UNIT 1: Introduction to Concept of Traditional Knowledge

Article 8(j) of the Convention on Biological Diversity puts forth that traditional knowledge
refers to the awareness, inventions, and traditions of local and indigenous cultures
worldwide.

WIPO(World intellectual property organisation) defines traditional knowledge as the

knowledge, skills, practices, and know-how that are developed, sustained, and passed on
from generation to generation within a community, often forming part of its cultural or
spiritual identity.

Need to Protect TK:

1. Increased demand for commercialization of biodiversity;
2. Traditional knowledge; and disruption of the interrelationship between TK generators
and their resources due to the business of bio-trade. Bio-trade refers to the transfer of
biological resources for real or potential benefit between countries, academic
companies, and individuals.
3. Bioprospecting: It is the exploitation of commercially valued biological resources. It
is the search for useful organic compounds found in extreme environments such as
rainforests, deserts, and hot springs in microorganisms, plants, and fungi.
4. Biopiracy: Conflict arises when ethnobotanists (Ethno-botany is the scientific study of
the relationships that exist between people and plants and the person specialists in
ethnobotany are ethnobotanists), pharmaceutical companies, and other industries
(textiles, handicrafts, seeds, etc.) exploit biological resources and associated
traditional knowledge without permission and profit-sharing with the original TK
holders, i.e. leading to biopiracy

Two angles to intellectual property protection exist:

• Defensive protection aims to stop people outside the community from acquiring
intellectual property rights over traditional knowledge. India, for example, has compiled a
searchable database of traditional medicine that can be used as evidence of prior art by patent
examiners when assessing patent applications. This database was created following a well-
known case in which the US Patent and Trademark Office had granted a patent (later
revoked) for the use of turmeric to treat wounds, a property well known to traditional
communities in India and documented in ancient Sanskrit texts. Defensive strategies might
also be used to protect sacred cultural manifestations, such as sacred symbols or words, from
being registered as trademarks by third parties.
• Positive protection is the granting and exercise of rights that empower communities to
promote their traditional knowledge, control its uses and benefit from its commercial
exploitation. This can be achieved through the existing intellectual property system, and a
number of countries have also developed specific legislation. However, any specific
protection afforded under national law may not hold for other countries, one reason why
many are advocating for an international legal instrument. Some of the examples of positive
protection would be:
 Prior information consent: PIC is the permission taken from original holders of
biological resources and related traditional knowledge to access and commercial
exploitation of resource and associated knowledge.
 Benefit-sharing: Benefit-sharing refers to an agreement of sharing benefits (both
monetary and nonmonetary) resulting from commercially exploiting the biological
 resources and associated knowledge of a traditional community with that community.

Why Traditional Knowledge is treated under Intellectual Property?

Traditional knowledge, distinct from conventional forms of intellectual property, has long
been overlooked in the intellectual property framework, which primarily caters to
technologically advanced societies. Only recently has the need to safeguard traditional
knowledge gained recognition, yet there is no comprehensive international mechanism for its
protection. Several practical and logistical challenges hinder its protection:

1. Organic Nature: Traditional knowledge is dynamic and ever-evolving, making it

incompatible with the limited timeframes of existing intellectual property systems.

2. Indefinite Protection: Unlike patents or trademarks, traditional knowledge must be

safeguarded indefinitely as it holds cultural and historical significance.

3. Oral Tradition: Much traditional knowledge is orally transmitted across generations

and remains undocumented, posing difficulties in formal protection.

To address these issues, countries like India, Peru, Panama, Costa Rica, Brazil, Thailand,
Philippines, and the United States have adopted sui generis models for traditional knowledge
protection. For instance, India established the Traditional Knowledge Digital Library (TKDL)
in 2001 to document traditional medicine, aiding patent examiners in identifying prior art.
However, this approach has drawbacks, including the risk of exposing traditional knowledge
and the omission of orally transmitted knowledge.

TK and Patents

Indian patent laws, specifically Section 3(p) of the Indian Patent Act, 1970, prohibit the
protection of traditional knowledge (TK) through patents. In essence, if an invention merely
involves traditional knowledge or combines known properties of traditional components, it
does not qualify as a patentable invention. For instance, a patent application for an improved
process for preparing Chyawanprash , which is based on traditional knowledge, would be
considered non-patentable under this law.

Indian intellectual property law recognizes that traditional knowledge is part of the public
domain and cannot be patented. Section 2(1)(j) of the Patents Act defines an "invention" as
something new, requiring an inventive step and capable of industrial use, which traditional
knowledge typically does not meet. Additionally, Section 3(e) of the Act states that
substances obtained through mere admixture, resulting only in the aggregation of component
properties, are not patentable.

Patent applications rooted in traditional knowledge can be rejected or opposed under various
sections of the Patents Act. Section 15 and clauses (d), (f), and (k) of section 25(1) allow for
denial during pre-grant opposition, while patents granted can be revoked under clauses (d),
(f), and (k) of section 25(2) if they contravene these legal provisions.

Copyright and TK
Copyright protects the expression form, and not the ideas themselves. Copyright holders are
authorized to do any of the acts provided under Section 14 of the 1957 Copyright Act.
Copyright may be used to shield TK holders’ artistic manifestations, in particular artists
belonging to indigenous and migrant cultures, from unauthorized reproduction and abuse of
these manifestations. Moral rights deal with the creators/artists/authors’ relationship with
their work. Such rights may provide an important way to secure indigenous peoples’ interests
in works derived from indigenous knowledge.
Also, Section 31A of the Copyright Act, 1957 deals with the compulsory license in case of
unpublished Indian work. Under this section, if the author of a work is dead, unknown or
cannot be traced or the owner of the copyright cannot be found, any person can apply to the
Copyright Board for a license to publish such work or a translation thereof in any language.
Before making an application the applicant shall publish his proposal in one issue of a daily
newspaper in the English language having circulation in the major part of the country and
where the application is for the publication of a translation in any language, also in one issue
of any daily newspaper in that language, so that if the original author of the work exists he
can claim his ownership.

Trade Secret and TK

The first step towards secret trade protection of indigenous knowledge is the realization of its
value by the holders: they must be aware of their rights and the long-term benefits they will
gain if they are protected as trade secrets. The incentives provided by the secrecy regime for
monitoring the distribution and use of TK must be made public within the sectors and
communities concerned. TK holders can also retain the right to determine whether to reveal
the information or not. TK’s security and its various representations by trade secrets has
many advantages over other types of IPRs.

Trademark and TK
Under the Indian Trademark Act of 1999, agricultural and biological products from
indigenous communities can receive protection through trademarks. This legal framework
allows various products crafted, produced, or offered by indigenous individuals, groups, or
cooperatives to be distinguished from similar goods and services provided by others through
the use of trademarks and service marks.
Collective marks can be employed to safeguard artisanal and cultural products, while
certification marks can differentiate a wide range of products and services, including
traditional art, food, clothing, and tourism services. Indigenous groups can register
trademarks to market their products, ensuring brand differentiation and guaranteeing their
unique quality. While trademarks can protect the reputation and fidelity of products
associated with traditional knowledge, they do not safeguard the knowledge itself.
Trademarks serve as a defensive protection measure against the misuse of traditional
knowledge designations on derivative products, similar to how they maintain product fidelity
after the expiration of patents, especially in fields like pharmaceuticals. If a patent restricts
indigenous communities from selling a product, they have the option to register a trademark
and subsequently license its use to companies, ensuring product authenticity. This approach
enhances product value and can lead to royalty collection on sales, providing indigenous
communities with a means to benefit economically from their traditional knowledge.

GI and TK
The Geographical Indications of Goods (GI) Act of 1999 in India defines a "Geographical
Indication" as an indication that identifies goods, be they agricultural, natural, or
manufactured, as originating in a specific region or locality within a country. This
designation is attributed to the fact that a particular quality, reputation, or characteristic of
those goods is essentially linked to their geographical origin. GI protection is granted when
at least one of the activities related to production, processing, or preparation of the
goods takes place within the defined territory.
GI functions similarly to trademarks by associating a known quality or reputation with
products from a particular geographical area. It prohibits the use of the geographical
indication in connection with products manufactured outside of that specific region. Notable
examples of GI in India include Darjeeling Tea, Kanchipuram Silk, Alphonso Mango, and
Nagpur Orange.
For indigenous communities, GI provides a powerful means of protecting traditional
knowledge (TK) collectively. GI protection lasts for ten years but can be renewed
indefinitely, ensuring perpetual safeguarding of the product's prestige. It acknowledges the
continuous improvement of production methods and rewards the goodwill and reputation
developed over time. GI rights are collective and cannot be transferred freely between
individuals.
Furthermore, GIs can be employed to protect traditional medicinal products, especially those
containing botanical components where the unique features are tied to the geographical
origin. This recognition through GIs not only adds value to the goods but also acknowledges
the cultural commitment, survival skills, conservation efforts, and social ties of the
indigenous farmers. Ultimately, GIs contribute to the preservation and evolution of society by
honoring the cultural values and ingenuity of TK holders.

Industrial designs
An industrial design is one type of intellectual property where the design method focuses on
an article’s aesthetic function, derived from its visual appearance. The style and shape of
traditionally made furniture, garments, receptacles, wooden objects, leather ceramics, etc.
prepared by indigenous people or association on behalf of indigenous people may be
classified as industrial designs. Traditional craft products such as hand-woven articles such as
carpets, cotton bed covers may also be classified as industrial design for safety. Countless
types of traditional designs are deeply rooted in India’s rich cultural heritage. For example,
the “chicken kadhai” of Lucknow is a famous traditional design of India.

UNIT 2: Types of Traditional Knowledge

1. Unfixed TK and Fixed TK

Fixed traditional knowledge refers to traditional knowledge that has been documented,
recorded, or expressed in tangible forms such as written texts, manuscripts, audio recordings,
or videos. It is tangible and can be easily referenced, shared, and protected under intellectual
property laws. Fixed traditional knowledge provides a clear record of the knowledge, making
it accessible for future generations and ensuring that its source is acknowledged. For
example, quipus were recording devices used in the Inca Empire and its predecessor societies
in the Andean region. Quipus could be made of cotton cords, which contained numeric and
other values encoded by knots in a base ten positional system. It is shown that most
information on the quipu is numeric, and that these numbers could be read.
Unfixed traditional knowledge, on the other hand, exists primarily in oral form, embedded
in the collective memory, practices, and traditions of indigenous and local communities. It
has not been formally documented or recorded in tangible ways. Unfixed traditional
knowledge can be more challenging to protect and share, as it relies on oral transmission and
may not fit within conventional intellectual property frameworks. Preserving and respecting
unfixed traditional knowledge often require unique approaches that consider its oral and
cultural nature.

2. Codified and Non-Codified TK

a) Codified systems of traditional medicine, which have been disclosed in writing in
ancient scriptures and are fully in the public domain, e.g. Ayurveda disclosed in ancient
Sanskrit scriptures26 or Traditional Chinese Medicine (TCM) disclosed in ancient Chinese
medical texts27; and
(b) non-codified traditional medicinal knowledge which has not been fixed in writing,
often remains undisclosed by traditional knowledge holders, and is passed on in oral
traditions from generation to generation. In South Asia, for example, the codified knowledge
systems include the Ayurvedic system of medicine, which is codified in the 54 authoritative
books of the Ayurvedic System, the Siddha system, as codified in 29 authoritative books, and
the Unani Tibb tradition, as codified in 13 authoritative books. 28 As pointed out by
Committee members, this distinction may have important intellectual property implications
for the compilation and use of traditional knowledge databases

3. Disclosed and Undisclosed TK

Disclosed traditional knowledge (TK) refers to traditional knowledge that has been made
publicly available or shared with the broader community. It may have been documented,
recorded, or disclosed in various forms, making it accessible to the public, researchers, or
other stakeholders. Disclosed TK may include information found in books, databases,
publications, or public forums.
 publicly disclosed TK, which can be accessed through physical documentation, the
internet and other kinds of telecommunication or recording. Such TK is widely open
to the public
 publicly available TK with limited accessibility. For example, some records on TK
are only kept in a specific library, archive or other repository. Even though these
records are publicly disclosed, they can be accessed only by those with access to the
repository;
 TK held within indigenous and local communities, which is disclosed and known
within such communities. Within indigenous and local communities, the disclosure
may be made by specific persons to specific individuals or groups in specific times,
spaces, manners, and for special purposes; and
 secret and confidential TK held by specific individuals or a class of individuals
within indigenous and local communities who are their traditional custodians. Such
TK cannot even be accessed by the other members of the indigenous and local
communities

Undisclosed traditional knowledge, on the other hand, remains confidential and has not
been shared or documented for public access. It is typically held within the specific
community or group that possesses this knowledge and is often passed down through
generations orally. Undisclosed TK is kept secret to protect its cultural, economic, or
ecological value and may only be shared selectively within the community. Protecting
undisclosed TK is essential to preserve its integrity and prevent misappropriation.

4. TK Directly Controlled by Indigenous and Local Communities and TK No

Longer in the Control of Indigenous and Local Communities
 5. Sacred TK and Secular TK
Sacred TK refers to the TK which includes religious and spiritual elements, such as totems,
special ceremonies, sacred objects, sacred knowledge, prayers, chants, and performances and
also sacred symbols, and also refers to sacred TK associated with sacred species of plants,
animals, microorganisms, minerals, and refers to sacred sites.
Whether TK is sacred or not depends on whether it has sacred significance to the relevant
community. Much sacred TK is by definition not commercialized, but some sacred objects
and sites are being commercialized by religious, faith-based and spiritual communities
themselves, or by outsiders to these, and for different purposes.

6. Individual and Collective TK

TK is, in general, developed collectively and/or regarded as belonged collectively to an
indigenous or local community or to groups of individuals within such a community.

7. Commercialized TK and Non-Commercialized TK

Some TK has already been commercialized. To “commercialize” may be defined as to

“exchange goods and services from the point of production to the point of consumption”. 68
Commercialization is done within a commercial or monetary system. TK might be
commercialized as part of local industrial traditions or community enterprises, or as part of a
business agreement with a third party.69 However, much TK has not been commercialized

UNIT 3: Legal Developments towards Traditional Knowledge – International TRIPS

and TK

First document which explicitly recognizes ‘TK’ internationally is the Convention on

Biological Diversity (CBD). Article 8 (i) of the Convention reads that: ‘Each contracting
party shall, as far as possible and as appropriate subject to its national legislation, respect,
preserve & maintain knowledge, innovation and practices of indigenous and local
communities embodying traditional life style and the equitable sharing of the benefits arising
from the utilization of such knowledge, innovation and practice.

Many forms of TK do not qualify for protection under TRIPs for various reasons. Such as
A) They are too old and in public domain (Art 27(1)of TRIP’S);
B) If protected, it follows that the right given for the holders is an exclusive rights for
unlimited period which would contravene the general rule in IP, i.e. limited protection so that
the property return to the mass (Art 33 of TRIP’S );
C) The difficulty in identifying the ‘TK’ right holder, and thus the chance to conclude there is
no right holder (Art 28 of TRIPs);
D) Problems faced when the right holder is identified with groups or communities;
E) The fact that same creation/inventions might express themselves in several versions and
incarnation; and
F) Applying for a patent requires full disclosure of the invention, shortly after the patent is
approved which will make the knowledge visible to public exploitation.

Art. 7 of the TRIPs which deals with technology transfer is stipulated in broad terms which
make it a subject of interpretation by WTO members as even a provision providing the
safeguard of TK. A similar position can be spoken for Article 67 of the TRIPs, as it talks of
cooperation between the developed and other nations (assistance including prevention of
abuse). Another important article with this aspect is the provision of Article 27(3.b). The
provision sets out conditions for which certain biological materials or intellectual innovations
are excluded from patenting

Before Doha
The review of Article 27.3(b) began in 1999 as required by the TRIPS Agreement. The topics
raised in the TRIPS Council’s discussions include:
 how to apply the existing TRIPS provisions on whether or not to patent plants and
animals, and whether they need to be modified
 the meaning of effective protection for new plant varieties (i.e. alternatives to
patenting such as the 1978 and 1991 versions of UPOV — the International Union for
the Protection of New Varieties of Plants). This has included the flexibility that
should be available, for example to allow traditional farmers to continue to save and
exchange seeds that they have harvested
 how to handle moral and ethical issues, e.g. to what extent invented life forms should
be eligible for protection
 how to deal with the commercial use of traditional knowledge and genetic material by
those other than the communities or countries where these originate, especially when
these are the subject of patent applications
 how to ensure that the TRIPS Agreement and the UN Convention on Biological
Diversity (CBD) support each other
The Doha mandate
The 2001 Doha Declaration made it clear that work in the TRIPS Council under the reviews
(Article 27.3(b) or the whole of the TRIPS Agreement under Article 71.1) and on outstanding
implementation issues should cover: the relationship between the TRIPS Agreement and the
UN Convention on Biological Diversity (CBD); the protection of traditional knowledge and
folklore; and other relevant new developments that member governments raise in the review
of the TRIPS Agreement.
It adds that the TRIPS Council’s work on these topics is to be guided by the TRIPS
Agreement’s objectives (Article 7) and principles (Article 8), and must take development
issues fully into account.

The TRIPS Council, under the World Trade Organization (WTO), has engaged in an
extensive debate regarding the intersection of the TRIPS Agreement and the Convention on
Biological Diversity (CBD). Several proposals and ideas have emerged in these discussions:
 Disclosure as a TRIPS Obligation: A group of countries, led by Brazil and India and
supported by various others including African nations, advocates for amending the
TRIPS Agreement. They propose that patent applicants must disclose the origin of
genetic resources and traditional knowledge used in their inventions. Additionally,
they should provide evidence of having obtained "prior informed consent" and
demonstrate "fair and equitable" benefit sharing.
 Disclosure through WIPO: Switzerland suggests amending the regulations of the
World Intellectual Property Organization's (WIPO) Patent Cooperation Treaty. This
amendment would allow domestic laws to require inventors to disclose the sources of
genetic resources and traditional knowledge when applying for patents. Failure to
comply could result in delays in patent issuance or, when done fraudulently, patent
invalidation.
 Disclosure Outside Patent Law: The European Union (EU) takes a different approach
by proposing that all patent applicants disclose the origin of genetic material.
However, the legal consequences of non-compliance would be addressed outside the
 realm of patent law, potentially through separate legislation.
 Use of National Legislation and Contracts: The United States suggests that the CBD's
objectives concerning access to genetic resources and benefit sharing can be best
achieved through national legislation. This legislation could include contractual
arrangements based on the legal framework. Such arrangements might involve
commitments to disclose any commercial applications of genetic resources or
traditional knowledge.

Unit 4: Legal Developments towards Traditional Knowledge – International

Convention on Biological Diversity and Nagoya Protocol

Nagoya Protocol and TK

The CBD’s 10th Conference of the Parties, in Nagoya 2010 adopted an international legally
binding protocol on access to genetic resources and benefit-sharing—the Nagoya Protocol.
The Protocol aims to implement the CBD’s third objective on access and benefit sharing, and
is binding on user countries as well as provider countries.
Previously, industrialised countries had no legal obligation to ensure benefits from using
genetic resources were shared equitably. The protocol requires user countries to introduce
legal, administrative or policy measures to ensure compliance with the access and benefit-
sharing law of provider countries.
The protocol requires countries to take the following measures with respect to indigenous and
local communities:
 Legislative, administrative or policy measures to ensure benefits from the use of TK
associated with genetic resources are shared fairly and equitably with the
communities concerned, based on mutually agreed terms. The same applies to genetic
resources that are held by indigenous and local communities, in accordance with
domestic legislation.
 Measures to ensure that TK associated with genetic resources is accessed with the
prior and informed consent or approval and involvement of indigenous and local
communities. The same applies to genetic resources, where communities have the
established right to grant access.
 Countries should take the customary laws, community protocols and procedures of
indigenous and local communities into consideration when implementing the
provisions on TK; and endeavour to support the development of community protocols
for access and benefit-sharing relating to traditional knowledge.
However, the Protocol has some limitations that reduce the scope for benefit-sharing with
countries and communities:
 It does not apply to genetic resources collected before it enters into force, or explicitly
to biochemicals derived from genetic resources (see art.2 & 3)
 Enforcement mechanisms are weak – eg. it only requires one unspecified checkpoint
in user countries.
 It does not itself require the prior informed consent of indigenous or local
communities, but requires countries to develop policy and legal measures for this,
which will take some time.
 Prior informed consent and benefit-sharing with indigenous and local communities for
access to genetic resources held by them is to be “in accordance with domestic
legislation”.
The Protocol emphasises state sovereignty over natural resources, but does not recognise the
customary rights of communities. This is a concern for many indigenous and local
communities, given their dependence on bio-genetic resources for food, health etc, and their
role in conserving and improving many genetic resources.
The Protocol refers to Article 8(j) and the UN Declaration on the Rights of Indigenous
Peoples in the preamble. However, it does not require the maintenance of traditional
knowledge for conservation and livelihoods, or the protection of rights over associated
traditional resources and lands and waters needed to sustain traditional knowledge.
Obligations
The Nagoya Protocol sets out core obligations for its contracting Parties to take measures in
relation to access to genetic resources, benefit-sharing and compliance.
Access obligations
Domestic-level access measures are to:
 Create legal certainty, clarity and transparency
 Provide fair and non-arbitrary rules and procedures
 Establish clear rules and procedures for prior informed consent and mutually agreed
terms
 Provide for issuance of a permit or equivalent when access is granted
 Create conditions to promote and encourage research contributing to biodiversity
conservation and sustainable use
 Pay due regard to cases of present or imminent emergencies that threaten human,
animal or plant health
 Consider the importance of genetic resources for food and agriculture for food
security
Benefit-sharing obligations
 Domestic-level benefit-sharing measures are to provide for the fair and equitable
sharing of benefits arising from the utilization of genetic resources with the
contracting party providing genetic resources. Utilization includes research and
development on the genetic or biochemical composition of genetic resources, as well
as subsequent applications and commercialization. Sharing is subject to mutually
agreed terms. Benefits may be monetary or non-monetary such as royalties and the
sharing of research results.
Compliance obligations
 Specific obligations to support compliance with the domestic legislation or regulatory
requirements of the contracting party providing genetic resources, and contractual
obligations reflected in mutually agreed terms, are a significant innovation of the
Nagoya Protocol. Contracting Parties are to:
 Take measures providing that genetic resources utilized within their jurisdiction have
been accessed in accordance with prior informed consent, and that mutually agreed
terms have been established, as required by another contracting party
 Cooperate in cases of alleged violation of another contracting party’s requirements
 Encourage contractual provisions on dispute resolution in mutually agreed terms
 Ensure an opportunity is available to seek recourse under their legal systems when
disputes arise from mutually agreed terms
 Take measures regarding access to justice
 Take measures to monitor the utilization of genetic resources after they leave a
country including by designating effective checkpoints at any stage of the value-
chain: research, development, innovation, pre-commercialization or
commercialization
Implementation
The Nagoya Protocol’s success will require effective implementation at the domestic level. A
range of tools and mechanisms provided by the Nagoya Protocol will assist contracting
Parties including:
 Establishing national focal points (NFPs) and competent national authorities
(CNAs) to serve as contact points for information, grant access or cooperate on
issues of compliance
 An Access and Benefit-sharing Clearing-House to share information, such as
domestic regulatory ABS requirements or information on NFPs and CNAs
 Capacity-building to support key aspects of implementation. Based on a
country’s self-assessment of national needs and priorities, this can include
capacity to
o Develop domestic ABS legislation to implement the Nagoya Protocol
o Negotiate MAT
o Develop in-country research capability and institutions
 Awareness-raising
 Technology Transfer
 Targeted financial support for capacity-building and development initiatives
through the Nagoya Protocol’s financial mechanism, the Global Environment
Facility (GEF)
CONVENTION ON BIODIVERSITY AND TK

The Convention on Biological Diversity was opened for signature on 5 June 1992 at the
United Nations Conference on Environment and Development (the Rio “Earth Summit”) and
entered into force on 29 December 1993. Th e Convention is the only international
instrument comprehensively addressing biological diversity. Th e Convention’s three
objectives are the conservation of biological diversity, the sustainable use of its components
and the fair and equitable sharing of benefits arising from the utilisation of genetic resources.
To further advance the implementation of the third objective, the World Summit on
Sustainable Development (Johannesburg, September 2002) called for the negotiation of an
international regime, within the framework of the Convention, to promote and safeguard the
fair and equitable sharing of benefits arising from the utilisation of genetic resources. Th e
Convention’s Conference of the Parties responded at its seventh meeting, in 2004, by
mandating its Ad Hoc Open-ended Working Group on Access and Benefit-sharing to
elaborate and negotiate an international regime on access to genetic resources and benefit-
sharing in order to effectively implement Articles 15 (Access to Genetic Resources) and 8(j)
(Traditional Knowledge) of the Convention and its three objectives.
Aft er six years of negotiation, the Nagoya Protocol on Access to Genetic Resources and the
Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on
Biological Diversity was adopted at the tenth meeting of the Conference of the Parties on 29
October 2010, in Nagoya, Japan.

Here are key points regarding the CBD and traditional knowledge:
1. Recognition of Traditional Knowledge: CBD Article 8(j): This article specifically
addresses the preservation, innovation, and use of traditional knowledge. It
 emphasizes the importance of respecting, preserving, and maintaining traditional
knowledge.
2. Access and Benefit-Sharing (ABS): CBD Article 15: This article establishes the
general framework for access to genetic resources and the fair and equitable sharing
of benefits arising from their utilization. Nagoya Protocol Article 5: This article
provides detailed provisions on access to genetic resources and traditional knowledge
associated with genetic resources.
3. Nagoya Protocol: The Nagoya Protocol itself is a supplementary treaty to the CBD. It
does not have separate articles within the CBD framework, as it operates alongside
the CBD to provide more detailed provisions on ABS and traditional knowledge.
4. Protection of Traditional Knowledge: CBD Article 8(j): This article also calls for the
protection and promotion of traditional knowledge and practices.
5. Sustainable Use: CBD Article 10(c): This article promotes sustainable use of
components of biological diversity, which includes traditional knowledge-based
practices in agriculture, medicine, and conservation.

UNIT 5: Legal Developments towards Traditional Knowledge – International

Topic Details: CASE STUDY: Branding of Traditional Knowledge and its overlap with
Geographical Indications – Angostura Limited

Angostura Limited, based in Trinidad and Tobago, is a company deeply rooted in traditional
knowledge, particularly in the production of its renowned Angostura Bitters and rum
products. This traditional knowledge has been pivotal to the company's success, intertwined
with intellectual property (IP) protection, branding, and commercialization strategies.

Traditional Knowledge and Heritage: Angostura's traditional knowledge is exemplified in

its secret recipe for Angostura Bitters, dating back to the early 1800s. This recipe, handed
down through generations, involves selecting and preparing herbs, spices, and botanicals to
create a distinctive flavor profile. Additionally, the company's expertise in rum distillation, a
practice deeply rooted in the Caribbean, contributes to its traditional knowledge.

Geographical Origin and Ingredients: The Caribbean islands, including Trinidad and
Tobago, offer ideal conditions for sugar cane cultivation. This crop has a long history in the
region, and Angostura utilizes locally sourced ingredients, such as sugar cane and oranges, to
create its products. These ingredients, tied to the geographical origin, contribute to the
uniqueness of Angostura's offerings.

Research and Development: Angostura's traditional knowledge includes the development of

its bitters, which were originally formulated for medicinal purposes. Over time, these
formulations transitioned into being used in alcoholic beverages. The company's unwavering
commitment to maintaining the same recipe for its bitters since 1824 reflects its dedication to
preserving traditional knowledge.

Branding and Marketing: Angostura skillfully incorporates its traditional knowledge and
heritage into its branding and marketing efforts. Its iconic oversized label and long history are
integral parts of its brand identity. The company positions its products as embodying the
spirit of Trinidad and Tobago, appealing to both domestic and international consumers.
Angostura Bitters are also marketed as a brand not just for cocktails but also as an essential
ingredient to enhance flavors of juice, ice cream, and marinades (44.7 % low alchohol
concentration only).

Trade Secrets and Trademarks: To protect its IP, Angostura relies on trade secrets,
particularly to safeguard its secret recipe for Angostura Bitters. The company limits access to
the mixing room to a select few, ensuring the recipe remains confidential. Taking such
measures has allowed the recipe to remain a secret since 1824 (according to the company)
and help keep the company competitive.
Moreover, Angostura has registered numerous trademarks both domestically (Domestically,
the company has made over 40 trademark) and internationally ( 10 USA, 13 Australia and 11
Europe), including the Angostura name and various product names, enhancing its IP
protection.

Domain Names and Digital Presence: The company utilizes domain names and digital
media to connect with customers and expand its reach. Owning domain names like
angostura.com and angosturabitters.com allows Angostura to provide detailed product
information, corporate history, and engage with a broader audience.

Commercialization and Global Presence: Angostura's commercialization efforts have

propelled its products into both domestic and international markets. Its diverse product
portfolio, including bitters and rum, appeals to a wide range of consumers. The company's
commitment to quality has earned it numerous awards and a strong global presence, with
products sold in over 160 markets.

Economic Impact: Angostura's success significantly contributes to the economy of Trinidad

and Tobago. In 2011, rum and bitters exports, primarily comprising Angostura products,
accounted for $33 million. The company's growth and revenue reached $82.1 million in the
first half of 2014, further underscoring its economic significance.

In summary, Angostura Limited's story exemplifies how traditional knowledge, when

combined with strategic IP protection, branding, and commercialization efforts, can
lead to enduring success in the global marketplace. The company's preservation of
traditional knowledge, commitment to quality, and innovative branding strategies have
enabled it to thrive and make a lasting impact on the economy of Trinidad and Tobago.

Unit 6: Legal Developments towards Traditional Knowledge – International

Topic Details: CASE STUDY: Traditional Knowledge and its overlap with Industrial Designs
– Oman Perfumery LLC
Oman Perfumery LLC, known as the House of Amouage, has successfully merged Oman's
rich fragrance heritage with modern perfumery, creating a globally recognized luxury
fragrance brand. Established in 1983 by the Sabco Group, owned by the Omani royal family,
Amouage(which means “waves of emotion”) had two primary objectives: to sustain Oman's
fragrance industry by producing internationally competitive modern perfumes and to reflect
and share Oman's heritage through these fragrances.

Amouage's success is rooted in the utilization of locally sourced ingredients like

frankincense, myrrh, and rosewater, which have deep cultural significance in Oman.
Frankincense, often referred to as the "gold of the desert," has a historical significance as one
of the world's most traded commodities. In Oman, fragrances and incense play an integral
role in daily life, cultural rituals, and celebrations.
The unique climate of Oman, particularly in the Dhofar region, provides ideal conditions for
the growth of boswellia sacra trees, the source of frankincense. This region, known as the
Land of Frankincense, is a UNESCO World Heritage Site. It has been essential for
frankincense production for millennia, and its unique climate led to the creation of myths to
protect the valuable resource.

Another fragrant ingredient, rosewater, is produced from roses grown in the Jebel Akhdar
region. The cool temperatures and precipitation at higher altitudes make it ideal for rose
cultivation. Myrrh, similar to frankincense, thrives in Oman's unique environmental
conditions.

Traditional knowledge is at the core of Amouage's production process. Harvesting

frankincense and myrrh involves careful, skilled techniques that have been perfected over
thousands of years. The resin harvested from these trees comes in various grades and colors,
each with distinct qualities. These natural ingredients have a wide range of uses, from
perfumes to medicinal and religious purposes.

Amouage's research and development have been instrumental in creating its internationally
acclaimed fragrances. The company collaborates with renowned perfumers and sources rare
ingredients globally. While traditional ingredients like frankincense are vital, Amouage also
utilizes synthetic molecules to meet international fragrance industry standards.

Industrial designs, such as the iconic dagger-shaped perfume bottles, are integral to
Amouage's brand identity. These designs are protected by the intellectual property system.
Trademarks for the company's name and logo also ensure brand recognition and protection in
various markets. Amouage made two applications to the United States Patent and Trademark
Office (USPTO), one for its unique dagger-shaped perfume bottle and another for Amouage’s
logo, which is a stylistic crest that evokes the brand’s origin. Both applications were
registered in October 1986.

Amouage's branding evolved over the years, moving from being predominantly Gulf-
oriented to establishing itself as an international luxury brand. A shift in artistic direction, led
by Creative Director Christopher Chong, emphasized the narrative and meaning behind each
fragrance, creating a cohesive brand identity.

Commercialization of Amouage's products involves an international process, with

fragrances developed in Grasse, France, and then produced and packaged in Oman. The
perfumery maintains a high level of quality control through handcrafted processes. This brief
is sent to professional perfume blenders and testers in the town of Grasse in southern France
(known in the industry as the “perfume capital of the world”). Known as “noses,” these
professionals develop the scent by first creating solutions of various ingredients based on the
brief received from Mr. Chong.

Amouage also contributes to public health initiatives, such as supporting the National
HIV/AIDS Prevention and Control Program in Oman. Fifty percent of the proceeds from its
Opus IV fragrance were pledged to this cause.

The company's business results reflect its successful international expansion, with standalone
stores in various countries. Amouage's products have received critical acclaim and
recognition from experts in the perfume industry.
In summary, Oman Perfumery LLC, operating as the House of Amouage, has skillfully
blended Oman's rich fragrance heritage with modern perfumery, creating a globally
recognized luxury brand. With a commitment to traditional knowledge, research, branding,
and quality, Amouage has become a leading niche luxury fragrance company known for its
unique scents and iconic designs.

UNIT 7: Legal Developments towards Traditional Knowledge – National

NATIONAL BIOLOGICAL DIVERSITY ACT

Salient Features of Biodiversity Act 2002: The salient features of the Biological
Diversity Act 2002 are as follows:

 Regulation of the biological resources in the country.

 Notify the threatened species and control or restrict their restoration, collection, and
conservation.
 The Biodiversity Act 2002 also protects the knowledge of local communities regards
to biodiversity.
 Sustainability and conservation of biological diversity.
 Offenses mentioned by the statute are defined as non-bailable and cognizable.
 To carry out the study involving the biological resources of the nation.

Exemptions from Biodiversity Act 2002

 This act excludes the biological resources of India that are sold as commodities.
 The Biodiversity Act 2002 also excludes the traditional uses of biological resources in
India when they are used for research purposes in India or foreign institutions with the
approval of the central government.
 Other exemptions are breeds and cultivators, beekeepers, livestock keepers, and
traditional healers, e.g., Hakims and Vaids.

Objectives of the Biodiversity Act 2002

The act envisages establishment at national and state levels. The objectives of the Biological
Diversity Act 2002 are mentioned below.

 Conserve biodiversity, use it sustainably, and promote its equitable sharing as a

common heritage of humankind.
 Provide for conservation of bio-geographical classification; establishment and
regulation of National Biodiversity Authority, and State Biodiversity Boards; setting
up Biodiversity Management Committees;
 Preparation of People’s Biodiversity Registers by such committees;
 Laying down procedures for access to biological resources and associated knowledge
by foreign citizens or companies;
 Establishing an effective mechanism for collecting and sharing benefits arising from
using biological resources, knowledge, etc.; laying down penalties for infringement,
etc.
Framework of Biodiversity Act 2002

To control access to biological resources, a three-tiered framework was envisioned by the

legislation:

 The Biodiversity Management Committees (BMCs)

 The National Biodiversity Authority (NBA)
 The State Biodiversity Boards (SBBs)

Biodiversity Management Committees (BMCs)

There must be a BMC or Biodiversity Management Committee in every local body as per
Section 41 of the Biodiversity Act 2002 for further protection, and recording of biological
variables such as conservations of landraces, preservation of habitats, Domesticated stocks
And breeds of animals, Folk varieties and cultivars, Microorganisms And Chronicling Of
Knowledge Relating To Biological Diversity.

National Biodiversity Authority (NBA): To carry out the provisions of the Biodiversity Act
2002, the National Biodiversity Authority was established under the Ministry of
Environments and Forest by the Government of India in 2003.

 NBA monitors and prevents the actions prohibited under the Biodiversity Act 2002.
 It also gives advice on how the government the conservation of biodiversity in India.
 NBA prepares a report on how the government should proceed with choosing
biological heritage sites.
 It shall notify the threatened species.

State Biodiversity Boards (SBBs): State Biodiversity Boards were established in accordance
with Section 22 of the Biodiversity Act 2002. It deals with matters relating to access to
biological resources for commercial purposes. It advises the state government on matters
relating to conservation and sharing equitable benefits. SBB also regulates granting of
approval for the commercial use of any biological resources by people.

Provisions of Biodiversity Act 2002

The Biological Diversity Act 2002 has provisions for:

 Establish National Biodiversity Authority (NBA) and State Biodiversity Boards

(SBB) to implement the provisions.
 Regulation of access to biological resources, including prior informed consent,
benefit-sharing, and submission of bio-survey reports.
 Punishment for offenses under the Biodiversity Act 2002
 Establish People’s Biodiversity Registers (PBRs) at the local level by SBBs to
document knowledge about local biodiversity and associated customary sustainable
practices.
 Intent to use traditional knowledge for commercial purposes.
 Publication or exhibit of traditional knowledge without prior consent.
Hence, it requests all the members of this esteemed Network to kindly disseminate
information about the Biodiversity Act 2002 in their respective states/Union Territories and
encourage stakeholders to submit proposals for obtaining access to biological resources and
associated knowledge wherever needed. It also urges them to take the necessary steps to
establish State Biodiversity Boards at their end to ensure effective implementation of the
Biological Diversity Act 2002.

Patents Act (Section 3(p))

Indian patent laws do not permit the protection of traditional knowledge under Section 3 (p)
of the Indian Patent Act, 1970. An invention which in effect, is traditional knowledge or
which is an aggregation or duplication of known properties of traditionally known
components is not an invention and cannot be patented. For example, the patent application
for a process for preparing an improved Chyawanprash discloses the process which involves
cutting, roasting, and mixing of dry fruits and then adding it to the Chyawanprash, which
under Section 3(p) of Patents Act 1970 (as amended in 2005) is not an invention. This
invention is based on traditional knowledge which is therefore not patentable under the Act.

TKDL
The Traditional Knowledge Digital Library (TKDL) project, initiated in India in 2001, is a
collaboration between the Council of Scientific and Industrial Research (CSIR), Ministry of
Science and Technology, and the Department of Ayurveda, Yoga and Naturopathy, Unani,
Siddha and Homeopathy (AYUSH), Ministry of Health and Family Welfare, of India. It is
being implemented at the CSIR. The inter-disciplinary team involved in the creation of the
TKDL for Indian Systems of Medicine included traditional medicine experts (Ayurveda,
Unani, Siddha and Yoga), patent examiners, IT experts, scientists and technical officers.

Facts
The TKDL contains documentation of publicly available traditional knowledge (TK) that:
 relates to Ayurveda, Unani, Siddha and Yoga
 is in digitized format
 is available in five languages: English, German, French, Japanese and Spanish.
The TKDL, which contains over 34 million pages:
 provides information on TK existing in India, in languages and a format
understandable by patent examiners at international patent offices
 contains information for patent examiners on prior art that would otherwise be
available only in Sanskrit and other local languages in Indian libraries
 lists the precise time, place and medium of publication for prior art searches by patent
examiners
 aims to prevent the granting of erroneous patents.
Goals
The TKDL:
 seeks to prevent the granting of patents for products developed utilizing TK where
there has been little, if any, inventive step
 intends to act as a bridge between information recorded in ancient Sanskrit and patent
examiners (with its database containing information in a language and format
understandable to patent examiners)
 facilitates access to information not easily available to patent examiners, thereby
minimizing the possibility that patents could be granted for “inventions” involving
only minor or insignificant modifications.
IP Office collaboration
Certain patents offices have been granted access to the TKDL for carrying out prior art
searches and patent examination:

 European Patent Office (February 2009)

 Indian Patent Office (July 2009)
 German Patent Office (October 2009)
 United States Patent and Trademark Office (November 2009)
 United Kingdom Intellectual Property Office (February 2010)
 Canadian Intellectual Property Office (September 2010)
 IP Australia (January 2011)

Ministry of AYUSH

UNIT 8: Legal Developments towards Traditional Knowledge – National

CASE STUDY: Enterprising of Traditional Knowledge – Shri Mahila Griha Udyog Lijjat
Papad, India

Cooperative Empowerment: Shri Mahila Griha Udyog Lijjat Papad (Lijjat) is an Indian
cooperative established by women, providing empowerment for low-income female workers.
It boasts over 40,000 members across 17 Indian states.
Product Range and Development: Lijjat produces quality products including papad (crispy
wafers), wafers, and bread. Capacity building and community programs enhance the skills of
its members.
Empowering Women: Lijjat's strategies have provided financial independence to thousands
of Indian women. The cooperative promotes community development and poverty reduction.
Traditional Knowledge: Lijjat's initial success was built on producing papad, a traditional
Indian food.Papad is made from black gram dough, following generations-old techniques. To
make papad in the traditional way, women across India have for generations kneaded and
rolled the dough by hand (often as a communal activity) into a thin, round wafer. Thereafter,
the wafer is seasoned and dried (customarily under the sun) before deep frying or roasting on
an open fire stove. Modern methods may use a microwave oven instead for heating the wafer.
Research and Development: Lijjat was founded by seven skilled women who began making
papad for a local merchant. Capacity expansion led to increased production and demand.
The cooperative adopted improved methods and professional practices.
Ethical Principles: Lijjat's core principles include mutual affection, devotion, and collective
ownership. Each member, referred to as "sister," plays an equal role in decision-making.
Lijjat promotes equality and self-sufficiency.
Financial Independence: Members work approximately six hours a day and earn a monthly
wage. The cooperative shares profits and losses among members, ensuring steady income.
All-Women Membership: Lijjat maintains an all-women membership, employing men only
for specialized roles.
Traditional, handcrafted methods are used for production.
Growth and Expansion: Lijjat expanded its operations, registering as a society in 1966.
It secured financing and achieved substantial growth.
Specialized buses improved productivity and efficiency.
Diversification: Lijjat diversified its product range, including spices, chapatti, and
detergents.
Product branding, competitive pricing, and distribution networks supported market entry.
Product Branding:
Lijjat developed distinct product sleeves with iconic images such as Babla and a rabbit.
Slogans like "A unique organization of women, by women, for women" defined its ethos.
Memorable marketing campaigns expanded brand recognition.
Trademark Protection: Lijjat registered multiple trademarks to protect its identity and
products. Intellectual property enforcement is a priority.
Challenges of IP Infringement: Despite trademark protection, Lijjat faces challenges from
counterfeiters. The cooperative educates customers on identifying genuine products.
Community Development: Lijjat prioritizes the financial, social, and health welfare of its
members. Scholarships, grants, and skill training programs empower women and their
families.
Business Success: Lijjat has grown into an internationally recognized organization.
It has received awards for women's empowerment, brand development, and ethical practices.
Financial Milestones: By 2013, Lijjat achieved an annual turnover of approximately Rs. 650
crore (around US$100 million).
Celebrating a Legacy: Lijjat marked over half a century of empowering urban and rural low-
income Indian women.
Social Impact: Lijjat's cooperative model empowers women economically and socially,
creating a lasting impact on communities and individuals.
Shri Mahila Griha Udyog Lijjat Papad exemplifies how a cooperative founded by women has
not only provided economic empowerment but also contributed to community development
and poverty reduction through traditional knowledge and ethical business practices.

Unit 9 Legal Developments towards Traditional Knowledge – National

Traditional Knowledge and Patent Strategies
A study of the Basmati, Neem Patent Case

BASMATI CASE:

Facts: In late 1997, the United States Patent and Trademark Office granted a patent to Ricetec
Inc., the United States based multinational company headquartered in Alvin, Texas for a
novel ‘grain’ also known as ‘basmati’. The company claimed the protection of new varieties
of ‘basmati’ crops with better qualities than the original crop. It has been using several
versions of the crop by selling it with the name ‘Jasmati’ or ‘Kasmati’ in the international rice
market. Moreover, it was also professed to have developed a novel strain of the aromatic rice
by inter-breeding of basmati rice with another crop known as American basmati or ‘Texmati’.
The patent was granted to the company for basmati rice grains and variety by USPTO.[3]
Later, the patent was opposed by the Indian NGOs like Research Foundation for Science,
Centre for Food Safety and ultimately, Centre for Scientific and Industrial Research too,
objected to it. The Indian sub-continent protected its traditional crop basmati while Thailand
contested for the safeguarding of its claim for jasmine rice. In 2000, after examining
evidence, the Indian Government challenged the patent claims by the company.
Issues raised
Several issues were raised at the occurrence of this controversy, which mainly were
concentrated towards the emerging patents, bio-piracy and geographical indication laws. The
major issues raised included:
 Whether the name ‘basmati’ is a ‘generic’ term or specifically originates from the
aromatic rice grown in India and various South-Asian countries?
 Whether the grain developed by Ricetec Inc. is a novel variety and strain?
 Is Ricetec Inc. guilty of bio-piracy and violation of traditional knowledge belonging
to indigenous communities of Southern-Asian countries?
  Whether the patent granted to Ricetec must be revoked due to protests by various
NGOs and Indigenous Communities?
 Whether USPTO’s decision to grant patent to Basmati Rice violates TRIPs
Agreement?
Origin of ‘basmati’ crop: Rice is considered as a staple food for South-Asian Countries and
has been a part of the culture since time immemorial. For centuries, the farmers in developing
countries have been working hard to nurture and develop various varieties of crops to suit the
taste or needs of people consuming it. It is known world-wide that the long-grain aromatic
rice known as ‘basmati’ has been produced widely in the Sub-himalayan region. Basmati rice
is one of the best-known varieties of rice originally cultivated in India, Pakistan and certain
regions of South Asia.

Case analysis : Ricetec originally got a patent grant for growing the rice crop, developing
such crops of identical characteristics and identifying rice on Starch Index test basis. The
company contented that its patent covered a novel form of basmati which was an improved
form over its previous varieties. With reference to the usage of geographical indication
named ‘Basmati’, it was argued that the term is not generic in nature to Indian sub-continent
and has adopted its generic way through usage in terminology like American Basmati, Thai
Basmati etc. It further stated that ‘Basmati’ does not infer a geographical area and falls within
the ambit of ‘public domain’.

Nonetheless, India contented that more than 75 percent of the United States rice imports are
from countries like Thailand, Pakistan and India that cannot be grown in the country. The
legal theory so supported was that the patent was not novel and obvious in nature.
Henceforth, the validity of the patent stands null or void. After a battle of three years, India
constructed data and evidence to challenge the patent validity. Whereas, the USPTO issued
the patent for three strains of hybrid basmati out of around 20 claims. The remaining three
strains of basmati were given protection due to a noticeable difference than the original strain
of the crop.

With regard to the usage of geographical indication and trademark ‘Basmati’ used by the
company, USPTO stated that since it was not a region, a trademark and geographical
indication in India unlike ‘Champagne, Porto, Burgundy or Sherry’, it can be utilized by the
company. Since, the crop was grown all over South-Asia than India, it was not a geographical
indicator. After subsequent protests made by India and Pakistan, the name ‘basmati’ was
ultimately disallowed to the patent-holder by USPTO.

Critical analysis and emergence of new geographical indication laws in India: Dr. Shiva
realized that patenting of basmati rice is not only perceived as an infringement of intellectual
property but a cultural theft which threatens the rights of developing countries, their
traditional knowledge and practice of such knowledge by local folklore and farming
communities. She states that the patent shall fool the consumers to believe that there is no
difference between the traditional crop ‘Basmati’ and the spurious developed one. The theft
so involved in Basmati’s case is threefold: theft of heritage and biodiversity of Indian
farmers; Indian traders and exporters and finally, a deceiving of its consumers.[7]

Ultimately, the importance for emergence of a statute to protect the geographical indicators
pertaining to Indian heritage and sub-continent was realized.[8] Subsequently, in 1999, India
enacted a legislation called Geographical Indication of Goods (Registration and Protection)
Act, 1999. It is administered as the first specific law to register and protect the geographical
indications. The crop basmati has been registered as a geographical indication under the Act
for states including Haryana, Uttar Pradesh, Punjab, Jammu & Kashmir, Uttarakhand, Delhi
and Himachal Pradesh. Prior to 1999, there was no specific legislation to regulate and protect
the geographical indications. It was, however, in 1999 that India adopted the act after
complying with Article 22 of the TRIPs Agreement. The Article stated with regard to the
‘protection of geographical indicators’ with the help of 3 essential clauses. Article 22 clause
(1) stated the definition of the term and clause (2) explained how the member states shall
provide the legal means for interested parties to prevent any sale of misleading products to
consumers and unfair competition in the market. Clause (3) suggested that member states
shall implement a legislation for registration or invalidation of a trademark which might
consist of geographical indications.

The Act protected the interest of producers, local communities, manufacturers and consumers
from being fraudulently sold such goods and services to attain economic benefits.
Subsequently, Indian Judiciary explained the term more vividly in landmark judgment
Imperial Tobacco Co. v. Registrar, Trademarks[9] wherein it was portrayed that indicators
are manufactured, agricultural or natural goods originating from a particular region.

THE NEEM CASE

The patent for Neem was first filed by W.R. Grace and the Department of Agriculture, USA
in European Patent Office. The said patent was deemed to be a method of controlling fungi
on plants comprising of contacting the fungi with a Neem oil formulation. A legal opposition
was filed by India against the grant of the patent. The legal opposition to this patent was
lodged by the New Delhi-based Research Foundation for Science, Technology and Ecology
(RFSTE), in cooperation with the International Federation of Organic Agriculture
Movements (IFOAM) and Magda Aelvoet, former green Member of the European Parliament
(MEP).

A tree legendary to India, from its roots to its spreading crown, the Neem tree contains a
number of potent compounds, notably a chemical found in its seeds named azadirachtin. It is
used as an astringent in so many fields. The barks, leaves, flowers, seeds of neem tree are
used to treat a variety of diseases ranging from leprosy to diabetes, skin disorders and ulcers.
Neem twigs are used as antiseptic tooth brushes since time immemorial. The opponents'
submitted evidence of ancient Indian ayurvedic texts that have described the hydrophobic
extracts of neem seeds were known and used for centuries in India, both in curing
dermatological diseases in humans and in protecting agricultural plants form fungal
infections. The EPO identified the lack of novelty, inventive step and possibly form a
relevant prior art and revoked the patent. Apart from this, several US patents were recently
taken out Neem-based emulsions and solutions.

Grace Patent under the US Laws: Under the US laws related to Patents, the Grace patent
appears to be an unexceptional example of American discovery, innovation and
commercialization. The laws provide that the purification or any type of modification of a
naturally occurring compound can result in the grant of a patent. As far as the Grace patent is
concerned, it appears to satisfy 35 sections of the US Code3. Sections 101, 102 and 103
provide the requirements for the grant: (1) has some practical usefulness, (2) is novel in
relation to the “prior art”4, (3) is not obvious from the “prior art” to a person of ordinary skill
in the art at the time the invention was made, and (4) provides a description that is adequate
to enable a knowledgeable person to practice the invention in the best mode. The fact that the
invention is “obvious” to the Indian farmers does not defeat the purpose of the patentability
in the United States. According to section 102(a) and (b), foreign knowledge can only defeat
a U.S. patent's novelty claim if that foreign knowledge appeared in a printed publication
before the invention or application by the U.S. applicant.

Analysis of the decision: Since the grant of the patent, Dr. Shiva, one of the activists in India,
along with the International Federation of Organic Agriculture Movement and the Green
Party in European Parliament, had been opposing it. Later, in 2000, the European Patent
Office revoked the patent but the victory was short-lived as the revocation was followed by
an appeal. Amidst the proceedings of the appeal, the opposers gave them evidence of farmers
using this knowledge for a long time and also gave them information about the two scientists
who had conducted research on neem before the patent had been granted.

The European Patent Office in Munich in 2005 dismissed an appeal against revoking a patent
granted by it for the preparation of a fungicide derived from the seeds of the neem tree. The
dispute was a long way to give confidence to the traditional users. Dr. Shiva, one of the three
parties opposing the patent stated “It was pure and simple piracy. The oil from neem has been
used traditionally by farmers to prevent fungus. It was neither a novel idea nor was it
invented. It is the major victory that the appeal has been dismissed.”

Post-dispute
In India, after the neem patent controversy, the need to protect the traditional knowledge of
India has gained importance. India has taken an initiative through TKDL (Traditional
Knowledge Digital Library), which helps the examiners of Patent Offices to search for any
information regarding substance or practice while granting patents and they can dismiss the
grant of patent, if the substance or practice is already there in the TKDL list as Indian
traditional knowledge.

Unit 10 Legal Developments towards Traditional Knowledge – National

CASE STUDY: Enterprising of TK through Jeevani – Kani Tribe Case Study
Using Traditional Knowledge to revive the Body and a Community
Know How Licensing Agreement between the TBGRI and Arya Vaidya Pharmacy, India

As part of the All India Coordinated Research Project on Ethnobiology, a team of scientists
conducted an ethnobotanical knowledge survey of the Kani people in the
Thiruvananthapuram forest in the southern section of the Western Ghat region in the state of
Kerala in 1987. (AICRPE). The Kani guides Mallan Kani and Kuttimathan Kani did not
experience exhaustion throughout the lengthy walks, but the scientists did. The scientists
were given fruits that the Kani guides regularly consumed. The fruits gave the researchers a
boost of energy when consumed. According to the Kani guardians, information about the
fruits was sacred and should not be shared with outsiders. If the plant was turned into a
product and sold, the scientists offered an equal cut of the profits in exchange for their word
that they wouldn’t “misuse” the information.

The guides eventually identified the plant as trichopus zeylanicus spp”arogyapacha,”.’s

which roughly translates to “evergreen health.” travancoricus, a rhizomatous perennial herb.
A thorough scientific examination was conducted, including chemical screening to identify
the active components. Although it had been previously documented and characterised, the
“outside” world kani tribe was unaware of its traditional use and unique characteristics.
Extensive research done at the Regional Research Laboratory (RRL) in Jammu has proven
arogyapacha’s ability to combat weariness. The existence of certain glycolipids and non-
steroidal substances (polysaccharides) with potent adaptogenic, immuno-enhancing, anti-
fatigue characteristics was discovered by phytochemical screening and pharmacological tests.
Only two to three fruits per plant were produced. Therefore, it was preferable to use its
evergreen leaves, which weigh 100–200 g, as a larger source for the commercial production
of a product with this anti–fatigue property.

In 1990, the researchers relocated to the Tropical Botanic Garden and Research Institute
(TBGRI) in Thiruvananthapuram, Kerala. The TBGRI’s Herbal Product Development
Division (Ethno-pharmacology) created the product “Jeevani,” a polyherbal drug that also
contains arogyapacha and three additional medicinal plants: withania somnifera
(ashwagandha), piper longum, and evolvalus alsinoides. Arogyapacha was the primary source
of anti-fatigue clinical effectiveness. Additional research indicated health-promoting qualities
that were later confirmed by science. Clinical properties and shelf life assessments were also
done.

Dr. Pushpangadan had firsthand knowledge of the therapeutic properties of arogyapacha, thus
he recognised that the action of the plant’s berries was unusual and that, if it was found to be
safe, it had a substantial market potential. He brought the plant back to the JNTBGRI’s
research facilities with his team of scientists, where they started doing a variety of chemical
and pharmacological experiments on it. Over the course of eight years of research, they found
that in addition to having immune-stimulating and anti-stress characteristics, the plant also
enhances endurance, reduces fatigue, aids in the control of cancers, and stimulates the body’s
natural defences and cellular immune system. After seven years, JNTBGRI’s investigation
pinpointed twelve chemical components in the plant that were responsible for the impacts
they felt. Arogyapacha was traditionally consumed by the Kani as its fruit. The best method
for extracting the twelve chemicals, according to JNTBGRI, was to crush the plant’s leaves.
The TBGRI then created a scientifically validated and standardised herbal formulation for its
replication by combining these compounds with three other plants. The product comes in
granules and is used with hot water or milk. JNTBGRI dubbed this formulation “Jeevani,”
which means “provider of life.”

Without intellectual property (IP) protection, Dr. Pushpangadan and his research group
understood they would not be able to make much money from Jeevani. Dr. Pushpangadan
was interested in assisting the Kani people as well, and he was aware that without IP
protection, the Kani people would not stand to profit financially. Thus, IP protection was
crucial. Therefore, JNTBGRI decided to file a patent application with the Office of the
Controller General of Patents, Designs, and Trademarks of India (IP India) in 1994 for the
production process of a herbal sports medicine based on the compounds isolated from
arogyapacha after successfully completing R&D and further refining Jeevani in collaboration
with the Council of Scientific and Industrial Research (CSIR), a leading Indian R&D
organisation. At Amity University in Uttar Pradesh, Dr. Pushpangadan was appointed
director general of the Amity Institute for Herbal & Biotech Products Development
(AIHBPD) in 2007. Dr. Pushpangadan and Amity University submitted an updated
application with IP India for Jeevani after the initial patent application in 2008. A patent has
not yet been issued despite the fact that the patent application was published in 2010.

AVP started the initial commercialisation of Jeevani. The property on which the Kani people
reside is really held by the Indian Forest Department, which is a distinctive component of the
commercialization process. Any land cultivation requires the previous consent of the Forest
Department since it is concerned about the sustainability of the forests and natural resources
in the area.

The Kani tribes that live in the Western Ghats region’s forests have a very rich legacy of
using traditional knowledge to make herbal medicines. This group has endured for decades
because to its herbal knowledge of the numerous wild plants in the area. They were able to
navigate treacherous terrain to gather food, shelter, and other resources because to their deep
understanding of the arogyapacha plant and its energising properties, which was crucial to
their survival. Their traditional wisdom cannot be disregarded, especially given that
JNTBGRI would not have learned about arogyapacha without the Kani people. Despite the
fact that the Kani tribe is not specifically mentioned in the patents, Dr. Pushpangadan and his
colleagues never took the contribution that the Kani people’s traditional knowledge made to
the discovery of the energizing properties of arogyapacha for granted.

Conclusion
In particular, the right of ownership of the lands they historically or traditionally use and
occupy, the rights to self-determination and autonomy, the right to development, and the right
to be free from discrimination, among others, are rights that implicitly grant indigenous
peoples permanent sovereignty over natural resources. Jeevani has been a tremendous success
for JNTBGRI, AVP, and the Kani people despite the absence of IP protection in important
areas like the United States. Jeevani, one of AVP’s most popular products, is now referred to
as the “ginseng of India.” As a result, JNTBGRI has consistently renewed AVP’s marketing
rights for Jeevani. More importantly, it has significantly impacted the Kani people’s quality
of life financially. The success of the benefit sharing agreement has prompted BMC to
suggest that the licence fee be doubled to US$ 52,000 and the royalty payment be also
doubled from two percent to four percent, which would result in even greater financial gains
for the Kani. The Kani have already received financial infusions into their community.

Unit 11 Legal Developments towards Traditional Knowledge due to COVID-19

Pandemic (International)

UN International Day of the World’s Indigenous Peoples: COVID-19 and Indigenous peoples
resilience (Leverage of TK practices during the Pandemic)
With the current COVID-19 pandemic, the link between environmental damage and
pandemics has again been established. Many indigenous peoples have warned over decades
about increasing threats to natural heritage so important for their survival. Through their
traditional knowledge and their relationship to nature, they have long known that
environmental dilapidation can trigger disease.

We are still in the midst of the combat against the spread of the pandemic, and in this context
it is more important than ever to listen to indigenous peoples, and safeguard their languages,
culture and traditional knowledge. Their territories are home to the vast majority of the
world's biodiversity : they can tell us a lot about how to rebalance our relationship with
nature and reduce the risk of future pandemics. The International Indigenous Peoples Forum
for World Heritage also addresses the close links between nature and culture, biological and
cultural diversity.

Indigenous peoples are looking for their own solutions to this pandemic. They take action and
use traditional knowledge and practices such as voluntary isolation and closure of their
territories, as well as other preventive measures.
Once again, they have demonstrated their high capacity to adapt in spite of the exceptionally
difficult context. This is why this year's theme is COVID-19 and Indigenous Peoples'
Resilience. A virtual event organized by the UN will include a panel discussion on innovative
ways Indigenous peoples continue to demonstrate resilience and strength in the face of the
pandemic, while also coping with to serious threats to their survival. Find here the UN web
page on the 2020 commemoration

The impact of COVID-19 on indigenous communities: Insights from the Indigenous

Navigator

Introduction:
The Indigenous Navigator, established in 2014, is a monitoring framework designed to
empower indigenous communities to track the implementation of international standards
related to indigenous peoples. These standards include the ILO Indigenous and Tribal
Peoples Convention, 1989 (No. 169), the United Nations Declaration on the Rights of
Indigenous Peoples (UNDRIP), and other relevant human rights instruments. The initiative
aims to enable indigenous communities to assess their progress in achieving the goals
outlined in the 2030 Agenda for Sustainable Development.

Development and Consortium Partners:

The Indigenous Navigator initiative began with the development of a conceptual framework
and tools in 2014, pilot-tested in six countries with support from the European Union. A
consortium of partners, including the International Work Group for Indigenous Affairs
(IWGIA), the Danish Institute for Human Rights (DIHR), the Forest Peoples Programme
(FPP), the Asian Indigenous Peoples Pact (AIPP), and the International Labour Organization
(ILO), played a crucial role in its inception. Since 2017, these partners have collaborated with
local partners in 11 countries globally, supporting indigenous communities in understanding
and advocating for their rights.

Impact of COVID-19 on Indigenous Communities:

The COVID-19 pandemic has disrupted the trajectory toward achieving the Sustainable
Development Goals, affecting over 476 million indigenous and tribal peoples worldwide. The
pandemic highlights the urgent need for high-quality data on the situation of indigenous
peoples to support targeted interventions. Historically, accessing disaggregated data on these
groups has been challenging due to inadequate or non-existent collection and disaggregation
efforts.

Development of Indigenous Navigator Framework:

Responding to the lack of qualitative and quantitative data on indigenous peoples, the
Indigenous Navigator framework was developed. Aligned with the Office of the United
Nations High Commissioner on Human Rights’ guidelines on human rights indicators, the
framework encompasses over 150 indicators grouped into 13 thematic areas. These include
self-determination, cultural integrity, lands, territories and resources, education, health, and
employment, among others.

Data Collection Process:

Over 200 indigenous communities participated in data collection coordinated by Indigenous
Navigator's local partners, comprising indigenous communities, NGOs, civil society
organizations, indigenous lawyers' associations, and women's organizations. Indigenous
peoples themselves conducted data collection through various methods, respecting the
internal processes of communities. This collaborative effort provided valuable insights into
the living conditions of indigenous peoples.

Network and Crisis Response:

The partnerships established through the Indigenous Navigator project proved beneficial
during the COVID-19 crisis. The existing network facilitated the collection of up-to-date
information on the challenges indigenous communities faced and the measures taken to cope
with the situation. This timely information is crucial for inclusive responses to the COVID-19
crisis, considering indigenous peoples' voices in efforts to achieve a "better normal."

Using Indigenous Navigator Data:

The Indigenous Navigator's indicators, derived from the UNDRIP's thematic areas, connect
directly with international human rights instruments. The framework employs three types of
indicators: structural, process, and outcome indicators. Structural indicators reflect the legal
and policy framework, process indicators measure ongoing state efforts, and outcome
indicators measure the actual enjoyment of human rights by indigenous peoples.

Relevance for COVID-19 Recovery Measures:

This report utilizes data from Indigenous Navigator to shed light on the conditions of
indigenous peoples before and during the COVID-19 pandemic in the 11 participating
countries. The analysis and recommendations presented aim to contribute to the design of
COVID-19 recovery measures that respect the rights of indigenous peoples, support their
livelihoods, economies, and resilience.

Unit 12 Legal Developments towards Traditional Knowledge due to COVID-19

Pandemic (National)
Role of Indian Traditional Medicine in mitigating Novel Corona Virus Effects

CHINESE TK - The first preliminary work on TCM (Traditional Chinese medicine)

treatment depending on differentiation of syndrome was performed in the treatment of
Idiopathic pulmonary fibrosis (IPF), a chronic, progressive and ultimately fatal interstitial
lung disease with unknown etiology. They did a basic evaluation of the efficiency and safety
of TCM treatment, which exhibited improved respiratory function and exercise capacity13. A
study has shown that Emodin isolated from plants from family Polygonaceae is efficient in
blocking the interaction of the SARS-CoV SNE (spike and envelope gene)-encode protein an
ion channel protein 3a (virus release is helped in the infected cells, through an ion-permeable
channel by a 3a protein coded by SARS-CoV open reading frame ORF-3a). Emodin or its
derivative compounds may become efficient novel therapeutic agents in the control of
Coronavirus-induced diseases and also SARS as reported14. Chinese herbal medicines have
been reported to contain numerous absorbable components which exert their effects on the
body. From the Chinese medicine database, 125 herbs were selected containing 13 natural
compounds. Out of the 125 plants, only 26 herbs, included detoxifying, antipyretic,
antitussive, antiasthmatic and also phlegm resolving medicines that were found to be
regularly used in the treatment of respiratory infections caused by viruses and exhibited
antiviral/immune modulatory/antiinflammatory activity

INDIAN TK- The lack of preventive vaccines and antiviral therapies poses a significant
threat to public health, particularly in the face of enhanced global travel and rigorous
urbanization, leading to alarming rates of epidemic outbreaks due to emerging and re-
emerging viruses. With only a limited number of approved antiviral drugs available, herbal
compositions have gained attention in both the United States and China as potential
alternatives for treating viral infections. Traditional medicines, such as Ayurveda, Siddha,
and Unani, have a rich history spanning thousands of years, utilizing herbs and natural
products for various ailments, including viral infections. Despite positive results observed
with herbal remedies, challenges include the absence of allopathic drugs and limited
knowledge about the specific viral strains causing infections. In response, a project led by Dr.
MS Valiathan aimed to study Ayurvedic concepts, treatment procedures, and the mechanistic
basis of therapeutic effects using scientific methods. Medicinal herbs have demonstrated
efficacy against certain infections, sometimes in combination with modern medicine and life
support systems under proper observation. The identification of antiviral properties in herbs
offers a valuable resource for novel drug development, shedding light on their ability to
interfere with the entire viral life cycle and target specific virus-host interactions. This
research represents a crucial step in addressing the growing drug resistance to antiviral
therapies.

Herbs to strengthen immunity- Various herbs offer promising immune-strengthening and

antiviral properties. Elderberry has been shown to enhance specific immune cell production
and inhibit flu virus spread. Sage, containing safficinolide, inhibits HSV1 and PI3 effectively.
Astragalus, widely used in Chinese traditional medicine, exhibits immune-boosting and
antiviral qualities. Oregano, with carvacrol, acts as a potent antibiotic and antiviral herb.
Ginseng, or Ashwagandha, fights viruses like Hepatitis B and Norovirus. Tulsi, or Holy basil,
is a natural immune booster with antimicrobial activity. Fennel inhibits herpes and influenza
viruses. Lemon balm, peppermint, echinacea, rosemary, licorice, dandelion, garlic, turmeric,
and ginger also show potent antiviral effects, providing potential natural remedies.

Unit 13 Legal Developments towards Traditional Knowledge due to COVID-19

Pandemic (National)
Guidelines for AYUSH Practitioners for COVID-19 – Ayurveda and Homeopathic

AYURVEDA
Ayurveda and COVID 19 infection management.

Ayurveda documented epidemics/pandemics under the context of Janapadodhvamsa

(conditions devastate the human settlements). Similarly, infectious diseases have been
considered under Sankramika rogas. Pollution of air, water, climate and environment is
responsible for the spread of diseases on such a large scale resulting in Janapadodhvamsa.
Causes of vitiation of air, water, climate and place along with their characteristics have been
enumerated in classics. Improper disposal of waste, distribution of polluted water, air
pollution, indulgence in unhealthy and unwholesome activities, failure of judgment and
misunderstanding of situation etc. also result in reasonable damage to the health of the
society; ultimately leading to Janapadodhwamsa. Such conditions will manifest in symptoms
like cough, breathlessness, fever etc . In Ayurveda, initial phases of the manifestation can be
comparable to Agantuja Vata Kaphaja Jwara. Uncontrolled conditions, further vitiate other
Doshaas and other Rasa, Rakta, Mamsadi dushyas thus entering into Sannipataja condition.
The “Protocol for Ayurveda Practitioners” is a guideline for the use of registered Ayurveda
Practitioners only. There are four sections covering the whole spectrum of COVID 19
infection management. The guideline deals with the symptomatology in these three stages:
  1st stage – Swasa-Kasa symptoms with Jwara (COVID 19 positive or negative with
mild symptoms)
 2nd stage – Vata-Kapha pradhan Jwara (Fever) (COVID 19 positive with specific
symptoms at moderate level)
 3rd Stage – Vata-KaphajaSannipatikaJwara(Fever)(COVID 19 positive with severe
symptoms with respiratory distress etc. )

Segmentation of subjects - Target Groups and management principle

Target groups Treatment

Target Group 1: Quarantine and Home isolation subjects without Preventive treatment
Corona positive test and health workers

Target Group 2: Subjects with Mild, Severe symptomatology , Co- Symptomatic treatment
morbid and Immuno-compromised conditions

Target Group 3: Vulnerable Subjects (Pregnant &Lactating women, Integrated Care (Ayurveda manage
Children, Geriatric subjects) medicines under regular observatio

Target Group 4: Post treatment restorative healthcare Treatment for recovery and Rejuve

All the standing instructions issued by Health authorities (Ministry of Health & Family
Welfare, World Health Organization and state and local health authorities) are to be adhered
completely and Ayurveda Management may stand as 'ADD ON' to the present contemporary
line of management.
The medicines recommended here are based on Essential Drugs List, Standard Treatment
Guidelines, Ayurvedic Pharmacopoeia of India, Ministry of AYUSH Govt. of India along
with considerations from other recommendations issued by various health authorities across
India. The practicing Vaidya has to have his/her own discretion in selecting medicines based
on the stage of the disease, symptom complex and availability of the drugs in their locality.
Use of Mask, Hand Sanitization, Social/Physical distancing to break the chain healthy
nutritious diet and measures of improving immunity and all other general health care
measures are to be advised as per the guidelines issued by health authorities from time to
time.
Quarantine and Home isolation subjects without Corona positive test and health workers

Ayurveda's intensive information on preventive care drives through the vastness of

Dinacharya (daily regime) and Ritucharya (Seasonal regime) to maintain healthy life. The
simplicity of awareness about oneself and the harmony each individual can achieve by
uplifting and maintaining their immunity is highly emphasized across Ayurveda's classical
scriptures. Further, Ayurveda emphasizes on PREVENTION first. In that direction
Svasthahitadravyas (recipes for healthy) have been indicated in the form of
Rasayana&Vajikarana. Ojus is considered as responsible for Vyadhikshamatva (immunity). It
is achieved by two approaches viz., Vyadhi Bala Virodhitva & Vyadhyutpadaka
Pratibandhakatva. Among them Vyadhibalavirodhitva is achieved by improving the
immunity of an individual's body, while Vyadhyutpadaka Pratibandhakatva is created by
using recipes which are specific in preventing disease.
Awareness about the mode of spread of this disease is highly recommended to prevent
oneself from falling prey to the same. As per WHO advisory, people can get infected by
COVID-19 from others who have the virus. The disease can spread from person to person
through small droplets that are spread when an infected person coughs or sneezes.
Subjects with Mild, Severe Symptoms, Comorbid & Immuno-compromised conditions

Management of Mild Symptoms

Sore throat is one of the main features or the first clinical presentation of the COVID 19
infection among clinical features of the disease. It is followed by fever, myalgia, dry cough,
dyspnea in mild state and severe dyspnea of Pneumonia in severe state, multi-organ failure
followed by fibrosis of lungs and death. A small percentage of cases are asymptomatic and
some uncommon clinical manifestations include loss of smell and taste (Rasa-Gandha Bodha
Nipata).
Vulnerable Group (Pregnant & Lactating women, Children & Geriatric subjects)

Children, pregnant women, elderly people, malnourished people, and people who are ill or
immune-compromised, are particularly vulnerable to any health disasters and they face
relatively high risk of the disease burden associated with emergencies. These groups of
population need special care in terms of prevention and management. The best way of
prevention is boosting the immunity and here are some proven immune boosters or Rasayana
drugs which can be prescribed to the vulnerable groups. Postpartum and lactating women
may continue with feeding the baby, and a prophylactic dose may be given to breast fed
children also.
These vulnerable groups, if they fall in suspected, quarantine or isolated cases with or without
Covid 19 test positive mild or severe symptoms, the management is the same as described in
Target Group 2. The guidliene provides some of the commonly prescribed Rasayana
medicines in each category, however Physicians should confirm the absence of fever and
other symptoms and the appetite is improved, if appetite is poor Deepana and Pachana drugs
may be added.
Post treatment restorative healthcare

Along with the daily spikes in confirmed coronavirus cases and deaths, a third, more hopeful
number is also ticking upward: the number of people who have recovered from COVID-19.
Public health experts have said covid19 is unique and complex. The growing number of
recoveries comes with a growing number of questions about what it means to overcome
COVID-19: about a patient's contagiousness, subsequent immunity to the disease, and long-
term effects. Much about the aftermath of the illness remains unclear or unknown, and there
is even uncertainty about the term "recover" in the coronavirus context.
According to the Ministry of Health's discharge policy for covid-19 cases, a patient is
discharged only after two samples test negative within 24 hours and there's evidence of chest
radiographic clearance and viral clearance in respiratory samples. Early evidence suggests
that coronavirus victims may experience lingering health effects of COVID-19, even after
testing negative. Medical experts in Hong Kong who have observed discharged COVID-19
patients report the patients had shortness of breath and may have lost some lung function, but
the researchers were unsure how long those ailments would last.

HOMEOPATHIC
Clinical presentation
Patients with COVID19 infection exhibit a wide range of symptoms. Most cases reported
have mild disease, and nearly 20% appear to progress to severe disease, including
pneumonia, respiratory failure and in some cases death . Fever (98%), cough (82%),
shortness of breath (55%), fatigue (70%), myalgia (44%) and sputum production (33%) are
most common symptoms reported whereas less common symptoms include headache (13%),
diarrhoea (10%), nausea and vomiting (10%) and haemoptysis (5%).
Term Case definition

Suspect A patient with acute respiratory illness {fever and at least one sign/symptom of respirat
Case shortness of breath or diarrhoea), AND a history of travel to or residence in a country/ar
transmission of COVID-19 disease during the 14 days prior to symptom onset.

A patient with acute respiratory illness {fever and at least one sign/symptom of respirat
shortness of breath or diarrhoea), AND a history of travel to or residence in a country/ar
transmission of COVID-19 disease during the 14 days prior to symptom onset.

A patient with severe acute respiratory infection {fever and at least one sign/symptom of respir
shortness breath)} AND requiring hospitalization AND with no other etiology that ful
presentation

A case for whom testing for COVID-19 is inconclusive

Lab A person with laboratory confirmation of COVID-19 infection, irrespective of clinical signs an
confirmed
Case

Contact A contact is a person that is involved in any of the following:

Providing direct care without proper personal protective equipment (PPE) for COVID-19 patien

Staying in the same close environment of a COVID-19 patient (including workplace, classroom

Travelling together in close proximity (within 1 m) with a symptomatic person who later tested

High risk Contact with a confirmed case of COVID-19

contact
Travel to a province where COVID-19 LOCAL TRANSMISSION is being reported as per WH

Touched body fluids of patients (respiratory tract secretions, blood, vomitus, saliva, urine, faece
 Touched or cleaned the linens, clothes or dishes of the patient

Close contact, within 3 feet (1 metre) of the confirmed case

Co-passengers in an airplane/vehicle seated in the same row, 3 rows in front and behind of a co

Low risk Shared the same space (same classroom/same room for work) or similar activity and not hav
Contact the confirmed/suspected case

Travel in the same environment (bus/train/flight/any mode of transit) but not having high risk e

Any traveller from abroad not satisfying high risk criteria

Warning Signs

 Pre-existing underlying serious illness such as cardiovascular disease, diabetes, end

stage renal disease, vacuities
 Greater severity of pneumonia at presentation
 Radio opacity and/or pulmonary infiltrates in chest X-ray
 Older age group
 Immunocompromised medical condition
 Organ failure

Homoeopathic Approach

It is advised that before taking up for homoeopathic medicines for prophylaxis, Amelioration
and mitigation, physician must acquaint himself of above sections.
In case of epidemics or pandemics, first approach is to follow preventive measures and
educate people about general measures and to provide such interventions which will keep
their immunity enhanced. Homeopathy therefore recommends issuing of public notice for
Genus epidemicus identified by the designated experts for immunity enhancement and
practitioners may suggest the same to the people and as per the Advisory issued by Ministry
of AYUSH.
Second approach is to provide homoeopathic symptomatic mitigation to affected persons.
Homoeopathic medicines are also useful in the treatment of communicable diseases like
Influenza Like Illness, dengue, acute encephalitis syndrome. Several studies are also
published which shows the immune modulatory potential of homoeopathic medicines in
preclinical studies. These medicines can be prescribed in an integrated manner or standalone
depending on the severity on a case to case
Therapeutic Aid

As a system with wholistic approach medicine were selected based on the presenting signs
and symptoms of each patients. The medicines given here are suggestive based on their use
and studies in the past in diseases of similar presentation like COVID-19. Patients of
COVID-19 are to be treated with adjuvant Homoeopathic medicines with the permission
from local health authorities and Medical Superintendent of the Hospital. Homoeopathic
doctors must follow all preventive measures (using PPEs) as are required for dealing with
COVID 19 patients.
The remedies according to different stages of disease are given below:
Mild Disease (Symptomatic Amelioration and Mitigation Approach): Medicines like Aconite
napellus, Arsenicum album, Bryonia alba, Gelsemium sempervirens, Rhus tox. Eupatorium
perfoliatum, Ipecacaucunha, Belladonna, Camphora,may be used depending upon the
symptoms similarities.
Severe disease but not in critical condition:
It is defined by following criteria (Dyspnoea, respiratory frequency ≥ 30/min, blood oxygen
saturation (SpO2) ≤ 93%, PaO2/FiO2 ratio < 300, and/or lung infiltrates > 50% within 24 to 48
hours)/)

 Suggested medicines are as adjuvant to Standard Management guidelines in the

hospital setting only with the approval of authorities and willingness of the
patient/guardian.
 The prescription is to be given only by institutionally qualified practitioner.
 Medicines like Phosphorus, Chelidonium, Veratrum Viride, Iodum, Camphora,
Cinchona officinalis, Lycopodium, Ars. iod., Antim ars., Stannum met, Carbo veg.,
can be prescribed on symptomatic indication.

Posology

The medicine selected for each patient is tailored to person specific, taking into
consideration, his/her mental make-up, physical symptoms, and characteristic particulars etc.
In case of long term illness, besides the above mentioned factors, age, occupation, previous
illnesses and life circumstance unique to that individual irrespective of the disease which
he/she is suffering from, are also taken into consideration; thus the dictum “Homoeopathy
treats the patient but not the disease”.
After the appropriate medicine is selected, it is essential to decide the requisite potency, dose
and repetition which is imperative for optimum response and faster recovery in each case.
Different types of potencies such as decimal or centesimal potencies can be employed for
treatment as are required for acute diseases. However, selection of potency of the remedy is
dependent on various factors like susceptibility of the patient (high or low), type of disease
(acute/chronic), seat/ nature and intensity of the disease, stage and duration of the disease and
also the previous treatment of the disease(24).

Unit 14 Codified Domains of Traditional Knowledge

 Introduction to The Protection of Plant Variety and Farmers Right Act, 2001

History of the Protection of Plant Varieties and Farmers’ Rights Act

The Protection of Plant Varieties and Farmers’ Rights Act was enacted in 2001 and
discussions took place in the nation after drawing on how licensed innovation rights ought to
be presented in Indian horticulture after the nation joined the World Trade Organization in
1995 and consented to actualize the Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS).
The decision before India had to take was to either sanction a law that ensured the interests of
cultivating networks or to acknowledge the system of plant reproducers’ privileges given by
the International Union for Protection of New Plant Varieties (UPOV Convention). The last
alternative was dismissed basically in light of the fact that the current adaptation of UPOV,
which was embraced in 1991, denied the farmers the opportunity to reuse ranch spared seeds
and to trade them with their neighbours.

Along these lines, in The Protection of Plant Varieties and Farmers’ Rights Act, India
presented a section on Farmers’ Rights, which has three legs:

 one, farmers are perceived as plant raisers and they can enlist their assortments;
 two, farmers occupied with the protection of hereditary assets of landraces and
wild family members of financial plants and their improvement through choice and
safeguarding are perceived and remunerated; and
 three, ensuring the customary acts of the farmers of sparing seeds from one gather
and utilizing the spared seeds either for planting for their next reap or offering
them to their homestead neighbours.
 A WEBSITE TOUR OF THE PROTECTION OF PLANT VARIETY AND
FARMERS’ RIGHTS AUTHORITY OFFICIAL WEBSITE
 THE PROTECTION OF PLANT VARIETIES AND FARMERS’ RIGHTS
ACT: FROM LEGISLATION TO IMPLEMENTATION,

Objectives of the Protection of Plant Varieties and Farmers’ Rights Act, 2000
The objective of the act acknowledges, to set up a compelling framework for the insurance of
plant assortments, the privileges of farmers and plant reproducers, and to energize the
advancement of new assortments of plants. To perceive and secure the privileges of farmers
in regard to their commitments made whenever monitoring, improving, and making
accessible plant hereditary assets for the advancement of new plant assortments.

To quicken rural advancement in the nation, ensure plant reproducers’ privileges and to
animate speculation for innovative work both in the open and private part for the
improvement of new plant assortments. To encourage the development of the seed industry in
the nation which will guarantee the accessibility of top-notch seeds and planting material to
the farmers.

Implementation of the Act

To execute the arrangements of the Act the Department of Agriculture, Cooperation and
Farmers Welfare, Ministry of Agriculture, and Farmers Welfare built up the Protection of
Plant Varieties and Farmers’ Rights Authority, 2001. The chairperson is the chief executive
of the authority. Other than the chairperson, the authority has 15 individuals, as advised by
the Government of India (GOI). Eight of them are ex-officio individuals speaking to different
departments/ministries, three from SAUs and the State Governments, one delegate each for
farmers, ancestral association, seed industry, and ladies association related with horticultural
exercises are assigned by the Central Government. The Registrar General is the ex-officio
member secretary of the authority.

General functions of the Authority

 Registration of new plant assortments, basically inferred assortments (EDV),

surviving assortments;
 Developing DUS (Distinctiveness, Uniformity, and Stability) test rules for new
plant species;
 Developing portrayal and documentation of assortments enlisted;
 Compulsory listing offices for all assortment of plants;
 Documentation, ordering, and listing of farmers’ assortments;
 Recognizing and remunerating farmers, network of farmers, especially inborn and
provincial network occupied with protection and improvement;
 Preservation of plant hereditary assets of financial plants and their wild family
members;
 Maintenance of the national register of plant varieties; and
 Maintenance of the National Gene Bank.

Convention countries
Convention countries implies a nation which has consented to a global show for the security
of plant assortments to which India has likewise acquiesced or a nation which has the law of
assurance of plant assortments based on which India has gone into an understanding for
allowing plant raisers’ privileges to the resident of both the nations. Any individual if applies
for the enlistment of an assortment in India within a year after the date on which the
application was made in the show nation, such assortment will, whenever enrolled under this
Act, be enlisted as of the date on which the application was made in show nation and that
date will be esteemed with the end goal of this Act to be the date of enlistment.

Plant Varieties Protection Appellate Tribunal

There is a momentary arrangement by which it is given that until the PVPAT is built up, the
Intellectual Property Appellate Board (IPAB) will practice the ward of PVPAT. Therefore,
the Plant Varieties Protection Appellate Tribunal (PVPAT) has been set up by delegating
technical members. All requests or choices of the registrar of authority identifying with an
enrollment of assortment and requests or choices of the registrar identifying with enlistment
as specialist or licensee can be bid in the Tribunal. Further, all requests or choices of
authority identifying with advantage sharing, renouncement of an obligatory permit, and
installment of pay can likewise be offered in the Tribunal. The choices of the PVPAT can be
tested in the High Court. The Tribunal will discard the intrigue inside one year.
International Union for Protection of New Plant Varieties (UPOV Convention)
The International Union for the Protection of New Varieties of Plants (UPOV) is an
intergovernmental association with a home office in Geneva (Switzerland). UPOV was built
up by the International Convention for the Protection of New Varieties of Plants. The
Convention was received in Paris in 1961 and it was changed in 1972, 1978 and 1991. The
strategy of UPOV is to ensure compelling plant safety arrangements to enable the
improvement of new plant ranges to promote society. The UPOV Convention gives the
premise to individuals to support plant rearing by giving raisers of new plant assortments, a
licensed innovation right: the producers correct.

In the instance of an assortment ensured by a raiser’s correct, the approval of the reproducer
is required to proliferate the assortment for business purposes. The reproducer’s privilege is
conceded by the individual UPOV individuals. Only the reproduction of another plant
assortment can ensure that new plant assortment. It isn’t allowed for somebody other than the
raiser to get insurance for an assortment. There are no limitations on who can be viewed as a
reproducer under the UPOV framework, a raiser may be an individual, a farmer, an analyst,
an open organization, a privately owned business, and so forth. However, India isn’t apart as
a member.

Unit 15 & 16 Codified Domains of Traditional Knowledge

Duration and effect of registration and benefit sharing under PVFR Act, 2001
Chapter IV of the Act (Section 24-30)
24. Issue of certificate of registration.—
(1) When an application for registration of a variety (other than an essentially derived variety)
has been accepted and either— (a) the application has not been opposed and the time of notice
of opposition has expired; or (b) the application has been opposed and the opposition has been
rejected, the Registrar shall register the variety.
(2) On the registration of the variety (other than an essentially derived variety), the Registrar
shall issue to the applicant a certificate of registration in the prescribed form and sealed with
the seal of the Registry and send a copy thereof to the Authority for determination of benefit
sharing and to such other authority, as may be prescribed, for information. The maximum time
required by the Registrar for issuing the certificate of registration from the date of filing of the
application for registration of a variety shall be such as may be prescribed.
(3) Where registration of a variety (other than an essentially derived variety), is not completed
within twelve months from the date of the application by reason of default on the part of the
applicant, the Registrar may, after giving notice to the applicant in the prescribed manner, treat
the application as abandoned unless it is completed within the time specified in that behalf in
the notice.
(4) The Registrar may amend the register or a certificate of registration for the purpose of
correcting a clerical error or an obvious mistake.
(5) The Registrar shall have power to issue such directions to protect the interests of a breeder
against any abusive act committed by any third party during the period between filing of
application for registration and decision taken by the Authority on such application.
(6) The certificate of registration issued under this section or sub-section (8) of section 23 shall
be valid for nine years in the case of trees and vines and six years in the case of other crops and
may be reviewed and renewed for the remaining period on payment of such fees as may be
fixed by the rules made in this behalf subject to the condition that the total period of validity
shall not exceed,— (i) in the case of trees and vines, eighteen years from the date of registration
of the variety; (ii) in the case of extant variety, fifteen years from the date of the notification of
that variety by the Central Government under section 5 of the Seeds Act, 1966 (54 of 1966); and
(iii) in other cases, fifteen years from the date of registration of the variety.

25. Publication of list of varieties.—The Authority shall, within such intervals as it thinks
appropriate, publish the list of varieties which have been registered during that interval.

26. Determination of benefit sharing by Authority.—

(1) On receipt of copy of the certificate of registration under sub-section (8) of section 23 or
sub-section (2) of section 24, the Authority shall publish such contents of the certificate and
invite claims of benefit sharing to the variety registered under such certificate in the manner as
may be prescribed.
(2) On invitation of the claims under sub-section (1), any person or group of persons or firm or
governmental or non-governmental organisation shall submit its claim of benefit sharing to
such variety in the prescribed form within such period, and accompanied with such fees, as may
be prescribed: Provided that such claim shall only be submitted by any— (i) person or group of
persons, if such person or every person constituting such group is a citizen of India; or 16 (ii)
firm or governmental or non-governmental organisation, if such firm or organisation is formed
or established in India.
(3) On receiving a claim under sub-section (2), the Authority shall send a copy of such claim to
the breeder of the variety registered under such certificate and the breeder may, on receipt of
such copy, submit his opposition to such claim within such period and in such manner as may
be prescribed.
(4) The Authority shall, after giving an opportunity of being heard to the parties, dispose of the
claim received under sub-section (2).
(5) While disposing of the claim under sub-section (4), the Authority shall explicitly indicate in
its order the amount of the benefit sharing, if any, for which the claimant shall be entitled and
shall take into consideration the following matters, namely:— (a) the extent and nature of the
use of genetic material of the claimant in the development of the variety relating to which the
benefit sharing has been claimed; (b) the commercial utility and demand in the market of the
variety relating to which the benefit sharing has been claimed.
(6) The amount of benefit sharing to a variety determined under this section shall be deposited
by the breeder of such variety in the manner referred to in clause (a) of sub-section (1) of
section 45 in the National Gene Fund.
(7) The amount of benefit sharing determined under this section shall, on a reference made by
the Authority in the prescribed manner, be recoverable as an arrear of land revenue by the
District Magistrate within whose local limits of jurisdiction the breeder liable for such benefit
sharing resides.

27. Breeder to deposit seeds or propagating material.—

(1) The breeder shall be required to deposit such quantity of seeds or propagating material
including parental line seeds of registered variety in the National Gene Bank as may be specified
in the regulations for reproduction purpose at the breeder's expense within such time as may be
specified in that regulation.
(2) The seeds or propagating material or parental line seeds to be deposited under sub-section
(1) shall be deposited to the National Gene Bank specified by the Authority. 28. Registration to
confer right.—(1) Subject to the other provisions of this Act, a certificate of registration for a
variety issued under this Act shall confer an exclusive right on the breeder or his successor, his
agent or licensee, to produce, sell, market, distribute, import or export the variety: Provided that
in the case of an extant variety, unless a breeder or his successor establishes his right, the
Central Government, and in cases where such extant variety is notified for a State or for any
area thereof under section 5 of the Seeds Act, 1966 (54 of 1966), the State Government, shall be
deemed to be the owner of such right. (2) A breeder may authorise any person to produce, sell,
market or otherwise deal with the variety registered under this Act subject to such limitations
and conditions as may be specified by regulations.
(3) Every authorisation under this section shall be in such form as may be specified by
regulations.
(4) Where an agent or a licensee referred to in sub-section (1) becomes entitled to produce, sell,
market, distribute, import or export a variety, he shall apply in the prescribed manner and with
the prescribed fees to the Registrar to register his title and the Registrar shall, on receipt of
application and on proof of title to his satisfaction, register him as an agent or a licensee, as the
case may be, in respect of the variety for which he is entitled for such right, and shall cause
particulars of such entitlement and conditions or restrictions, if any, subject to which such
entitlement is made, to be entered in the Register: Provided that when the validity of such
entitlement is in dispute between the parties, the Registrar may refuse to register the
entitlement and refer the matter in the prescribed manner to the Authority and withhold the
registration of such entitlement until the right of the parties in dispute so referred to has been
determined by the Authority.
(5) The Registrar shall issue a certificate of registration under sub-section (4) to the applicant
after such registration and shall enter in the certificate the brief conditions of entitlement, if any,
in the 17 prescribed manner, and such certificate shall be the conclusive proof of such
entitlement and the conditions or restrictions thereof, if any.
(6) Subject to any agreement subsisting between the parties, an agent or licensee of a right to a
variety registered under sub-section (4) shall be entitled to call upon the breeder or his
successor thereof to take proceedings to prevent infringement thereof, and if the breeder or his
successor refuses or neglects to do so within three months after being so called upon, such
registered agent or licensee may institute proceedings for infringement in his own name as if he
were the breeder, making the breeder or his successor a defendant.
(7) Notwithstanding anything contained in any other law, a breeder or his successor so added as
defendant shall not be liable for any costs unless he enters an appearance and takes part in the
proceedings.
(8) Nothing in this section shall confer on a registered agent or registered licensee of a variety
any right to transfer such right further thereof.
(9) Without prejudice to the registration under sub-section (4), the terms of registration— (a)
may be varied by the Registrar as regards the variety in respect of which, or any condition or
restriction subject to which, it has effect on receipt of an application in the prescribed manner of
the registered breeder of such variety or his successor; (b) may be cancelled by the Registrar on
the application in the prescribed manner of the registered breeder of such variety or his
successor or of the registered agent or registered licensee of such variety; (c) may be cancelled
by the Registrar on the application in the prescribed manner of any person other than the
breeder, his successor, the registered agent or the registered licensee on any of the following
grounds, namely:— (i) that the breeder of a variety or his successor or the registered agent or
registered licensee of such variety, misrepresented, or failed to disclose, some fact material to
the application for registration under sub-section (4) which if accurately represented or
disclosed would have justified the refusal of the application for registration of the registered
agent or registered licensee; (ii) that the registration ought not to have been effected having
regard to the right vested in the applicant by virtue of a contract in the performance of which he
is interested; (d) may be cancelled by the Registrar on the application in the prescribed manner
of the breeder of a registered variety or his successor on the ground that any stipulation in the
agreement between the registered agent or the registered licensee, as the case may be, and such
breeder or his successor regarding the variety for which such agent or licensee is registered is
not being enforced or is not being complied with; (e) may be cancelled by the registrar on the
application of any person in the prescribed manner on the ground that the variety relating to
the registration is no longer existing.
(10) The registrar shall issue notice in the prescribed manner of' every application under this
section to the registered breeder of a variety or his successor and to each registered agent or
registered licensee (not being the applicant) of such variety.
(11) The Registrar shall, before making any order under sub-section (9), forward the
application made in that behalf along with any objection received by any party after notice
under sub-section (10) for the consideration of the Authority, and the Authority may, after
making such inquiry as it thinks fit, issue such directions to the Registrar as it thinks fit and the
Registrar shall dispose of the application in accordance with such directions.

29. Exclusion of certain varieties.—

(1) Notwithstanding anything contained in this Act, no registration of a variety shall be made
under this Act in cases where prevention of commercial exploitation of such variety is necessary
to protect public order or public morality or human, animal and plant life and health or to avoid
serious prejudice to the environment.
(2) The Central Government shall, by notification in the Official Gazette, specify the genera or
species for the purposes of registration of varieties other than extant varieties and farmers’
varieties under this Act.
(3) Notwithstanding anything contained under sub-section (2) and sub-sections (1) and (2) of
section 15, no variety of any genera or species which involves any technology which is injurious
to the life or health of human beings, animals or plants shall be registered under this Act.
Explanation.—For the purposes of this sub-section, the expression “any technology” includes
genetic use restriction technology and terminator technology.
(4) The Central Government shall not delete any genera or species from the list of genera or
species specified in a notification issued under sub-section (2) except in the public interest.
(5) Any variety belonging to the genera or species excluded under sub-section (4) shall not be
eligible for any protection under this Act.

30. Researcher’s rights.—Nothing contained in this Act shall prevent— (a) the use of any variety
registered under this Act by any person using such variety for conducting experiment or
research; or (b) the use of a variety by any person as an initial source of variety for the purpose
of creating other varieties: Provided that the authorisation of the breeder of a registered variety
is required where the repeated use of such variety as a parental line is necessary for commercial
production of such other newly developed variety.

Unit 17 : Cases under the Protection of Plant Variety and Farmers Right Act, 2001
Monsanto Litigations under the PVFR Act, 2001
MONSANTO V/S NUZIVEEDU, MONSANTO V/S CCI

Background of the case

Monsanto is an American multinational agrochemical and agricultural biotechnology corporation,
whereas Nuziveedu Seeds is an Indian agribusiness company, known to be among the largest
hybrid seed companies in the country. Monsanto had licensed its patent IN214436 relating to Bt.
Cotton technology to different Indian companies including Nuziveedu Seeds, for which a lifetime
fee of Rs. 50 lakh was charged along with a recurring ‘trait value’ as compensation. The Indian
companies utilized said patented technology to produce cotton seeds that are resistant to boll-
worm attacks.
The Indian companies demanded Monsanto to reduce the trait fee as the State Governments
were passing new price control orders to fix the trait fees. Monsanto refused to reduce the trait
fees. Consequently, the Indian companies stopped paying royalties to Monsanto since October
2015. Subsequently, Monsanto sent a notice to Nuziveedu in November 2015 regarding the
termination of their sub-license. Nuziveedu and few other Indian companies approached
Competition Commission of India (CCI) against Monsanto and alleged Monsanto of anti-
competitive practices including “the abuse of dominant position” and “anti-competition
agreements”.
Monsanto terminated its contract and initiated arbitration proceedings for the recovery of the due
amount of Rs. 400 crores from the Indian companies. Additionally, a lawsuit was initiated by
Monsanto before Delhi High Court against Nuziveedu Seed Ltd., Prabhat Agri Biotech Ltd. and
Pravardhan Seeds Pvt. Ltd, seeking an injunction for patent and trademark infringement.
As a response to the infringement allegations, the defendants filed a counter-claim for the
revocation of the plaintiff’s patent. The defendant urged to revoke the patent as per the
provisions of Section 8, Section 10(4) and argued that the patent is invalid, as it falls within the
scope of Section 3(j) and 3(h) of Patents Act.

Decision by Single Judge of the Delhi High Court

The Single Judge of the Delhi High Court reinstated the sub-licence that was terminated by
Monsanto. It allowed Nuziveedu Seeds and other Indian companies to continue using the
patented technology till the suit is disposed, wherein, the trait fee must be paid in accordance
with the government set rates. The Single Judge also rejected the arguments of the defendant
about the validity of the patent.

Appeal to Division Bench of Delhi High Court

Both the parties appealed to the Division Bench of Delhi High Court against the order of Single
Judge. Monsanto challenged the decision of the Single Judge to re-instate the licence terminated
by them. The defendants challenged the rejection of their arguments about the validity of
plaintiff’s patent.

Decision by Division Bench of the Delhi High Court

The Division Bench concluded that the subject patent falls under the provisions of Section 3(j) of
the Patent Act and held that the claims of the patent are unpatentable. The Division Bench
upheld the order of Single Judge regarding the trait fee payable by the Indian companies to
Monsanto. The court gave a time period of three months to Monsanto to seek protection for its
invention under “The Protection of Plant Variety and Farmers Right Act, 2001”.

Analysis on the Judgement

The order of the Division Bench to invalidate the patent under Section 3(j) is not convincing in our
view. The court appears to have arrived at the judgement without adequate claim construction
and expert witness. The claim construction is the primary requirement in deciding the validity of
a patent, which in the present case, appears to have been inadequate. The misinterpretation of
Section 3(j) to invalidate the patent is a major setback to innovation in the field of plant
biotechnology.
According to Section 3(j), following inventions are not patentable:
“(j) plants and animals in whole or any part thereof other than micro organisms but
including seeds, varieties and species and essentially biological processes for production
or propagation of plants and animals”
According to Section 3(j), plants and animals per se or any part thereof are not patentable.
Moreover, ‘essentially biological processes’ to produce plants and animals are also not
patentable. Though the definition of ‘essentially biological processes’ was not defined in the
Patents Act, Rule 26(5) of the EPC states that “a process for the production of plants or animals
is essentially biological if it consists entirely of natural phenomenon such as crossing or
selection”.
In the present case, the court made an observation that:
“The conclusion that the court draws therefore, is that transgenic plants with the integrated
Bt. Trait, produced by hybridization (that qualifies as an “essentially biological process” as
concluded above) are excluded from patentability within the purview of section 3(j), and
Monsanto cannot assert patent rights over the gene that has thus been integrated into the
generations of transgenic plants.”
It is to be observed that, Monsanto got a patent for the introgression of specific Bt. bacteria
genes into the cotton genome with human intervention. This cannot be considered as an
essentially biological processes. So, the court’s observations in considering the claims of the
Monsanto’s patent as essentially biological processes appears to be inappropriate.
Monsanto had alleged infringement of Claim 25 of the patent; claim 25 is recited below:
“A nucleic acid sequence comprising a promoter operably linked to a first polynucleotide
sequence encoding a plastid transit peptide, which is linked in frame to a second
polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis 8-endotoxin protein,
wherein expression of said nucleic acid sequence by a plant cell produces a fusion protein
comprising an amino-terminal plastid transit peptide covalently linked to said 5- endotoxin
 protein, and wherein said fusion protein functions to localize said 5-endotoxin protein to a
subcellular organelle or compartment.”
The claim deals with the extraction of a specific nucleic acid sequence from Bacillus thuringiensis
(Bt bacterium) and inserted into a plant cell. The modified nucleic acid sequence produces
toxins that are resistant to boll-worm attacks.
Better claim construction and expert witness would have helped the court to prevent the
misinterpretation of Section 3(j).
Monsanto has appealed before the Supreme Court and challenged the decision of Division
Bench. We wish the apex court pronounces a judgement with reasoning, such that companies
can continue to innovate and seek protection within the framework of the Patents Act and
international obligations, which India has agreed to by way of TRIPS, and the like.

Unit 18. The Farmers’ Produce Trade And Commerce (Promotion And
Facilitation) Act, 2020
Traditional Knowledge and its importance in the Value chain – through the Act
The Farmers’ Produce Trade And Commerce (Promotion And Facilitation) Act, 2020
Highlights of the Ordinance

 The Farmers’ Produce Trade and Commerce (Promotion and Facilitation) Ordinance,
2020 allows intra-state and inter-state trade of farmers’ produce beyond the physical
premises of APMC markets. State governments are prohibited from levying any
market fee, cess or levy outside APMC areas.

 The Farmers Agreement Ordinance creates a framework for contract farming through
an agreement between a farmer and a buyer prior to the production or rearing of any
farm produce. It provides for a three-level dispute settlement mechanism: the
conciliation board, Sub-Divisional Magistrate and Appellate Authority.

 The Essential Commodities (Amendment) Ordinance, 2020 allows the central

government to regulate the supply of certain food items only under extraordinary
circumstances (such as war and famine). Stock limits may be imposed on agricultural
produce only if there is a steep price rise.

Key Issues and Analysis

 The three Ordinances aim to increase the availability of buyers for farmers’ produce,
by allowing them to trade freely without any license or stock limit, so that an increase
in competition among them results in better prices for farmers. While the Ordinances
aim to liberalise trade and increase the number of buyers, de-regulation alone may not
be sufficient to attract more buyers.

 The Standing Committee on Agriculture (2018-19) noted that availability of a

transparent, easily accessible, and efficient marketing platform is a pre-requisite to
ensure remunerative prices for farmers. Most farmers lack access to government
procurement facilities and APMC markets. It noted that small rural markets can
emerge as a viable alternative for agricultural marketing if they are provided with
adequate infrastructure facilities.

 The Standing Committee also recommended that the Gramin Agricultural Markets
scheme (which aims to improve infrastructure and civic facilities in 22,000 Gramin
 Haats across the country) should be made a fully funded central scheme and scaled to
ensure presence of a Haat in each panchayat of the country.

Agricultural markets in India are mainly regulated by state Agriculture Produce Marketing
Committee (APMC) laws. APMCs were set up with the objective of ensuring fair trade
between buyers and sellers for effective price discovery of farmers’ produce.[1] APMCs can:
(i) regulate the trade of farmers’ produce by providing licenses to buyers, commission agents,
and private markets, (ii) levy market fees or any other charges on such trade, and (iii) provide
necessary infrastructure within their markets to facilitate the trade.

The Standing Committee on Agriculture (2018-19) observed that the APMC laws are not
implemented in their true sense and need to be reformed urgently. Issues identified by the
Committee include: (i) most APMCs have a limited number of traders operating, which leads
to cartelization and reduces competition, and (ii) undue deductions in the form of commission
charges and market fees.13 Traders, commission agents, and other functionaries organise
themselves into associations, which do not allow easy entry of new persons into market
yards, stifling competition.[2] The Acts are highly restrictive in promotion of multiple
channels of marketing (such as more buyers, private markets, direct sale to businesses and
retail consumers, and online transactions) and competition in the system.13

During 2017-18, the central government released the model APMC and contract farming
Acts to allow restriction-free trade of farmers’ produce, promote competition through
multiple marketing channels, and promote farming under pre-agreed contracts. ,[4] The
[3]

Standing Committee (2018-19) noted that states have not implemented several of the reforms
suggested in the model Acts.13 It recommended that the central government constitute a
Committee of Agriculture Ministers of all states to arrive at a consensus and design a legal
framework for agricultural marketing. A High Powered Committee of seven Chief Ministers
was set up in July 2019 to discuss, among other things: (i) adoption and time-bound
implementation of model Acts by states, and (ii) changes to the Essential Commodities Act,
1955 (which provides for control of production, supply, and trade of essential commodities)
for attracting private investment in agricultural marketing and infrastructure.[5]

The central government promulgated three Ordinances on June 5, 2020: (i) the Farmers’
Produce Trade and Commerce (Promotion and Facilitation) Ordinance, 2020, (ii) the Farmers
(Empowerment and Protection) Agreement on Price Assurance and Farm Services
Ordinance, 2020, and (iii) the Essential Commodities (Amendment) Ordinance, 2020.[6],[7],[8]
The Ordinances collectively seek to (i) facilitate barrier-free trade of farmers’ produce
outside the markets notified under the various state APMC laws, (ii) define a framework for
contract farming, and (iii) impose stock limits on agricultural produce only if there is a sharp
increase in retail prices. The three Ordinances together aim to increase opportunities for
farmers to enter long term sale contracts, increase availability of buyers, and permits buyers
to purchase farm produce in bulk.

Key Features

The Farmers’ Produce Trade and Commerce (Promotion and Facilitation) Ordinance,
2020

 Trade of farmers’ produce: The Ordinance allows intra-state and inter-state trade of
farmers’ produce outside: (i) the physical premises of market yards run by market
committees formed under the state APMC Acts and (ii) other markets notified under the
state APMC Acts. Such trade can be conducted in an ‘outside trade area’, i.e., any place of
production, collection, and aggregation of farmers’ produce including: (i) farm gates, (ii)
factory premises, (iii) warehouses, (iv) silos, and (v) cold storages.

 Electronic trading: The Ordinance permits the electronic trading of scheduled farmers’
produce (agricultural produce regulated under any state APMC Act) in the specified
trade area. An electronic trading and transaction platform may be set up to facilitate the
direct and online buying and selling of such produce through electronic devices and
internet. The following entities may establish and operate such platforms: (i)
companies, partnership firms, or registered societies, having permanent account
number under the Income Tax Act, 1961 or any other document notified by the central
government, and (ii) a farmer producer organisation or agricultural cooperative society.

 Market fee abolished: The Ordinance prohibits state governments from levying any
market fee, cess or levy on farmers, traders, and electronic trading platforms for trade of
farmers’ produce conducted in an ‘outside trade area’.

The Farmers (Empowerment and Protection) Agreement on Price Assurance and Farm
Services Ordinance, 2020

 Farming agreement: The Ordinance provides for a farming agreement between a

farmer and a buyer prior to the production or rearing of any farm produce. The
minimum period of an agreement will be one crop season, or one production cycle of
livestock. The maximum period is five years, unless the production cycle is more than
five years.

 Pricing of farming produce: The price of farming produce should be mentioned in the
agreement. For prices subjected to variation, a guaranteed price for the produce and a
clear reference for any additional amount above the guaranteed price must be specified
in the agreement. Further, the process of price determination must be mentioned in the
agreement.
  Dispute Settlement: A farming agreement must provide for a conciliation board as well
as a conciliation process for settlement of disputes. The Board should have a fair and
balanced representation of parties to the agreement. At first, all disputes must be
referred to the board for resolution. If the dispute remains unresolved by the Board
after thirty days, parties may approach the Sub-divisional Magistrate for resolution.
Parties will have a right to appeal to an Appellate Authority (presided by collector or
additional collector) against decisions of the Magistrate. Both the Magistrate and
Appellate Authority will be required to dispose of a dispute within thirty days from the
receipt of application. The Magistrate or the Appellate Authority may impose certain
penalties on the party contravening the agreement. However, no action can be taken
against the agricultural land of farmer for recovery of any dues.

The Essential Commodities (Amendment) Ordinance, 2020

 Regulation of food items: The Essential Commodities Act, 1955 empowers the central
government to designate certain commodities (such as food items, fertilizers, and
petroleum products) as essential commodities. The central government may regulate or
prohibit the production, supply, distribution, trade, and commerce of such essential
commodities. The Ordinance provides that the central government may regulate the
supply of certain food items including cereals, pulses, potatoes, onions, edible oilseeds,
and oils, only under extraordinary circumstances. These include: (i) war, (ii) famine,
(iii) extraordinary price rise and (iv) natural calamity of grave nature.

 Stock limit: The Ordinance requires that imposition of any stock limit on agricultural
produce must be based on price rise. A stock limit may be imposed only if there is: (i) a
100% increase in retail price of horticultural produce; and (ii) a 50% increase in the
retail price of non-perishable agricultural food items. The increase will be calculated
over the price prevailing immediately preceding twelve months, or the average retail
price of the last five years, whichever is lower.