDRP. Ongoing cases highlight the evolving
nature of cyber-squatting challenges and the need for a comprehensive legal framework.

Policy Upgradation Recommendations for National and International Levels

1. National Legislation:

 Committee Formation: Establish a committee comprising legislators, technical experts, and judges to
frame cyber-specific laws.Expedite the enactment of laws to address technological differences in trademark
infringement on the internet.
 Stringent Provisions: Include stringent provisions in laws to indemnify victims adequately. Introduce
harsh penal measures and provisions for exemplary damages to deter cyber-squatting.
 Monetary Compensation: Introduce provisions for monetary compensation in cases of cyber-squatting.
Ensure that penalties are sufficient to act as a deterrent against malicious activities.
 Special Tribunals: Form special tribunals with High Court Judges and technical experts for swift
resolution. Address cases based on the nature of the dispute and the potential monetary harm.

2. Judicial Training and Awareness:

 National Judicial Academy (NJA): Organize training sessions, seminars, and workshops by NJA at
national and state levels. Educate judges on the nuances of threats posed by cyberspace to trademarks and
intellectual property.
 Collaboration with Delhi High Court: Seek collaboration with judges from Delhi High Court, known for
expertise in Intellectual Property on the internet.

3. International Legislation (ICANN and UDRP):

 Monetary Compensation in UDRP: ICANN should amend UDRP to incorporate provisions for monetary
compensation. Arbitrators should have the authority to award damages to compensate adversely affected
parties.
 Enhanced Disclosure Norms: Strengthen disclosure norms by verifying information provided by domain
name registrants. Implement pre-registration notifications on ICANN's website for opposition to prevent
later disputes.
 Sufficient Connection Requirement: Require registrants to establish a 'sufficient connection' with the
intended domain name. Align registration requirements with the basis for trademark registration in the
physical world.
 Review Article 4(k) of UDRP: Reevaluate Article 4(k) of UDRP, which deals with court proceedings
availability. Encourage appeals to a specially constituted tribunal and the Supreme Court, respecting the
sanctity of ICANN decisions.

4. Addressing Global Cyber-Squatting:

 International Cooperation: Encourage international cooperation to combat cyber-squatting effectively.


Facilitate information sharing and coordinated efforts against cyber threats.

5. Trust in Judicial Wisdom:

 Dynamic Trademark Laws:


o Acknowledge that trademark laws are dynamic and can adapt to new forms of infringement.
o Trust the judiciary to incorporate new challenges into settled trademark principles.
 Avoid Unnecessary Legislation:
o Avoid unnecessary legislation that may curb freedom of expression.
o Rely on precedent and 'stare decisis' to guide the judiciary in dealing with emerging issues.

Conclusion:The proposed policy measures aim to create a comprehensive legal framework, both nationally and
internationally, to address the evolving challenges of cyber-squatting. Through collaborative efforts, legislative
enhancements, and judicial awareness, the goal is to curb cyber threats and protect the interests of trademark
owners in the digital age.

IPR and Information Technology

Introduction: The integration of information technology into various aspects of life has transformed the global
landscape, presenting both opportunities and challenges for Intellectual Property Rights (IPR). As technology
permeates sectors like telecommunications, finance, healthcare, and business, the protection and management of
intellectual property become paramount. This discussion explores the intersection of IPR and information
technology, addressing concerns related to patents, copyrights, and trade secrets.

1. Global Impact of Information Technology:

 Networks and the Internet: The Internet as a worldwide network transcends territorial boundaries,
contributing to globalization. Challenges arise due to the accessibility of information, potentially leading to
concerns about proprietary rights.
 Cybernetics Revolution: The success of the cybernetics revolution poses challenges for intellectual
property laws. Rapid advancements in information technology result in new inventions, innovations, and
creations.

2. Feasibility of Protection Under IPR:

 Role of Patents: Traditional patent protection for tangible inventions in computer hardware and equipment.
Evolution of patent law to address challenges in patenting non-physical inventions like computer programs
and software.
 Copyright Protection: Significance of software as the lifeblood of information technology. Exploration of
copyright protection for software, considering its functions and role in information technology.
 Trade Secrets: Possibility of protecting information technology inventions under trade secrets law.
Evaluation of the efficacy of trade secrets in safeguarding innovations in the field.

3. Patenting Computer Programs and Software:

 Historical Perspective: Traditionally, computer-related inventions like hardware were protected through
patents. Initial reluctance in patenting computer programs and software.
 Evolution of Patent Law: Progressive steps taken, especially in the US, to establish criteria for
patentability of computer programs. Examination of court decisions shaping patent law for software, with a
focus on US jurisprudence.
 Understanding Software: Software as the driving force in the modern world's efficiency. Importance of
the functionality and practical utility of software in determining patentability.
 Current Trends: Evaluation of recent trends in patenting software. Growth in software-related patents,
including methods of doing business implemented through software.

4. Software Patents Globally:

 US Leadership: US patent law's innovative and liberal interpretation, especially in patenting computer-
related inventions. Examination of landmark cases shaping the patentability of software.
 Europe and Japan: Growth in software patents in Europe and Japan. Consideration of technical
contributions as a basis for software patent issuance.
 EPO Guidelines: Introduction of guidelines by the European Patent Office (EPO) for governing the
patenting of software. Notable examples of information technology giants obtaining software patents.

Conclusion: The intersection of IPR and information technology presents a dynamic landscape, where
traditional laws evolve to accommodate the complexities of the digital age. The feasibility of protection under
patents, copyrights, and trade secrets is crucial for fostering innovation while balancing the interests of inventors
and the public. As technology continues to advance, a harmonized global approach to intellectual property rights
in information technology becomes increasingly essential.

Copyright and Information Technology: Navigating Challenges in the Digital Era

Introduction: The dynamic evolution of technology has played a pivotal role in shaping the trajectory of
copyright law. From its origins in protecting literary and artistic works, copyright law has expanded to
encompass diverse realms, including audio-video recordings, computer programs, satellite broadcasting, and the
internet. This discussion delves into the feasibility of copyright protection for information technology, with a
focus on computer software, examining the Indian legal framework, fair use provisions, and the challenges
posed by the digital landscape.

1. Inclusion of Computer Programs in Copyright Act (1994): Amendments to the Copyright Act in 1994
marked a response to the challenges posed by advancing computer technology. The inclusion of the term
'computer program' aligned with international standards, as reflected in the WIPO Model Law on the Protection
of Computer Software (1977).

2. Scope of Copyright Protection for Computer Programs:

 Definition of 'Computer Program':


o The Copyright Act (1994) defines 'computer,' 'computer program,' and 'communication to the
public.'
o Computer programs, recorded in high-level languages, are protected as 'literary works' under
Indian law.
 Copyright Rights for Computer Programs:
o Copyright holders have the right to reproduce, issue copies to the public, communicate to the
public, make translations, and adaptations, among other rights.
o Fair use provisions allow lawful possessors certain rights for utilizing computer programs.

3. Fair Use Provisions and Challenges:

Extensive Fair Use Provisions: Fair use provisions permit users to make copies or adaptations for specific
purposes, including utilization and creating backup copies. Lawful possessors can undertake acts necessary for
obtaining information for interoperability.

Impact on Software Manufacturers: The broad scope of fair use provisions has led software manufacturers to
advocate for more stringent intellectual property rights (IPR) protection. The need for exploring other IPR
protections is emphasized.

4. Challenges in the Digital Landscape:

 Active Nature of Computer Technology: Unlike conventional works, computer technology is active,
involving changes, manipulations, and transformations of digitally stored information. The emergence of
the internet and easy accessibility have heightened piracy concerns.
 Piracy in the Digital Arena: Internet accessibility and downloading capabilities have given rise to
widespread piracy issues.The ease of access to the internet has facilitated copyright infringement, impacting
the growth of original and creative works.
 International Agreements and Gaps: TRIPS Agreement and Berne Convention lack specific provisions
addressing digital piracy. WIPO Internet Treaties, although not in force, attempt to address challenges in
online enforcement and licensing.
Conclusion: The intersection of copyright and information technology unveils a complex landscape influenced
by technological advancements and legal adaptations. While the Copyright Act (1994) and fair use provisions in
India provide a framework for protection, challenges persist in the digital realm. Striking a balance between user
rights and creator incentives remains crucial. International cooperation and updated agreements are essential to
address the nuances of digital piracy and strengthen copyright protection in the ever-evolving landscape of
information technology.

Principles of Protection: Navigating Copyright Law in the Software Landscape

Introduction: The safeguarding of computer programs under copyright law revolves around three core
principles: originality, expression, and fixation. This discussion explores the challenges and considerations
associated with these principles in the context of software, emphasizing the need for legal clarity amidst the
evolving landscape of technology.

1. Originality and Lack of Definition:

 Determining Originality: Originality is a prerequisite for copyright protection, yet the term lacks a
statutory definition in the Copyright Act.Indian courts draw from English case laws, further complicated by
the absence of a clear definition in English law.
 Complexity of Originality in Software: The determination of originality in the realm of computer
programs is intricate, with courts often resorting to principles from the European Copyright Directive.

2. Expression vs. Ideas:

Copyright's Fundamental Principle: Copyright protects expression but not ideas, posing a challenge in
defining the starting point for considering computer programs. The Whelan case in the U.S. broadens the scope,
including the structure of a program within the idea.

Need for Clear Boundaries: The boundary between idea and expression needs clearer demarcation, especially
given the transformative nature of computer technology and software.

3. Fixation Challenges:

Recording Software: Software is recorded in the written draft version of the source code, raising questions
about the permanency required for fixation. The existence of a program in the volatile RAM memory
complicates the concept of fixation.

Permanency Concerns: Fixation challenges prompt consideration of whether certain permanency standards are
needed for a work to be considered fixed.

Why IPR Over Software:

Incentives Through Intellectual Property Rights: Intellectual property rights provide creators exclusive
rights, fostering innovation by offering incentives to share creations. The trade-off involves balancing societal
interests in non-rival goods' creation with potential monopoly issues.

Software's Role in the Knowledge-Based Economy: Given software's pivotal role in contemporary life,
protecting it under the IPR regime is crucial for encouraging creativity, innovation, and investment.

Copyright Protection in the U.S., UK, and Canada:

U.S. Perspective: The 1976 U.S. Copyright Act, amended in 1980, extends copyright protection to
software.Court decisions, such as Apple v. Franklin and Whelan Associates, emphasize the protection of
instructions, including non-literal elements.
UK Copyright, Designs, and Patent Act (1988): The UK Act includes computer programs under "literary
work," with source code eligible for copyright. Fair dealing provisions under s 50B allow reverse engineering
under certain conditions.

Canada's Copyright Act: Software qualifies as a literary work under the Copyright Act of Canada, with
automatic copyright acquisition. Rights include exclusive reproduction, renting, and the ability to assign or
license the copyright.

Conclusion: Navigating the principles of originality, expression, and fixation in copyright law concerning
software demands a delicate balance. The evolving nature of technology necessitates clear legal definitions and
boundaries to ensure fair protection for creators. Intellectual property rights over software play a pivotal role in
fostering innovation, contributing to the knowledge-based economy. As legal frameworks continue to adapt, a
harmonious interplay between copyright law and technological advancements is essential for sustained growth
and creativity in the software industry.

Intellectual Property Protection for Software: Beyond Copyright

Introduction: Intellectual Property Rights (IPR) protection for software extends beyond copyright,
encompassing patents, design laws, and, in some cases, trade secrets. The debate surrounding the choice
between patent and copyright, or a combination of both, for safeguarding software is ongoing. This discussion
delves into the nuances of patents in the context of software and their role in encouraging innovation.

Patents and Software:

1. Promoting Innovation: Patents are designed to foster innovation by encouraging timely disclosure of
inventions and protecting investments made for commercialization. They necessitate a full and prompt
disclosure of how to make and use the invention in exchange for a limited-time monopoly.
2. Debate on Software Patents: Opponents argue that the novelty in the software business is low, and
granting patents could lead to monopolies over ideas. The debate centers around whether patents are
suitable for an industry characterized by rapid innovation and incremental improvements.
3. Secure Protection: Patents offer more secure protection than copyright or trade secrets, focusing on the
functionality or idea of the software. The boundaries of patented software are precisely defined by the
claims laid down in the patent document.
4. Global Perspective: Many countries, including the USA, Japan, EU, Philippines, and Australia, allow the
filing of patents for software, recognizing the role of patents in promoting innovation.

Software Patenting: Lessons for India:

1. Global Practices: The USA has successfully integrated patents into the software industry to promote
information technology. India, with its booming IT industry, is undergoing significant economic growth and
technological advancements.
2. Indian IT Landscape: India's IT industry, a global player, has become a cornerstone of economic
development, contributing significantly to GDP growth. The government's encouragement of foreign
investments and free competition has fueled the industry's growth.
3. Need for Patent Protection: The growth of the IT industry warrants robust protection through patents and
copyrights. While copyright protection is granted to IT inventions, patents are not provided for computer
programs and software per se under Section 3(k) of the Indian Patents Act.

Evolution of Software Patenting:

1. Historical Perspectives: Initially, computer programs and software were not considered patentable,
especially in the US. The US Supreme Court's decision in Grottschal v. Benson emphasized the view that
software, involving algorithms, is a mental act and not patentable.
2. Shift Towards Patentability: Over time, decisions such as In re Toma and Diamond v. Diehr signaled a
shift, recognizing software as a patentable subject matter. State Street Bank and Trust Co v. Signature
Financial Group established that even software for conducting business methods could be granted a patent.
3. Guidelines for Computer-Related Inventions: The US Patent Office formulated specific examination
guidelines for computer-related inventions to streamline the patent-granting process. The guidelines
acknowledged the technical complexities involved in software patents.

Current Scenario in India:

1. Legal Framework: Section 3(k) of the Indian Patents Act explicitly states that "a mathematical or business
method or a computer programme per se or algorithm is not patentable." Draft Manual attempts to provide
room for patenting software in combination with hardware.
2. Challenges and Opportunities: There is an increasing demand for patent protection for information
technology inventions like computer programs and software in India. The draft manual recognizes
computer-implemented inventions, opening possibilities for patents with technical applications.

Conclusion: While the debate on software patents continues, the global trend, especially in technologically
advanced nations, favors granting patents to software. India, as a hub for IT innovation, needs to carefully
consider the role of patents in incentivizing and protecting the rapidly evolving software industry. Balancing the
need for protection with fostering innovation is crucial for sustained growth and recognition on the global stage.
The ongoing discussions, including public opinions and stakeholder views, will shape the future landscape of
software patenting in India.

The Case for Software Patents and Trade Secrets

Why Software Should Be Patented:

1. Promotion of Research and Development:


 Patents serve as incentives for investment in research and development.
 By providing a limited-time monopoly, inventors are encouraged to explore and innovate in the
software domain.
2. Alignment with Patent Principles:
 The basic principles of patent law, developed before computers, aim to promote the development of
useful arts.
 Software, being integral to modern life, should receive similar incentives to those granted to other
useful arts.
3. Accelerating Software Development:
 Patents contribute to the acceleration of software development by making previously unknown
inventions public.
 They facilitate the sharing of knowledge, pushing the boundaries of the state of the art.
4. Disclosure for Public Knowledge:
 Patents disclose inventions in detail, allowing others skilled in the art to make and use the invention
without undue experimentation.
 The disclosure requirement ensures the advancement of knowledge within the public domain.
5. Revocability and Quality Control:
 Granted patents can be revoked if found invalid, preventing bad patents from blocking development.
 This revocability feature encourages a focus on quality in the patenting process.
6. Complementary to Copyright:
 While copyright protects certain aspects of software, patents focus on the protection of ideas and
innovation in the useful arts.
 The dual protection ensures a comprehensive safeguarding of software creations.
7. Limited Duration of Monopoly:
 Patent protection lasts for 20 years, providing a temporary monopoly to the inventor.
 Compared to copyright protection, which extends for life plus 60 years, patenting software serves a
more immediate public purpose.
8. Compliance with International Law:
 International law on patents, such as TRIPS (Trade-Related Aspects of Intellectual Property Rights),
mandates protection for inventions in all fields of technology.
 Granting patents for software aligns with international standards.
Software Patents in the Context of IT Growth in India:
1. Recognition of IT Significance:
 India's thriving IT industry, a major contributor to GDP growth, deserves strong protection for its
innovations.
 Acknowledging the importance of IT to the economy warrants an amendment to the existing patent
laws.
2. Call for Amendment:
 While the draft patent manual attempts to include software in patentable subject matter, a more
effective approach is an amendment to the patent act.
 Amending Section 3(k) to grant patentability to software and computer programs would eliminate
ambiguity and offer clear guidelines.
Trade Secrets and Software:

1. Complementary Protection:
 Trade secrets, often used in conjunction with copyright, provide an additional layer of protection for
software.
 While patents require disclosure, trade secrets maintain the secrecy of proprietary information.
2. Criteria for Trade Secrets:
 Trade secrets encompass formulas, patterns, devices, processes, or compilations of information that
offer a competitive advantage.
 To qualify, the information must be used in business, kept secret, and provide a competitive edge.
3. Limitations of Trade Secrets:
 Trade secrets may have limited utility for software, especially when technology is easily replicable.
 The protection is contingent on maintaining secrecy, making it less effective for technologies easily
reverse-engineered.
4. Hardware Assisted Software Protection (HASP):
 In cases like HASP installers, trade secrets are used to protect algorithms preventing software copying
and cracking.
 Once the algorithm becomes public, the effectiveness of trade secrets diminishes.
5. Challenges in Enforcement:
 Trade secrets may face challenges in enforcement, especially when the infringing party is unknown or
lacks the resources to compensate for damages.
6. Additional Costs of Secrecy:
 Keeping technology secret imposes additional costs, and the value of trade secrets diminishes once the
information is public.
7. Protection for Embedded Software:
 Hardware-embedded software, relying on integrated chip layouts, may find protection under design
laws and Semiconductor Integrated Circuits Layout Design Act.
In conclusion, while software patents offer explicit incentives and protection, trade secrets play a
complementary role, especially in conjunction with copyright. Balancing these mechanisms ensures a robust
safeguarding of innovations in the dynamic field of software development. In the context of India's growing IT
sector, amendments to patent laws can provide the necessary impetus for continued innovation and economic
growth.

Copyright Law's Role in Protecting Intellectual Property: Intellectual Property Rights (IPR) regimes
worldwide aim to grant creators exclusive rights to their intellectual works, fostering innovation and societal
efficiency. Copyright law, a key component of IPR, bestows a range of rights on creators within its sphere. Any
unauthorized use of these rights constitutes copyright infringement, leading to legal consequences. While
copyright ownership is transferable, infringement remains a serious concern in the age of rapid technological
advancement.

Challenges of Copyright Infringement in the Digital Age: In contemporary times, copyright infringement has
become a global issue, exacerbated by technological progress. The Copyright Act provides various remedies
against infringement, including civil, criminal, and administrative measures. The Information Technology (IT)
Act of 2000 in India addresses computer damage and the liability of Network Service Providers for client
violations. However, a critical question arises: Does the current legal framework effectively protect copyrighted
works on the Internet?

The Digital Millennium Copyright Act (DMCA) and Global Perspectives: In the United States, the Digital
Millennium Copyright Act of 1998 specifically identifies and compensates for piracy of copyrighted works on
the Internet. However, in India, neither the Copyright Act of 1957 nor the Information Technology Act of 2000
comprehensively deals with internet-related copyright issues.

The Need for Comprehensive Copyright Law for the Internet: To control piracy effectively, especially on
the internet, there is a pressing need for a comprehensive legal framework within the domain of copyright law.
The scope of copyright law should extend to cover computer programs and copyright on the internet.
Leveraging guidelines under the WIPO Internet Treaties and WIPO Copyright Treaty of 1996 can serve as a
valuable source for strengthening existing copyright laws.

Software Copyright: Balancing Innovation and Protection: Computer software, characterized by constant
innovation, faces two opposing viewpoints on Intellectual Property Rights. Corporate software manufacturers
advocate a stringent IP regime, including patentability over software. Conversely, solo programmers and
computer enthusiasts argue that existing protection is excessive, suggesting IP protection only if the
manufacturer discloses the source code.

Copyright as the Viable Solution for Software Protection: While patent law presents challenges due to cost
and applicability uncertainties, trade secrecy has become less effective in the era of mass-marketed computer
programs. Copyright emerges as the most viable solution for protecting software. The Apple Computer case in
the U.S. established a global standard, affirming that software is protectable under copyright law.

India's Copyright Approach: Eliminating Patent Protection for Software: India has adopted a prudent
approach by eliminating patent protection for software and embracing copyright protection. This aligns with the
global trend where copyright law remains the primary source of software protection. Eliminating artificial
distinctions between types of software and their expressions enhances the extent of copyright protection,
reinforcing the role of copyright in safeguarding intellectual property. In conclusion, as the digital landscape
evolves, a robust and comprehensive copyright framework is essential to address emerging challenges and
protect intellectual property rights, especially in the dynamic field of software development.

IPR and Semi-Conductors

Semiconductor Technology and Intellectual Property Rights

Introduction: The Triumphs and Challenges of Semiconductor Innovation: The journey of semiconductor
technology, from meticulous research and layout optimization to global business prospects, underscores both the
triumphs and challenges faced by the intellectual minds behind it. As the world embraces the shrinking
dimensions of electronics, the protection of intellectual property (IP) becomes paramount. This narrative delves
into the genesis of semiconductor technology, the basics of its science, and the legal frameworks that safeguard
its innovations.

Basics of Semiconductor Science and Integrated Circuits: A semiconductor, with electrical conductivity
between a conductor and an insulator, forms the bedrock of modern electronics. Devices made from
semiconductors, such as transistors and integrated circuits (ICs), power electronic equipment worldwide.
Silicon, widely used in semiconductor fabrication, undergoes a meticulous process involving doping with
impurities to modify its conductivity. The genesis of integrated circuits, envisioned by radar scientist Geoffrey
W.A. Dummer and realized by innovators like Jack Kilby and Robert Noyce, revolutionized electronics.

Semiconductor Device Fabrication and Integrated Circuit Design: Semiconductor device fabrication is a
multi-step process that involves creating electronic circuits on a wafer of pure semiconductor material, often
silicon. The manufacturing process, from wafer preparation to chip packaging, takes several weeks. The
integration of numerous tiny transistors into a small chip, made possible by large-scale production capabilities,
led to the widespread adoption of standardized integrated circuits. Cost-effectiveness and superior performance
became the hallmarks of integrated circuits.

Semiconductor Layouts and the Need for Protection:The culmination of intellectual prowess, financial
investments, and research time results in unique layout-designs of integrated circuits. However, the threat of
reverse engineering looms large, with chip pirates capable of replicating layouts to enter the market unlawfully.
Traditional intellectual property mechanisms, like patents and copyrights, fall short in providing adequate
protection for semiconductor layouts.
Sui Generis Protection: Semiconductor Chip Protection Acts: Recognizing the need for specialized
protection, the United States initiated the Semiconductor Chip Protection Act (SCPA) in 1984. Japan followed
suit with the Japanese Circuit Layout Right Act (JCLRA) in 1985. The European Union, through the IPIC Treaty
(1989), incorporated similar provisions into the TRIPS Agreement. India, aligning with global efforts, enacted
the Semiconductor Integrated Circuit Layout-Design Act in 2000, though its implementation is pending.

Challenges and Solutions in Semiconductor IP Protection: While copyright and patents provide some
protection, semiconductor layouts demand sui generis measures. The unique three-dimensional organization of
chips necessitates stringent norms for originality. Existing legal frameworks fall short, emphasizing the need for
a dedicated legal apparatus. The TRIPS Agreement, by incorporating provisions from the IPIC Treaty, attempts
to harmonize international efforts in protecting semiconductor layouts.In conclusion, the semiconductor industry
stands at the crossroads of innovation and vulnerability. As technology propels the world into the era of
nanotechnology, safeguarding intellectual property in semiconductor layouts becomes imperative. Legal
frameworks, both national and international, must evolve to meet the unique challenges posed by this dynamic
and indispensable field of technology.

Intellectual Property Protection in Semiconductor Technology: A Global Perspective

Introduction: The realm of semiconductor technology, integral to the modern world, encounters challenges that
necessitate robust legal frameworks. This analysis traverses the international landscape, exploring the TRIPS
Agreement, US Semiconductor Protection, and India's Semiconductor Integrated Circuits Layout-Design Act
(SICLD) 2000.

TRIPS Agreement: Ensuring Design Protection: The TRIPS Agreement mandates compliance with the Paris
Convention, emphasizing protection for independently created industrial designs. Article 25.1 obligates
members to safeguard new or original designs, with flexibility to exclude those lacking significant differences or
dictated by technical considerations. Design protection, extending for at least 10 years, grants owners exclusive
rights to prevent unauthorized commercial reproduction.

Semiconductor Protection in the US: Balancing Innovation and Competition: US Semiconductor Chip
Protection Act 1984 distinguishes between topography protection and concepts, processes, or encoded
information within. Reverse engineering is permitted, but limits exist. Brooktree v. AMD case exemplifies the
nuanced stance – reverse engineering is permissible unless it results in a substantially identical chip,
emphasizing the fight against piracy.

Semiconductor Protection in India: The SICLD Act: India's SICLD Act, aligning with TRIPS, protects
semiconductor layout-designs. Originality is key, with protection extending for ten years from the date of
application. The Act introduces criminal remedies, unique compared to other IP laws in India, aiming to combat
infringement. Notably, it allows for reverse engineering for analysis and encourages creativity.

Enforcement and Duration of Protection: Enforcement in India involves criminal remedies, emphasizing the
gravity of layout-design infringement. Protection starts from the date of application, fostering innovation and
ensuring a competitive market. The Act also permits government use in exceptional circumstances, striking a
balance between public interest and intellectual property rights.

Technology Transfer and Future Outlook: The Act facilitates technology transfer through assignments and
transmission, empowering the registered proprietor. While providing exclusive rights, it accommodates
exceptions for scientific evaluation and analysis. Looking forward, India, positioned for a semiconductor
revolution, can harness the Act's strength to sustain growth and inspire confidence in global players.

Conclusion: Uniting Technology and Law for Future Innovation: The synthesis of technology and law
becomes imperative to secure the fruits of innovation. The global enactment of protection statutes signifies a
positive step, yet challenges persist in enforcement. India's SICLD Act, though robust, awaits full enforcement.
As technology advances, the intersection of legal frameworks and technological solutions, such as EPIC, may
fortify the semiconductor industry against piracy, ensuring a thriving future. In this dynamic landscape,
collaboration between legal systems and technological innovations remains pivotal for sustained growth and
protection in the semiconductor industry.
Module 3

AI and Regulatory Concerns: As artificial intelligence (AI) integrates into daily life, Access Now conducts a
preliminary study on potential human rights issues. AI's scale and real-life impact exacerbate existing concerns.
This report suggests safeguards within data protection, government and private sector AI use, and calls for more
research. It aims to prevent and mitigate harms, particularly those affecting marginalized groups, utilizing
international human rights law as a framework. AI's evolution from science fiction to global discourse prompts
examination of its impact on human rights. Divergent expert opinions highlight the complexity of defining AI.
This report builds on discussions at RightsCon and proposes a scoping of AI's intersection with human rights,
emphasizing the need for further research to determine necessary safeguards.

Definitions

1. Artificial Intelligence (AI): Undefined consensus; categorized into systems thinking or acting like humans,
thinking rationally, or acting rationally. Currently, "Narrow AI" is in use, with "Artificial General
Intelligence" (AGI) aspiring to generalized cognitive tasks in the future.
2. Big Data: Complex datasets surpassing traditional processing capabilities, crucial for AI advancements.
3. Data Mining: Extracting patterns and information from large datasets, often facilitated by machine learning
(ML).
4. Machine Learning (ML): Sub-field of AI using algorithms to enable machines to learn from data,
currently more accurate than humans in specific tasks.
5. Deep Learning: ML technique using neural networks, inspired by the human brain, capable of processing
massive datasets with precision.
6. Machine Vision, Natural Language Processing, Speech Recognition: Specific ML approaches
facilitating image recognition, language understanding, and translation.
7. Algorithm: A set of instructions for computers, crucial within AI; Algorithmic Decision-Making involves
using algorithm outputs for decision-making.
8. Robot: Physical entities with mobility incorporating AI, interpreting environmental changes for actions.
9. Bots: Software applications running automated tasks, increasingly powered by ML.
10. Open Data: Freely available data for public use.
11. Protected Information: Non-public data requiring protection, including metadata revealing significant
information.
12. Bias: Inclination or prejudice, societal or statistical, affecting fairness in AI.

How Bias Operates in AI

I. Bias at the System Level: AI bias manifests at the system and data levels. At the system level, developers
may unintentionally embed biases into parameters or labels, affecting outcomes. This unintentional bias often
arises from:

1. Conflating Correlation with Causation: For example, using social connections as parameters in credit
score algorithms can perpetuate biases linked to income levels.
2. Using Proxies for Known Bias: Developers may avoid explicit bias but inadvertently include proxies like
income, education, or postal code, resulting in biased outcomes.

II. Bias at the Data or Input Level: Bias can originate from biased historical data or input data that lacks
representativeness, leading to various issues:

1. Use of Historically Biased Data: ML systems, relying on historical data, perpetuate existing biases. For
instance, a university admissions model using biased historical student data may favor specific
demographics.
2. Selection Bias: Input data not representing the target population leads to biased recommendations. For
example, a GPS mapping app favoring wealthier areas due to a higher concentration of smartphone users.
3. Poorly Selected Input Data: Incomplete or incorrectly selected data, such as excluding public
transportation schedules from a mapping app, results in biased outcomes.
4. Incomplete, Incorrect, or Outdated Data: Inaccurate results arise from insufficient, incorrect, or outdated
data. ML models must be continually updated to maintain accuracy.
III. Challenges in Mitigating Bias: Biases in AI are prevalent due to human-produced data, necessitating
research on mitigation strategies. Challenges include teaching ML systems to learn without bias and addressing
societally biased outcomes.

IV. Unique Risks of AI

1. Evolution from Existing Technologies: AI's evolution from technologies like big data and algorithmic
decision-making introduces new challenges, amplifying existing issues.
2. Algorithmic Decision-Making in the Digital Era: Unlike deterministic algorithms, AI-driven algorithmic
decision-making is more complex, capturing intricate patterns beyond human comprehension.
3. Calibration and Tracing Challenges: ML algorithms calibrate themselves, making it challenging to trace
decisions or recommendations. This lack of transparency raises accountability concerns.
4. Impact of Error Rates: Despite ML systems often surpassing human accuracy, error rates persist. Even
with low error rates, the scale of AI tools can impact thousands, as illustrated by Google Photos mislabeling
black people as gorillas.

V. Conclusion: Understanding and addressing bias in AI is crucial for equitable and responsible AI
development. Challenges in mitigating bias, coupled with unique risks posed by AI's complexity and scale,
emphasize the need for ongoing research, transparency, and accountability in AI systems.

AI and Human Rights: The Crucial Connection

The Proliferation of AI: A Call for Attention: The widespread integration of AI in data analytics, fueled by the
surge in big data, permeates various facets of Western society. Algorithmic decision-making, underpinned by
machine learning, has become ubiquitous, impacting credit scores, job recruitment, and college admissions. The
rapid deployment of AI systems, coupled with their extensive reach and immediate effects on individuals, raises
novel challenges.

Helpful and Harmful AI: A Dichotomy with Nuances

Helpful AI: Advancing Healthcare: AI aids in disease diagnosis, treatment, and healthcare accessibility,
notably demonstrated by IBM's Watson and startups like Aajoh in Nigeria. Assisting Visually Impaired
Individuals: Image recognition tools enhance internet and real-world navigation for the visually impaired.
Optimizing Agriculture: Precision agriculture, combining satellite imagery and data, improves crop yields and
addresses environmental changes.

Harmful AI: Bias in Criminal Justice: AI contributes to biased risk scoring and predictive policing,
unintentionally perpetuating existing biases. Mass Surveillance: AI facilitates extensive surveillance, raising
concerns about privacy infringement and potential misuse. Discriminatory Profiling: Facial recognition
technology not only identifies but also discriminates against specific groups. Disinformation Spread: AI-driven
targeted propaganda and social media algorithms can spread false content, fueled by engagement.

AI and Human Rights: A Crucial Nexus: AI's impact on human rights is profound, creating new forms of
oppression and disproportionately affecting vulnerable populations. Human rights, universal and binding, offer a
framework for contesting actions by powerful entities like states and corporations. Respecting human rights is
mandatory for both governments and companies, with international law providing a robust system for
accountability and redress.

Ethics and Human Rights: A Complementary Approach: While ethics discussions dominate AI discourse,
human rights play a crucial role. Ethics principles, such as justice, fairness, transparency, and accountability,
guide AI development. Major players, including Google and Microsoft, formulate ethical AI principles.
However, human rights, being more universal and well-defined, provide accountability and redress mechanisms.
The intersection of ethics and human rights allows for comprehensive guidelines, reinforcing ethical principles
with established human rights standards.

Recommendations for Stakeholders


Integration of Ethics and Human Rights: Stakeholders should align internal policies with both ethical
principles and human rights standards. Guiding AI Development: Ethical considerations, such as avoiding
social biases, can be bolstered by human rights principles, ensuring accountability and respect for privacy and
non-discrimination. Leveraging International Human Rights Regime: The violation of ethical AI principles
often aligns with human rights violations, enabling stakeholders to use established international frameworks for
redress.

In navigating the evolving landscape of AI, a harmonious integration of ethics and human rights is essential for
responsible development and deployment.

Threats from AI: The provided text discusses various threats to human rights posed by the increasing use of
artificial intelligence (AI) technologies. It categorizes these threats into direct and indirect ones across different
domains of human rights. Let's summarize the key points:

Direct Threats:

1. Freedom of Expression: Internet companies use AI to flag content, leading to potential errors and
censorship. Governments pressuring companies to remove content quickly may result in unjustified
censorship. Authoritarian governments, like China, replace human censors with AI for increased censorship.
2. Freedom of Religion: AI can assist in monitoring and targeting persecuted religious groups, forcing them
into secrecy. Censorship of religious content violates freedom of religion.
3. Freedom of Association: AI-enabled censorship can restrict the freedom of association by removing
groups and content. This can hinder global assembly and protest movements organized through social
media.

Indirect Threats:

1. Right to Privacy: AI-powered surveillance has a chilling effect on free expression. Facial recognition
technology used in public spaces may hinder assembly at protests.
2. Freedom of Thought: AI algorithms in social media and search engines may contribute to filter bubbles,
limiting diverse views. People's limited time and attention may lead to reliance on social media as the
primary source of information.
3. Online Harassment: Bot-enabled online harassment, increasingly perpetrated by bots, has a chilling effect
on free expression. Predictive AI may be used pre-emptively by governments to predict and prevent public
demonstrations.

Rights to Equality and Non-Discrimination:

Discrimination in AI Systems: AI models may perpetuate historical biases, impacting areas such as criminal
justice and online advertising. Facial recognition software may disproportionately affect people of color due to
higher error rates.

Rights to Work and an Adequate Standard of Living:

1. Job Automation: AI automation poses a threat to the right to work by shifting the labor market.
Governments need to address challenges to ensure an adequate standard of living.
2. Access to Public Services: Automated systems in poverty-related programs may raise questions about
transparency and accountability.

Right to Health: AI in Healthcare: AI in healthcare may result in discrimination or prioritize outcomes over
patient well-being. Negative feedback loops in AI recommendations raise ethical concerns in medical decision-
making.

Right to Education: Equal Access to Education: AI systems in university admissions may perpetuate
discrimination, and ML-based systems may hide biases. AI tracking and predicting student performance could
limit educational opportunities.
Right to Take Part in Cultural Life and Enjoy Benefits of Scientific Progress:

Criminalization of Cultures: AI could be used to identify and repress cultural groups, potentially criminalizing
certain cultures. Developing countries fear being left behind in the global AI race, contributing to deeper
inequality.

Right to Marry, Children’s Rights, and Family Rights: Reproductive Screening: AI technology used for
health and reproductive screening may impact the right to marry and have children. In summary, the text
highlights the multifaceted challenges and risks associated with the use of AI technologies in various aspects of
human rights, calling for careful consideration and safeguards to protect fundamental rights in the face of
advancing technology.

Recommendations for Private-Sector and Non-State Use of AI: Private-sector actors are urged to uphold
human rights, independent of state obligations. The following recommendations are made to ensure responsible
AI use:

1. Conduct Human Rights Due Diligence:


o Identify potential adverse outcomes for human rights by assessing risks that an AI system may
cause or contribute to violations.
o Consult with relevant stakeholders, including affected groups, human rights organizations, and
independent experts.
o For systems intended for government use, both public and private actors should conduct
assessments.
2. Take Effective Action and Track Responses:
o Correct the system to mitigate risks in training data, model design, or system impact.
o Ensure diversity and inclusion to prevent bias and submit high-risk AI systems to independent
third-party audits.
o Halt deployment if the risk of human rights violations is too high or cannot be mitigated.
o Track mitigation steps over time, conduct regular quality assurance checks, and implement audits
throughout the system’s life cycle.
3. Transparency about Harm Mitigation Efforts:
o Publicly disclose information on identified human rights risks and the system's design or usage
context.
o Publish technical details, including samples of training data and data sources.
o Provide transparency and explainability, especially in high-impact areas like medicine or content
recommendation.
4. Establish Mechanisms for Accountability and Remedy:
o Establish internal accountability mechanisms for AI system functioning.
o Ensure clear delineation of responsibility and accountability between vendors and clients for third-
party-developed AI systems.
o Create transparent processes for individuals to submit complaints and seek redress for human
rights harms, feeding findings back into product and policy development.

The Need for More Research of Future Uses of AI: Collaboration between states, private-sector entities, civil
society organizations, and academia is recommended to investigate future AI uses and their potential human
rights impacts. Emphasis on multi-stakeholder and pluralistic fora to identify and address potential threats while
ensuring marginalized voices are not diminished.

Rebuttal: Transparency and Explainability Will Not Kill AI Innovation: Arguments against transparency
and explainability are addressed. Full transparency is advocated in high-risk cases, and private-sector actors are
encouraged to facilitate access to relevant code for trusted third-party audits. Meaningful explainability is
deemed achievable and vital, fostering user trust, increasing accountability, and driving innovation in AI.

Conclusion: AI systems have the potential to interfere significantly with human rights. While existing laws and
safeguards may mitigate some risks, ongoing efforts are necessary as AI technology evolves. The report aims to
stimulate deeper conversations on safeguarding human rights in the age of AI. Access Now is committed to
defending and extending digital rights globally.
AI and Human Rights

Rights to Life, Liberty, and Security, Equality before the Courts, and a Fair Trial:

1. Right to Liberty and Security: AI in the criminal justice system, especially risk-scoring software, may
lead to arbitrary arrest or detention. Risk-scoring systems, not prescribed by law, may result in unlawful or
arbitrary detention decisions.
2. Right to Equality Before the Courts: Risk-scoring software can falsely label individuals as high risk,
impacting bail conditions and sentencing. Predictive policing software risks imputing guilt based on biased
past data, potentially affecting fair trial rights. Decisions informed by AI tools may lack transparency,
violating the right to a fair trial.
3. Right to a Fair Trial: Risk-scoring systems interfere with the presumption of innocence, impacting fair
trial rights. Judges relying on AI results without understanding its workings raises concerns about the
fairness of court decisions.
4. Looking Forward: Facial recognition software in law enforcement may lead to wrongful arrests and loss
of nuance. Increased use of AI in law enforcement may include analyzing social media for risk prediction,
impacting rights to equality and a fair trial.

Rights to Privacy and Data Protection:

1. Right to Privacy: AI systems analyzing big data sets interfere with the right to privacy. ML models can
predict personal details from location data, posing privacy risks.
2. Right to Data Protection: Collection and analysis of data by AI systems interfere with the right to data
protection. Government social media monitoring programs and bulk data collection violate human rights.
3. Looking Forward: IoT devices and smart cities increase data generation, posing risks to privacy and data
protection. AI-enabled surveillance threatens anonymity, impacting freedom of association and
disproportionately affecting marginalized populations.

Right to Freedom of Movement:

1. Right to Liberty of Movement: AI-powered surveillance, combining various data sources, may restrict
freedom of movement. Mapping underserved communities for predictive policing may impact movement
rights.
2. Looking Forward: Increased mapping and AI use in predictive policing could inhibit movement in certain
areas. Automation of travel decisions by AI, like placing individuals on a "Do Not Fly" list, risks unjustly
restricting freedom of movement.

Rights to Freedom of Expression, Thought, Religion, Assembly, and Association:

1. Freedom of Thought, Conscience, and Religion: AI surveillance may lead to coercion and impair
freedom of thought, conscience, and religion.
2. Freedom of Expression: AI's role in government surveillance and decision-making may impact freedom of
expression.
3. Right to Peaceful Assembly and Freedom of Association: AI's potential misuse in surveillance might
restrict the right to peaceful assembly and freedom of association.

In conclusion, the impact of AI on human rights is extensive, touching on various aspects of individual liberties,
privacy, and fairness in legal systems. As AI continues to evolve, it is crucial to ensure its responsible and
ethical deployment to safeguard fundamental human rights.

Robotics and AI - Impact of AI-Powered Robots on Human Rights:

Right to Life:

1. Autonomous Weapons Systems: Development of fully autonomous weapons raises concerns about
adherence to laws of armed conflict. Lack of nuance in AI systems could lead to unintended harm or death
of civilians in conflict situations.
2. Healthcare Robots: AI-powered robots in healthcare, including surgical and rehabilitative robots, pose
risks to the right to life. Accountability and pathways for remedy are unclear if health robots make mistakes
or are manipulated for harm.

Right to Privacy:

Surveillance Drones and Robots: Military and law enforcement use of AI-powered surveillance drones raises
concerns. Facial recognition technology and autonomous capabilities in drones may violate principles of
necessary and proportionate state surveillance.

Right to Work: Job Automation: AI-powered robots enabling job automation can threaten the right to work.
Automation may lead to job displacement and impact individuals' ability to earn a living.

Right to Education:

Use of Robots in Education: AI-powered robots in education, such as language teaching and storytelling
robots, pose risks to equal access. Replacement of human teachers with robots may result in unequal educational
experiences for students.

Challenges and Considerations:

 Accountability in Healthcare:
o Lack of established pathways for accountability if health robots cause harm.
o Questions about responsibility and redress in cases of interference by bad actors.
 Surveillance and Privacy:
o Concerns about invasive surveillance with AI-powered drones violating principles of necessity and
proportionality.
o Potential for non-state actors to misuse autonomous surveillance technology.
 Job Displacement:
o Threat to the right to work due to job automation by AI-powered robots.
o Need for policies addressing job displacement and retraining programs.
 Equal Access in Education:
o Risks of unequal access to education if robots replace human teachers.
o Consideration of the impact on the quality of education and individual learning experiences.

As AI-powered robots become more prevalent in various sectors, it is crucial to address these challenges to
ensure they align with human rights principles and values. Balancing technological advancements with ethical
considerations is essential to mitigate potential negative impacts on individuals and society.

Artificial Intelligence: A study from legal and policy perspective

Artificial Intelligence and Human Rights: A Legal and Policy Perspective

1. Introduction:

 Challenges to Human Rights: AI presents complex challenges to human rights, questioning the traditional
assumption of human superiority.
 Debates and Concerns: Considered sentient and intellectually superior, AI sparks debates among elites
regarding its impact on human life (Simon, 2019).
 Superiority and Threats: The perceived superiority of AI in various aspects places it at the forefront of
discussions on potential threats to human rights (Freeman, 2018).
 Context of Development: AI is not developed in isolation; it operates within societal frameworks and is
deployed by specific actors for decision-making in various domains (Narain et al., 2019).

2. Gradual Integration into Daily Lives:


 Increasing Intervention: AI is gradually becoming an integral part of daily life, with growing intensity in
its impact on human rights.
 Exacerbation of Threats: While existing technologies already pose threats, AI's interference has magnified
abuses of human rights in scale, impact, and proliferation (Mohd-Sulaiman and Hingun, 2020; Saveliev and
Zhurenkov, 2020).
 Comparative Impact: The disruptive influence of AI surpasses that of preceding technologies,
contributing to a greater extent of help or harm to humanity (Ahmed and Mohamad, 2017).
 Infancy Stage: Despite being in its infancy, AI has demonstrated erratic consequences, hinting at potential
future challenges that may grow in scope and severity over time.

3. Future Outlook:

 Anticipated Growth: As AI matures, its impact on human rights is expected to grow both in scope and
severity.
 Unpredictable Consequences: The full extent of AI's consequences, positive or negative, is yet to be fully
understood, making it crucial to closely monitor and regulate its development and deployment.

In navigating the intersection of artificial intelligence and human rights, it becomes imperative for legal and
policy frameworks to adapt proactively. Addressing ethical concerns, ensuring accountability, and fostering
responsible AI development are vital aspects in safeguarding fundamental human rights in an era increasingly
influenced by advanced technologies.

Innumerable Perspectives on AI: Diverse Perceptions: AI is perceived through various lenses, with experts
offering innumerable perspectives on its capabilities and impact (Fernandes, 2018). Association with
Intelligence: The concept of 'intelligence' in AI is linked to its ability to predict the future and solve complex
tasks, influencing a broad spectrum of devices and applications.

1.1 Indian Laws and AI: Data Analysis Without Human Intervention: AI's analysis of citizens' data without
human intervention raises concerns about potential misuse, jeopardizing the right to privacy under the
Indian Constitution (Articles 19(1)(a), 19(2), and 21). Legal Remedies: Aggrieved individuals can seek
legal remedies under the Information Technology (Reasonable Security Practices and Procedures and
Sensitive Personal Data or Information) Rules, 2011, and the Indian Contract Act, 1872. However, suing AI
entities becomes complex due to uncertainties regarding AI's legal status (Lauterbach, 2019). Section 72(A)
of IT Act, 2000: Prosecution against offenders, including AI, can be pursued under Section 72(A) of the
Information Technology Act, 2000, which addresses the unauthorized disclosure of personal information,
prescribing penalties.
1.2 Indian Legal Framework and AI: Limited AI Contribution: The Indian legal framework has seen
limited contributions from AI, and legal practitioners often adhere to traditional methods.
2 Potential Paradigm Shift: AI is anticipated to bring about a paradigm shift, offering legal practitioners
unprecedented insights and transforming the analysis of laws in the evolving Indian legal system
(Sumanjeet, 2010).
3 Enhanced Efficiency: AI can enhance the efficiency of legal practitioners by providing quick and
insightful analyses of legal matters. Legal startups in India, such as Pensieve, Near Law, Practice League,
Case Mine, and SpotDraft, utilize AI-based Natural Language Processing (NLP) applications to expedite
processes and improve accuracy (Bakhshi et al., 2019).
4 Operational Shift: The adoption of AI in the legal field is still in its early stages, but the gradual
integration of advanced tools is expected to revolutionize the operational landscape of Indian jurisprudence
(Seharwat, 2020).

AI Algorithm and Legal Issues:

1. Algorithm in AI:
 Definition: An algorithm is a set of guidelines describing how to perform a task, particularly in the
context of computing (Winter, and Davidson, 2019).
 Neural Network: A type of algorithm utilized in AI systems.
 Big Data and Machine Learning: The effectiveness of algorithms in AI is closely tied to the concept
of 'Big Data,' which allows for the processing of vast datasets through machine learning, drawing
inferences from existing patterns (Barn, 2019).
 Privacy Concerns: While algorithms in AI often outperform humans, they may perpetuate human
biases unless preventive measures are implemented. The analysis of 'Big Data' by AI can infringe on
individuals' privacy, posing a threat to human rights (Ryan, and Stahl, 2020).
 Data Protection Laws: Various countries, particularly in the West, have enacted regulations like
GDPR in the European Union and other privacy laws in the United States to safeguard personal data
and protect human rights.
2. Indian Legal Framework and Data Protection:
 Legal Momentum: In India, the concept of data protection gained momentum following a Supreme
Court judgment recognizing privacy as a fundamental right (Puttaswamy Case).
 Legislation: Efforts have been made to address data protection concerns through the Personal Data
Protection Bill, 2018, awaiting parliamentary approval. Committees have been formed to develop a
comprehensive AI policy and regulations to prevent misuse that endangers human rights.

AI and Human Rights Issues:

1. AI's Impact on Human Rights:


o Sophistication and Scale: AI is perceived to have exacerbated existing questions and introduced
new challenges related to human rights issues.
o Algorithmic Decision Making: AI introduces complexities in algorithmic decision-making,
presenting intricate patterns that traditional statistical modeling cannot represent. This complexity
poses challenges to human understanding and increases the risk of violating human rights.
o Drawbacks in Intersection with AI: AI intersects with human rights issues in various ways,
including bias in criminal justice, mass surveillance, discriminatory profiling, rapid spread of
misinformation, bias in job markets, and more.
o New Forms of Oppression: AI has created new forms of oppression, disproportionately affecting
vulnerable populations. Human rights provide a framework to contest actions by powerful actors,
such as states and corporations (Ryan, and Stahl, 2020).
2. Ethics, Human Rights, and AI:
o Ethical Discourse: Ethical concepts, including fairness, justice, accountability, and transparency,
play a crucial role in judging AI applications' impact on society.
o AI Developers' Ethical Principles: Major global AI players like Microsoft, IBM, and Google
have developed ethical principles to guide their AI initiatives.
o Mutual Reinforcement: Ethical principles and human rights are mutually reinforcing. If the use
of AI is perceived as unethical, it may violate human rights and international human rights laws
(Miao, 2019).

The article emphasizes the need for ethical considerations in AI development to ensure alignment with human
rights principles and international laws.

AI and Discrimination Issues:

1. Impact on Human Rights Documents:


o International Human Rights Laws: AI technology affects various human rights recognized in
key international documents, including the Universal Declaration of Human Rights (UDHR),
International Covenant on Civil and Political Rights (ICCPR), and International Covenant on
Economic, Social and Cultural Rights (ICESCR). The European Union Charter of Fundamental
Rights, emphasizing the right to data protection, is also crucial in this context.
2. Ramifications of AI on Human Rights:
o Personal Liberty: AI applications, particularly risk-scoring software in the criminal justice system
of the USA, impact personal liberty rights (Article 9 of ICCPR and Article 14 of ICCPR). The risk-
scoring system, which labels black defendants as high risk, can lead to biased bail conditions, pre-
trial detention, and longer prison sentences.
o Criminal Risk Assessment Software: AI-based Criminal Risk Assessment software used in
sentencing decisions can prejudice the fair trial system, posing risks to human rights (Mascarenhas
et al., 2018).
o Predictive Policing Software: Predictive Policing software, also AI-based, may confirm guilt with
biases as it relies on past data. Judges' reliance on this software without a deep understanding
raises concerns about fair trial decisions.
o Flexibility of Laws: AI interference challenges the flexibility of laws, as laws should not be
considered absolute. Lack of nuance in AI applications, especially in smart cities with robots, may
lead to wrongful arrests and fines without considering extenuating circumstances.
3. Privacy and Data Protection Concerns:
o Infringement on Privacy: AI's interference is perceived to infringe on privacy and data protection
mechanisms. Safeguards under Article 17 of ICCPR and Articles 7 and 8 of the EU Charter of
Fundamental Rights are designed to protect privacy of data (Donnelly, 2019).
o Risks of Surveillance: The use of AI in surveillance and data analysis raises concerns about the
extensive collection and potential misuse of personal data, challenging privacy rights.

The ethical debate around AI's role in accelerating discrimination becomes a central concern, particularly
regarding its impact on fundamental human rights. Legal frameworks need to address these issues to ensure
fairness, accountability, and protection of individual rights in the face of advancing AI technologies.

Privacy Laws and AI Policy:

1. Fundamental Right to Privacy:


o Connection with Human Dignity: Privacy is considered a fundamental right connected to human
dignity. It intersects with other rights such as freedom of association and expression.
o Data Protection and Privacy: Governments recognize data protection as a fundamental right,
intimately linked with the right to privacy. Within the UN Human Rights system, data protection is
closely associated with privacy.
2. AI and Data Analysis:
o AI's Analytical Power: AI efficiently analyzes Big Data without human intervention, collecting
information for feedback mechanisms and continual refinement.
o Risk to Personal Data: AI, through Machine Learning, can assess individual characteristics and
predict future locations, posing a risk to personal data and privacy. Protection of such data is
crucial for safeguarding human rights.
3. Surveillance and Facial Recognition:
o Increased Government Surveillance: The growth of the internet has increased government
surveillance, with AI contributing to more invasive tools.
o Facial Recognition Systems: Facial recognition systems, powered by AI, are in use in many
countries, threatening anonymity and freedom of association. Over 56% of adults in the US are
part of facial recognition databases, raising privacy concerns.
4. Impact on Rights:
o Freedom of Movement: AI's surveillance capabilities directly affect the right to freedom of
movement (Article 12 of ICCPR), infringing on human rights.
o Healthcare Robotics: The use of AI in healthcare robotics, such as fully autonomous surgery,
poses threats to the right to life and impacts human rights adversely.
5. Impact on Society and Business:
o Micro and Macro Economic Impact: AI influences both micro and macro levels of the economy,
impacting employment, wealth gap, economic development, and consumer choices.
o Digital Divide: AI contributes to a digital divide, with developed countries advancing rapidly in
digitalization while others await access to the internet.
o Political Influence: AI can influence public opinion and election campaigns, as seen in the case of
personalized advertising during Donald Trump's election campaign.
6. Ethical and Social Impact:
o Two Clear Areas: The ethical and social impact of AI is divided into human perspective and AI
perspective, each raising critical questions and concerns.
o Human Perspective: Examining AI as a moral agent, evaluating its potential for social
transformation, and addressing salient ethical issues that shape AI algorithms.
7. Human Perspective Questions:
o AI as a Moral Agent: Can AI technology be considered a moral agent, exhibiting characteristics
like autonomy, intention, and responsibility?
o Social Transformation: To what extent can AI contribute to social transformation, and how do
human choices influence AI's impact on society?
o Ethical Issues in AI Algorithms: Identifying and addressing ethical issues in algorithms that
underlie AI systems.
In summary, the intersection of AI with privacy laws, data protection, surveillance, and its broader impact on
society and business raises significant legal and ethical considerations that require careful attention and
regulation. The implications of AI on human rights and societal values are complex, emphasizing the need for
comprehensive legal frameworks and ethical guidelines.

AI and Contractual Relationship: In 1996, Tom Allen and Robin Widdinson foresaw a future where
autonomous computers roam the Internet for new trading partners, raising concerns about the compatibility of
existing Indian contract law with rapidly advancing technology. International contracts resulting from
interactions between automated systems and individuals can be considered enforceable and valid under the UN
Convention on the Use of Electronic Communication. The United Nations Commission on International Trade
Law (UNCITRAL) Secretariat emphasized that messages from automated systems should be treated as
originating from a legal entity, sparking discussions on whether AI should be granted legal personhood.

Employment and AI: AI and robotics are addressing the growing demand for automation across various
industries, aiming to reduce man-hours and enhance machine efficiency. Worldwide, industries are increasingly
incorporating AI to replace human labor, leading to challenges in existing employment laws and the need for
new legislation to address the evolving employment landscape. The deployment of AI technology and robotic
systems in workplaces is prompting the need for modern legislation to adapt to the changing nature of work
influenced by AI and robotics (Hughes et al., 2019).

Adoption of AI in Industries and Legal Framework: Industries and establishments need to adapt their
compliance systems for recruitment policies due to increased use of AI. Collaboration between industrial
authorities and lawmakers is crucial for establishing a relevant and acceptable employment framework.

AI and Existing Legal Framework in India: The Constitution of India serves as the fundamental legal
structure, but the legal status of AI under Indian law remains unclear, leading to debates on the applicability of
existing regulations to AI machines. Recognizing the importance of AI in various sectors, the Government of
India (GOI) formed a task force in August 2017, named "Task force on AI for India’s Economic
Transformation," comprising academics, industry leaders, and experts. Chaired by Dr. V. Kamakoti, the task
force aimed to explore opportunities for AI development across sectors. In March 2018, the task force published
a report with key recommendations:

 Identified ten areas for AI applications in India, including Agriculture, Education, Health, Manufacturing,
National Security, and Technology for differently-abled.
 Highlighted challenges, emphasizing secure data collection, protection, and utilization through a robust
technological framework, including IoT for digitization and protection against cyberattacks.
 Addressed concerns related to the use of autonomous devices and their impact on employment.

Specific recommendations from the report were submitted to the Department of Industrial Policy and Promotion
(DIPP) to inform the formulation of AI policy for India.

Create Data Banks and Ombudsman: Ensuring accuracy in digital data banks is crucial for analysts and
decision-makers. Laws must be formulated to secure data exchange, with MeitY, GOI as the nodal agency and
DIPP responsible for regulations on data security and privacy. The Ministry of Industry and Commerce, GOI, is
proposed to establish a data ombudsman to swiftly address data-related issues.

Specify Standards: The task force recommends that the Bureau of Indian Standards (BIS) should initiate
measures to implement international standards for AI systems.

Develop Human Resources: The proposal emphasizes the need for an educational curriculum to cultivate
skilled human researchers to meet the growing demand for AI professionals. The HRD department of GOI, with
the assistance of the Skill Development Ministry, is tasked with developing skilled individuals.

AI Policy Enablement: The task force urges the development of a comprehensive and implementable AI policy.
Two key inclusions are proposed:

 Formulating a policy for handling data, with MeitY and DIPP taking the lead.
 Providing tax incentives for individuals using AI technology, particularly those involved in socially relevant
projects.

Enable Bilateral Cooperation and International Rule-Making: Inter-ministerial coordination and


collaboration are recommended for active participation in international conferences discussing AI development.
Knowledge-sharing initiatives are suggested for Indians to engage with AI issues globally.

Intellectual Property and Legal Issues of AI:

Patents and AI: The Patent Act allows the true and first inventor, or someone assigned by them, to file for a
patent, without specifying the inventor as a natural person. AI's role in patent law is significant, with Natural
Language Processing (NLP) used to generate patent claims, enhancing the scope of inventions. AI aids in
identifying prior art, contributing to the originality of inventions and potentially preventing ideas easily derived
from existing knowledge.

Copyright Issues and AI: Copyright protection in India is granted to a 'work' meeting the 'modicum creativity'
standard, requiring a minimal degree of creativity and substantive variation, as established in the Eastern Book
Company Case. The court did not explicitly state whether AI meets the 'modicum of creativity' requirement,
leading to uncertainty about AI's eligibility for copyright protection. Another condition for AI to claim copyright
ownership is being recognized as an 'author' under the Copyright Act of 1957. The challenge arises from AI
lacking legal personality, posing a legal problem concerning authorship under copyright laws. The involvement
of a human programmer in AI-created works raises the question of authorship: is it the programmer or AI? The
Eastern Book Company case does not clarify this aspect, making AI's status regarding the condition of
'modicum of creativity' uncertain. Determining ownership under section 2(d)(vi) of the Copyright Act, which
defines the person causing computer-generated works, becomes contentious when the creator is AI, lacking legal
personhood.

AI and Industrial Design: Many companies use AI technology for creating industrial designs, enhancing
creativity beyond the limitations of Computer-Aided Design and Drafting (CAD) architectures. Section 1(j)(iii)
of the Design Act, 2000, designates the 'proprietor of a new or original design' as the author of the design.
However, the question of whether AI can be considered an 'author' remains unclear, echoing the concerns
discussed in copyright issues. The identification of actual ownership or authorship in AI-created industrial
designs is confusing within the context of Indian jurisprudence, and clarification is anticipated in the future.

Personal Data Protection and AI: AI's increasing role in society, coupled with the rise of the Internet of Things
(IoT), has led to the creation of a "datafield society" where AI analyzes Personally Identifiable Information (PII)
for behavioral patterns. AI's analysis of PII raises privacy concerns, necessitating a comprehensive and
executable framework for privacy protection. The recent Supreme Court judgment recognizing privacy as a
fundamental right has added momentum to the need for a technology-neutral data protection framework. While
existing enactments in India address data protection, the Supreme Court recommended a more comprehensive
framework. The Ministry of Electronics and Information Technology (MeitY), GOI, formed a committee
chaired by Justice B. N. Srikrishna to identify and address data protection issues. The committee's white paper
and draft data protection bill await parliamentary approval.

AI and E-Contracts in India: Electronic contracts are considered equivalent to normal paper contracts under
Section 10A of the Information Technology Act, provided they meet the conditions of a valid contract. The
legality of AI entering contracts independently is a complex issue under the Indian Contract Act, as it requires a
'legal person' to enter into a valid contract. AI and robots are generally not considered 'legal persons' in India,
leading to uncertainty in the legal position regarding AI in E-contracts.

Standard of Care: The issue of the standard of care expected from AI and the consequences when these
standards are not met, leading to harm or damage, requires thorough discussion. In Indian jurisprudence,
machines are traditionally treated as simple consumer products, and standard product liability laws apply.
However, the growth of AI calls for transparency and clarification regarding the 'standard of care' concerning AI
systems and product liability. Currently, there is a weakness in legal jurisprudence in India regarding the
'standard of care' for AI systems. While other countries follow the 'strict product liability' principle, India is
expected to address this issue in the near future.
Liability of AI in Indian Legal Context:

Civil Liability: Indian legal systems currently do not recognize AI or robots as legal or natural persons, making
them exempt from liability. The question of liability arises concerning the lawful relationship between AI and its
developer. In civil liability, damage compensation is a crucial condition, requiring the affected person to prove
the offense to seek remedy. The issue of AI possessing autonomy and super-intelligence raises questions about
its responsibility for wrongful actions. Legal experts argue that if AI is fully autonomous and aware, it should be
held responsible for any wrongful action. However, challenges arise in attributing legal personality, rights, and
duties to AI, as these are traditionally associated with legal persons.

Criminal Liabilities: The fear of uncontrolled AI functions, particularly in warfare, prompted concerns from
researchers. Gabriel Hallevy questioned the ethical and legal guidelines needed to control AI, raising concerns
about criminal liabilities for AI actions. Criminal liabilities involve mens rea (mental element) and actus reus
(guilty act). Gabriel Hallevy proposed three models for considering AI in the context of criminal liability.

Misuse of AI and Legal Punishment: If AI commits an offense, questions arise about personalizing
punishment. Issues include serving sentences, capital punishment, imprisonment, and fines. Similar challenges
exist in considering punishment for corporations.

AI and Tax Issues: Technological advances, including AI, pose challenges to traditional taxation norms.
Determining 'who' and 'where' to tax becomes complex due to digitalization and the question of granting legal
person status to AI entities. Tax issues related to AI emerge, requiring consideration of AI's status and the impact
of its activities on taxation laws.

Conclusion

Impact of AI Growth: The use of driverless cars, fully automated AI-based machines, and robotic technology
has increased globally, aligning with the prediction that people would increasingly rely on AI systems. Statistical
information supports the prediction, indicating that AI is expected to contribute economically, with an average
growth of 1.7% across various industries by 2035 (Accenture, 2017).

Concerns and Issues: The integration of AI with industries and society has raised concerns about security and
privacy, particularly in the context of responsibilities for AI wrongdoings. Accelerated progress in robot
technology has heightened issues related to AI and its impact on ethics, law, and societal norms.

Policy Recommendations: To address the entangled issues, there is a need for appropriate and implementable
policies on AI, especially in culturally diverse countries like India. Lawmakers should adopt a balanced
approach to protect individual rights while ensuring the growth and beneficial application of AI for
society.Failure to establish effective regulations may jeopardize citizens' human rights and impede innovation
and creativity that AI can offer.

Guidelines for Programmers: Policymakers should provide pragmatic guidelines regarding the obligations and
rights of AI programmers. Ethical norms and standards must be established for programmers engaged in AI or
robot systems.

Challenges in Taxation and General Laws: Due to a lack of proper regulations in India, grey areas exist in
taxation issues and general laws related to AI applications. Challenges in cross-border transactions, such as
double taxation and aggressive tax planning, may be aggravated due to the evolving capabilities of AI.

International Cooperation: To address global taxation issues related to AI, organizations like the United
Nations (UN) and the Organization for Economic Cooperation and Development (OECD) are working on
articulating model principles. India is expected to formulate legal frameworks by amending existing laws, such
as the Income Tax Act, 1961, to harmonize international tax issues related to AI.

Module 4

Current and Future Issues in International Space Law


Introduction: The domain of space presents a multitude of legal challenges and complexities, encompassing
issues related to sovereignty, commercial activities, environmental protection, and defense. Precision in
language and definition becomes crucial in navigating these challenges. Various perspectives on what space
represents lead to different legal implications.

1. Lack of Definition for Space and Sovereignty:

 Undefined Boundaries: Treaties and laws lack a precise definition of where Earth's atmosphere ends
and space begins.
 Commercial Space Activities: For commercial purposes, the Earth's atmosphere, the edge of outer
space, and achieving orbit are distinct areas with unclear legal boundaries.
 Sovereignty and Licensing: Nations have sovereignty over their airspace, and through treaties, no
nation can claim sovereignty in outer space. Licensing regimes, such as the one established by the FAA
in the United States, address commercial flights to the edge of space.

2. Differing Perspectives on Space:

 Geographic Location: Space can be seen as a geographic location without sovereignty.


 Research and Business: It serves as a place for research, business activities, and extracting valuable
resources.
 Hostile Environment: Space is a hostile environment requiring life-support systems for human
habitation.
 Military Significance: It holds importance for defense, security, and military operations.

3. Legal Implications:

 Access and Use of Space: Differing views impact rights to access and use space for research, business,
and defense purposes.
 Commercial Transactions: Legal implications extend to commercial transactions, liability for
environmental damage, and responsibility for damages arising from human use of space.
 Consistency and Predictability: With the growth of commercial and security uses of space, ensuring
consistency and predictability in the legal regime for different uses becomes crucial.
 International Cooperation: Encouraging international cooperation and defining liability for damages
caused by space activities are key considerations.

4. Legal Precedents and Principles:

 Multinational Treaties and Agreements: Space law draws on legal precedents from various treaties
and agreements, including the U.N. Charter, Antarctic Treaty System, maritime and aviation laws, and
agreements related to nuclear arms, defense, commerce, and intellectual property.
 U.N. Treaties on Space: International space law is primarily governed by U.N. Treaties negotiated
during the 1960s and 1970s, reflecting compromises between major space powers.
 Basic Principles:
o Space as the "province of mankind," accessible to all nations for mutual benefit.
o Freedom of scientific investigation, exploration, and use of space, with encouragement for
sharing findings.
o States' responsibility for their actions and citizens in space, emphasizing financial liability and
environmental protection.
o Space to be used for peaceful purposes, with a prohibition on weapons of mass destruction.

Conclusion: International space law faces ongoing challenges due to evolving perspectives on space and the
diverse activities conducted in this domain. The legal framework must adapt to accommodate commercial,
scientific, and defense-related uses of space while ensuring consistency, predictability, and international
cooperation. The foundational principles of U.N. Treaties continue to guide space law, emphasizing shared
access, responsible behavior, and the peaceful use of space.

Treaties and Resolutions in International Space Law:


Treaties:
1. Outer Space Treaty (OST):
2. Rescue and Return Agreement:
3. Liability Convention:
4. Registration Convention:
5. Moon Treaty:

Resolutions:
1. Declaration of Legal Principles (1963):
o Governs the exploration and use of outer space.
2. Principles on the Use of Artificial Earth Satellites (1982):
o Addresses international direct television broadcasting.
3. Principles Relating to Remote Sensing of the Earth (1986):
o Guides activities related to remote sensing from outer space.
4. Principles Relevant to the Use of Nuclear Power Sources in Outer Space (1992):
o Addresses the use of nuclear power sources in space.
5. Declaration on International Cooperation in the Exploration and Use of Outer Space (1996):
o Emphasizes cooperation for the benefit of all states, particularly developing countries.
6. Application of the Concept of the "Launching State" (2004):
o Focuses on clarifying the definition of a launching state.
7. Recommendations on Enhancing the Practice of States in Registering Space Objects (2007):
o Encourages uniform reporting, determination of the state of registry, and notification of new
owners.

Challenges and Future Issues:

1. Property Rights on Celestial Bodies:


o Balancing property rights on the Moon and celestial bodies without violating treaty provisions
prohibiting sovereignty.
2. Environmental Protection vs. Commercial Interests:
o Addressing the conflict between protecting the space environment and commercial interests that
may disturb pristine territories.
3. Safety Regulations for Human Activities in Space:
o Developing international safety regulations for human activities in space and on the Moon.
4. Cooperative Space Programs and Export Restrictions:
o Facilitating civil government and commercial international space programs without undue
hindrance from export restrictions and security measures.

The resolution of these issues will shape the future of commercial space activities and determine the benefits
derived from space endeavors for all nations and peoples. Ongoing legal developments will play a crucial role in
adapting the existing legal framework to the evolving landscape of space exploration and use.

Fifty Years of Space Law: Basic Decisions and Future Challenges

1. Outer Space Treaty (OST) Anniversary:


o Celebrated its 50th Anniversary on January 27, 2017.
o Rooted in the Declaration of Legal Principles adopted in 1963.
o Represents the fundamental legal basis for outer space exploration and use.
2. Comprehensive Legal Framework:
o Complemented by four additional conventions:
 Rescue of Astronauts (1968)
 Liability in Cases of Damage (1972)
 Registration of Space Objects (1975)
 Moon Treaty (1979)
3. Space Law in Public International Law:
o Space Law is a distinct part of Public International Law.
o Significant for both spacefaring nations and the global space industry.
4. Outer Space Treaty (OST) as a Framework:
o Provides the basic framework for exploring and using outer space.
o Has endured for 50 years, demonstrating its resilience and relevance.
5. Historical Context: Negotiation and Conclusion:
o Negotiated during a challenging period in the 1960s, marked by global crises.
o Despite political tensions, the U.S. and the Soviet Union prioritized drafting and concluding the
treaty.
6. Milestones in Space Exploration:
o Acknowledges significant spaceflights, including Sputnik 1 (1957) and manned flights by Gagarin
and Shepard (1961).
7. Critiques and Responses:
o Some scholars criticized the treaty's wording and perceived ineffectiveness.
o Critics argued it was an instrument for political relaxation, with minimal obligations.
o Historical context and the geopolitical climate of the 1960s are emphasized in response to
critiques.
8. Global Acceptance and Ratifications:
o Despite initial critiques, 105 states had ratified the Outer Space Treaty by the summer of 2017.
o Recognized as a historic achievement that shaped the legal order for outer space.
9. Continued Relevance and Future Challenges:
o After 50 years, the treaty's achievements are acknowledged, and future challenges in space law are
anticipated.
10. Role of Outer Space Treaty:
o Considered a cornerstone in shaping the legal environment for international cooperation and
exploration in outer space.

The Outer Space Treaty, despite initial skepticism, stands as a testament to international cooperation and legal
efforts to govern activities in outer space. Its endurance over five decades underscores its importance in guiding
the exploration and use of outer space.

1. Common Heritage of Mankind Concept:


o Introduced in the Antarctic Treaty of 1959 and later incorporated into Space Law.
o The GA-Resolution of 1963 emphasized the exploration and use of outer space for the benefit and
interests of all mankind.
2. Evolution of Terminology:
o The term "Common Heritage of Mankind" was initially introduced by Arvid Pardo in 1967
concerning the Seabed in the Law of the Sea context.
o Initially, the Outer Space Treaty (OST) used the terms "interest of all mankind" and "province of
all mankind" but later adopted the term "Common Heritage of Mankind."
3. Legal Equivalence of Terms:
o Despite different terms, scholars argue there is no legal difference between "province of all
mankind" and "Common Heritage of Mankind."
o Both terms express the substantial understanding that outer space is a shared resource for the
benefit of all.
4. Key Elements of Common Heritage Principle:
o No State shall claim or exercise sovereignty over any part of the area or its resources.
o International cooperation between States involved is required.
o Obligation to explore and use the area for peaceful purposes.
o Identified as a "hard core" principle in various international treaties.
5. Legal Provisions in Treaties:
o Art. II of the Outer Space Treaty, Art. 137 and 89 of the UN Convention on the Law of the Sea,
and Art. 11 of the Moon Treaty embody the Common Heritage principle.
o The Moon Treaty explicitly states that neither the surface nor subsurface of the Moon shall become
property of any State.
6. International Cooperation and Management System:
o The Common Heritage principle requires international cooperation.
o The need for an international management system is an open question, with arguments for and
against its establishment.
7. Peaceful Use of International Common Goods:
o Peaceful use is a core element of the Common Heritage principle.
o Treaty rules emphasize the exclusive use of the Moon and other celestial bodies for peaceful
purposes.
8. Implementation into Public International Law:
o Space Law serves as a clear example of how the Common Heritage principle has been
implemented into Public International Law.

The Common Heritage of Mankind principle, despite evolving terminology, has been a guiding concept in Space
Law, emphasizing shared benefits, international cooperation, and the peaceful use of outer space resources for
the benefit of all nations.

1. Non-Appropriation Rule (Art. II):


o Art. II of the Outer Space Treaty (OST) establishes the Non-Appropriation rule.
o This rule clarifies that outer space, including celestial bodies like the moon, is not subject to
national appropriation, sovereignty claims, or any other means of occupation.
2. Relation to Common Heritage Principle:
o The Non-Appropriation rule is connected to the common heritage principle, emphasizing the
prohibition of acquiring properties on celestial bodies.
3. Three Critical Events: a) Dennis Hope's Moon Sales:
o Dennis Hope, a U.S. citizen, claimed ownership of the Moon and other celestial bodies based on
the Homestead Act of 1862.
o Founded "Lunar Embassy" and started selling lunar properties since 1996.
o Hope argued that Art. II prohibits "national appropriation" but not appropriation by private
individuals.

b) Maria Angeles Duran Lopez's Sun Claim:

o Spanish woman claimed ownership of the Sun and attempted to sell parts of it on eBay in 2013.
o Planned to share the profits for social causes.
o eBay deleted the offer based on its rules; legal case ensued.

c) Space Launch Competitiveness Act (2015):

o The U.S. President, Barack Obama, signed the Space Launch Competitiveness Act in 2015.
o Part IV of the Act allows U.S. citizens to claim natural resources found during U.S. space
missions.
4. Evaluation of Non-Appropriation Rule:
o The discussion arises whether Art. II prohibits private appropriation or is limited to national
appropriation.
o Arguments supporting the prohibition of private appropriation:
 Art. I guarantees free access to outer space, moon, and celestial bodies for everyone.
 Allowing private appropriation would violate the common heritage principle and free
access.
 Preventing a State from changing its status to claim property rights as a private entity.
o Contrary arguments:
 Art. II refers explicitly to "national" appropriation, suggesting a narrower interpretation.
 The Moon Treaty extends the prohibition to "any natural person," but the OST does not.
5. Conclusion:
o A serious academic debate surrounds whether Art. II prohibits private appropriation.
o Major opinion supports a broad interpretation, arguing against legal gaps.
o Despite contrary arguments, the mentioned cases (Moon sales, Sun claim, U.S. Space Launch
Competitiveness Act) are seen as violating the Non-Appropriation rule of Art. II.

4. Prohibition of Militarization (Art. IV): ◦ Art. IV of the Outer Space Treaty prohibits the
militarization of outer space. ◦ State parties agree not to place objects carrying nuclear weapons or
weapons of mass destruction in Earth's orbit or on celestial bodies. ◦ Military bases, installations,
testing of weapons, and military maneuvers on celestial bodies are forbidden. ◦ Exception: The use
of military personnel or equipment for scientific research or peaceful purposes is not prohibited. ◦
Notably, there is no practical realization of militarization as depicted in movies like "Star Wars."
5. North Korea's Missile Tests: ◦ Despite global concerns about North Korea's ballistic missile tests,
North Korea is a State party to the Outer Space Treaty. ◦ In 2009, North Korea signed and ratified
the Outer Space Treaty and additional conventions (excluding the Moon Treaty). ◦ The missile
tests by North Korea violate provisions of Space Law, creating a challenge for Art. IV of the Outer
Space Treaty.
6. Rescue of Astronauts (Art. V): ◦ Art. V of the Outer Space Treaty addresses the rescue of
astronauts in cases of emergency or distress. ◦ Astronauts are regarded as "envoys of mankind" and
are to be assisted in case of accidents, distress, or emergency landings on the territory of another
State party or on the high seas. ◦ Astronauts making such landings should be safely and promptly
returned to the State of registry of their space vehicle. ◦ The term "envoys of mankind" has sparked
legal discussions but is generally understood not to confer special legal status on astronauts. ◦ The
legal question of the definition of "astronaut" arises, with some arguing for a broader definition
covering all persons on board a spaceship, while others restrict it to those with specific technical
functions for the mission. ◦ The duty to rescue under Art. V is debated in relation to private space
travelers, sick astronauts, and passengers without technical roles. ◦ The interpretation of humanity
is suggested as a new form of legal interpretation to encompass the broader sense of the term
"astronaut" and uphold the humanitarian spirit of the Rescue Agreement of 1968.

Satellites as Economic Use:


 States are keenly interested in the economic use of outer space, especially for positioning satellites.
 Economic use includes satellite applications for communication (broadcasting, telecommunication,
internet), weather forecasting, natural disaster prediction, and navigation for transport and military
purposes.
 Legal questions arise about which states are entitled to place satellites in outer space orbits, and
whether entitlement is limited to high-technology states.

7. Procedure before the ITU:


 Every state intending to place a satellite in outer space must submit an order to the
International Telecommunication Union (ITU) in Geneva.
 The ITU checks orders primarily for technical aspects, and the allocation principle is
generally "first come, first serve."
 Developing countries criticized the unequal access to space, leading to discussions on a
fair allocation procedure.
8. Legal Solution of the Allocation Conflict:
 The Outer Space Treaty lacked a suitable provision for the distribution of satellite
positions, so the focus turned to relevant regulations of the ITU.
 In the mid-1980s, the ITU Constitution was amended to declare that all orbits in outer
space are "limited natural resources."
 The amendment ensures that every state party to the ITU Constitution has the right to
claim at least one position on every orbit, irrespective of economic or scientific
development.
9. Paper Satellites:
 The phenomenon of "Paper Satellites" involves developing countries ordering
geostationary orbit positions without the capability to construct and place satellites.
 The ITU, lacking efficient legal instruments to distinguish between realistic and
unrealistic applications, regularly allocates ordered orbit positions.
 Countries then lease these positions for significant amounts to interested states, leading to
concerns about commercialization and potential violations of the Non-Appropriation rule
of the Outer Space Treaty.
 There is a need for new provisions to prevent the abuse of orbit positions and the practice
of "Paper Satellites."

These points highlight the legal complexities and challenges associated with the economic use and allocation of
satellite positions in outer space.

8. The Beginning and the End of Outer Space:


o The Outer Space Treaty addresses a range of basic achievements and fundamental aspects for the
reasonable and peaceful use of outer space.
o Unresolved questions in Space Law include determining the exact applicability of Space Law and
the geographical lines of outer space.

a) The Beginning of Outer Space:

o There is a need to determine where outer space begins, with scholars suggesting various opinions.
o The "Kármán Line" at 100 km is a commonly accepted legal threshold, creating an intermediate
zone between airspace (up to 83 km) and outer space.

b) The End of Outer Space:

o The Outer Space Treaty refers to the "Moon and other celestial bodies," and the Moon Treaty adds
"within the solar system" to define the outer limit of outer space.
o Our solar system is considered the outer limit for the application of Space Law, particularly the
Outer Space Treaty.

II. Future Challenges:

1. International Space Station (ISS):

o The ISS, a collaborative project involving the U.S., Russia, Japan, Canada, Europe, and Brazil, has
been successful.
o Political tensions may affect the future of the ISS, and there is a need for sustained cooperation
with common space stations between the U.S. and Russia.

2. Exploitation of Natural Resources on the Moon:

o With increasing concerns about Earth's diminishing resources, the Moon is considered a potential
source.
o The Moon Treaty of 1979 outlines principles for mining on the Moon, but it has limited
ratifications.
o Legal studies explore modifications to the Moon Treaty to address contemporary needs and fair
access.

3. Reduction of Space Debris:

o Space debris poses challenges and dangers, with incidents of collision with working space objects.
o Space debris mitigation guidelines were established in 2007, but legal results have been limited.
o A proposal suggests that states are obliged to remove their non-functional space objects and bear
the removal costs.

4. Space Tourism:

o The term "space tourism" is debated, with a focus on distinguishing between flights to the ISS and
suborbital flights.
o Suborbital flights, exemplified by Virgin Galactic's project, raise legal framework questions,
including contracts, liability, insurance, and informed consent.
o Current international legal frameworks for space tourism are limited, and the need for regulations
is discussed in the context of potential risks and unknowns.

These future challenges highlight evolving issues in Space Law, including international collaborations, resource
exploration, debris management, and the legal framework for emerging activities like space tourism.

27. National Legislation on Space Law:


 Article 6 of the Outer Space Treaty allows states to enact national acts to specify
international obligations, especially concerning private space missions.
 National space acts are crucial for providing legal certainty and predictability, particularly
in the cost-intensive space industry.
 Despite being a major player in the space industry, Germany has yet to create a national
space act, leading to uncertainties for its space industry.
28. Discoveries and Legal Reactions:
 The advent of technical capabilities for space exploration prompted the need for the
international legal order to respond, leading to the establishment of Space Law through
UNCOPUOS.
 This parallels historical developments in maritime law when the discovery of oceans led
to the creation of the Law of the Sea.
 Similar legal responses occurred with the discovery of airspace and, more recently, with
the internet, giving rise to Cyber Law.
 Each of these spaces, including outer space, necessitated the evolution of new fields
within Public International Law.
29. Space Law as Part of Public International Law:
 Space Law is positioned as a distinct part of Public International Law, akin to other
established branches like the Law of the Sea, Environmental Law, or Economic Law.
 Space Law holds a unique position by recognizing Earth as a space object within the
broader universe, challenging the traditional perception of Earth as the center of the
universe.
 Space Law introduces a new vertical dimension to legal horizons, emphasizing the
interconnectedness of Earth with the vastness of outer space.

This conclusion underscores the evolution of Space Law in response to technological advancements, positioning
it as a crucial component of Public International Law that reflects a broader perspective on Earth's role in the
universe.

IPR and OSL

Territorial and International Application of Intellectual Property (IP) Rights:

1. IP rights can be acquired and applied territorially or internationally.


2. Multilateral treaty frameworks related to IP rights, combined with national treatment provisions, make
securing and enforcing IP rights essentially global.
3. Challenges arise in applying IP rights in outer space, where claims of sovereignty are not applicable.

II. International Principles Governing Outer Space Activities:

1. The Outer Space Treaty emphasizes the exploration and use of outer space for the benefit of all countries,
irrespective of economic or scientific development.
2. Outer space, including the Moon and celestial bodies, shall not be subject to national appropriation by
sovereignty claims, ensuring a collective and cooperative approach.
3. The Declaration on International Cooperation in Outer Space underscores the global, equitable, and
mutually acceptable nature of space exploration.

III. Principles of International Cooperation:

1. Principles of international cooperation and collective development in space activities are fundamental,
emphasizing global benefits.
2. Private sector participation in space activities must align with the principles of equitable development and
non-appropriation of outer space.

IV. Challenges and the Role of Intellectual Property:

1. The increasing participation of the private sector in space activities requires a balance between intellectual
property rights and socio-economic justice.
2. The TRIPS Agreement suggests provisions for developed states to incentivize technology transfer to less-
developed states.
3. Lack of a definitive mechanism and framework to balance socio-economic justice with intellectual property
rights in space activities.

V. UN Recognition and High-Level Fora:

1. The UN recognizes the potential of space activities for globally inclusive socio-economic development.
2. High-level forums, such as the one in 2016 with the Dubai Declaration, highlight space exploration as a
driver for innovation, international cooperation, and addressing global challenges.

VI. Role of Intellectual Property Protection in Space Ventures:

1. Intellectual property protection is crucial for private entities investing in commercial space ventures.
2. Assurance of IP protection, including patents, trade secrets, and proprietary data, is necessary to
incentivize investment in developing the commercial potential of space activities.
3. IP protection plays a vital role in shaping successful space business models involving public-private
collaborations.

Overall, the need for a balanced approach that considers intellectual property rights alongside principles of
international cooperation and socio-economic justice is highlighted in the context of outer space activities.

Challenges in Applying Intellectual Property (IP) Laws to Outer Space Activities:

1. IP protection laws are territorially based, posing challenges for securing and enforcing IP rights in outer
space activities.
2. Distinctions are made between outer space activities performed in outer space, those performed in a
space vehicle or object, and those performed within the territorial jurisdiction of a state(s).
3. A uniform international legal framework may be more critical for activities beyond the territorial limits
of a state.

II. Sovereignty, Jurisdiction, and Quasi-Territoriality:

1. The sovereignty of a state is essential for securing and enforcing IP rights.


2. The Outer Space Treaty grants jurisdiction and control over space objects to the state of registry, not
the launching state.
3. The doctrine of quasi-territoriality is extended to space objects, emphasizing the importance of the state
of registry's domestic legal framework.

III. Outer Space Treaty and Jurisdiction:

1. Article 8 of the Outer Space Treaty establishes that the state of registry retains jurisdiction and control
over a space object in outer space.
2. The control and jurisdiction of the state of registry exist from the launch of the space object.

IV. Application of Doctrine of Temporary Presence:

1. The Paris Convention's Article 5ter, concerning the doctrine of temporary presence, is not expressly
extended to space objects.
2. The jurisdictional nexus for applying IP laws to outer space activities depends on the registration of all
space objects connected to intellectual property.

V. International Space Station Intergovernmental Agreement (IGA):

1. The International Space Station (ISS) IGA provides a modality for regulating IP rights in outer space
and promoting cooperative space activities.
2. Article 21(2) of the IGA deems activities on a Space Station flight element to occur within the territory
of the Partner State of that element's registry.
3. Special provisions exist for the European Space Agency's registered elements under Article 21(2).
4. Article 21(3) addresses the filing of patent applications, preventing domestic laws concerning secrecy
from hindering filings in other Partner States.
5. Article 21(6) adopts the doctrine of temporary presence, stating that the temporary presence of articles
in transit between Earth and an ISS-registered flight element does not form the basis for patent
infringement proceedings in the first Partner State.

The ISS IGA exemplifies a practical approach to regulating IP rights in outer space, considering the unique
challenges presented by overlapping jurisdictions and the multiplicity of legal proceedings.

Non-Creative Databases: These are sometimes called 'sweat of the brow' databases and are not inherently
creative but involve effort or investment.

Global Perspectives on IP Protection for Databases: There is no global consensus on the eligibility criteria
for IP protection for non-creative databases. Some countries use traditional copyright frameworks, while others
establish sui generis legislative frameworks. The European Union's Database Directive 96/9/EC is an example
of the latter.

Technical Aspects of Satellite Remote Sensing: Primary remote sensing data undergo auxiliary processing for
further analysis. The distinction between primary and other types of remote sensing data implies a reluctance to
protect data under copyright rules.

European Union's Database Directive: It codifies the right of the database maker to prevent unauthorized
extraction or re-utilization of substantial parts of the protected database.

Weak Protection Without Sui Generis Legislation: In the absence of sui generis legislation, protection for
non-creative databases relies on contractual arrangements and licenses, offering limited protection against
licensee actions.

II. Patents in Outer Space Activities:

1. Challenges in Patentability Criteria: Space inventions may face challenges in proving novelty, non-
obviousness, and usefulness or functionality on Earth.
2. Cooperative Efforts and Jurisdiction: Patents invented in outer space through cooperative efforts
pose questions about jurisdiction and entitlement to file for patent protection.
3. Enforcement Challenges: Territorial nature of patent protection and the principle that outer space is
the province of all mankind pose challenges in enforcing patent rights.

III. Intellectual Property (IP) Norms and Challenges:

1. Challenges with Copyright: Copyright norms are ill-suited for protecting non-creative data sets
resulting from remote sensing activities, where protection of actual content is crucial.
2. Challenges with Patents: Patent eligibility criteria create hurdles for space-related technologies and
inventions, particularly in demonstrating functionality on Earth.
3. Enforcement Challenges for Copyright and Patents: Territorial nature of copyright and patents
poses enforcement challenges.

IV. Trademark Protection in Outer Space:

1. Doctrine of Quasi-Territoriality: Trademark protection in outer space, especially with the growth of
space tourism and commerce, can be secured using the doctrine of quasi-territoriality.

V. Need for International Harmonization:


1. Current Harmonization of IP Laws: While domestic intellectual property laws may seem fairly
harmonized, states apply internationally agreed principles with their own interpretations.
2. Summation: An international legal framework addressing IP needs for space activities should consider
various interests, including innovation, exploration, socio-economic development, private and state
interests, and the needs of less developed states.
3. Recommendations: International good practices or principles may include incorporating the doctrine
of quasi-territoriality, exceptions for the doctrine of temporary presence, provisions for the protection
of non-creative databases, eligibility criteria for protecting remote sensing data, patentability criteria
for space inventions, incentives for private entities, and substantive provisions for sharing remote
sensing data and space technology on fair and reasonable terms.

Copyright and ISL

1. Definition of Outer Space: The concept of outer space lacks a fixed definition, but the Von Karman line
(imaginary line 100 km above Earth) is often used to delineate it. The 21st century is marked by mass
digitalization, technological advancements, and increased research in multidisciplinary fields.
2. Evolution of Intellectual Property Rights (IPR) and Outer Space Recognition:
o IPR, recognized in the 19th century with the Paris Convention (1883) and Berne Convention
(1886), evolved earlier than the laws safeguarding outer space.
o Outer space recognition dates back to stargazing in the 12th century, with a more practical
approach emerging during World War II.
3. United Nations' Role: The United Nations, particularly the United Nations Office for Outer Space Affairs
(UNOOSA) and the Committee on the Peaceful Uses of Outer Space (COPUOS), plays a crucial role in
shaping legislations for outer space activities.
4. Five Treaties: In response to the power struggle during the Cold War, five treaties, including the Outer
Space Treaty, were established to prevent dominance and ensure a legal order in outer space.
5. Extra-Territorial Approach: The Outer Space Treaty recognizes outer space as a separate domain with an
extra-territorial approach, treating it similarly to high seas.
6. Jurisdiction and Common Heritage of Mankind: The Liability Convention and Registration Convention
determine jurisdiction based on the nation responsible for launching a spacecraft. The principle of Common
Heritage of Mankind prohibits appropriation, ensuring outer space resources are for the common benefit of
all.
7. Intersection with Intellectual Property Regime: The intersection of outer space and Intellectual Property
Rights (IPR), particularly trademarks and patents, has gained attention in interdisciplinary studies.
Trademark activities related to outer space have increased, but challenges in copyright legislation remain.
8. Scope for Legal Regime: Despite progress in trademark and patent studies, the intersection between outer
space and copyright legislation is not fully recognized. A legal regime addressing this intersection becomes
crucial in the 21st century.

In summary, the complex relationship between outer space and intellectual property, the recognition of outer
space as a separate domain, and the need for a legal framework to address evolving challenges highlight the
ongoing exploration of these interdisciplinary fields.

Collision of Principles:

 IPR principles, based on exclusive rights, clash with the prohibition of appropriation in outer space
according to the Outer Space Treaty.
 John Locke's Labour Theory, emphasizing exclusive rights through appropriation, conflicts with the
non-appropriation principle in outer space.

2. Definition of Property in Outer Space:

 Outer space is defined as starting 100 km above Earth's surface, including celestial bodies such as the
Moon, asteroids, and meteors.
 Common Heritage of Mankind principle applies to outer space entities except those sent from Earth. A
resolution by IISL states that asteroids or meteors landing on Earth lose outer space status.

3. Appropriation and Satellites:


 The term "appropriation" lacks a universally accepted definition but generally refers to using or taking
another's property without consent.
 In the context of outer space, appropriation requires global consent due to the Common Heritage of
Mankind principle.
 Satellites sent from Earth may raise questions about appropriation, especially if they extract or
consume outer space resources.

4. Understanding Appropriation:

 Oxford Dictionary defines appropriation as using another's property without consent.


 Arthur Goldberg's interpretation includes setting apart a constituent of a material, consuming a
commodity, or disrupting the motion of a celestial body.
 These interpretations become part of universally accepted international law under the United Nations
Celestial Bodies Convention.

5. International Law Recognition:

 Articles 38 of the International Court Of Justice Statute recognize conventions as part of international
law, including terms officially recognized by the United Nations Celestial Bodies Convention.

In conclusion, the clash between IPR principles and the non-appropriation principle in outer space, the definition
of property, and the understanding of appropriation, especially concerning satellites, pose challenges that need
careful consideration and balance to harmonize these two distinct regimes. The need for global consent and
adherence to principles becomes crucial in navigating this intersection.

Summary: Functioning of Satellites in Outer Space - Appropriation or Mere Use

1. Satellite Launch and Velocity:

 Satellites are launched from a space station using rockets, attaining velocity through chemical reactions
at the rocket's rear end.

2. Control Mechanisms:

 Operational activities of a satellite in outer space are predominantly pre-designed, with partial control
by the launching space station.
 Satellites locate themselves on a targeted orbit and move along that orbit.

3. Forces Acting on Satellites:

 Two primary forces act on a satellite:


o Centrifugal force generated by the velocity acquired from the rocket.
o Centripetal force, gravitational in nature, pulling the satellite toward Earth.

4. Balancing Mechanism:

 The balancing mechanism involves perpendicular action of centrifugal and centripetal forces.
 This balance allows the satellite to move along its designated orbit without appropriating any property
of outer space.

5. Conclusion:

 Satellites, while collecting information subject to copyright protection, operate through a balancing
mechanism and do not engage in appropriation.
 The activity of satellites aligns with exploration and use, not conflicting with the principle of Common
Heritage of Mankind that strictly prohibits appropriation.
 Intellectual Property Rights mechanisms applicable to outer space are consistent with the non-
appropriation principle, ensuring harmony in the space domain.

Summary: Copyrightability of Information Generated by Remote Sensing Satellites

1. Satellite Launch and Functioning:

 Satellites, launched into outer space by various space organizations, examine and send information
about Earth and celestial bodies.
 Geo-synchronous satellites on higher orbits play a crucial role in data collection and analysis.

2. Types of Satellites:

 Two broad categories: Remote Sensing Satellites and Direct Broadcasting Satellites.
 Remote Sensing Satellites focus on data acquisition for analysis and research.

3. Remote Sensing Satellite Functionality:

 Sensors on satellites detect and record electromagnetic radiation emitted and reflected by Earth's
surface.
 Recorded radiation signals are sent to receiving stations for analysis.

4. Types of Information Generated:

 Raw Data: Recorded radiation signals.


 Processed Information: Transcribed data from binary language to a commonly accepted language.
 Enhanced Information: Analyzed and compiled data, involving creativity and modicum of creativity.

5. Copyright Protection:

 Artistic Work (Imagery): Protected under copyright laws worldwide.


 Literary Work (Information): Protected under copyright laws, including raw data and analyzed
information.
 Primary Information: Result of transcription process.
 Secondary Information: Compiled, involving creativity for copyright protection.

6. Legal Precedents:

 Mason v/s Montgomery Data, Inc.: Maps not generally copyrighted, but creative compilations may
receive protection.
 Burrow-Giles Lithographic Company v. Sarony: Photographs granted copyright protection due to skill,
labor, and judgment involved in capturing images.

7. Conclusion:

 Information generated by Remote Sensing Satellites, including imagery and analyzed data, is subject to
copyright protection.
 Creativity involved in the transcription, analysis, and compilation processes qualifies the data for
copyright protection under various legislations worldwide.

National and International Legislation on Copyright Protection of Satellite Imagery and Broadcasting
Signals

1. Legislation in India:

 Indian Copyright Act, 1957 initially governed protection.


 Remote Sensing Data Policy, 2020 distinguishes ownership but needs clarity on copyright aspects.
 Recognition of the difference between raw data and analyzed data is needed.

2. International Legislation:

 International Telecom Union recognizes information as subject to Intellectual Property Rights.


 Berne Convention and World Intellectual Property Organization acknowledge satellite-generated works
as literary or artistic.

3. Direct Broadcasting Satellite (DBS):

 DBS falls under Fixed Satellite Service, facilitating radio-communication.


 Operates with ground stations, uplinks, DBS, downlinks, and broadcasted content.

4. Copyrightability of Broadcasted Content:

 Broadcasted content, including sound recordings and cinematography, is considered original and
copyrightable globally.

5. Mechanism of DBS:

 Ground stations with computer systems connect to antennas capturing, sending, and receiving signals.
 Signals undergo frequency changes within the satellite for redistribution.
 Signal piracy poses threats, especially during events like the COVID-19 pandemic.

6. Signal Protection and Copyright Legislation:

 Ownership of signals linked to media houses and content generators.


 Signal protection crucial for revenue generation and combating piracy.
 Lack of a protective regime for source code in copyright legislation allows offenses related to signals.

7. Need for Legislation:

 Calls for a separate legislation recognizing the entire direct broadcasting mechanism, protecting each
constituent.
 Recognizing the owner of broadcasting elements essential for comprehensive protection.
 Existing copyright laws cover computer programs but need adaptation for signal protection.
 International conventions addressing signal protection are yet to be established, eliminating ambiguity
in global interpretations.

International Recognition, Indian Perspective, and the Way Forward for Satellite-Related Copyright
Protection

1. International Instruments Recognizing DBS:

 Brussels Convention indirectly recognizes signals but lacks regulatory authority.


 International Telecom Union acknowledges DBS efficiency but doesn't provide a separate protection
mechanism for computer-generated programs.

2. Indian Perspective:

 India has advanced in satellite connectivity but lacks specific legislative protection for individual
satellite elements.
 Previous attempts, like the Communications Convergence Bill, 2001, aimed at consolidating rules but
lapsed in 2004.
 Existing laws covering telecommunication, broadcasting, and satellite policies need an overhaul for
comprehensive protection.

3. Challenges and Signal Piracy:

 Absence of recognition for individual satellite elements leads to signal piracy.


 India lacks a consolidated law specifically addressing satellite-related copyright protection.

4. The Way Forward:

 A comprehensive interdisciplinary approach is needed to address overlapping issues between outer


space affairs and intellectual property rights.
 Recognition of satellite information under copyright regimes is crucial for creator rights and
discouraging exploitation.
 International agreements like the Berne Convention and WIPO treaties provide a generalized protection
system but may not be sufficient for satellite-related issues.
 Framing specific laws recognizing satellite-generated information under intellectual property rights is
essential for effective protection and acknowledgment of all relevant elements at the intersection of
copyright and outer space domains.

Module 5

INTRODUCTION TO FINTECH

Part 1: Introduction

 Financial system shaped by global financial crisis and rise of fintech.


 Regulatory response to crisis in progress (Basel III), while fintech regulation is still evolving.
 Paper reviews financial regulation objectives, guiding principles, and current practices.
 Identifies three core objectives, three guiding principles, and three regulatory practices.

Part 2: Objectives

 Financial regulation aims to address market failures: information asymmetry, externalities, and
monopoly power.
 Core objectives: investor and consumer protection, financial stability, and market integrity.
 Fintech introduces challenges and opportunities; regulation should align with traditional goals.
o 2.1 Reduce Information Asymmetry: Investor and Consumer Protection
 Fintech introduces risks (e.g., ICOs) and opportunities to lower information
asymmetry.
 Digital finance can empower consumers in remote areas, enhancing financial
inclusion.
o 2.2 Financial Stability
 Focus on solvency and liquidity; fintech's impact on stability still evolving.
 Bigtech entry poses challenges related to competition, data protection, and financial
stability.
o 2.3 Market Integrity
 Trust in financial transactions crucial; fintech introduces risks like money laundering.
 Privacy issues heightened; GDPR in EU addresses data protection.

Part 3: Principle-Based Regulation

 To achieve objectives, regulators use principle-based approach.


 Key principles: legal certainty, technology neutrality, and proportionality (risk-based).
 Principles adapt well to evolving fintech, promoting a level playing field.
o 3.1 Legal Certainty
 Defines regulatory perimeters and promotes transparent application of the law.
 Challenges include fast fintech development and the need for coding knowledge.
 Regulatory sandboxes and fintech licenses address challenges.
o 3.2 Technology Neutrality
 Regulators focus on functionality, not technology, to accommodate fast-paced
changes.
 Avoids taking sides, promotes industry innovation.
o 3.3 Proportionality
 Basel framework sets minimum requirements; proportionality allows flexibility.
 Questions arise on whether fintech should have full-fledged licenses or specific
function regulation.

Part 4: Regulatory Practices in Fintech

 Fintech regulation differs across activities and jurisdictions; three options: ignore, duck type, or code.
o 4.1 Ignore: "Keep It Unregulated"
 Initial approach to leave fintech unregulated; evolved as market grew.
 Increased fraud and market practices led to regulatory warnings.
o 4.2 Duck Type: "Same Risk, Same Rules"
 Regulate based on economic function or risk, irrespective of technology.
 Examples include ICO guidelines by FINMA focusing on economic function.
o 4.3 Code: "New Functionality, New Rules"
 Tailor regulations to new functionalities arising from fintech.
 Examples include blockchain implications, cross-segment expansion, and digital
operational risks.

Part 5: Conclusion

 Regulators face the challenge of balancing innovation-friendliness with zero tolerance for criminal
behavior.
 Clear objectives and guiding principles crucial for effective fintech regulation.
 Core objectives of non-digital financial regulation remain relevant for fintech.
 Early approaches were ignore or wait-and-see; similar activities treated similarly when regulation
deemed appropriate.
 Need to be alert to limits of duck typing; engage in open dialogue among stakeholders for effective
regulation.

FINTECH REGULATION

Part 1: Introduction to Fintech Regulations: Definition: Fintech regulations encompass rules governing
fintech companies leveraging technology for financial services. Industry Disruption: Fintech's growth challenges
traditional finance, posing risks like data security and consumer protection. Regulatory Evolution: Global
regulators develop frameworks to balance innovation, consumer protection, and financial stability.

Part 2: Fintech Regulatory Frameworks in the United States: OCC Oversight: The OCC regulates national
banks; in 2020, it allowed digital asset custody by national banks. CFPB Consumer Protection: The CFPB
ensures consumer protection, acting against deceptive practices in fintech. SEC Securities Regulation: The SEC
oversees securities, impacting fintech through ICO scrutiny and increased regulation. Federal Reserve Role: The
Federal Reserve regulates banks and explores central bank digital currencies (CBDCs). State-Level Variances:
Fintechs must navigate varying state regulations, with some states offering regulatory sandboxes.

Part 3: Fintech Regulations in the European Union: GDPR Compliance: Fintechs must adhere to GDPR,
governing personal data collection, use, and storage. PSD2 for Payments: PSD2 regulates payment services,
requiring banks to open infrastructure to third-party fintech providers. AMLD Anti-Money Laundering: AMLD
regulates money laundering prevention, imposing due diligence and reporting requirements. MiFID II for
Trading: MiFID II governs trading of financial instruments, requiring authorization and transparency
compliance. E-Money Directive: Regulates electronic money issuance, setting rules for authorization, capital
requirements, and consumer protection. Regulatory Sandbox: The EU provides a sandbox for controlled testing
of fintech products, offering exemptions and guidance.
Part 4: Fintech Regulations in Asia

 China's Regulations: China regulates its growing fintech sector, recently implementing stricter controls.
 Singapore's Innovation Hub: Singapore promotes fintech innovation with regulatory support, including
a regulatory sandbox.
 Japan's Balanced Approach: Japan regulates fintech with a focus on innovation, introducing sandboxes
and rules on digital currencies.
 India's Complex Landscape: India's fintech industry faces complex regulations covering e-KYC, data
protection, and payment processing.
 South Korea's Development: South Korea introduces regulations to encourage fintech innovation while
addressing data and consumer protection.

Part 5: Fintech Regulations in Africa

 South Africa's Hurdles: Despite a developed financial sector, South Africa's fintechs navigate
significant regulatory challenges.
 Nigeria's Growth Amid Complexity: Nigeria's burgeoning fintech industry faces evolving regulations,
including licensing and compliance.
 Kenya's Mobile Payments Leadership: Kenya leads in mobile payments, but fintechs must comply with
evolving regulations.
 Egypt's Growing Industry: Egypt's fintechs, while growing, face complexities in obtaining licenses and
complying with regulations.
 Ghana's Emerging Market: Ghana's fintech industry grows amidst ongoing regulatory development and
compliance challenges.

Part 6: Emerging Trends in Fintech Regulations

 Digital Identity Importance: Regulators emphasize digital identity frameworks (e.g., eIDAS, Aadhaar)
for fraud prevention.
 Open Banking Promotion: Many countries endorse open banking to enhance competition and
innovation (e.g., PSD2, Consumer Data Right).
 Cryptocurrency Regulations: Evolving regulations (e.g., AMLD5) address challenges posed by
cryptocurrencies, ensuring due diligence.
 Regulatory Sandboxes: Global trend of implementing regulatory sandboxes facilitates controlled
testing, aiding fintech innovation.
 International Cooperation: Recognizing fintech's global nature, organizations work on international
standards for cross-border regulation.

Part 7: Challenges and Opportunities for Fintech

Challenges:

 Lack of Clarity: Developing regulations lack clarity, creating uncertainty for fintech companies,
especially in areas like cryptocurrency.
 Regulatory Fragmentation: Operating across jurisdictions results in a patchwork of regulations,
challenging for fintech companies.
 Costs of Compliance: Complying with regulations, especially for smaller fintech firms, can be
expensive, limiting entry and competition.
 Technology Advancements: Rapid tech evolution poses challenges for regulators to keep up with
emerging business models and innovations.

Opportunities:

 Financial Inclusion: Fintech can enhance financial inclusion, providing services to underserved
populations and promoting economic growth.
 Innovation Drive: Fintech fuels innovation, introducing products and services to improve efficiency
and reduce costs in the financial sector.
 Consumer Protection: Fintech regulations protect consumers, ensuring the safety and transparency of
financial products and services.
 Data Protection: Regulations set standards for data security and privacy, safeguarding consumer data in
the fintech industry.

FINTECH SELF-REGULATION

Part 1: Reason behind the proposal

 Evolution of Industry Best Practices:


o Fintechs operate in a dynamic environment, prompting the need for evolving practices aligned
with legal frameworks.
o Emphasis on responsible and ethical business conduct.
 Privacy and Data Protection Norms:
o Fintechs deal with sensitive customer data.
o Importance of robust privacy measures in compliance with data protection laws.
 Preventing Mis-selling:
o Mis-selling prevention as a standard.
o Ensuring transparent marketing and sales practices.
 Promoting Ethical Business Practices:
o Crucial role of ethical conduct in maintaining customer and stakeholder trust.
o Emphasis on fair and honest dealings.
 Transparency of Pricing:
o Essential for informed consumer decisions.
o Fintechs urged to provide clear information on costs and charges.
 SRO Proposal Rationale:
o Establishing a framework for fintech collaboration.
o Addressing industry-specific issues and promoting responsible practices.
o Facilitating self-regulation and adherence to ethical and legal standards.

Functions of a Self-Regulatory Organization (SRO)

 Communication Channel:
o Bridging between member organizations and regulatory authorities.
o Facilitating effective communication, cooperation, and collaboration.
 Establishing Standards:
o Setting and enforcing industry standards and benchmarks.
o Ensuring consistency and fairness.
 Training and Awareness:
o Providing training programs for knowledge enhancement.
o Keeping industry professionals updated on best practices and regulatory requirements.
 Grievance Redressal:
o Establishing mechanisms for dispute resolution.
o Addressing conflicts among member organizations fairly and efficiently.

Part 2: Expectations outlined by RBI for fintech players

Industry Best Practices

 Continuous Evolution:
o Fintechs expected to adopt and evolve with industry best practices.
o Incorporation of the latest trends and standards.

Privacy and Data Protection Norms

 Robust Norms:
o Implementation of measures to safeguard customer data.
o Compliance with data protection laws for trust-building.

Setting Standards

 Preventing Mis-selling:
o Encouragement for fintechs to set clear standards.
o Prevention of deceptive promotion and sale of financial products.

Promoting Ethical Practices

 Core of Operations:
o Ethical business practices crucial for trust and credibility.
o Fair and honest dealings with customers, partners, and stakeholders.

Transparency of Pricing

 Customer Confidence:
o Essential transparency in pricing structures.
o Clear and understandable information for informed customer decisions.

Summary

 Role of SROs:
o Critical for promoting responsible and ethical conduct.
o Facilitate communication, uphold standards, and ensure a transparent and well-regulated
environment.

Module 6

INTRODUCTION + GENERATIONS

Part 1: Defining Biotechnology

1. Origins of the Term:


o Coined by Hungarian engineer Karl Erkay in 1919.
o Encompassed the use of living organisms for producing products from raw materials.
2. Etymology:
o "Biotechnology" combines "bio" (from Greek "bios," meaning life) and "technology" (application
of scientific knowledge for practical purposes).
3. Definition:
o Involves using life or living entities (microorganisms, plants, animals) for practical and
commercial purposes.
o Application of scientific knowledge on life processes for desired results.
o Encompasses a range of advanced technologies: biology, chemistry, biochemistry, microbiology,
protein engineering, process engineering, and genetic engineering.
4. Evolution:
o Historically involved art (e.g., wine, beer, cheese production).
o Now includes multidisciplinary advanced technologies, with a significant impact from genetic
engineering innovations.
5. Definitions by Organizations:
o No universally accepted definition.
o Various definitions by different organizations: UN Congress, European Federation of
Biotechnology, British biotechnologists, Japanese biotechnologists.
6. Broad Concept:
o Broadly defined as any technique using living organisms to make or modify products, improve
plants or animals, or develop microorganisms for specific uses.
o Multidisciplinary nature, combining various advanced technologies.
7. Biotechnological Inventions:
o Defined as inventions concerning products containing biological material or processes using
biological material.

Part 2: Historical Development of Biotechnology

1. Ancient Practices:
o Practices resembling biotechnology observed since ancient times (e.g., fermentation for wine,
beer, bread).
o Sumerians and Babylonians used yeast for beer around 6000 B.C.
2. Biotechnology Roots:
o Biotechnology traced back to zymotechnology, initially focused on industrial fermentation,
especially beer production.
3. Advancements in Ancient World:
o China discovered fermentation for preserving milk (yogurt, cheese).
o Babylonians celebrated date palm pollination rituals.
4. Ancient Bread Making:
o Egyptians discovered leavened bread using yeast by 4000 B.C.
5. Early Scientific Speculations:
o Greek philosophers (Socrates, Hippocrates, Aristotle) speculated on heredity and
reproduction.
6. Hindu Observations (1000 AD):
o Hindu philosophers observed familial diseases, believed children inherit all parents'
characteristics.
7. Medieval Developments:
o Distillation of spirits widespread by 1400 AD.
o Religious influences affected research in some regions.
8. Eighteenth Century Developments:
o Smallpox inoculation practiced for immune response.
o Cross-fertilization, crop rotation, and sterilization discovered.
9. Nineteenth Century Milestones:
o Louis Pasteur demonstrated fermentative ability of microorganisms.
o Pastuerization invented in 1873.
o Complicated techniques for mass cultivation of microorganisms introduced.
10. Twentieth Century Milestones:

 Gregor Mendel's law of heredity, Pasteur's rabies vaccine, antibiotics discovery, DNA isolation (1953),
chromosome discovery, protozoan plasmodium as cause of malaria.

1. Revolution in 1970s-1980s:

 Greatest revolution when the interaction between biology and technology gained prominence, termed
as "biotechnology."

Part 3: Generations of Biotechnology

1. Roots of Modern Biotechnology:


o Emerged in the early 1980s with the development of recombinant DNA technology or genetic
engineering.
2. Focus on Genetic Engineering:
o Modern biotechnology is primarily concentrated on genetic engineering.
o Commercial production of human insulin through recombinant DNA technology demonstrated
its potential.
3. Process and Protein Engineering:
o Development of process engineering and protein engineering enhances modern biotechnology.
o Involves methods of protein production through recombinant DNA technology.
4. Three Generations of Biotechnology:
o First Generation: Empirical practices using biological organisms (Stone Age techniques, e.g.,
bread, wine, cheese).
o Second Generation (Interwar Period): Developments in fermentation technology,
innovations like penicillin.
o Third Generation: Introduces tissue cell culture, Hibridoma technology, and recombinant
DNA technology (genetic engineering).

Part 4: Application and Scope of Biotechnology

1. Interdisciplinary and Multidisciplinary Nature:


o Biotechnology is interdisciplinary and multidisciplinary, involving concepts and methodologies
from various disciplines.
2. Diverse Applications:
o Widely applied across fields: agriculture, animal husbandry, medical and pharmaceutical industry,
forestry, fisheries, environment protection, chemical industries, food, and beverages.
3. Green Biotechnology (Agriculture):
o Addresses the hunger needs of the world.
o Biotechnology enhances traditional methods like crossing, budding, and tissue culture, replacing
them with genetic engineering for increased agricultural production.
4. Red Biotechnology (Animal Husbandry):
o Aims to produce high yields of milk, flesh, and wool through tissue culture or genetic engineering.
o Genetic engineering offers potential improvements in disease resistance and high-yield traits.
5. Biotechnology and Health Services:
o Biotechnology contributes to the medical and pharmaceutical industry, producing new drugs,
medicines, therapies, and surgical methods.
o Genetic engineering, recombinant DNA technology lead to innovative medicines and vaccines.
6. Ecological Applications:
o Biotechnology plays a role in abating pollution and protecting the environment.
o Natural microorganisms contribute significantly to waste treatment and pollution control.
o Biotechnological processes, like composting, decompose solid organic wastes, promising a clean
and green environment.
7. Global Impact:
o Biotechnology inventions impact various industries, making it indispensable in food, agriculture,
medical, and environmental sectors.
o Biotechnology's potential and reach contribute to its status as a modern-day miracle in science and
technology.

Food, Beverages, and Biotechnology

8. Addressing Hunger Needs:


1. Biotechnology aims to provide food security by genetically engineering crops.
2. Introduction of Genetically Modified Food (GMO) revolutionizes the food industry.
9. Benefits of Genetically Modified Food:
1. GMOs show higher protein levels and vitamins compared to regular food.
2. Promises improved quality, nutrition, safety, and prolonged preservation.
10. Influence on Consumable Plants:
1. Genetically engineered consumable plants like rice, wheat, tomato, and potato enhance
consumable value.
2. Increased yields observed in insect-resistant genetically modified rice and wheat.
11. Diverse Applications of Biotechnology:
1. Biotechnology extends beyond food, influencing various fields.
2. Plays a role in the mining industry for metal extraction and in developing/splitting
chemicals in the chemical industry.
3. Biotechnological techniques like tissue culture, genetic engineering, and cloning conserve
extinct species in forestry.
4. Applied in aquaculture to enhance fish production through gene transfer and cloning.
12. Global Impact:
1. Biotechnology has widespread applications in different industries.
2. Considered indispensable in food, agriculture, medical, and environmental sectors.
3. Described as a modern-day miracle due to its innovations and far-reaching impact.

Biotechnology Policy in India

4. Historical Context:
 Biotechnology's roots trace back to ancient times, primarily through fermentation
technology.
 Genetic engineering, including recombinant technology, brings biotechnology into the
spotlight.
5. National Biotechnology Policy:
 The National Science and Technology Policy and the Vision Statement on Biotechnology
guide India's biotech sector.
 Emphasis on public-private collaboration, creating a quadrilateral agreement between
universities, industry, laboratories, and the State.
6. Main Features of the Policy:
 Increasing Doctoral Programs: Aiming to strengthen academic leadership with graduate
and post-graduate programs.
 Mature Technologies: Focus on diagnostics and vaccines, encouraging private sector
participation in R & D infrastructure.
 IPR and Value of R & D: Emphasis on increasing the value of R & D and intellectual
property rights.
 Government Support: Advocates for government support, tax incentives, and financial
aid for research-intensive companies.
 SBIR Initiative: Establishing a Small Business Innovation Research Initiative to support
small and medium-sized enterprises.
 Biotechnology Parks: Creating parks to facilitate technology transfer and encourage
entrepreneurship.
 Bio-security Assessment: Calls for a national authority on biotechnology for a consistent
and effective assessment of bio-security.
7. Overall Vision: The policy envisions sustained innovation, increased focus on R & D, and a
supportive environment for the growth of the biotechnology sector in India.

BIOTECH + IP

Part 1: Biotechnology and Intellectual Property Rights (IPR)

 Biotechnology Overview:
o Biotechnology is characterized as the technology of the 21st century, with roots in traditional
production processes but witnessing significant advancements in the last 50 years.
o Modern biotechnology involves manipulating biological systems, particularly through genetic
engineering techniques.
 Intellectual Property Rights (IPR):
o Intellectual Property Rights are crucial for protecting biotechnological inventions due to the time-
consuming and costly nature of research and development (R&D) in this field.
o IPR includes patents, trade secrets, copyrights, trademarks, geographical indications, industrial
designs, and semiconductor chips.
 Legal Characterization and Trade-Related Processes:
o The emergence of modern biotechnology raises legal questions about how trade-related
biotechnological processes and products should be characterized and treated.
o The lack of internationally accepted guidelines for managing IPR in biotechnology adds
complexity to these discussions.
 Tangible vs. Intangible Property:
o Tangible property involves physical objects like land, while intellectual property is intangible,
covering patents, copyrights, trade secrets, etc.
o In biotechnology, intellectual properties incentivize industries to invest in labor, research, and
development for commercially marketable items.

Part 2: Legislative Framework

 Sensitivity in Legal Protection:


o Legal protection in biotechnology, especially agricultural biotechnology, is complex due to
technical and ethical considerations.
o The Indian biotech industry faces challenges with the Trade-Related Aspects of Intellectual
Property Rights (TRIPS) compliant patent system.
 Exclusions and Inclusions in Patent System:
o TRIPS excludes biological processes for plant or animal production but allows patents for
microorganisms and non-biological processes.
o Issues of royalty payments, material transfer agreements (MTA), and legal obligations arise
with increased transgenic research.
 Ethical Issues and Concerns:
o The patenting of new life forms, genes, DNA, cells, raises ethical questions about private
ownership and the potential impact on biodiversity, food security, and livelihoods.

Part 3: Choice of Intellectual Property Protection

 Factors Influencing Protection Methods:


o The choice between patents, trade secrets, copyrights, and trademarks depends on factors like
technological development pace, associated costs, security considerations, and the need to
show patents.
 Trade Secrets in Biotechnology:
o Trade secrets include proprietary information granting a competitive advantage, such as
hybridization conditions, cell lines, merchandising plans, or customer lists.
o Despite the unlimited duration of trade secrets, maintaining secrecy in biotechnology faces
challenges due to the research's public nature.

Part 4: Copyright and Biotechnology

 Copyright and DNA Sequences:


o Copyright may cover DNA sequence data in biotechnology, but alternative sequences coding
for the same protein can be prepared, avoiding copyright infringement.
 Trademark and Identification:
o Trademarks in biotechnology identify goods, like laboratory equipment and vectors in
recombinant research, contributing to the industry's intellectual property.
 Limitations of Copyright:
o Copyright protection is limited, allowing ideas from copyrighted material to be used for any
purpose, unlike patents and trade secrets.
 Impacts of IPR on Developing Countries:
o Developing countries like India face challenges with IPR, with concerns about bio-piracy and
the exploitation of traditional knowledge by private industries.

Part 5: Patents and Biotechnology

 Patent System Controversies:


o The patent system has been a subject of heated debates globally, particularly regarding the
recent controversies surrounding the patenting of life and biotechnological inventions.
o Critics argue that granting patents on living systems involves converting life, a natural gift,
into private property.
 Principles of Patent Law:
o Patents are viewed as a monopoly right granted to inventors for contributing new inventions to
society.
o The principles of patent law emphasize that inventions must qualify as patentable subject
matter, a concept with a broad and evolving scope.
 Evolution of Patentable Subject Matter:
o The concept of patentable subject matter has undergone significant changes, especially with
the rise of biotechnology and claims of genetically modified life forms as patentable.

Part 6: Microorganisms as Patentable Subject Matter

 Life Forms Classification:


o Life on Earth is broadly classified into lower life forms (microorganisms) and higher life
forms (plants, animals, and humans).
o Traditionally, life in any form was not considered patentable until the 1980s.
 Legal Evolution:
o Legal perspectives on patenting life shifted, starting with the German Federal Supreme Court
allowing patent protection for new microorganisms in the early 1970s.
o The debate intensified globally, reaching a turning point with the US Supreme Court's
decision in the Chakraburty case.
 Chakraburty Case:
o Dr. Chakraburty sought a patent for a genetically modified microorganism capable of
consuming crude oil spills.
o The case raised the question of whether living matter is patentable. The Supreme Court, by a
majority, ruled that non-naturally occurring, genetically engineered microorganisms are
patentable.
 Impact on Biotechnology Patents:
o The Chakraburty decision led to a surge in patent applications worldwide for genetically
engineered microorganisms, marking a new era in biotechnology patent law.

Part 7: Plant as Patentable Subject Matter

 Extension of Debate:
o The Chakraburty decision not only included microorganisms but fueled debates over patenting
other living materials, including plants.
o Biotechnological advancements, particularly in transgenic plants, prompted researchers to
claim patents for novel plant features.
 Exparte Hibberd Decision:
o In 1986, Exparte Hibberd marked another milestone as it granted a patent for maize mutants, a
living plant.
o The decision overturned the initial rejection by emphasizing that the claimed plant did not
exist in nature and was a product of human ingenuity.
 Expansion of Patentable Subject Matter:
o The decision in Exparte Hibberd laid the foundation for patenting non-natural plants, such as
genetically engineered or biotechnologically produced plants.
o Following this decision, the US Patent Office started accepting patent applications for plants
and related inventions, leading to a surge in claims for transgenic plants.
 Legal Recognition of Plant Patents:
o Legal precedents, including the HiBred International Vs. JEM AG Supply, Inc. case, upheld
patents on plants, plant cells, and tissues.
o As a result, plants and their related inventions are now considered eligible for patent
protection, marking another milestone in the intersection of biotechnology and patent law.

Conclusion: The dynamic nature of science and the versatility of biotechnology continue to drive legal
adaptations, with the law evolving to regulate and accommodate the progress in biotechnological innovations.

Summary of Part 8: Animal as a Patentable Subject Matter

3. Introduction to Animal Patents:


 Animals are considered higher life forms.
 Transgenic plants paved the way for transgenic animals.
 Chakraburty decision triggered the patenting of genetically manipulated animals.
4. First Animal Patent Claim (Exparte Allen):
 In 1987, an oyster with foreign genes was claimed for a patent.
 Opposition based on the belief that animals, being creations of nature, cannot be
patented.
 The patent office rejected the claim, citing obviousness, but did not deny the
patentability of non-natural animals.
5. Policy Shift and Oncomouse Patent:
 U.S. Patent Office stated that non-naturally produced non-human multi-cellular
living organisms, including animals, are patentable.
 In 1988, the Oncomouse, a genetically modified mouse susceptible to cancer, was
patented.
 This marked a shift in the approach to animal patenting, leading to patents on various
non-natural animals.
6. Expanding Patents to Transgenic Animals:
 At least sixteen patents were granted for inventions related to transgenic mice.
 Patents extended to transgenic pigs, rabbits, sheep, and more.
 Patent applications included animals, animal genes, tissues, and other genetic
material.
7. Biotech Industry Pressure and Policy Statement:
 Biotech industry pushed for animal patents due to their potential utility.
 The U.S. Patent Office issued a policy statement supporting the patenting of non-
naturally occurring non-human multi-cellular living organisms, including animals.
8. Biotechnological Progress and Unpredictable Developments:
 Various non-natural animals were claimed and patented.
 Unexpected developments challenged the traditional view that living beings are not
patentable.
 The U.S. judiciary's liberal approach became a foundation for patenting life forms.
9. Conclusion:
 Patent law now protects genetically modified or transgenic animals.
 A wide range of transgenic animals, from mice to cattle, received patent protection.
 The evolution of biotechnology patent law was mostly driven by judicial
interpretation.

Summary of Part 9: Patenting of Genetic Material and Biotech Processes

10. Biotech Industry Growth:


 In developed countries like the U.S., biotech became a major industry.
 Significant investments in biotech research and development.
11. Patenting Human Genetic Material:
 Surge in patents on human genetic material in the U.S.
 Thousands of gene patents awarded, with more pending.
12. Human Genome Project Impact:
 Human genome decoding revolutionized medical science.
 Over 100,000 provisional patent applications pending on various segments of the
human genome.
13. Extensive Patentable Subject Matters:
 Patent protection extended to various living beings, from plants and animals to
microorganisms.
 Processes for isolating and utilizing genetic material patented.
 Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement endorsed
the U.S. approach internationally.

Summary of Part 10: Patent Law and Biotechnology in India

14. Patent Act 1970 and Initial Biotech Gap:


 The Indian Patent Act did not initially address biotechnological inventions.
 Biotech industry gained momentum in India with global developments.
15. TRIPS Agreement Influence on Indian Patent Law:
 India amended its patent law in 1999, aligning with TRIPS requirements.
 Further amendments in 2002 and 2005 brought significant changes.
16. Biotech Patent Law Evolution in India:
 Patents granted on living beings before TRIPS implementation.
 Amendments facilitated the patenting of living organisms, processes, and products.
 Budapest Treaty recognition for depositing microorganisms for patent procedures.
17. Ongoing Changes and International Recognition:
 Continuous amendments to align with international standards.
 India's biotechnology patent law evolution recognized internationally.
 A liberal interpretation allowing product and process patenting in the biotech field.

BIOTECH, TRADE + DEVELOPMENT

Part 1: Biotechnology in Agriculture

1. Biotechnology in Agriculture:
o Biotechnology, particularly agro-biotechnology, offers opportunities to enhance agricultural
productivity and reduce food production costs.
o The principal contribution is the creation of Genetically Modified Organisms (GMOs) or
crops with desired traits like pest resistance, longer shelf life, and improved growth in adverse
conditions.

Summary of Part 2: WTO Agreements and CBD Concerns on GMO

1. International Framework:
o WTO agreements, specifically the SPS Agreement and TBT Agreement, address trade
concerns related to GMOs.
o The CBD acknowledges the potential adverse effects of GMOs on biological diversity and
introduces the Cartagena Protocol on Biosafety (CPB) to regulate cross-border trade and
accidental release of GMOs.

Summary of Part 3: Agreement on Sanitary and Phyto-sanitary Measures (SPS)

1. SPS Agreement:
o SPS mandates that measures must be based on scientific principles and not maintained without
sufficient scientific evidence.
o Requires risk assessment techniques developed by international organizations and emphasizes
transparency in regulations.
o Allows stricter measures than international standards with sufficient scientific justification.

Summary of Part 4: Agreement on Technical Barriers to Trade (TBT)

1. TBT Agreement:
o Applies to technical barriers not related to sanitary or phytosanitary purposes.
o Prohibits unjustifiable discrimination against imports through technical regulations.
o Standards must not be more trade-restrictive than necessary, with no strict scientific
justification required compared to SPS Agreement.

Summary of Part 5: Convention of Biological Diversity (CBD)

1. CBD and Cartagena Protocol:


o CBD defines biotechnology and recognizes the precautionary approach.
o Cartagena Protocol on Biosafety addresses potential risks of cross-border trade and accidental
release of GMOs, reflecting concerns for biological diversity.

Summary of Part 6: GMO and Bio-safety Concerns


1. Safety Concerns in Biotechnology:
o Genetically modified organisms (GMOs) and living modified organisms (LMOs) raise
environmental and biological safety concerns.
o Debate exists on the potential adverse effects of GMOs on human health and the environment.
o The Cartagena Protocol on Biosafety emerged to regulate the trade, handling, and use of
genetically modified products, responding to global concerns and demands for transparency
and labeling.

Summary of Part 7: The Cartagena Protocol on Biosafety and Biotechnology

4. Context and Purpose: Earth Summit 1992 discussions led to concerns about biotechnology's
potential and the need for international regulation, reflected in Agenda 21 and CBD Articles
8(g) and 19. Article 8(g) emphasizes the need for nations to regulate risks associated with
living modified organisms (LMOs) from biotechnology.

Summary of Part 8: Understanding the Strategy of Regulating Environmental Concerns of Trade in


GMOs

5. Priority of Bio-safety: Nations prioritize bio-safety at both international and domestic levels,
particularly regarding genetically modified organisms (GMOs). Cartagena Protocol provides a
framework for advanced consent, safety precautions, and a clearinghouse for experimentation
involving GMOs.

Summary of Part 9: Advanced Informed Agreement (AIA) Procedure

6.
AIA Procedure Overview: AIA is a prior notification and consent procedure for exporting
and importing LMOs, forming the core of the Cartagena Protocol. Applies to a small
percentage of traded LMOs. The exporting party must notify the importing party in writing,
revealing taxonomic details, modification techniques, and regulatory status. The importing
party acknowledges receipt and decides whether to proceed within 90 days. A risk assessment
is crucial, and decisions may include approval with conditions, prohibition, request for more
information, or an extension of the response deadline. The protocol establishes a Bio-safety
Clearing-House for information exchange. Liability and redress mechanisms for damage
resulting from transboundary movements are debated, with unresolved questions about
implementation.
Summary of Part 10: Liability and Redress under the Protocol

7. Liability and Redress: The Cartagena Protocol addresses liability and redress for damage
from transboundary movements of LMOs. The discussions revolve around creating a
mechanism for exporters to pay for damages and the challenges in implementing such a
provision. The need for a liability mechanism is acknowledged, but the details of "how" and
"when" to implement it remain unresolved. The summary provides an overview of the
discussions on the Cartagena Protocol, its goals, the AIA procedure, and the ongoing debate
regarding liability and redress mechanisms.

Summary of Part 11: Cartagena Protocol and WTO

8. Synergy and Conflict: The Cartagena Protocol focuses on the transboundary movement of
Living Modified Organisms (LMOs), emphasizing safety and environmental impact. Potential
conflicts arise with the WTO (World Trade Organization), which aims to secure trade
interests, leading to a need for mutual understanding and synergy. Other agreements related to
trade, international transit, and health also play a role in the context of LMOs.

Summary of Part 12: Indian Response to International Developments on GMO

9. Constitutional Alignment: The production of GMOs raises ethical, environmental, economic,


and health concerns. The Indian response emphasizes the need for a legal framework aligned
with the Constitution, considering Directive Principles of State Policy (DPSPs) such as Article
47 and Article 48A. While GMOs are not specifically addressed in Indian domestic laws,
guidelines like the Recombinant DNA Safety Guidelines and legislations like the Protection of
Plant Varieties and Farmer’s Rights Act, 2001 and the Biodiversity Act, 2002, attempt to
regulate aspects of biotechnology.

Summary of Part 13: Recombinant DNA Safety Guidelines

10. Guidelines Overview: The Recombinant DNA Safety Guidelines (1990, Amended in 1994)
by the Department of Biotechnology, Ministry of Science and Technology, address various
issues related to recombinant DNA technology. Institutional mechanisms, including
committees like Recombinant DNA Advisory Committee (RDAC), Institutional Bio-safety
Committee (IBSC), Review Committee on Genetic Manipulation (RCGM), and Genetic
Engineering Approval Committee (GEAC), are proposed for implementation.

Summary of Part 14: Indian Council for Medical Research (ICMR) Guidelines on GMO

11. ICMR Guidelines: ICMR (Indian Council for Medical Research) has formulated draft
guidelines in 2007 for the safety assessment of foods derived from genetically engineered
plants. These guidelines aim to assess whether GM foods present new or greater risks
compared to traditional counterparts and ensure reasonable certainty of safety under
anticipated conditions of processing and consumption.

Summary of Part 15: Protection of Plant Varieties and Farmer’s Rights Act, 2001

12. Legislation Overview: The Protection of Plant Varieties and Farmer’s Rights Act, 2001, is a
response to TRIPs obligations, providing protection to breeders through Plant Breeder Rights
(PBR). Farmers' rights, including the privilege to save, exchange, and sell seeds, benefit-
sharing, and ownership, are recognized. However, concerns arise about the impact on
traditional farming practices and farmers' ability to reuse and sell protected seeds. The
summary captures key points related to the Cartagena Protocol, WTO interactions, India's
response to GMOs, guidelines, and legislations influencing the regulation of genetically
modified organisms in India.

Summary of Part 16: The Biological Diversity Act, 2002

13. Regulation of GMOs: The Biological Diversity Act, 2002, in India, addresses concerns
related to GMOs. Aims include the conservation of biological diversity, sustainable use, and
fair sharing of benefits from biological resources and knowledge. Genetic material of plants,
animals, and micro-organisms is considered part of "biological resources" under the Act. Prior
approval from the National Biodiversity Authority is required for obtaining biological
resources for research, commercial use, or bio-survey. Prohibits applying for intellectual
property rights related to inventions based on Indian biological resources without authority
approval. Criticized for not providing a holistic approach to concerns in agro-biotechnology,
lacking a strict regulatory framework needed for biodiversity maintenance in the technological
age.

Part 17: Summary

14. Cartagena Protocol Evaluation:


 The Cartagena Protocol represents a rational approach to international GMO
regulation in the absence of consensus on the risks posed by GMOs.
 The Protocol's 'not subordinate' nature implies a sense of urgency for collaborative
preventive action, avoiding WTO disputes with detrimental impacts on trade and the
environment.
 Highlights of the Cartagena Protocol include its treatment of the precautionary
principle, norms for GMO labeling, the Bio-safety Clearing-House, and the
Advanced Informed Agreement procedures.
 Weaknesses include lack of specific details in labels, exclusion of processed plant
and animal products from labeling, and exemption of GMOs in the pharmaceutical
industry.
 The Protocol is deemed a mixed package, postponing some tough issues and leaving
others unsettled through ambiguity.
 Despite shortcomings, the Cartagena Protocol is recognized for setting up a
framework for information distribution, subjecting potentially dangerous GMO
imports to importers' approval, and contributing to international environmental law
and enlightened trade policy-making.

BIOTECH + HUMAN RIGHTS

Part 1: Natural Law, Human Rights, and Biotechnology

Natural law principles are pre-moral and universal. Human rights, tied to the intrinsic values of life (dignity,
integrity, etc.), are universal. Biotechnology's manipulation of living beings raises concerns about disturbing
inherent values. Patenting biotechnological inventions serves as an incentive but raises ethical questions and
human rights concerns.

Part 2: Biotechnology from Human Rights Perspectives

 Biotechnology involves practical applications of living organisms for industrial purposes.


 Multidisciplinary in nature, it spans biology, chemistry, biochemistry, etc.
 Human intervention in biological processes raises ethical questions and human rights concerns,
especially in genetic research.

Part 3: Biotechnology and Human Genetic Research

 Genetic research enables organ production for transplants and cures for genetic diseases.
 Manipulation of human genetic material sparks debates, with ethical and human rights concerns.
 Research in human genomics, embryonic research, and stem cell research faces criticism from human
rights forums.

Part 4: Patenting Human Genetic Material and Human Rights

 Biotechnology's capacity to manipulate extends to humans, raising ethical questions.


 Patenting human genetic material, despite objections, becomes prevalent in the U.S. in the 1990s.
 Critics argue that patenting genes and DNA violates human dignity and equates to a form of slavery.

Part 5: Patenting Human Cell Lines and Human Rights

 Patenting human cell lines becomes a focal point, exemplified by the John Moore case.
 The Supreme Court of California allows patenting isolated cell lines, emphasizing the scientific
perspective.
 Instances, including a U.S. government patent claim, prompt international criticism and reflect the
ongoing struggle to balance biotechnological advancements with human rights considerations.

Part 6: Human Cloning

Introduction:

 Cloning involves producing identical organisms through various methods, including embryo division
and nuclear transfer.
 Dolly, the cloned sheep in 1997, sparked ethical debates and concerns about the implications of
cloning.

Legal Standpoints:
 The U.S. takes a firm stance against patenting or cloning human beings, citing the thirteenth
amendment to the Constitution.
 Pioneer Hibred International case emphasized that human cloning violates public policy and human
dignity.
 The U.S. patent office supports this view, holding that transgenic human beings are not patentable
under the constitution.
 Despite prohibiting cloning for reproduction, therapeutic cloning is allowed, raising debates about
ethical considerations.

Legislation and Policy:

 In 2003, the U.S. introduced legislation prohibiting human cloning, with ten years' imprisonment for
violations.
 The U.N.'s Universal Declaration on the Human Genome and Human Rights (UDHGHR) prohibits
reproductive cloning as contrary to human dignity.
 The U.N. Declaration on Human Cloning seeks to ban all forms of cloning, though not binding on
member-states.

International Perspectives:

 The Expert Group on Human Rights and Biotechnology recognizes therapeutic cloning's potential but
acknowledges controversy in reproductive cloning.
 The Ad Hoc Committee on an International Convention Against Reproductive Cloning supports
banning reproductive cloning, with debate on therapeutic cloning.
 The World Health Organization deems reproductive cloning morally unacceptable but encourages non-
reproductive cloning research for tissue repair.

Legal Position in India:

 India opposes reproductive cloning as unethical and contrary to respect for human beings.
 Stem cell research in India is regulated by ICMR guidelines and DNA safety guidelines.
 Draft guidelines for stem cell research allow research on embryonic stem cells but prohibit therapeutic
cloning.
 Two committees, NAC-SCRT and IC-SCRT, are planned to oversee and regulate embryonic stem cell
research in India.

Conclusion:

 Cloning remains a contentious issue globally, with debates around ethics, human rights, and the balance
between scientific progress and moral considerations.

Part 7: International Conventions on Human Rights Issues in Biotechnology

European Union Convention for the Protection of Human Rights and Fundamental Freedoms:

 Aligns with the Universal Declaration of Human Rights, emphasizing inherent human dignity.
 Prohibits patents violating human dignity and freedom under the convention, especially in the context
of genetic material patents.
 Aims to balance research progress with human dignity, particularly concerning patents on DNA, genes,
and cell lines.

Convention on Human Rights and Biomedicine:

 Focuses on protecting human dignity in biomedical research.


 Requires informed consent for research involving human beings, tissues, organs, or the human genome.
 Prioritizes the interests and welfare of individuals over the sole interest of science.
 Prohibits the use of human body parts for financial gain.
 Addresses concerns about the misuse of human embryos and prohibits the creation of embryos solely
for research.

Declaration on Human Genome and Human Rights:

 Addresses human rights concerns in biology, genetics, and medicine.


 Recognizes freedom of research within ethical standards and human dignity.
 Encourages research to guarantee the right to health and alleviate suffering.
 Prohibits certain biotechnological techniques, such as germ line intervention, that are contrary to
human dignity.
 Urges member states to implement legal measures respecting ethics and human rights.

Conclusion:

 International conventions reflect a commitment to balancing biotechnological advancements with


human rights and dignity.
 Emphasis on informed consent, prioritizing welfare, and prohibiting unethical practices highlights the
global consensus on ethical biotechnological research.

Part 8: TRIPS Agreement, Biotechnology, and Human Rights

TRIPS Agreement:

 Universal agreement addressing ethics, morality, and public order as restrictions on patentability.
 Excludes inventions against public order, morality, or detrimental to human, animal, or plant dignity
and health from patentability.
 Prohibits patenting of surgical, therapeutic, and diagnostic methods for human treatment.

Human Cloning and TRIPS Agreement:

 Advocates of human rights argue that TRIPS excludes human cloning and patenting of human beings.
 Patenting cloning methods and research in human cloning is deemed to violate the TRIPS agreement.
 TRIPS agreement aligns with human rights principles by excluding unethical patents on human beings
and certain medical methods.

Part 9: European Union Directive on Human Rights Issues in Biotechnology

European Union Directive:

 Comprehensive mechanism regulating biotechnology, addressing human rights and dignity concerns.
 Acknowledges advancements like human genetic research, embryo cloning, and stem cell research
while cautious about related human rights issues.
 Empowers the European Group on Ethics in Science and New Technologies to evaluate ethical and
human rights concerns regularly.

Exclusions from Patentability in Human Genetics under the Directive:

1. Human body at various stages of formation and development, including the discovery of its elements.
2. Inventions contrary to public order and morality, such as cloning of human embryos, modifying germ
line genetic identity, use of embryos for commercial purposes, and modifying animal genetics causing
unjustified suffering.

Conclusion:

 The European Union Directive serves as a regulatory framework addressing ethical and human rights
challenges posed by biotechnological developments.
 Exclusions from patentability reflect a commitment to preventing the violation of human dignity and
ethical standards.

BIOTECHNOLOGY + BIODIVERSITY

Part 1: Introduction

 Biological diversity is fundamental to biotechnological progress, providing resources for improving


plant and animal productivity.
 Challenges arise in protecting biodiversity due to globalized economic shifts towards strict intellectual
property rights.
 Striking a balance between protecting innovation and preventing exploitation of biological resources is
crucial.

Part 2: Convention on Biological Diversity (CBD)

 CBD originated from the United Nations Conference on Environment and Development (UNCED) in
1992, focusing on conserving Earth's biological diversity.
 Intellectual property rights addressed in three CBD articles relating to indigenous people.
 CBD objectives include conservation, sustainable use of components, and fair benefit sharing from
genetic resource utilization.

Part 3: Defining Biodiversity

 CBD distinguishes between biodiversity and biological resources, defining the former as variability
among living organisms.
 The Indian Biodiversity Act aligns with CBD's definition, emphasizing the variability within and
between species and ecosystems.
 Biodiversity, in essence, encompasses the multifaceted expressions of life on Earth, requiring
conservation for sustainability.

Part 4: Bio-Prospecting or Bio-Piracy?

 Debates surround the relationship between intellectual property rights, genetic resource appropriation,
and traditional knowledge.
 Bio-prospecting involves exploring plants and animals for commercially valuable genetic resources,
while bio-piracy refers to exploiting indigenous knowledge commercially.
 Disputes arise over whether life can be "owned" and if corporations have the right to own components
of traditional knowledge systems.

Part 5: Controversial Bio-Piracy Cases in India

1. Turmeric:
o U.S. Patent Office granted patents to the University of Mississippi Medical Centre for the "use
of Turmeric in wound healing" in 1995.
o Indian government challenged and revoked the patent, emphasizing turmeric's medicinal use
in India for thousands of years.
2. Neem:
o W.R. Grace and the U.S. Department of Agriculture filed a patent application for a method
involving neem oil's fungicidal effects.
o Patent revoked due to the known and centuries-old use of neem seeds in India.
3. Basmati Rice:
o Rice Tec Inc. filed a generic patent on basmati rice in the U.S., claiming exclusive rights over
novel Basmati lines and grains.
o Patent revoked as basmati rice is a staple in India and considered part of Indian biological
resources.
4. Amla:
o The U.S. Patent and Trade Mark Office (USPTO) granted five patents on amla to Unilever
Corporation, claiming its use in a hair coloring preparation.
o Amla, a traditional ayurvedic ingredient, has been used in India for thousands of years.
5. Karela and Jamun:
o The USPTO granted a patent on Karela (Bitter gourd) and Jamun (Syzigium Cumini) for
reducing sugar levels.
o Patent granted despite the use of these herbs being mentioned in several Indian texts.
6. Other Controversial Patents:
o Patents granted on Anar, Salai, Dudhi, Gulmendhi, Bagbherenda, Rangoon-ki-bel, Erand,
Vilayetishisham, Chamkura.
o Urgent need for the Indian government to challenge and revoke these patents to protect rich
biological resources.

Conclusion:

 India faces challenges of bio-piracy and controversial patents on its biological resources.
 The need for stringent laws and international cooperation is crucial to safeguard biodiversity and
traditional knowledge from exploitation.

Part 6: The TRIPS and CBD Controversy (Continued)

The controversy between the TRIPS agreement and the CBD is complex, and member states hold different
views:

1. Some argue there is no conflict, and the two can be implemented mutually.
2. Others suggest further study is needed on the patent system's impact.
3. Some propose international intervention to ensure mutual support.
4. The most debated view suggests an inherent conflict, requiring amendments to the TRIPS agreement.

CBD Objectives vs. TRIPS Objectives:

 CBD aims to conserve biodiversity, ensure sustainable use, and facilitate fair benefit sharing from
genetic resource utilization.
 TRIPS focuses on providing private rights over innovations, including those resulting from the use of
biological resources.

Conflicting Views:

 CBD aligns with developing countries' interests, emphasizing sovereign rights over biological
resources.
 TRIPS caters to corporate interests, especially the life sciences industry, and imposes obligations that
may conflict with CBD.

Differing Principles:

 CBD recognizes traditional knowledge's role in biodiversity conservation and insists on its protection.
 TRIPS, based on Western-style patents, lacks mechanisms for recognizing or protecting biological
resources.

Conflict Resolution:

 CBD mandates free prior informed consent for access to genetic resources, while TRIPS may hinder
benefit sharing and sustainable utilization.
 The Bonn Guidelines encourage consent and benefit sharing, but TRIPS obliges states to protect
monopolies, hindering biodiversity conservation.

Inherent Conflict:
 The fourth view suggests an inherent conflict, necessitating TRIPS amendments to align with CBD
objectives.
 CBD gives sovereign rights to member states, allowing them to decide whether biological resources
should be patentable.

Unclear Provisions:

 Article 22(1) of CBD states it should not affect existing international agreements unless causing serious
damage to biodiversity.
 TRIPS contains no explicit reference to CBD or other environmental agreements, leading to
uncertainty in case of conflicts.

Views on Compatibility:

 Some developed countries argue that CBD and TRIPS are not in conflict and can be implemented
mutually.

Part 7: The Indian Biological Diversity Act

Introduction:

 In December 2002, India enacted a comprehensive Biological Diversity Act restricting access to
biological material within its territory.

Objectives:

 Aims to promote conservation, sustainable use, and equitable benefit sharing of India's biodiversity
resources.

Key Features:

1. Establishment of Authorities:
o National Biodiversity Authority, State Biodiversity Boards, and Biodiversity Management
Committees at local levels.
2. Restrictions on Foreign Entities:
o Prohibits foreign individuals or corporations from obtaining biological resources or associated
knowledge without prior approval.
3. Benefit Sharing:
o Requires equitable benefit sharing for the use of accessed biological resources, by-products,
and associated knowledge.
4. Intellectual Property Rights:
o Prohibits applying for intellectual property rights for inventions based on research or
information on biological resources without approval.

Loopholes and Criticisms:

 Exemptions for plants under the Protection of Plant Varieties and Farmers' Rights Act.
 Soft treatment of Indian entities, requiring only prior intimation for commercial use.
 Weak representation of local communities in decision-making bodies.
 Lack of empowerment for local communities to protect their resources and knowledge.

Conclusion:

 While criticized for flaws, some see the Biological Diversity Act as a tool to preserve biodiversity and
traditional knowledge with necessary amendments.
Module 8-

IMPORTANCE OF FORENSIC SCIENCE IN LAW

Introduction:

 The application of science and technology in crime identification and justice administration in India
has a historical foundation dating back to the 'Arthashastra' of Kautilya.
 Forensic science, also known as criminalistics, has become a crucial component of the legal system,
evolving from ancient methods to a multidisciplinary approach.

Meaning of Forensic Science:

 Forensic science involves the application of scientific methods to legal matters, serving as a vital tool
in investigating and analyzing evidence from crime scenes.

Nature and Scope of Forensic Science:

 Forensic science draws on principles from traditional sciences like biology, physics, and chemistry,
expanding to include specialized branches such as forensic odontology, toxicology, anthropology, and
criminalistics.
 It is a significant investigative tool, answering questions in criminal, civil, and social contexts by
examining physical evidence and presenting expert testimony.

Categories of Forensic Science:

1. Criminalistics:
o Focuses on the detection, identification, and assessment of physical evidence using natural
science principles.
o Involves analyzing trace evidence like glass, hair, and blood to recreate events, applicable not
only to criminal but also civil and regulatory cases.
2. Forensic Odontology:
o Helps identify victims by examining teeth, mouth structure, and restorative dental corrections.
o Plays a crucial role in bite mark research in criminal cases.
3. Forensic Toxicology:
o Deals with identifying and monitoring toxins and drugs in biological samples.
o Essential in cases of accidents, poisoning, and drug-related incidents, providing information
on substance presence and dosage.
4. Forensic Anthropology:
o Analyzes injured human remains or skeletons to ascertain gender, height, age, and ethnicity.
o Aids in recognizing victims and determining the time of death, especially in unrecognizable
conditions.
5. Impression and Pattern Evidence:
o Involves the examination of impressions like fingerprints and three-dimensional patterns such
as markings on bullets.
o Criminalists analyze friction ridge patterns, loops, whorls, and arches to link crime scenes
with suspects or tools.
6. Forensic Pathology and Medico-legal Death Investigation:
o Forensic pathology determines the cause of death by examining a corpse.
o Medico-legal death investigation involves processing medical samples, with forensic
pathologists providing evidence admissible in court.
7. Trace Evidence:
o Created when two objects come in contact, leaving behind traces exchanged during the
interaction.
o Includes fingerprint, tire and footprint analysis, and fiber analysis, aiding in linking
individuals or objects to a crime scene.
3.8. Ballistics:

 Forensic technology involving the motion, conduct, and effects of projectiles like bullets, rockets, etc.
 Used in criminal cases for identifying guns and linking crimes based on ballistic details.
 Ballistic details stored in a global database accessible to law enforcement agencies.

3.9. Questioned Documents Examination (QEE):

 Focuses on contested documents in legal cases.


 Involves analysis of alteration, paper, forgery, and other issues.
 Indented writing's significance in detecting alterations.
 Techniques include low angle oblique light, photography, and Electrostatic Detection Apparatus for
imaging.

3.10. DNA Evidences:

 Utilizes unique gene markers for individual identification.


 DNA acquired from articles with body fluids like saliva, semen, or blood.
 Tests conducted to identify genetic markers and substances like alcohol or narcotics in toxicology.

4. Forensic Science and Legal Statutes:

 Forensic professionals gather, examine, and present evidence in court.


 Indian laws recognize forensic scientists as experts.
 Indian Evidence Act 1872 allows opinions of experts in science and identification as relevant facts.
 Criminal Procedural Code empowers forensic examinations for crime-related samples.

5. Landmark Cases - "Neeraj Grover Murder Case":

 Involved planning and execution of murder by two accused.


 Accused attempted to eliminate evidence, burning the victim's body.
 Forensic science played a crucial role in evidence collection, including DNA testing.

5.1. Landmark Cases - "Nirbhaya Case":

 Rape and murder case in Delhi involving brutal assault on a female victim.
 Forensic evidence, including DNA, fingerprints, and bite marks, played a pivotal role.
 Supreme Court relied on forensic analysis to sentence the offenders to capital punishment.

6. Education and Growth of Forensic Science in India:

 Rise in population leads to an increase in crime.


 Forensic science education should be an essential part of the curriculum.
 Limited job opportunities for forensic science graduates, especially in government labs.
 Private labs emerging but face challenges in gaining acceptance in the legal system.

CONCLUSION:

 Ancient legal procedures lacked formal forensic processes.


 Forensic science is crucial for logical conclusions in modern criminal justice.
 Labs at state and national levels assist investigations with forensic evidence.
 Encouragement needed for skilled medical practitioners in medical legal work.
 Continuous improvement in evidence perception and court recognition of forensic professionals is vital
for the justice system.

FORENSIC SCIENCE/TECH/LAW
Introduction:

 Science's progression has introduced sophisticated identification technologies.


 Evolution from primitive fingerprint identification to the era of biometric technology.
 Biometrics involves recognizing humans based on intrinsic physical or behavioral traits.
 Characteristics include face, fingerprint, iris, and ongoing research explores vascular patterns, hand
geometry, DNA, and body odor.
 Behavioral biometrics encompasses handwriting, voice, keystroke patterns, and emerging fields like
gait recognition.

Challenges and Controversies in Biometrics:

 Despite advancements, biometrics faces challenges and controversies.


 Example: In 2002, a researcher breached a biometric system using fake fingerprints from Gummi Bear
sweets.
 Instances of erroneous imprisonment due to 'false positives.'
 Civil liberties organizations emphasize privacy concerns and caution against overreliance.
 Nevertheless, substantial investments indicate continued growth in the European market.

Generations in Forensic Technology:

 Forensic technology evolution categorized into first and second generations.


 First-generation includes traditional forms like handwriting, fingerprints, and ballistics.
 Limitations: Experiential, observational, and limited applicability.
 Second-generation embraces biometric technologies, DNA typing, data mining, and location tracking.
 Characteristics: Wide applicability, scientific robustness, and sophisticated methodologies.

Implications of Second-Generation Forensic Sciences:

 Second-generation forensic sciences offer wider applicability to various offense types and cases.
 Scientific rigor demands specialized knowledge, making these techniques less accessible to laypersons.
 Tool and methodology sophistication raises concerns about proprietary interests.
 Departure from reactive nature to proactive methodologies capable of identifying suspects from the
outset.
 Transformative shift with opportunities and challenges, necessitating a nuanced approach to privacy,
security, and ethical use.

Science of Biometric Technology:

1. Introduction:
o Biometrics involves using unique and unchanging human traits for recognition.
o Traits must be unique and resistant to change for effective recognition.
o Examples include fingerprints, face, hand geometry, speaker, iris, DNA, ear, gait, and more.
2. Commonly Used Biometrics:
o DNA:
 Ultimate unique code for individuality, used mainly in forensic applications.
 Challenges include contamination, sensitivity, real-time recognition issues, and privacy
concerns.
o Ear:
 Ear shape and cartilaginous tissue structure considered distinctive.
 Ear recognition relies on matching distances of salient points, but not highly distinctive.
o Face Recognition:
 Non-intrusive, hands-free, and accepted by most users.
 Captures facial images and models key features for continuous authentication.
o Fingerprints:
 Accounts for a significant portion of biometric technology sales.
 Analyzes friction ridges on fingertips for unique patterns.
o Gait:
 Complex spatio-temporal biometric related to walking style.
 Discriminatory in low-security applications but may not be highly distinctive.
o Hand and Finger Geometry:
 Measures physical characteristics like length, width, thickness, and surface area.
 Used in physical access control, time and attendance systems, and personal
authentication.
o Iris:
 Unique iris patterns, detectable in video pictures and isolated from external environment.
 Highly random pattern with many degrees of freedom, stable throughout life.
o Retinal Scanning:
 Uses vascular patterns of the retina for personal authentication.
 Stable patterns throughout an individual's life, requires user cooperation.
o Signature Verification:
 Measures dynamic signature features like speed, pressure, and angle.
 Focus on e-business applications due to the uniqueness of signatures.
o Voice Recognition:
 Identifies a speaker from acoustic features of speech.
 Sensitive to background noise, suitable for phone-based applications.
3. Performance Considerations:
o No biometric technology can guarantee 100% accuracy.
o Each biometric has its own advantages and limitations.
o User acceptance, ease of use, and technical considerations impact performance.
4. Implications and Challenges:
o Privacy concerns, proprietary interests, and security implications.
o Second-generation biometrics pose challenges in disclosure and validation.
o Proactive methodologies capable of identifying suspects from the outset.
o Nuanced approach required for ethical use, balancing privacy and security concerns.

Biometric Technology – Indian Case Law Analysis:

5. Data Protection Laws in India:


 Nascent stage with the need for safeguards in emerging economies.
 Constitution under Article 21 provides privacy laws, but insufficient for data protection.
 IT Act, 2000, introduced provisions for the protection of stored data.
6. Personal Data Protection Bill:
 Introduced in 2006 to protect personal information and prevent unauthorized usage.
 Aims to entitle individuals to claim compensation for disclosure without consent.
 Specifies the nature and quantum of data for specific purposes.
7. Information Technology Act, 2000:
 Provides legal recognition for electronic transactions and e-commerce.
 Section 69 allows interception, monitoring, and decryption for cybercrime investigation.
 Imposes penalties for unauthorized data downloading, introduction of computer
contaminants, and tampering.
8. IT (Amendment) Act, 2008:
 Substituted Section 66, focusing on dishonest or fraudulent acts.
 Introduced Section 43-A for compensation for failure to protect data.
 Added sections like 67, 69, 72, 74, addressing data protection.
9. Challenges and Globalization:
 Increased BPO industry in India necessitates data protection legislation.
 Concerns raised about employees or systems leaking personal information without
consent.
 Global expectations for data protection due to the outsourcing industry's involvement.
 European Union guidelines require data protection laws for transacting with other
countries.
10. Incidents Questioning Data Protection:
 Instances of data breaches and frauds leading to embarrassment for the outsourcing
industry.
 Lack of data protection laws affects Indian BPO outfits, limiting them to lower-end value
chain work.
 Restrictions in financial, HR, medical domains due to compliance requirements and
privacy laws.
11. Impact on Various Sectors:
 Financial sector limited in offshoring due to statutory compliance and data privacy laws.
 HR domain faces restrictions on sharing personal information.
 Medical domain requires protection for patient history.
 Identity theft concerns in credit card transactions necessitate protection.
12. Call for Legislation and Protection Measures:
 Need for comprehensive data protection laws to prevent data flow to non-complying
countries.
 Lack of legislation may result in a loss of data processing business for Indian companies.
 Past incidents highlight the urgency for robust data protection measures in India.

FINGERPRINTING TECH

Introduction: The pivotal role of forensic evidence, particularly fingerprinting, in criminal investigations.
Evolution and significance of forensic evidence in proving crimes, establishing key elements, and aiding in the
identification of suspects.

Science of Fingerprinting Technology:

 Skin Structure and Friction Ridges: Recognition of skin as a complex organ with multiple tissues,
sensory receptors, and a vascular network. Friction ridges on hands and feet are distinctive due to unique
patterns and heightened nerve and pore concentrations.
 Types of Fingerprints:
o Plastic fingerprints:
 Formed when a finger presses against materials like wax, gum, or newly painted objects.
 Easily detected due to their visibility to the naked eye.
o Contaminated prints:
 Result from fingers pressed in a layer of dust, with some dust adhering to friction ridges.
 Identifiable when the finger touches another surface.
o Latent fingerprints:
 Develop from small amounts of grease, sweat, or dirt on touched objects.
 Various methods like dusting, iodine, and lasers used for development.
 Fingerprint Characteristics:
o Approximately 2,700 ridge units per square inch of friction skin.
o Ridge characteristics formed at the junction of the outer (epidermis) and inner (dermis) skin layers.
o Perspiration, salts, and skin oil leave distinctive patterns on surfaces touched by fingertips.
 Technological Advances:
o Historical method involved recording fingerprints with ink on paper.
o Modern databases enable law enforcement to store and access digital fingerprints globally.
o Automated fingerprint identification relies on scanning devices for digital minutiae conversion,
facilitating high-speed processing.

Fingerprinting Technology – Legal Scenario:

 Legislation in India:
o Identification of Prisoners Act, 1920 grants authority to law enforcement for fingerprinting of
convicted and non-convicted individuals.
o Magistrates empowered to direct fingerprinting during investigations and criminal trials.
o Fingerprint evidence deemed admissible in court under the Indian Evidence Act.
 Case Law Analysis (Indian):
o Courts rely on expert opinions, often corroborated by other evidence.
o Fingerprinting not considered self-incrimination under Article 20(3) of the Indian Constitution.
o Fingerprint evidence used to corroborate substantive evidence in court.
o Courts exercise caution, examining characteristics using magnifying glasses.
 Case Examples:
o Illustrative cases highlight successful identifications through chance prints, aiding in crime
resolution.
o Courts emphasize reliance on expert opinions when supported by corroborative evidence.
o Detailed analysis of cases where fingerprinting played a decisive role in establishing guilt or
innocence.

Technical Terms and Advancements:

 Automated Fingerprint Identification:


o Explanation of the automated process involving scanning devices and digital minutiae conversion.
o Importance of this technology in enhancing the efficiency of criminal justice systems.
 Fingerprint Minutiae:
o Understanding the ridge characteristics, such as endings and bifurcations, used for digital
representation.
o Importance in establishing unique patterns for identification.
 Empirical Studies:
o Significance of studies conducted in West Bengal, analyzing the practical application of fingerprint
technology in judicial adjudication.
o Key findings and insights derived from questionnaires targeting lawyers and judges.

Conclusion: Recapitulation of fingerprinting's pivotal role in criminal investigations. Affirmation of the legal
framework in India, empowering law enforcement with admissible fingerprint evidence. Recognition of the
cautious approach in the legal system, emphasizing expert opinions and corroborative evidence.
Acknowledgment of technological advancements enhancing the effectiveness of fingerprinting in criminal
justice.

POLYGRAPH EVIDENCE - ADMISSIBILITY

I. Introduction:

 Evolution of Criminology:
o Integrated Discipline: Over the decades, criminology has evolved from a singular focus on
crime to becoming an integrated, pragmatic, and multi-disciplinary field. It amalgamates
academic criminology with contemporary societal concerns about criminal behavior.
o Vocational Role: Criminology, in a vocational sense, is intricately tied to enhancing the
immediate practices of the criminal justice system. Its endeavors are directed at making some
aspect of the criminal justice system 'better' at various levels.
 Criticisms and Challenges:
o Denigration of Criminological Research: The field has faced criticism, with some asserting
that criminological research has been futile, citing incompetence in scientific methodologies.
o Intellectual Core Critique: There's a perspective suggesting that criminology lacks an
intellectual core, challenging its status as a true discipline.
 Role of Forensic Psychophysiology/Polygraphy:
o Verification of Truthfulness: Given the qualitative nature of criminological study, the need
arises to question the veracity of information provided. Forensic
psychophysiology/polygraphy emerges as a method to verify truthfulness or deception in
various criminological settings.
o Distinct Application: Polygraphy is seen as possessing a distinct criminological application
and is deemed effective in the ongoing battle against the rising problem of crime.
 Controversies Surrounding Lie Detection:
o Polarized Views: The term 'lie detection,' or the broader 'credibility assessment,' evokes both
excitement about flawless detection and cynical amusement at the idea. This polarization
reflects the debate surrounding the efficacy of such methods.
 Intersection of Criminology and Polygraphy:
o Alignment of Ideals: Despite criticisms, the ideals and objectives of criminology and
polygraphy are fluid and intersect, nourishing each other in many areas. Dr. David C. Raskin
highlights the increasing utilization of polygraph techniques in various stages of the criminal
justice process.

II. Science of Polygraph Test:

 Historical Roots:
o Lombroso's Experimentation: Lombroso's early experimentation with a machine measuring
blood pressure and pulse to assess honesty provides a historical foundation for polygraph
examination.
o Marston's Contribution: Dr. William Marston's recognition of consistent blood pressure
increases during lying leads to the development of an instrument for monitoring blood
pressure during interrogations.
o Modern Polygraph Invention: In 1921, John Larson invents the modern polygraph instrument,
measuring blood pressure, heart rate, respiration rate, and electro-dermal response
simultaneously.
 Working Principles:
o Physiological Indicators: Polygraph tests are grounded in the theory that lying produces
physiological responses distinct from those in normal circumstances.
o Instrumentation: Instruments such as cardiographs, pneumographs, cardio-cuffs, and sensitive
electrodes are used to measure changes in respiration, blood pressure, blood flow, pulse, and
galvanic skin resistance.
 Polygraph Examination Techniques:
o Relevant-Irrelevant Technique: This technique compares responses to relevant and irrelevant
questions. Lack of standardization raises challenges for scientific evaluation.
o Control Question Technique: Involves comparing responses to relevant questions with those to
questions believed to elicit physiological reactions. Varied procedures make it unsuitable for
standardized evaluation.
o Directed Lie-Control Technique: Developed to address issues associated with the probable-lie
test, it uses directed lies to control physiological responses.
 Limitations and Criticisms:
o Accuracy Challenges: The accuracy of polygraph tests is questioned due to the ambiguous
nature of physiological responses, which can be triggered by various emotions beyond
deception.
o Research Progress: Polygraph research has been criticized for not progressing in line with
scientific fields, lacking construct validation, and failing to accumulate knowledge or
strengthen its scientific underpinnings.
o Inherent Complexities: Errors in polygraph tests are categorized into 'false positives' and 'false
negatives.' Conditions like memory-hardening and the potential for countermeasures raise
concerns about the test's reliability.
 Conclusion:
o Recognition of Limitations: Acknowledgment of the inherent complexities in polygraph
testing and the need for caution in relying solely on physiological responses for conclusive
evidence.
o Qualifications of Examiners: Emphasis on the qualifications and competence of polygraph
examiners to navigate potential errors and extraneous conditions.
o External Assessments: Echoing the conclusions from the U.S. National Research Council and
the British Psychological Society on the questionable scientific basis of polygraph testing.

III. POLYGRAPHY – LEGAL SCENARIO (Continued):

A. Polygraphy and its Physiological Basis:

 Definition of Polygraph:
 Not a Lie Detector: Despite colloquially known as a "lie detector," the polygraph does not directly
measure lies. It records physiological changes associated with the autonomic nervous system, regulated
by the central nervous system, which responds to stress.
 Physiological Responses and Stress:
 Autonomic Nervous System: The autonomic nervous system, largely outside conscious control, reacts to
stress by enhancing arousal. This involves increased blood and oxygen supply to muscles, changes in
cardiovascular and respiratory activity, slowed visceral activities, and activated sweat glands.
 Polygraph's Basis: The polygraph is based on the premise that deception induces a stress response in
the autonomic nervous system, measurable and interpretable by a polygraph examiner.
 Theoretical Basis and Criticisms:
 Undefined Theoretical Basis: Critics highlight the absence of a well-defined theoretical basis in
polygraphy and the lack of a specific physiological "lie response." The arousal observed might stem
from various factors such as fear, emotional salience, cognitive work, or other mechanisms.
 Polygraph Examination Process:
 Components: The examination involves a pre-examination interview, the test itself where the examinee
responds to "yes" or "no" questions while connected to the instrument, and a post-test debriefing
interview.
 Aim: The examiner aims to establish a psychological set in the examinee, increasing the likelihood that
observed arousal is linked to deceptive responses.
 B. Legal Status of Polygraphy:
 Controversial Accuracy: Polygraph accuracy has long been debated, with a review by the American
National Academy of Sciences suggesting an accuracy rate between 81% and 91%. However, it falls
short of perfection, and concerns include lack of standardization, variation in examiner technique, and
susceptibility to countermeasures.
 Polygraph Usage in the USA:
 Widespread Application: Despite criticisms, the polygraph is extensively used in the USA by federal
and local law enforcement agencies for criminal investigations. Polygraph evidence is accepted in
approximately 20 state courts and two-thirds of federal circuits.
 Legal Challenges: Following a Supreme Court ruling, polygraph evidence is not accepted in military
judicial settings.
 C. Legal Framework and Human Rights:
 Universal Declaration of Human Rights: Prohibits compelled testimony against oneself.
 ICCPR: Guarantees the right not to be compelled to testify against oneself or confess guilt,
emphasizing the importance of fair procedures and protection against improper compulsion.
 Use of Truth Serums: The ICCPR explicitly opposes torture or degrading treatment, categorizing the
use of truth serum tests as a form of torture.

IV. Polygraphy in Indian Legal System:

 Historical Background:
 Crime Investigation Challenges: Scientific interrogations, including polygraph tests, were introduced
in response to challenges faced by investigating agencies in crime investigations.
 High Court Acceptance: High courts in various states initially supported the use of polygraph tests,
with their acceptance later challenged in the Supreme Court on constitutional grounds.
 Constitutional Challenges:
 Article 20(3) and Polygraph Tests: Article 20(3) of the Indian Constitution, which protects against self-
incrimination, becomes a focal point in the legal discourse surrounding polygraph tests.
 Dinesh Dalmia Case: The Madras High Court ruled that subjecting an accused to a polygraph test does
not violate Article 20(3), emphasizing voluntariness.
 Supreme Court's Landmark Decision:
 Selvi v State of Karnataka (2010): The Supreme Court clarified that the compulsory administration of
polygraph tests violates the right against self-incrimination under Article 20(3).
 Informed Consent: The court emphasized the importance of voluntary consent, access to legal
representation, and the recording of consent before a judicial magistrate.
 Protection of Rights: The ruling expanded the protective scope of Article 20(3) to the investigative
stage, ensuring reliability and voluntariness of statements.
 Guidelines for Polygraph Tests:
 National Human Rights Commission Guidelines: The court referred to guidelines that include obtaining
the accused's consent, providing access to a lawyer, recording consent before a judicial magistrate, and
conducting tests in the presence of an independent agency.

V. Conclusion: Balance of Rights: The legal discourse around polygraphy in India underscores the delicate
balance between effective crime investigation and protecting constitutional rights. The Supreme Court's ruling
in Selvi v State of Karnataka establishes clear guidelines to ensure the voluntariness and reliability of polygraph
tests while upholding the fundamental right against self-incrimination.*

NARCO-ANALYSIS & APPLICABILITY

Introduction

1. Evolution of Crime: Crime has evolved with society, becoming more complex, and criminals employ
sophisticated methods.
2. Scientific Response: To combat modern crimes, scientists and specialized agencies have developed
technologies like DNA fingerprinting, lie-detector tests, brain-mapping, and narco-analysis.
3. Cognitive Psychophysiology: Modern offenses often involve cognitive psychophysiology, focusing on
how the brain processes information rather than physical evidence.
4. Relevance of Techniques: Scientific investigation techniques play a crucial role in cases with no physical
evidence or when conventional methods fall short, as seen in high-profile cases like the stamp paper scam
and the Aarushi murder case.
5. Challenges to Techniques: Courts in India have faced challenges to the constitutionality of these scientific
tests, but their validity has been consistently upheld at the High Court level.
6. Status of the Law: The Supreme Court is addressing the matter, but some issues remain unaddressed.
Recent cases highlight the acceptance of narco-analysis tests as evidence, but their exact legal status is
debated.
7. Practical Utility: The utility of these tests in providing investigative clues supports their continuation,
although challenges regarding safeguards against abuse exist.

Narco-Analysis Test: Procedure and Concerns

1. Purpose of the Test: Narco-analysis involves administering drugs to induce a semi-conscious state,
suppressing reasoning but not memory or speech, aiming to elicit truthful responses.
2. Twilight State Concept: The test neutralizes imagination and affects reasoning, placing the subject in a
semi-conscious state where truthful answers are spontaneous and manipulation is difficult.
3. Truth Serums: Commonly used drugs for truth serum tests are anesthetics like Sodium Pentothal,
administered intravenously to induce a garrulous and confessional state.
4. Test Administration: Narco-analysis is conducted by mixing Sodium Pentothal or Sodium Amytal in
distilled water and administering it intravenously over three hours, under the supervision of an anesthetist.
5. Deadly Effects: Incorrect doses can be fatal, leading to coma or death. Controlled administration aims to
drive the accused into a hypnotic trance safely.
6. Recording and Evidence: The subject is interrogated in the presence of doctors, and revelations are
recorded in both video and audio formats. The expert-prepared report serves as evidence.
7. Legal Procedure: The test is conducted in government hospitals after a court order, and the personal
consent of the subject is required.
8. Debate on Use: The distinction between investigative and evidentiary stages is debated. While statutory
safeguards exist for judicial proceedings, concerns about abuse in investigative processes lack sufficient
attention.

Detailed Summary: Narco-Analysis – Legal Scenario

1. Legal Foundations:
o International Declarations: Emphasis on the right against compelled testimony and self-
incrimination in documents like the Universal Declaration of Human Rights, US Constitution, and
European Convention of Human Rights.
o UN Covenant on Civil and Political Rights (ICCPR): Recognizes the entitlement to not be
compelled to testify against oneself or confess guilt, essential for fair procedures in criminal
charges.
2. International Legal Standards:
o European Convention for the Protection of Human Rights and Fundamental Freedoms
(ECHR): Affirms the right to a fair and public hearing within a reasonable time by an independent
tribunal, acknowledging civil and political rights.
o International Covenant on Civil and Political Rights (ICCPR) Preamble: Highlights the
foundation of freedom, justice, and peace in recognizing the inherent dignity and equal rights of all
individuals.
3. Use of Truth Serum Test as Torture:
o UN Definition of Torture: Explicitly implies that truth serum tests leading to severe mental
suffering or coercion constitute torture.
o Amnesty International: Declares the administration of truth serums, like Sodium Pentothal, as
cruel, inhuman, and degrading treatment, challenging international standards of interrogation.
4. Prohibition of Evidence Obtained under Duress:
o Human Rights Committee: Prohibits the admissibility of statements or confessions obtained
through torture or other prohibited treatment in judicial proceedings.
o Legal Challenge in Democratic Countries: Confessions made under the influence of truth
serums, as documented in the former Soviet Union and the United States, are considered
involuntary and inadmissible.
5. Indian Legal Landscape:
o Ratification of UN Convention against Torture: India has not ratified the UN Convention
against Torture, despite signing the same, indicating a gap in international alignment.
o Narco-Analysis Procedure: Involves injecting controlled quantities of substances for two or three
hours, inducing a hypnotic trance for interrogation, and recording statements on audio and video
cassettes.
6. National Human Rights Commission Guidelines:
o Consent Requirement: Guidelines recommend obtaining the subject's consent before
administering the test, stipulating that the police cannot conduct the test without Magistrate
approval.
o Recommendatory Nature: Guidelines are recommendatory, lacking binding force on
investigating agencies, raising questions about enforcement.
7. Supreme Court Intervention:
o Krushi Co-operative Bank Case: The Supreme Court stayed an order for narco-analysis,
emphasizing the need for consent and marking a significant legal intervention in scientific
techniques.
o Ongoing Decision: As of the latest update, the Supreme Court had reserved its decision on the
Krushi Co-operative Bank case, indicating a potentially impactful legal stance.
8. Global Perspective:
o Limited Use in Democratic Countries: Narco-analysis is not openly permitted for investigative
purposes in most developed and democratic countries, prompting scrutiny of its validity and
admissibility.
o Media and Public Attention: Criticism and media attention have risen, questioning the scientific
credibility of narco-analysis and its impact on individual fundamental rights.
9. Team Composition for Narco-Analysis in India:
o Multidisciplinary Team: Narco-analysis in India involves an anesthesiologist, a psychiatrist, a
clinical/forensic psychologist, an audio-videographer, and supporting nursing staff.
o Evidence Verification: Revelations are strengthened by subjecting the person to polygraph and
brain mapping tests, underlining a comprehensive approach to forensic investigations.
10. Mainstreaming Narco-Analysis in India:
o Increasing Integration: Narco-analysis is gradually becoming mainstreamed into investigations,
court hearings, and laboratories in India, signifying its growing significance.
o Public and Media Scrutiny: Public and media attention has sparked debates on the infringement
of individual fundamental rights and the test's reliability as admissible evidence.
11. Legal Principles and Constitutional Observations:
o Definition of Self-Incrimination: Legal precedents clarify that self-incrimination involves
conveying information based on personal knowledge, excluding the mere mechanical process of
producing documents in court.
o Executive Power Limitations: Observations in the Ram Jawayya Kupar case assert that executive
power cannot intrude on constitutional rights and liberties, emphasizing the need for legal
frameworks.

Case Law Analysis - Indian Context


1. Background and Need for Scientific Interrogations:
o Challenges in Crime Investigation: Investigating agencies faced difficulties, and atrocities during
interrogations raised human rights concerns.
o Custodial Death Impact: Instances of police torture leading to custodial deaths prompted the
exploration of scientific interrogation methods.
2. Support for Narco-Analysis in High Courts:
o Acceptance at State Levels: Narco-analysis found support in high courts of different states, later
challenged in the Supreme Court on constitutional grounds.
o Veracity Debates: Cases in India delved into the evidentiary value of narco-analysis, focusing on
potential constitutional infringements.
3. Constitutional Challenge - Article 20(3):
o Dinesh Dalmia v State Case: Accused misappropriated funds, and the Madras High Court upheld
narco-analysis, emphasizing its voluntary nature and likening it to medical tests like MRI or CT
Scan.
4. Bombay High Court Perspective on Truth Serum Test:
o Maharashtra Control of Organized Crimes Act Case: Bombay High Court questioned whether
a truth serum test can be forcibly conducted, emphasizing protections under Indian Evidence Act,
Criminal Procedure Code, and Article 20(3).
5. Gujarat High Court Empowerment of Investigating Agency:
o Santokben Sharmanbhai Jadeja Case: Gujarat High Court affirmed the statutory right of
investigating agencies to conduct narco-analysis, emphasizing the duty to find the truth and the
investigative agency's master status.
6. Fundamental Rights and Narco-Analysis:
o Right to Life and Liberty Concerns: Narco-analysis raises fundamental issues like the right to
life and liberty, human rights, and the privilege against self-incrimination.
o Variable Supreme Court Opinions: Apex court opinions vary on narco-analysis, considering its
impact on individual life and mind.
7. Evolution of Narco-Analysis in India:
o Introduction and Initial Use (1936-2002): Narco-analysis introduced in 1936, first used in
Godhra Carnage Case in 2002.
o Bombay High Court Judgment (2004): Ramchandra Ram Reddy v State of Maharashtra marked
the beginning of public debates on the violation of Article 20(3).
8. Legal Principles and Constitutional Observations:
o Article 20(3) Distinction: Technical distinction between 'Statement' and 'Testimony' in the context
of compelled evidence under Article 20(3).
o Nandini Satpathy Case (1978): Right to silence upheld, emphasizing the protection against
compelled statements during interrogation.
o Ram Jawaya Kapoor Case: Executive power cannot intrude on constitutional rights and liberty,
especially in the absence of specific laws.
9. Supreme Court Clarifications and Limitations:
o Selvi v State of Karnataka (2010): Results of narco-analysis not admissible as evidence;
consented information may be admissible under Section 27 of Indian Evidence Act.
o Supreme Court in Rojo George Case: Acknowledgment of the need for modern techniques due
to sophisticated crimes; testing under expert supervision not a violation of fundamental rights.
10. Duty of Citizens and Balancing Acts:
o Dharampal v State (2005): Duty of citizens to assist the state in criminal justice, striking a
balance between privacy rights and social responsibility.
o State of Gujarat v Anirudh Singh (2006): Witness duty to assist the state justified; adverse
impressions permissible against those withholding information.
11. Judicial Struggle for Balance:
o Constitutional Provisions vs. Crime Investigation: Courts grapple with balancing constitutional
provisions, especially Article 20(3), with the practical necessity of crime investigation methods.
o Challenges and Dilemmas: Difficulty in balancing the rights of the accused with the imperative
of effective crime resolution.
12. Conclusion:
o Complex Legal Landscape: The legal landscape surrounding narco-analysis in India is complex,
involving constitutional, human rights, and practical investigative considerations.
o Ongoing Debates: The judiciary continues to navigate challenges, seeking a balance between
protecting individual rights and enabling effective crime resolution.

Supreme Court's Judgment on Narco-Analysis - Constitutional Implications

1. Landmark Decision of 2010:


o Scope of Article 20(3): The Supreme Court, in a landmark decision in 2010, concludes that
compulsory administration of narco-analysis violates the right against self-incrimination under
Article 20(3) of the Constitution of India.
2. Protective Scope of Article 20(3):
o Reliability and Voluntariness: The Court emphasizes that the underlying rationale of the
right against self-incrimination is to ensure the reliability and voluntariness of statements
admitted as evidence.
o Extension to Investigative Stage: Article 20(3) protects accused persons, suspects, and
witnesses during an investigation, broadening its protective scope.
3. Testimonial Character of Results:
o Compelled Conveyance of Personal Knowledge: The results of narco-analysis bear a
testimonial character, preventing the forcible conveyance of personal knowledge relevant to
the facts in issue.
o Categorization as Material Evidence: The Court clarifies that the results cannot be
categorized as material evidence.
4. Procedural Aspect and Legal Justification:
o Explanation Clause in Section 53: The Solicitor General argues that narco-analysis finds
legal sanction under the Explanation clause added to Section 53 of the Criminal Procedure
Code in 2005.
o Inclusion of 'Such Other Tests': The phrase 'such other tests' in Section 53 accommodates
advancements in forensic science, including narco-analysis, as recognized by Justice Shah in
Santokben Jadeja v. State of Gujarat.
5. Purpose of Section 53:
o Efficient and Scientific Investigation: Section 53 is intended to facilitate efficient and
scientific investigation by incorporating modern forensic techniques.
o Advancements in Crime Detection: The provision acknowledges the need for modern
scientific methods in crime detection, ensuring the collection of evidence for proving guilt or
innocence.
6. Constitutional Rights vs. Procedural Laws:
o Article 20(3) Prevails: Despite legal justification in procedural laws, the Supreme Court's
judgment in Selvi's case reaffirms that violation of constitutional rights cannot be allowed.
o Person's Prerogative: The decision makes it clear that undergoing a narco-analysis test is the
prerogative of the person, and it must not be left to the discretion of the police.
o Free Consent Requirement: If conducted with the free consent of the person, it may be
permitted; free consent implies voluntariness without coercion.
7. Voluntariness and Coercive Circumstances:
o Example of Voluntariness: Voluntariness is demonstrated when a person expresses a wish to
take a lie detector test to clear their name.
o Linking Freedom to the Test: Statements by the police linking freedom to the lie detector
test make the consent non-voluntary and self-incriminatory.
8. Conclusion:
o Illegal and Unconstitutional Conduct: Selvi's judgment establishes that unless narco-
analysis is allowed by law and conducted with free consent, it is considered illegal and
unconstitutional.
o Primacy of Individual Prerogative: The decision reinforces the primacy of an individual's
choice in undergoing such tests, safeguarding constitutional rights against compelled self-
incrimination.

NHRC Guidelines for Lie Detector and Narco-Analysis Tests

1. Informed Consent Principle:


o Lie Detector and Narco-Analysis: The National Human Rights Commission (NHRC)
suggests guidelines for lie detector tests, based on the premise of "informed consent," and
proposes that the same principle can be extended to narco-analysis tests.
2. Guidelines for Narco-Analysis Tests:
o Informing the Accused: The accused should be informed of the physical, emotional, and
legal implications of the narco-analysis test.
o No Evidentiary Value: The accused must be made aware that statements made during the test
hold no evidentiary value in a court of law.
o Consent Recorded Before Magistrate: The final option to undergo the test should be given
to the accused, and consent should be recorded before a judicial magistrate in writing, with
both the accused and their lawyer signing the consent form.
3. Possibility of Vindication:
o Equal Probability of Vindication: The process has an equal probability of vindicating falsely
accused individuals, as indicated by Dr. B.M. Mohan, Director of Forensic Science
Laboratories.
4. Questioning Patterns and Lawyer's Role:
o Open Questions: The questioning pattern during the test must involve open questions,
preventing suggestive interrogation.
o Lawyer's Involvement: The lawyer of the accused should inspect the questionnaire for the
nature of questions, be present during the procedure, and ensure compliance with guidelines.
5. Non-Mention of Test Results in Court:
o Prohibition on Mention in Court: Neither the prosecution nor the defense should be allowed
to mention that evidence is derived from narco-analysis during the trial.
o Admissibility Challenge: Any reference to the test results should render the evidence
inadmissible, preventing bias in the judge's mind.
6. Exceptional Circumstances - 'Ticking Bomb Scenario':
o Exception for National Security?: In cases of a 'ticking bomb scenario' or imminent threat,
should an exception be provided to the consent requirement for narco-analysis?
o Court's Observation: The Supreme Court's observation in Nandini Satpathy v. P.L. Dani
emphasizes that narco-analysis without informed consent amounts to compelled self-
incrimination, violating Article 20(3).
o Fundamental Rights vs. National Security: The dilemma arises regarding whether
fundamental rights can be dispensed with in the interest of national security in exceptional
cases.
7. Concerns and Temptations:
o Risk of Exploitation: Allowing exceptions may lead to the exploitation of such measures,
posing a risk of misuse.
o Professor Kadish's Warning: Professor Kadish warns about the danger of legitimizing
repugnant practices in special cases, which may lead to a loosening of antipathy toward such
practices in general.
8. Conclusion:
o Balancing Rights and Security: The guidelines emphasize the need to balance individual
rights, informed consent, and constitutional protections while addressing exceptional
circumstances, avoiding potential exploitation.

BRAIN MAPPING & LAW

Introduction to Brain-Based Lie Detection:

 Evolution of scientific tools in law enforcement for gathering evidence.


 From fingerprints to DNA testing, the quest for more direct evidence led to the exploration of brain-
based lie detection.

Polygraph Limitations and Quest for Accuracy:

 Polygraph's reliance on physiological responses faced skepticism about its reliability.


 U.S. Supreme Court's observation in 1998: "no consensus that polygraph evidence is reliable."
 Limited admissibility of polygraph results in legal proceedings.
 Prompted the search for more accurate and reliable lie detection methods.

Advances in Brain Scans - A Promising Solution:

 Recent neuro-technological advancements explored brain scans for accurate lie detection.
 Brain scans offered the potential for a direct physiological response confirming personal knowledge of
a crime.

Two Leading Brain Scan Methods:

 Brain Fingerprinting and BOLD fMRI detection emerged as prominent methods.


 Focus on correlating physiological brain activity with psychological and behavioral tendencies.

Brain Imaging Technologies and Subjectivity:

 Aimed to bypass subjectivity by emphasizing the brain as an obliging and quantifiable organ.
 Shift toward a "biological mind" reinforced the mind-brain-body hierarchy.
 Raised questions about mind-body duality and the implications of spatial metaphors.

Spatial Metaphors and Brain Mapping:

 Spatial metaphors like "mapping" and "storage" concretized intangible concepts.


 Brain Fingerprinting likened the brain to a filing cabinet or a "hard drive."
 Sustained a locational and mechanistic understanding of the body and brain.

P300 Concealed Information Test (CIT):

 Specific focus on the P300 CIT, a brain-based test addressing reliability concerns.
 Involves presenting words related to a case, including neutral, probe, and target words.
 Aims to activate associated memories without expecting an oral response.
 EEG-ERP Neuro Scan records brain responses for analysis.

Legal Implications and Criticisms:

 Legal theorists highlight increased reliability of brain-based tests.


 Persistent skepticism in legal systems, particularly in the U.S., regarding potential abuse.
 Concerns about encroachment on the court's domain of determining witness credibility.

Conclusion and Dilemmas:

 Exploration of brain-based lie detection techniques raises dilemmas about reliability and potential
misuse.
 Balancing advancements in forensic technology with safeguards against miscarriages of justice remains
a critical challenge in legal systems worldwide.

IV. P300 Waves Test in Brain-Based Lie Detection:

Introduction to P300 Waves Test:

 Conducted by attaching electrodes to the subject's scalp.


 Measures emission of P300 wave components associated with brain activity.
 Requires a controlled environment to prevent distortions from weather conditions.

Collaboration and Stimuli Design:

 Collaboration essential between investigators and examiners.


 Designing effective stimuli, known as 'probes,' crucial for test accuracy.
 Exposure to auditory or visual stimuli, including words, sounds, pictures, and videos.

Material Probes and Neutral Probes:

 Material probes: Relevant to the facts being investigated, including crime-related information.
 Neutral probes: Irrelevant stimuli used as a baseline for comparison.

Underlying Theory and Emission of P300 Waves:

 Guilty suspects exhibit P300 wave components when exposed to material probes.
 Examiner analyzes recorded wave components to infer familiarity with crime-related information.

Two Methods of Measuring Brain Activity:

1. Functional Magnetic Resonance Imaging (fMRI):


o Creates magnetic images of blood oxygen in the brain.
o Brighter areas indicate active brain regions.
o Color-coded three-dimensional map created using computer software.
2. Electroencephalographic (EEG) Method:
o Measures brain's electrical activity with sensors on the head.
o Compares brain activity for familiar and unfamiliar stimuli.
o P300 wave, detected through EEG, evoked by rare and meaningful stimuli.

Brain Fingerprinting and BEOS Test:

 Dr. Lawrence Farwell's Brain Fingerprinting and BEOS (Brain Electrical Oscillations Signature) test.
 Developed to address the need for a detectable physiological signal.
 Unlike autonomic signals, brain-based signals less susceptible to countermeasures.

P300 CIT - An Effective Brainwave Detection:

 P300 (event-related potential) brainwave detected using EEG monitor.


 Evoked when subject presented with rare and meaningful stimuli, e.g., crime-related information.
 Lawrence Farwell's early experiments suggested high accuracy rates (around 90%).

Controversies and Criticisms:

 Farwell's test faced controversies, criticized for lack of scientific credibility and proper peer review.
 Rosenfeld Lab's version attempts to address issues, including countermeasures and ecological validity.
 Reported accuracy levels vary from 75% to 90%, with potential for extensive field testing.

Application in Forensic Contexts:

 P300 CIT considered for systematic use in forensic contexts.


 Focus on increasing accuracy, addressing countermeasures, and ecological validity.
 Potential for extensive field testing before systematic use in legal proceedings.

Diverse Methods in Brain Scan Technology:

 Measurement during active subject response (e.g., saying "yes" or "no").


 Measurement of passive perception without subject response.
 Brief presentation of images for subconscious processing.

Intelligence Agencies and Counterterrorism:


 Brain scan technology explored for counterterrorism efforts.
 U.S. government invests in brain-based lie detection for counterterrorism investigations.
 Potential applications in intelligence acquisition and screening of terrorism suspects.

Conclusion:

 Ongoing advancements and debates surrounding brain-based lie detection methods.


 Potential legal applications require addressing scientific credibility, reliability, and ethical
considerations.
 The intersection of neuroscience and law poses challenges and opportunities for the justice system.

V. Brain Mapping in Legal Scenarios:

1. Introduction to Brain-Based Lie Detection:

 Recent decades marked by excitement about brain-based lie detection technologies.


 Claimed advancements and experimental results suggest potential for sophisticated mind reading.
 Technologies aim to decipher neural patterns for more reliable truth verification.

2. Forensic Benefits and Legal Skepticism:

 Potential forensic benefits include overcoming uncertainties in witness testimony.


 Legal systems, especially in the U.S., historically skeptical due to concerns about reliability and
potential for abuse.
 Skepticism rooted in the perceived unreliability of such tests and potential for misuse in legal
proceedings.

3. Legal Theorists' Perspective:

 Some legal theorists argue for reconsideration, emphasizing increased reliability of brain-based tests.
 Highlight comparative advantages over traditional epistemic methods in legal systems.
 Address concerns through rigorous scientific validation and improved methodologies.

4. P300 CIT's Role in Criminal Justice:

 Strategic use of P300 CIT addresses the 'innocence problem' in the plea bargaining system.
 Potential to offer a more effective resolution compared to existing proposals.
 Advocates argue for its use at specific stages in the criminal justice process to enhance accuracy and
fairness.

5. Historical Use of Neuroscience in Courts:

 John Hinckley's Trial (1981):


o CT scans admitted to show evidence of schizophrenia.
o Impact on the jury's verdict raises questions about the role of neuroscientific evidence in legal
proceedings.
 People v. Weinstein and McNamara v. Borg:
o PET scans introduced during murder trials to provide behavioral explanations for defendants'
actions.
o Indications that neurological evidence tends to influence the outcomes of criminal cases.

6. Case Law Analysis in India:

 Ranjit Singh Sharma v State of Maharashtra (2005):


o Authenticity of brain mapping test results requires further consideration.
o Courts cautious about admitting brain-based evidence without establishing probative value.
 A. Panneerselvam v State (2009):
o Authenticity of polygraph and brain mapping reports ascertained during trial.
o Emphasis on assessing the credibility of such tests in conjunction with other evidence.
 Purshottam Swaroopchand Soni v State Of Gujarat (2014):
o Court orders brain mapping test, emphasizing the accused's right for a fair trial.
o Recognition of the accused's right to present scientific evidence in their defense.
 Jude Chidibere v NCB (2016):
o Accused's request for scientific tests considered valid only at the defense stage.
o Balancing the accused's right to establish innocence with the procedural considerations of the
trial.
 State of Karnataka v Smt. Renukamma (2010):
o Brain mapping results not admissible as evidence, limited use under Section 27 of the Indian
Evidence Act.
o Courts restrict the admissibility of certain brain-based tests, aligning with legal principles.
 M.A. Abdullah v The State (2008):
o Brain mapping test constitutionally permissible, supports modern technology in investigations.
o Acknowledgment of the evolving role of neuroscience in criminal investigations.
 Selvi v State of Karnataka (2010):
o Compulsory administration of narcoanalysis, polygraph, and BEAP violates the right against
self-incrimination.
o Legal establishment of limitations on involuntary administration of specific tests, upholding
constitutional rights.

7. Changing Legal Perspectives:

 Legal perspectives on brain-based lie detection have evolved over time.


 Selvi case establishes restrictions on involuntary administration of certain tests, emphasizing the right
against self-incrimination.
 Ongoing debates on ethical implications, admissibility criteria, and potential impact on the justice
system.

8. Conclusion:

 Balancing the potential forensic benefits with legal safeguards is crucial in shaping the role of
neuroscience in the justice system.
 Continued dialogue and research needed to establish standardized protocols, address ethical concerns,
and ensure the fair and just use of brain-based lie detection technologies in legal proceedings.

VI. Legal Implications of Brain Mapping – Constitutional Standpoint:

1. Supreme Court's Landmark Decision (2010):

 Constitutional Violation Under Article 20(3):


o Compulsory administration of brain mapping violates Article 20(3) to ensure the reliability
and voluntariness of statements.
o Supreme Court broadens the scope of Article 20(3) to extend protection during the
investigative stage in criminal cases.

2. Scope of Article 20(3) and Testimonial Character:

 Broader Interpretation by Supreme Court:


o Article 20(3) safeguards an individual's choice between speaking and remaining silent,
covering both inculpatory and exculpatory testimonies.
o Results from brain mapping and related tests are considered testimonial, falling within the
purview of constitutional protection.

3. Procedural Aspects and Legal Justifications:


 Solicitor General's Argument (2010):
o Narco analysis justified as an investigatory tool under Section 53 of the Criminal Procedure
Code.
o The 2005 Explanation clause recognizes new forensic techniques, encompassing brain
mapping.
o Legal sanction provided for narco analysis despite constitutional concerns.
 Purpose of Section 53:
o Section 53 aims for efficient and scientific investigation, accommodating advancements in
forensic science, including future techniques like brain mapping.

4. Constitutional Rights vs. Procedural Laws:

 Santokben Jadeja v. State of Gujarat (2001):


o Section 53 intended for efficient and scientific investigation, accommodating advancements,
including brain mapping.
o Constitutional rights take precedence over procedural laws, ensuring a balance between
investigative needs and individual rights.
 Selvi v State of Karnataka (2010):
o Referral to NHRC Guidelines for Administration of Lie Detector Test.
o Constitutional rights take precedence despite procedural laws.
o Emphasis on adherence to safeguards during brain mapping and related tests.

5. NHRC Guidelines and Safeguards:

 Consent and Voluntariness:


o Lie Detector Tests administered based on accused consent.
o Accused given the option to avail the test voluntarily.
 Legal Representation and Judicial Oversight:
o Accused provided access to a lawyer with an explanation of implications.
o Consent recorded before a Judicial Magistrate.
o Magistrate ensures a fair hearing with legal representation.
 Independent Recording and Medical Documentation:
o Lie Detector Test recorded by an independent agency in the presence of a lawyer.
o Full medical and factual narration documented for transparency.

6. Supreme Court's Upheld Safeguards for Brain Mapping:

 Adherence to NHRC Guidelines:


o Similar safeguards recommended during brain mapping tests.
o Emphasis on voluntary participation, legal representation, and judicial oversight.
 Inclusion of "Such Other Tests":
o Section 53 incorporates "such other tests" to accommodate advancements in forensic science.
o The phrase reflects a provision for recognizing newly developed techniques, including brain
mapping.

7. Conclusion – Balancing Technology and Rights:

 Evolution of Legal Perspectives:


o Constitutional rights take precedence over procedural laws.
o Continued emphasis on safeguards in the use of advanced forensic techniques.
o Balancing the benefits of technology with the protection of individual rights remains a
paramount consideration.

8. Ongoing Dialogues and Ethical Considerations:

 Contemporary Relevance:
o Ongoing debates on ethical implications.
o Need for continuous dialogue to adapt legal frameworks to technological advancements.
o Ensuring fair and just use of brain mapping technologies in the evolving legal landscape.

DIGITAL FORENSICS

I. INTRODUCTION:

 Significance of Signatures:
o Authentication, authorization, and acceptance of document contents often achieved through
signatures.
o Encompasses various forms: handwritten, marks, symbols, and digital signatures.
 Historical Context:
o Historical examples, like Edward III's signature in 1362, highlight the enduring importance of
signatures.
o Typewritten or printed names in agreements were recognized before legislative developments
on Electronic Signatures.
 Principle of Signatures:
o Core principle: Intent of parties to be bound by agreed terms.
o Statute of Frauds in the UK (1677) underscores the importance of handwritten signatures for
enforceable contracts.
 Role of Electronic Medium:
o As dependence on electronic mediums grew, authentication methods evolved.
o UNCITRAL Model Laws on Electronic Commerce and Electronic Signatures provide a global
framework for electronic authentication.

II. ELECTRONIC SIGNATURE TECHNIQUES:

 Historical Roots:
o Ancient practices of marks, symbols, and names on crafts signify authentication from the
Indus Valley Civilization.
o Identification through symbols or names in creative works has a historical legacy.
 Progress in Authentication:
o Technological advancements introduced varied authentication methods.
o Authentication crucial for legal validity and creation of relationships via electronic
communication.
 Applications in Practice:
o Handwritten signatures in diverse applications, e.g., report cards, bank transactions, official
dealings.
o Distinct signatures for different contexts, with digital signatures requiring periodic renewal.
 Authentication Challenges:
o Evolving electronic signatures, e.g., passwords, light pen signatures, pose challenges in
proving authenticity over time.
o Digital signatures backed by certificates require periodic renewal, altering the signature.
 Diversity in Techniques:
o Cryptography widely accepted, but not the sole method.
o Various electronic signature techniques, each with its applications and considerations.

III. LEGAL FRAMEWORK IN INDIA:

 Information Technology Act, 2000 (Amended in 2008):


o Recognizes digital signatures as part of electronic signatures.
o Section 3A allows various electronic signature techniques, emphasizing reliability and
adherence to prescribed conditions.
 Government's Role:
o Central Government empowered to prescribe techniques, procedures, and security measures
for electronic signatures.
o Legal recognition of electronic signatures for documents requiring authentication by signature.

IV. CASE ANALYSIS:

 Ongoing Evolution:
o Continuous evolution in electronic signature methods.
o Striking a balance between user-friendliness and robust security measures is paramount.
 Adaptable Legal Framework:
o The law must adapt to ongoing technological advancements.
o Continuous dialogue and adjustments essential to align regulations with technological
progress.

V. CONCLUSION:

 Balancing Tradition and Innovation:


o Historical significance of signatures endures alongside technological innovations.
o Adaptable legal frameworks crucial for striking a balance between tradition and innovation.
 Continuous Dialogue:
o Ongoing advancements demand continuous dialogue between legal frameworks and
technological progress.
o Flexibility and adaptability in regulations ensure the efficacy of electronic signature laws.

A. CRYPTOGRAPHY:

1. Secret Key Cryptography (Symmetric Key):


o Utilizes a single key for both encryption and decryption.
o Involves the sender encrypting plaintext into ciphertext.
o Essential to establish secure key allotment and maintain security between the sender and
receiver.
2. Public-Key Cryptography (Asymmetric Key):
o Deploys two keys - private key for the sender and a public key for the receiver.
o Widely considered one of the most secure forms of cryptography.
o Used for creating digital signatures and encrypting messages.

B. OTHER METHODS:

1. Passwords:
o Secure passwords for various accounts (email, laptops, mobiles) are recognized as electronic
signatures.
o Serves as a fundamental yet critical method for authentication.
2. Personal Identification Number (PIN):
o Commonly employed in credit cards, ATMs, etc.
o Despite its simplicity, it holds significance as an electronic signature.
3. Scan of Handwritten Signature:
o Involves manually signing a document and scanning it for electronic communication.
o Simple in execution but raises concerns regarding potential misuse.
4. Biometrics:
o Leverages unique physiological/behavioral identifiers (iris scan, fingerprint) for individual
authentication.
o Increasingly integrated into governmental recognition systems.
5. Light Pen:
o Allows individuals to sign directly on a computer screen using a light pen.
o Recognized as an electronic signature, albeit with considerations about potential disparities
from manual signatures.

III. LEGAL SCENARIO IN INDIA:


A. Information Technology Act, 2000 (As Amended in 2008):

1. Recognition of Digital Signatures:


o Electronic signature definition expanded to encompass digital signatures.
o Section 3 outlines the authentication of electronic records, primarily using digital signatures.
2. Subscriber and Digital Signature:
o Subscribers authenticate electronic records using a digital signature.
o Asymmetric crypto system emphasized for the security of digital signatures.
3. Authentication Techniques Beyond Digital Signatures:
o Section 3A allows the use of specified techniques for electronic records' authentication.
o Criteria for reliable electronic signatures include control, linkage, detectability, and adherence
to prescribed conditions.
4. Central Government's Role:
o Empowered to prescribe techniques and procedures for affixing electronic signatures.
o Prescribed techniques must meet stringent criteria, and procedures for identification and
security are pivotal.
5. Government and Agency Usage:
o Electronic signatures deemed permissible for official government work if following prescribed
procedures.
o Central Government has the authority to lay down rules governing the type, manner, and
security of electronic signatures.
6. Legal Effect of Electronic Signatures:
o Valid authentication even when using electronic signatures, following the Central
Government's specified manner.
o Electronic signatures permitted for any document requiring authentication by signature.
7. Security Measures and Practices:
o Secure electronic signatures emphasized when the signatory maintains exclusive control over
signature creation data.
o Central Government authorized to prescribe security procedures ensuring integrity, security,
and confidentiality.

IV. LEGAL FRAMEWORK AND CERTIFYING AUTHORITIES:

1. Reliability Criteria for Electronic Signatures:


o Exclusivity Criteria:
 (a) Signature data linked exclusively to the signatory or authenticator.
 (b) Signature data under the sole control of the signatory or authenticator during
signing.
o Detectability Criteria:
 (c) Detectable alterations to the electronic signature made post-affixing.
 (d) Detectable alterations to the information after its authentication by electronic
signature.
o (e) Compliance with additional prescribed conditions.
2. Central Government's Oversight:
o Technique Oversight:
 In-depth scrutiny and approval of electronic signature techniques.
 Flexibility in adding or omitting methods.
 Parliamentary awareness ensured through dual-house notifications.
3. Authentication Validity:
o Central Government Approval:
 Electronic signatures validated if conforming to Central Government specifications.
 Authorization for official use following prescribed procedures.
4. Controller's Role in Certifying Authorities:
o Certifying Authority Appointment:
 Certifying Authority appointed by the Controller.
 Responsibilities include certifying public keys and setting CA standards.
 Resolution of conflicts between subscribers and Certifying Authorities.
5. Controller's Responsibilities:
o Multi-faceted Oversight:
 Certifying public keys.
 Setting and maintaining CA standards.
 Specifying employee qualifications.
 Managing databases.
 Resolving conflicts of interest.
 Ensuring CA compliance.
6. Foreign Certifying Authorities:
o Recognition Mechanism:
 Recognition of Foreign Certifying Authorities through government notification.
 Electronic Signature Certificates (ESCs) from recognized Foreign CAs deemed valid.
7. License Granting and Renewal:
o Detailed Process:
 Comprehensive evaluation based on qualifications, expertise, and infrastructure.
 Non-transferable licenses.
 Periodic and renewable licenses.
8. Suspension and Revocation of License:
o Controller's Authority:
 Authority to suspend, revoke, or refuse renewal in case of non-compliance.
 Mandatory public notification for transparency.
9. Obligations of Certifying Authorities:
o Comprehensive Responsibilities:
 Secure software and hardware usage.
 Provision of reliable services.
 Adherence to strict security procedures.
 ESC repository management.
 Furnishing of ESC-related information.
10. Criminal Liability for Non-compliance:
o Non-compliance Consequences:
 Criminal liability for failing to return suspended or revoked licenses.
 Imprisonment and fines as punitive measures.
11. Disclosure and Intimation:
o Obligations for CAs:
 Timely disclosures.
 Subscriber intimation regarding ESC status.
12. ESC Issuance and Revocation:
o CA Powers:
 ESC issuance and certification of compliance.
 CA's authority to suspend or revoke ESCs with public notification.
13. Intent Behind Signatures:
o Recognition of Varied Forms:
 Inclusivity of sound or consent in telephonic conversations as electronic signatures.
 Emphasis on reflecting intent as the core purpose.
14. E-Contracts and E-Auctions:
o Legal Obligations:
 Third-party obligations in ensuring applicant possession of required digital signature
certificates.
 Licensing prerequisites for entities providing digital signature certificates.
15. Licensed Certifying Authorities:
o Key Aspects:
 Licensing under Controller's oversight.
 Obligations spanning digital signature grants, applicant training, and software
currency assurance.
16. Continuous Evolution:
o Dynamic Legal Framework:
 Acknowledgment of evolving electronic signature laws.
 Striking a balance between robust security measures and user-friendly processes.
 Ongoing alignment with technological advancements.
ELECTRONIC AND DIGITAL SIGNATURES IN E-COURTS:

1. Background and Initiatives:


o Early Digitalization Efforts:
 Informal computerization since the 1990s led by the National Informatics Centre.
 Formalized initiative with the E-Committee established in 2004.
o National E-Governance Plan:
 2006: Twenty-seven mission mode projects, including the E-Court Mission Mode
Project.
 Aimed at computerizing government departments at various levels.
2. E-Court Mission Mode Project:
o Project Objectives:
 Chief goal: Paperless courts through digitalization.
 Three-phase computerization plan within five years.
 Initial delay resulted in the current second phase.
3. Authentication Challenges:
o Crucial Role of Electronic Systems:
 E-Court success hinges on a robust electronic document authentication system.
 Mandate for uploading orders and judgments on e-court website.
 Provision for certified copies and official documents online.
 Emphasis on e-filing of cases.
4. Digital Signature Provision:
o NIC's Responsibility:
 National Informatics Centre (NIC) tasked with court computerization.
 Provision of digital signatures a pivotal role.
 USB-Based Token Digital Signatures provided to Supreme Court officers in Phase I.
5. Challenges and Discrepancies:
o NIC's Digital Signature Delivery Issues:
 Inconsistencies reported in digital signature allocation.
 State NIC's failure to provide digital signatures to officers.
 Officers in various courts awaiting digital signatures since 2007.
 Periodic data submissions without corresponding signature allocation.
6. Potential Reasons for Delays:
o Funding and Responsibility Questions:
 Unclear reasons for NIC's failure in digital signature allocation.
 Possible factors: Funding shortages, lack of responsibility.
7. Significance of Authentication:
o Project Implications:
 E-Court project's success linked to timely digital signature provisioning.
 Judicial officers and court staff need digital signatures for workflow continuity.
8. Project Milestones and Citizen-Centric Approach:
o E-Court Project Highlights:
 Orders and judgments uploaded for public accessibility.
 Certified copies and official documents accessible online.
 E-filing mechanisms implemented.
 Emphasis on citizen-centric accessibility.
9. Digital Signature Role in E-Court Workflow:
o Workflow Continuity Assurance:
 Digital signatures essential for authentication in e-filing and document sharing.
 Integral role in maintaining efficient court operations.
10. Current Status and Future Outlook:
o Ongoing Phase and Future Prospects:
 E-Court Project currently in the second phase.
 Need for resolving digital signature allocation issues.
 Future success dependent on addressing authentication challenges.
11. Collaborative Efforts and Coordination:
o NIC's Role in Collaboration:
 NIC's collaboration with judicial bodies crucial for success.
 Coordination needed for effective implementation and issue resolution.
12. Impact on Judicial Processes:
o Broader Implications:
 Delayed authentication processes affecting overall judicial workflow.
 Importance of digital signatures in modernizing legal processes.
13. Policy Recommendations and Governance:
o Addressing Challenges:
 Policy-level interventions to streamline digital signature allocation.
 Governance improvements for efficient project execution.
 Ensuring adequate funding for seamless implementation.
14. Lesson for Future E-Governance Initiatives:
o Learning from Setbacks:
 Identifying and rectifying shortcomings for future e-governance projects.
 Emphasizing continuous improvement and adaptability in digitalization efforts.

Module 9 - NANOTECHNOLOGY & LAW

Introduction:

Nanotechnology and Regulatory Challenges:

1. Dynamic Nanotechnology Development:


o Nanotechnology evolving faster than regulatory frameworks.
o Diverse materials and characteristics, necessitating tailored approaches.
o Lack of standardized regulations due to the rapid pace of nanotechnological advancements.
2. Market Growth and Potential:
o Significant investment in nanomaterials production since the 2000s.
o Nanomaterials market projected to reach USD 100 billion by 2025.
o Versatile applications across healthcare, consumer products, environment, etc.
3. Functionalities and Applications:
o Nanomaterials offer diverse functionalities due to unique physical and chemical properties.
o Applications in diagnostics, therapeutics, food, agriculture, and more.
o Increased integration in medical products, necessitating regulatory adaptability.
4. Regulatory Framework Adaptation:
o Regulatory science must evolve to align with nanotechnology advancements.
o Emphasis on safety assessment, employing the 'safe-by-design' concept.
o Development of guidelines for toxicological assessments and analytical methods.
5. Certainty Amidst Complexity:
o Growing complexity with various nanomaterials and applications.
o Overlapping technologies and novel products pose challenges to regulatory science.
o Need for harmonized approaches and effective safety assessments.

Nanotechnology in Focus:

1. E-Court Mission Mode Project:

 Initiative aimed at digitizing courts for a transition to a paperless system.


 Computerization planned in phases to address evolving challenges.
 National Informatics Centre (NIC) entrusted with providing digital signatures for judicial officers.

2. Authentication Challenges:

 Electronic systems pivotal for document authentication within the E-Court Project.
 Mandate for uploading orders, judgments online to enhance accessibility.
 Challenges reported in the timely delivery of NIC's digital signature allocation.

3. Digital Signature Provision:


 NIC entrusted with computerizing courts and providing digital signatures.
 Initial provision of USB-Based Token Digital Signatures during Phase I.
 Discrepancies reported in the distribution of digital signatures to judicial officers.

4. Potential Reasons for Delays:

 Unclear reasons for NIC's inability to allocate digital signatures promptly.


 Funding shortages or a lack of responsibility potential contributing factors.
 Timely provision of digital signatures deemed crucial for the success of the E-Court Project.

5. Significance of Authentication:

 Digital signatures integral for facilitating e-filing and document authentication.


 Crucial role in ensuring the seamless operation and workflow efficiency of the E-Court system.

6. Project Milestones and Citizen-Centric Approach:

 Orders, judgments made accessible online for public scrutiny.


 Provision of certified copies and official documents digitally to enhance citizen-centric services.
 Emphasis on e-filing to ensure accessibility and ease of use for citizens.

7. Digital Signature Role in E-Court Workflow:

 The continuity of the E-Court workflow reliant on the effective utilization of digital signatures.
 Digital signatures critical for e-filing, document sharing, and ensuring the authenticity of legal
proceedings.

8. Current Status and Future Outlook:

 E-Court Project currently in the second phase, actively addressing identified challenges.
 Necessity for resolving issues related to the allocation of digital signatures to judicial officers.
 Future success of the project contingent on addressing authentication challenges.

9. Collaborative Efforts and Coordination:

 Collaboration between NIC and judicial bodies deemed imperative for the project's success.
 Coordination essential for the effective implementation of digital signatures and resolution of
associated issues.

10. Impact on Judicial Processes:

 Delays in authentication processes affecting the overall efficiency of judicial workflows.


 Recognizing the pivotal role of digital signatures in modernizing and streamlining legal processes.

11. Policy Recommendations and Governance:

 Policy interventions required to streamline the process of digital signature allocation.


 Governance improvements necessary for the efficient execution of the E-Court Project.
 Ensuring adequate funding to facilitate seamless implementation of digitalization initiatives.

12. Lesson for Future E-Governance Initiatives:

 Identification and rectification of shortcomings crucial for future e-governance projects.


 Emphasizing continuous improvement and adaptability in digitalization efforts.
 Lesson-learning for enhancing the efficacy of subsequent e-governance initiatives.
Nanoplastics:

1. Plastic Debris Formation:


o Arises from the fragmentation of larger objects with synthetic or modified natural polymers.
o Categorized by size (microplastics, sub-micron, and nanoplastics), shape, color, and origin.
o Microplastics transform into nanoplastics when external dimensions fall below a certain size.
2. Primary and Secondary Microplastics:
o Primary: Intentionally manufactured (pellets, powders, scrubbers).
o Secondary: Result from plastic breakdown (e.g., fishing gears, packaging) or in-use
degradation.
o Concerns about adsorption of contaminants and attraction of microorganisms.
3. Environmental Impact and Human Exposure:
o Microplastics enter the food chain, potentially ingested by humans through fish and seafood.
o Lack of formal and harmonized definitions for micro- and nanoplastics.
o Current definitions vary, with agreement on microplastics (<5 mm) and ambiguity on
nanoplastics.
4. Defining Nanoplastics:
o Proposal to link the definition of nanoplastics to the established term "nanomaterial."
o Suggestion to align with the EC Recommendation for nanomaterials containing synthetic or
semi-synthetic polymers.
o Open question on the required polymer fraction for a material to qualify as nanoplastics.
5. Regulatory Landscape on Nanomaterials and Nanoplastics:

European Union:

o Safe-by-Design Concept:
 Essential for nanomaterials in product development and market release.
 Focus on safety across the product lifecycle, from production to waste.
o Digital Innovation Hubs and Test Beds:
 Support mechanisms for driving nanotechnology innovation.
 Facilitate access to technology, testing instruments, financial advice, and market
intelligence.
o ECHA's Role:
 Addresses safety assessment of chemicals, including nanomaterials, under REACH.
 Nano-specific information requirements introduced in 2018 amendment.
o EU Observatory for Nanomaterials:
 Hosted by ECHA, providing objective information on innovation and safety aspects.
 Aims to inform the public about nanomaterials on the EU market.
o EFSA's Involvement:
 Establishes a scientific network for nanotechnologies in food and feed risk
assessment.
 Offers guidance on risk assessment of nanoscience and nanotechnologies in the food
and feed chain.
o EMA's Definition of Nanomedicines:
 Medicinal products with components at the nano-scale, offering specific clinical
advantages.
 Defined to provide clinical benefits, such as improved dosage, targeting, or reduced
toxicity.
o European Green Deal:
 Drives a sustainable, circular economy with a focus on reducing single-use plastics.
 Aims to address issues related to microplastics and promote the use of biodegradable
and bio-based plastics.
6. Challenges and Future Directions:
o Global efforts needed for waste legislation review, efficient waste management, and labeling
measures.
o Regulatory measures crucial for addressing micro- and nanoplastics challenges, enhancing
transparency, and promoting innovation.
o Limited data on human and environmental exposure to micro- and nanoplastics, emphasizing
the importance of regulatory science.

Regulatory Approaches in Different Regions:

1. United States of America (USA):


o Definition of Regulatory Science:
 FDA defines regulatory science as tools, standards, and approaches for assessing
FDA-regulated products.
o Nanotechnology Regulation Approach:
 Emphasis on existing regulations for nanomaterials, avoiding new specific
regulations.
 Utilizes horizon scanning and internal reviews for product submissions.
 FDA CORES program for collaborative research on product characterization and
safety assessment.
 Training programs and guidance documents for staff and industry support.
 Collaboration with US government departments and agencies via the National
Nanotechnology Initiative (NNI).
2. Canada:
o Regulatory Focus Areas:
 Health Canada, Environment and Climate Change Canada, Agriculture and Agri-
Food Canada, and Canadian Food Inspection Agency involved.
 Regulatory approach follows OECD recommendations on safety testing of
manufactured nanomaterials.
 Chemical Management Plan (CMP) actions on harmful substances, including
nanomaterials.
 Collaboration with the US for common nanomaterial risk assessment.
3. Asia (Japan, India, Singapore):
o Regulatory Science in Japan:
 Ministry of Health, Labour and Welfare, PMDA, NIHS, and AMED involved.
 Regulatory Science Centre focuses on advanced therapies and nanotechnologies.
 Emphasis on clinical data, electronic healthcare records, and large population
evaluations.
o India:
 Guidelines for evaluating nanopharmaceuticals released in 2019.
o Singapore:
 National University of Singapore conducts research on nanomedicines.
 Challenges include predicting nanoparticle elimination and limited data on nano-
carrier characterization.
4. Chile:
o Legislation and Initiatives:
 Circular economy models explored, plastic recycling efforts, and a ban on plastic
bags initiated in 2018.
 Citizen science projects involve school children in the National Sampling of Small
Plastic Debris.
5. International Collaboration:
o IPRP and ICH:
 International Pharmaceutical Regulators Programme (IPRP) under ICH addresses
shared interests in pharmaceutical regulation.
 Nanomedicines working group collaborates globally on non-confidential information
sharing, regulatory harmonization, and outreach.
6. Reporting Metrics:
o Varied Requirements:
 Reporting metrics for nanomaterials depend on specific regulations, e.g., particle
numbers for EU REACH, weight fraction for US EPA ToXic Substances Control Act.
 Requirements may differ based on jurisdiction and sectors.

Nanotechnology in the Agriculture/Food/Feed Sector:


1. Food Additives and Labeling (EU):
o Titanium dioxide, a nanomaterial, used as a food additive in the EU.
o Regulation (EU) No. 1169/2011 mandates clear labeling for engineered nanomaterials, with
the term "nano" in brackets.
o Nanotechnology benefits in food production include improved bioavailability, taste masking,
controlled release, and protection of encapsulated substances.
o Challenges in nano-sized delivery systems: compatibility, food-grade safety, and release
dependent on various factors.
o Ongoing research for optimal formulations to enhance bioavailability and use fewer
ingredients.
2. Nanotechnology in Plant Protection:
o Addressing weaknesses in existing pesticides through nanotechnology.
o Nano-enabled pesticides on the market include metals, metal oxides, and nano-carriers loaded
with active substances.
o Focus on efficient application, reduced losses, and improved interactions with hosts.
o Challenges include measuring durability and characterizing nanopesticides over time after
field application.
o Research on nutrient use efficiency in agriculture using nanoscale elements to suppress plant
diseases and increase crop yields.
3. Reducing Waste and Enhancing Food Safety:
o Nanomaterials used to reduce waste due to bacterial, chemical, or fungal spoilage.
o Rapid detection of pathogens using nanomaterials, enhancing sensitivity of sensors.
o Development of nano-sized biosensors for the detection of pathogens, reducing detection time
from days to hours.
o Research on printable nano-based sensors for detecting pathogen residues in agricultural
fields.
4. Food Packaging with Nanocomposites:
o Nanocomposites used in renewable and degradable food packaging.
o Smart functionality achieved by synthesizing designer hybrids with active materials.
o Regulation of nano-materials in food packaging governed by REACH (EC Regulation
1007/2006) with specific nano-clauses (EC Regulation 2018/1881).
o EFSA provides guidance on risk assessments for nanomaterials in various applications in the
food chain.
5. Risk Assessment Challenges:
o Physico-chemical characterization crucial for risk assessment, considering parameters like
size, shape, composition, stability, solubility, and reactivity.
o Lack of generic methods for nanomaterial characterization; a variety of individual methods
available.
o Need for harmonization and standardization of analytical approaches; development of specific
methods for nanoparticle/matrix combinations.
o Challenges in applying grouping and read-across approach in the food sector due to limited
case studies, scarce mechanistic information, and data quality issues.
6. Initiatives and Projects:
o International initiatives, e.g., eNanoMapper, GRACIOUS project, contribute to information
sharing and databases.
o Agreement on data quality requirements essential, requiring more research for standardized
and validated methods.
o Challenges associated with grouping and read-across addressed by projects like GRACIOUS,
developing innovative frameworks for risk assessment.

Examples and Challenges in Safety Assessments of Nanomaterials:

4. Global Safety Assessment Efforts:


 Ongoing international efforts, such as those led by specific OECD working parties,
aim to harmonize the safety assessment of nanomaterials.
 Various government agencies and research bodies globally work on test guidelines,
standards, and risk assessment frameworks.
5. Impact on Marine Environment:
 The US EPA has a research program to understand the toXicity and bioaccumulation
levels of nanomaterials in the marine environment.
 Salinity is a key factor affecting nanomaterial stability and bioavailability.
 Challenges include the need for appropriate analytical methods to identify
nanomaterials in the marine ecosystem, especially when mixed with natural
materials.
6. Regulatory Measures in the EU:
 ECHA, in collaboration with EFSA and other European Commission bodies, is
finalizing guidance documents and tools for safety assessments of nanomaterials.
 The European Union Observatory for Nanomaterials provides information on
innovation and safety aspects.
 EU Cosmetics Regulation covers the safe use of nanomaterials in cosmetic products,
with specific provisions and safety concerns addressed by SCCS.
7. Challenges in Cosmetics Safety Assessment:
 Challenges in safety assessment of nanomaterials in cosmetics include uncertainties
in physicochemical properties, environmental behavior, and toXicological effects.
 Dossier evaluation challenges involve high-quality material characterization,
understanding uncertainties, addressing internal exposure, employing non-animal
testing methods, and applying a robust weight of evidence approach.
8. Characterization Challenges:
 Detailed studies on the characterization of nanomaterials, such as titanium dioxide in
confectionery products, emphasize the importance of appropriate analytical methods
and sample preparation.
 Characterization and safety assessment challenges extend to all nanomaterials.
9. Safety Assessment of Nanomedicines:
 EMA evaluates nanomedicines, including liposomes, iron nanoparticles,
nanocrystals, albumin nanoparticles, and lipid nanoparticles.
 Challenges involve diverse nanomedicine types, lack of standardization, and the need
for early attention to critical quality attributes and analytical methods.
10. US-FDA's Assessment of Medical Devices:
 US-FDA's CDRH assesses medical devices containing nanotechnology, considering
physico-chemical characterization, in vitro and in vivo models, and toXicological
risk assessment.
 Challenges include understanding the effects on blood platelets and vascular
endothelial cells, determining nanomaterial dosimetry, and developing in vitro
models for diverse nanomaterials.
11. Risk Assessment of Silver Nanoparticles:
 NIHS in Japan focuses on the risk assessment of silver nanoparticles used in various
consumer products.
 Challenges include understanding toXicity dependence on particle size and obtaining
data on excretion and accumulation of nanomaterials.
12. Biopharmaceutical Challenges:
 Challenges in biopharmaceutics involve changes in parameters affecting many
characteristics, requiring robust nanomaterial characterization methods.
 Challenges in evaluating effects on blood coagulation include appropriate sample
preparation, nanomaterial dosimetry, assay selection, and standardization.
13. Bionanotechnology Risks:
 Risks of bionanotechnology-derived products, like DNA- and RNA-origami, are
unknown, with knowledge gaps in pharmacokinetics, pharmacodynamics, and
immune responses.
 National and global actions on safety assessments are ongoing, but challenges persist
due to the vast diversity of nanoparticle characteristics.

Challenges Concerning Nanoplastics:

14. Limited Information on Synthesized Nanoplastics:


 Limited information exists on synthesized nanoplastics, and stability of secondary
nanoplastics is unknown.
 Potential fast degradation and decomposition of nanoplastics in the environment pose
challenges in understanding their fate.
15. Reactivity and Impact on Atmosphere and Surface Waters:
 Studies show that smaller nanoplastic particles have higher reactivity with hydroXyl
radicals, releasing organic compounds in aqueous phases.
 Urgent need for improved waste management to minimize pollution and address the
potential impact on aquatic environments.
16. Lack of Consistent Definition and Harmonization:
 Lack of a consistent and widely accepted/harmonized definition for terms like
'microplastics' and 'nanoplastics.'
 Challenges in proposing regulatory measures due to the absence of a standardized
definition.
17. Gap Between Real Environmental Exposure and Laboratory Studies:
 Gap between real environmental exposure and laboratory-based studies hampers
sound risk assessments.
 Challenges in understanding the actual concentrations, sizes, shapes, polymer types,
and weathering states in the environment.
18. Mobility and Fate in Soil:
 Nanoplastics are highly mobile in soil, and their fate is influenced by organic
substances, posing challenges in predicting their environmental impact.
 Plastic additives may affect transportation efficiency and deposition in soil.
19. Need for Reliable Data on Concentrations and Properties:
 Urgent need for reliable data on concentrations and properties of nano- and
microplastics in the environment and the food chain.
 Reports indicate the presence of plastics in various food products, emphasizing the
need for comprehensive studies.
20. Inadequate Analytical Methodology:
 Lack of adequate analytical methodology for detecting and characterizing
nanoplastics.
 Existing methods effective for microplastics but not suitable for smaller-sized
nanoplastics.
21. Risk Assessment Challenges:
 Challenges in assessing the risks of nanoplastics due to uncertainties in potential
hazard, exposure, and uptake.
 Limited data on the ecotoXicological effects of nanoplastics, especially at lower
concentrations in the environment.
22. Comparative Behavior of Nano- and Microplastics:
 Nanoplastics are physically less likely to settle than microplastics, increasing the
likelihood of longer-distance transport.
 Potential higher entry of nanoplastics into the food chain, emphasizing the need for
further investigation.
23. Identification and Quantification Challenges:
 Difficulty in unambiguously identifying and quantifying micro- and nanoplastics due
to their composition resembling biological matrices.
 Analytical methods for engineered inorganic nanoparticles may not be directly
applicable to micro- and nanoplastics.
24. Unresolved Issues in Research:
 Many unresolved issues in definitions, sampling, characterization, and the assessment
of hazard and exposure for nanoplastics.
 Virtually non-existent research data on nanoplastics compared to available
information on microplastics.
25. Coordinated Efforts and Information Exchange:
 Coordinated efforts needed for the development of reference materials, standardized
methods, and legislation for nano- and microplastics.
 Lack of a platform for global information exchange on nano- and microplastics,
hindering progress in understanding their environmental impact.
26. Formation and Release of Nanoplastics:
 Limited understanding of where and how nanoplastics are formed and released, such
as via tire abrasion or washing of synthetic textiles.
 Importance of determining chemical identity and form, not just mass or number of
particles, in regulatory considerations.
Documentary and Material Standards in Nanotechnology:

27. Role of Standards:


 Standards consolidate well-established knowledge and are not a primary means of
sharing new research information.
 Developers typically fund the creation of standards, and they deal with classification,
terminology, guidance, good practices, and test methods.
28. Documentary Standards:
 Focus on nanotechnology/manufactured/engineered nanomaterials.
 Address physicochemical characterization, in vitro assessment, and considerations
for widely used materials (e.g., liposomes).
 Standardization organizations actively develop documentary standards, e.g., ASTM
International, ISO, and OECD.
29. ASTM International:
 ASTM E56 Committee works on nanotechnology standards.
 Standards address physicochemical characterization, in vitro assessment, and other
regulatory needs.
 Extensive inter-laboratory studies are involved in the standardization process.
30. ISO (International Organization for Standardization):
 ISO Technical Committee 229 focuses on nanotechnologies.
 Develops consensus-based international standards in collaboration with
standardization bodies like ASTM, CEN, and OECD.
 Involves a lengthy development process with consultation, comments, and
acceptance.
31. CEN (European Committee for Standardization):
 Nanotechnologies Technical Committee 352 involves 34 European countries.
 Collaborates with ISO and jointly plans new standards projects.
 Adopts or modifies ISO standards for European legislative and market requirements.
32. China (SAC - Standardisation Administration of the People’s Republic of China):
 Provides guidance and standards on nanotechnology through TC 279.
 Develops standards for applications of silver, gold nanoparticles, and carbon-based
nanomaterials.
 Collaboration with international bodies like ISO is planned.
33. US FDA (Food and Drug Administration):
 Develops standards for nanotechnology drug products.
 Concept of product-specific guidance for FDA-approved nanomaterial-containing
products.
 Nanotechnology standards database hosted by ANSI (American National Standards
Institute).
34. OECD (Organization for Economic Co-operation and Development):
 OECD WPMN collaborates with ISO and develops test guidelines for regulatory
testing applicable to nanomaterials.
 Test results following OECD TG are legally accepted in member countries and
adherents.
35. ISO/TC 229 Development Process:
 ISO/TC 229 has developed over 70 standards and related documents with more in
progress.
 Scope includes terminology, nomenclature, metrology, instrumentation, reference
materials, test methodologies, modeling, simulation, and health, safety, and
environmental practices.
36. Challenges in Test Methods and Standards:
 Developing and validating fit-for-the-purpose analytical methods for nanoparticles is
challenging.
 Inter-laboratory studies, method validation criteria, and specificity for
nanoparticle/matrix combinations are crucial.
 Deficiencies in pre-competitive test methods and standards compared to the rising
number of nanomaterial-containing drug product submissions.
37. Reference Materials and Inter-Laboratory Studies:
 Lack of reference materials for different measurands complicates inter-laboratory
studies.
Certified reference nanomaterials mainly exist for particle size determination,
provided by organizations like US NIST and JRC.
38. Commercially Available Certified Reference Nanomaterials:
 Limited availability of certified reference nanomaterials, mainly for particle size
determination.
 Organizations like US NIST and JRC provide such materials, focusing on specific
analytes.

These standards play a crucial role in harmonizing approaches, ensuring safety, and facilitating regulatory
compliance in the field of nanotechnology. They promote consistency, comparability, and reliability in the
assessment of nanomaterials across different laboratories and industries.

Newly Adopted OECD TGs and GDs for Nanomaterials:

39. OECD TG 412: Environmental Media Subacute Inhalation Toxicity - 28-Day Study
(Updated in 2018):
 Addressing manufactured nanomaterials.
 Developed to specifically assess the subacute inhalation toxicity of nanomaterials.
 Adapted to address nanospecific issues.
40. OECD TG 413: Subchronic Inhalation Toxicity - 90-day Study (Updated in 2018):
 Nanospecific adaptation to address issues related to subchronic inhalation toxicity.
 Developed to assess the effects of nanomaterial exposure over a 90-day period.
41. ENV/JM/MONO Guidance Document on Acute Toxicity Studies:
 Ongoing development of more nano-specific TGs and GDs.
 Adaptation of existing TGs and GDs to address specific issues related to
nanomaterials.
 Focus on acute toxicity studies to understand the immediate effects of nanomaterial
exposure.
42. Need for Adaptation and Development:
 Rapid developments in nanotechnology necessitate the adaptation of existing TGs
and GDs.
 New TGs and GDs are essential to address emerging issues and challenges specific to
nanomaterials.
 Ensuring that regulatory frameworks are relevant and effective in the context of
nanotechnology.
43. Challenges and Progress:
 Progress detailed by Rasmussen et al. (2019b) as of 2019.
 Challenges include the need for nano-specific TGs and GDs, adaptation of existing
ones, and addressing specific issues.
 Emphasis on characterizing environmental media and understanding inhalation
toxicity.
44. Collaboration and Coordination:
 International efforts by ISO, OECD, ASTM International, US NIST, and the
European Commission (JRC) in method validation and reference materials.
 Call for better collaboration and communication to accelerate work on reference
materials and standards.
 Avoiding duplication of efforts and ensuring harmonized approaches in nanomaterial
assessments.
45. Characterization Methods and Challenges:
 Many existing methods are highly product-specific.
 Lack of harmonized analytical protocols for method validation and reference material
production.
 Challenges in developing standardized methods for characterizing nanoparticles in
various matrices.

The ongoing efforts in developing and adapting OECD TGs and GDs highlight the importance of staying abreast
of nanotechnological advancements and ensuring regulatory frameworks are well-suited to address emerging
challenges in the field. Collaboration and coordination are emphasized to enhance the efficiency and
effectiveness of these endeavors.
Future Directions in Nanotechnology Governance:

46. Growing Applications in Nanomedicines and Beyond:


 Increased utilization of nanomaterials in medical products and nanomedicines.
 Expanding applications in the agri/food sector and other domains.
 Continued attention needed from regulatory scientists, regulators, and research
funders.
47. Advancements in Nanoscale Manipulability:
 Ongoing technological developments focus on manipulability at the nanoscale.
 Bio-nanotechnology emerges as a prominent area.
 Regulatory and policy perspectives evolving to address potential risks and safety
concerns.
48. Holistic Risk-Benefit Assessment:
 Emerging need for a holistic view on both risks and benefits.
 Especially crucial for complex nanomedicines.
 Close collaboration between scientific, regulatory communities, and research
funders.
49. Early Consideration of Risks and Benefits:
 Integration of risk and benefit assessment as early as possible in the development
process.
 Evolving applications demand a proactive regulatory approach.
 Ensuring rigorous, reproducible, and comparable testing of nanomaterials.
50. Public-Private Partnerships for Innovation:
 Public-private partnerships considered essential for developing new medical
solutions.
 Collaboration between public and private sectors required.
 Early involvement of regulators in the innovation process ensures regulatory
preparedness.
51. Adoption of Safe-by-Design Principles:
 Safe-by-design approach essential for materials at the nanoscale.
 Balancing safety and functionality through collaborative dialogue.
 Stakeholders involved in a trusted environment for informed decision-making.
52. Challenges in Global Standardization:
 Lack of global standardization in nomenclature, test methods, and characterization.
 Potential divergence in regulatory approaches globally.
 Addressing challenges through regulatory frameworks, legislation, and global
alignment.
53. Multidisciplinary Approach to Nanoplastics:
 Rising concern about plastic litter impact on ecosystems, biodiversity, and human
health.
 Nanoplastics pose a multidisciplinary global challenge.
 Research gaps in terminology, definitions, sampling, and hazard/exposure
assessment.
54. Regulatory Challenges and Stakeholder Involvement:
 Regulatory challenges persist in nanotechnology/nanomaterials and nanoplastics.
 Fit-for-purpose regulatory system requires collaboration of all stakeholders.
 Global harmonization efforts crucial for effective governance.
55. Role of GCRSR and JRC:
 GCRSR commitment to continued discussions and summits.
 JRC offers open access to nanobiotechnology laboratory infrastructure.
 Proposal for an international working group under GCRSR to monitor global
guidance and standards.
56. Call for International Collaboration:
 Invitation extended to experts globally for participation.
 Coordination of laboratory-related activities, including inter-laboratory validation.
 Global collaboration imperative due to the developmental phase of nanoscience.

NANO-TECH & AGRO-PRODUCTS


Introduction:

1. Challenges in Food, Nutrition, and Energy Security:


o Climate and Population Pressure: Intense strain due to climate issues, population growth.
o Limited Resources: Scarcity of arable land, diminishing crop yields, and crop use for
industrial purposes.
2. Limitations of Conventional Plant Breeding:
o Insufficiency of Classical Methods: Traditional breeding methods insufficient for immediate
global food and fodder demands.
o Inability for Novel Features: Conventional methods incapable of introducing features not
present in many plant species.
3. Role of Modern Scientific Advancements:
o Need for Technological Solutions: Modern, scientific, and technical advancements crucial to
address agricultural insufficiencies.
o Nanobiotechnology Potential: Nanobiotechnology emerges as a potential solution for
leveraging advanced biotechnological techniques.
4. Nanobiotechnology in Agriculture:
o Revolutionizing Genetic Engineering: Nanocarriers have the potential to revolutionize plant
genetic engineering.
o Biomolecule Transport: Nanocarriers employed for transporting biomolecules into plant
cells.
5. Advancements in Nanotechnology for Agriculture:
o Recent Surge: Recent years witness a surge in nanotechnology applications in agriculture.
o Diverse Applications: Nanomaterials contribute to enhanced fertilization, optimized nutrient
yields, and reduced dependence on plant protection agents.
6. Cell Wall as a Barrier in Nanomaterial Delivery:
o Physical Barrier: Cell wall acts as a physical barrier with a size exclusion limit (5–20 nm).
o Promise of Nanoparticles: Nanoparticles show promise for efficient delivery of DNA, RNA,
and proteins into plant cells.
7. Global Adoption of Nano-Based Agricultural Products:
o Addressing Agricultural Challenges: Nanotechnology addresses challenges in sustainable
agriculture.
o Diverse Applications: Development of nanopesticides, nanobiofertilizers, nanobiosensors,
and soil decontamination.
8. Need for Regulatory Frameworks:
o Global Regulations: Regulatory frameworks globally developed for genetically engineered
agricultural products.
o Focus on Oversight: Emphasis on overseeing nanocarrier-based products in plant genetic
engineering.

Advanced Approaches for Biomolecules Delivery:

1. Nanotechnology-Based Gene Delivery:


o Cost-Effective and Reliable: Nanotechnology-based techniques suggested as low-cost,
simple, and reliable for gene transfer.
o Successful Delivery: Genes and compounds successfully delivered into plant cells using
nanotechnology.
2. Genetic Engineering for Crop Improvement:
o Enhancing Productivity: Genetic engineering employed for increased productivity,
nutritional quality, and stress resistance.
o Efficiency Boost: Nanotechnology-based methods enhance genetic engineering efficiency.
3. Categorization of Nanoparticles for Gene Delivery:
o Diverse Nanoparticle Categories: Carbon nanotube-based, silicon-based, metallic-based,
and polymer-based nanoparticles.
o Impactful Properties: Size, concentration, and properties crucial for efficacy and toxicity
assessment.
4. Toxicity Considerations:
o Determinants of Toxicity: Size, concentration, and properties impact the toxicity level.
o Promising Results: Carbon nanomaterials and metal-based nanomaterials show promising
results with reduced toxicity.
5. Nano-Priming Technology:
o Molecular, Chemical, and Physiological Enhancement: Nano-priming enhances plant
properties at molecular, chemical, and physiological levels.
o Seed-Based Approach: Enhanced plants produced through nano-primed seeds.

Nanotechnology-Based Agriculture Products:

1. Diverse Applications of Nanotechnology:


o Versatile Tools: Nanodevices and nanocapsules utilized for improving, diagnosing, and
treating plant diseases.
o Addressing Global Concerns: Tools to transport active ingredients, purify wastewater, and
enhance nutrient absorption.
2. Global Food Security Concerns:
o Designing Solutions: Nanotechnology-based agriculture products designed to enhance food
security globally.
o Tackling Challenges: Addressing challenges posed by climate change, population growth,
and agricultural pests and diseases.

Applications of Nanotechnology in Agri-Food Sector:

3. Nanofertilizers:
 Challenges of Conventional Fertilizers: Indiscriminate use of chemical fertilizers
leads to nutrient loss and high application rates.
 Advantages of Nanofertilizers: Nanofertilizers (<100 nm) reduce nutrient loss,
enhancing nutrient uptake and reducing fertilizer application rates.
 Focus on Micronutrients: Research focuses on micronutrients like iron, zinc,
manganese, copper, nickel, and molybdenum.
 Nano-Carbons and Chitosan NPs: Nano-carbons (Biochars), carbon nano-onions,
and Chitosan NPs enhance crop growth and quality.
4. Nanopesticides:
 Unsustainable Pesticide Use: Indiscriminate use of pesticides leads to
environmental damage, harming non-target species and humans.
 Characteristics of Nanopesticides: Nanopesticides (nanometer size) offer increased
solubility, slow/targeted release, and protection against premature degradation.
 Various Types: Nanopesticides can be nanoemulsions, nanodispersions, solid-liquid
nanoparticles, and nano metals.
 Effectiveness and Reduced Toxicity: Silica Nanoparticles, Temperature-responsive
mixed micelle, Carboxymethyl chitosan, and Nanometal-based imidacloprid show
high effectiveness with reduced toxicity.
5. Nano-based Plant Growth Regulators:
 Controlled Release of Plant Growth Hormones: Nanoparticles enable controlled
release of plant growth hormones for sustained efficacy.
 Examples: Nitric oxide-releasing chitosan nanoparticles, Multi-walled carbon
nanotubes, Poly (γ-glutamic acid) and chitosan polymers encapsulated gibberellic
acid.
6. Nanosensors:
 Monitoring Environmental Conditions: Nanosensors contribute to real-time
monitoring of environmental conditions, crop growth, diseases, pest attacks, and
nutrient efficiency.
 Materials Used: Nanocomposites with polymers, Carbon nanotubes, Gold
nanoparticles, and Quantum dots.
 Applications: Detection of pesticides, soil nutrients, volatile organic compounds
emitted by plants, and real-time soil monitoring.
7. Nanotechnology in Transgenic Plant Development:
 Importance of Genetic Engineering: Crucial for enhancing crop output, quality,
and resilience to stressors.
 Methods of Gene Delivery: Nanotechnology-based methods show excellent
transformation efficiency, biocompatibility, and protection of exogenous nucleic
acids.
 CRISPR-Cas Integration: Integration with CRISPR-Cas-mediated genome editing
being explored for advanced applications.
8. Safety and Regulations for Nanotechnology-Based Agri-Products:
 Regulatory Oversight: Each country has its regulatory framework (EPA, USDA,
ECHA, EFSA) for nanotechnology in agriculture.
 Risk Assessment: Evaluation of nanomaterial toxicity, potential environmental
release, and human health impact required for approval.
 Labeling: Nanotechnology-based agri-products must be labeled to inform
consumers.
 International Standards: ISO standards (e.g., ISO/TS 80004-1) provide
terminology and definitions for nanomaterials.
 Research and Development: Encouragement for ongoing research and development
to ensure product safety.
 Collaborative Effort: Collaboration among researchers, manufacturers, regulatory
bodies, and consumers crucial for safe use.
 Monitoring and Assessment: Continuous monitoring and risk assessment essential
for ensuring safety and effectiveness.

Regulation of Nanotechnology-Based Agri-Products in the United States:

9. Regulatory Framework:
 Governmental Oversight: Nanotechnology-based agricultural products are
regulated by the FDA, EPA, and USDA in the United States.
 Approved Nanomaterials: FDA-approved nanomaterials include titanium dioxide,
silica, zinc oxide, and iron oxide for various food applications.
10. Key Laws and Regulations:
 Toxic Substances Control Act (TSCA):
 EPA Authority: EPA regulates production, importation, use, and disposal of
nanomaterials under the TSCA.
 Information Requirements: Companies must provide EPA with health and
environmental effects information for nanomaterials used in agri-products.
 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA):
 Pesticide Regulation: FIFRA regulates registration and use of pesticides
containing nanomaterials, ensuring safety and efficacy.
 Food, Drug, and Cosmetic Act (FD&C Act):
 FDA Regulation: FDA oversees nanotechnology use in food and cosmetics,
requiring safety, efficacy, and proper labeling of products.
 National Organic Program (NOP):
 USDA Regulation: NOP, a USDA program, sets standards for organic
labeling, though specific guidelines for nanomaterial use are not outlined.
 Nanotechnology Research and Development Act (NRDA):
 Coordination Efforts: NRDA directs federal agencies to coordinate
nanotechnology research to understand risks and benefits, ensuring
appropriate regulations.
11. Safety Measures and Recommendations:
 Rigorous Safety Testing:
 Identification of Risks: Companies should conduct thorough safety testing
to identify potential risks associated with nanomaterials.
 Proper Labeling:
 Consumer Information: Properly labeling products with ingredient
information is necessary, and additional details about nanomaterial
properties are recommended.
 FDA Guidance: FDA recommends providing information on nanomaterial
properties (size, shape, surface area) for risk assessment and management.
 Environmental Impact Assessments:
 Assessment Requirement: Companies should conduct assessments to
determine potential environmental impacts of nanotechnology-based agri-
products.
 Employee Training:
 Proper Handling: Training employees on proper handling and disposal of
nanomaterials is essential to reduce exposure risks.
12. Evolution of Regulation:
 Dynamic Field: The regulation of nanotechnology-based agri-products in the U.S. is
evolving.
 Continuous Updates: Companies must stay updated on the latest laws, safety
measures, and regulations to ensure the safety and efficacy of their products.

In summary, the United States has a comprehensive regulatory framework and safety measures in place to
govern nanotechnology-based agri-products, emphasizing risk assessment, proper labeling, environmental
impact assessments, and employee training. The dynamic nature of the field requires continuous updates and
adherence to evolving regulations.

Regulation of Nanotechnology-Based Agri-Products in the United Kingdom:

13. Governmental Oversight:


 Regulatory Authorities: The regulation of nanotechnology-based agri-products in
the UK involves several agencies, including the Food Standards Agency (FSA),
Department for Environment, Food and Rural Affairs (DEFRA), and Health and
Safety Executive (HSE).
 Responsibilities:
 FSA: Ensures safety and quality of food products, including those
incorporating nanotechnology.
 DEFRA: Provides guidance on nanomaterial use in agriculture,
emphasizing safe handling and disposal.
 HSE: Produced Nanotechnology Safety Guidance in 2011 for safe use
across various industrial sectors, including agriculture.
14. Key Regulation and Guidance:
 Nanotechnology Safety Guidance (2011):
 HSE Production: Issued by HSE, offering information on safe handling
and use of nanomaterials in different industrial settings, including
agriculture.
 FSA Report (2014):
 Safety Assessment: FSA published a report recommending risk assessment
and evaluation for nanotechnology in food products to ensure safety.
 DEFRA Guidance (Updated in 2018):
 Safe Handling: DEFRA guidance on nanomaterials in agriculture, covering
safe handling and disposal, reflecting the latest scientific knowledge.
15. Evolution of Regulations:
 Dynamic Field: Regulation of nanotechnology-based agri-products in the UK is
rapidly evolving.
 Regular Updates: New regulations and guidance are issued regularly to align with
the latest scientific understanding of potential risks and benefits of nanotechnology.

In summary, the United Kingdom employs a multi-agency approach, involving FSA, DEFRA, and HSE, to
regulate nanotechnology-based agri-products. The Nanotechnology Safety Guidance, FSA's safety report, and
DEFRA's guidance provide comprehensive frameworks for safe use, risk assessment, and disposal. The dynamic
nature of the field necessitates continuous updates to regulations and guidance to stay aligned with evolving
scientific knowledge.

Regulation of Nanotechnology-Based Agri-Products in Europe:

16. Regulatory Framework:


 Scope: Nanotechnology-based agri-products, including pesticides, fertilizers, and animal feed
additives, are regulated in Europe to ensure safety for human health and the environment.
Key Legislations:

 Regulation (EC) No 1107/2009:


 Focus: Governs the market placement of plant protection products in the EU.
 Requirements: Mandates authorization and data requirements for plant protection products, including
those with nanomaterials (Year: 2009).
 Regulation (EC) No 396/2005:
 Objective: Establishes maximum residue levels (MRLs) for pesticides in food and feed from plants and
animals.
 Inclusion: Applies to pesticides containing nanomaterials (Year: 2005).
 Regulation (EC) No 1935/2004:
 Purpose: Sets safety standards for products and materials in contact with food.
 Applicability: Encompasses all nanomaterials used in food contact materials, including agri-products
(Year: 2004).
 Regulation (EC) No 767/2009:
 Scope: Governs authorization and marketing rules for feed additives in the EU.
 Requirements: Ensures safety for animals and the environment, covering feed additives with
nanomaterials (Year: 2009).
 Regulation (EU) No 2019/1009:
 Objective: Establishes rules for CE-marked fertilizers, emphasizing safety for human health and the
environment.
 Applicability: Enforces safety standards for fertilizers containing nanomaterials (Year: 2019).

17. Supplementary Guidelines and Recommendations:


 Issuing Authorities: Various European agencies and organizations, including the
European Chemicals Agency (ECHA) and European Food Safety Authority (EFSA).
 Focus: Guidelines and recommendations on safety assessments of nanomaterials in
agri-products.
18. Comprehensive Safety Oversight:
 Holistic Approach: Regulations cover different aspects, including authorization,
safety standards, residue levels, and market availability.
 Collaboration: Involves multiple regulatory bodies, ensuring a comprehensive and
coordinated approach to safety in nanotechnology-based agri-products.

The European regulatory framework employs a multifaceted approach, with specific regulations addressing
diverse agri-products containing nanomaterials. The comprehensive oversight ensures the safety of these
products while promoting advancements in agricultural technology.

Regulation of Nanotechnology-Based Agri-Products in India:

19. Regulatory Landscape:


 Agencies Involved: Department of Biotechnology (DBT), Ministry of Environment,
Forest and Climate Change (MoEFCC), Food Safety and Standards Authority of
India (FSSAI), Indian Council of Agricultural Research (ICAR).
 Legislation Framework: Multiple laws and guidelines contribute to the regulatory
oversight of nanotechnology-based agri-products.
20. Key Laws and Regulations:
 Environment (Protection) Act, 1986:
 Empowers: MoEFCC for regulating hazardous substances, including
nanomaterials.
 Hazardous Waste (Management, Handling, and Transboundary Movement)
Rules, 2016:
 Requirements: Registration and authorization for facilities dealing with
hazardous wastes, including nanomaterials.
 Food Safety and Standards Act, 2006:
 Regulator: FSSAI oversees safety and quality of food products, issuing
guidelines for nanotechnology use in agri-products.
 Insecticides Act, 1968:
 Scope: Regulates registration, sale, distribution, and use of insecticides,
covering nanotechnology-based insecticides.
 Seeds Act, 1966:
 Regulation: Governs seed quality, amended to include provisions for
regulating genetically modified seeds using nanotechnology.
21. Guidelines and Notifications:
 DBT Guidelines (2017):
 Focus: Safety assessment of foods derived from genetically engineered
plants and microorganisms, including nanotechnology applications.
 MoEFCC Notification (1989):
 Requirements: Compliance with safety and environmental regulations for
manufacturers and importers of hazardous chemicals, including
nanomaterials.
 FSSAI Regulations (2011):
 Conditions: Specifies conditions for using food additives, including those
derived from nanotechnology, in food products.
 ICAR Guidelines (2010):
 Framework: Provides guidelines for safe and responsible use of
nanotechnology in agricultural research and development.
 IPC Guidelines (2019):
 Characterization: Framework for nanoparticle characterization, including
those used in agri-products.
22. Evolving Regulatory Landscape:
 Challenges: The regulation of nanotechnology-based agri-products is evolving in
India.
 Need: Calls for more comprehensive and coordinated regulatory frameworks to
ensure safety and efficacy.

The regulatory framework in India for nanotechnology-based agri-products involves multiple agencies and laws,
emphasizing safety, compliance, and the need for ongoing development in regulatory approaches.

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