UNIT 7: rights for COVID-19 tools to enable wider production, reflecting global recognition that patent

barriers could jeopardize public health.

Pharmaceutical Drug Patenting and Right to Health
3. Essential Medicines and Human Rights
Introduction
Patenting essential medicines—like vaccines or antiretrovirals—without mechanisms to ensure
Pharmaceutical patents grant exclusive rights to inventors for a specific period, allowing them
accessibility can undermine basic human rights. The Doha Declaration (2001) reaffirms that
to commercialize their inventions and recover R&D investments. However, during public health
TRIPS should not prevent members from protecting public health and promoting access to
emergencies like the COVID-19 pandemic, this exclusivity can create tension between patent
medicines for all.
rights and the fundamental human right to health, particularly when it restricts access to life-
saving medications. Compulsory Licensing:

1. Scope of Patents and the COVID-19 Experience  India’s Section 84 of the Patents Act, 1970 allows for compulsory licensing in public
interest.
Under the TRIPS Agreement (WTO), patents are granted for inventions that are novel, involve
an inventive step, and are industrially applicable, including pharmaceuticals. These patents  In the Natco v. Bayer case (2012), India granted a compulsory license for the cancer
typically last for 20 years. During COVID-19, major pharmaceutical companies obtained patents drug Nexavar, setting precedent for prioritizing affordability and public health over
over vaccines, treatments (like Remdesivir), and diagnostics. exclusive patent rights.

Impact: During COVID-19, however, no compulsory license was issued in India, though debates
intensified over licensing Remdesivir and other therapies.
 High pricing and supply restrictions due to exclusive patent rights hindered equitable
global access to COVID-related drugs and vaccines, especially in developing countries. 4. Balancing Innovation and Access

 Countries like India faced shortages and had to rely on voluntary licensing or foreign aid Pharmaceutical companies argue that patents incentivize innovation by rewarding R&D
to meet domestic demand. investment. However, during global crises:

2. Patents vs. Right to Health  Innovation should be aligned with global solidarity.

The right to health, recognized under Article 12 of the International Covenant on Economic,  Governments and NGOs often fund a significant portion of vaccine R&D (e.g., Oxford-
Social and Cultural Rights (ICESCR) and interpreted under Article 21 of the Indian Constitution, AstraZeneca), weakening the justification for monopoly pricing.
includes access to essential medicines.
Solution Approaches:
Conflict Arises When:
 Public-private partnerships (e.g., COVAX)
 Patent holders charge unaffordable prices.
 Patent pooling (e.g., WHO’s COVID-19 Technology Access Pool - C-TAP)
 Global south countries cannot manufacture generics due to IP restrictions.
 Open licensing and technology transfers to local manufacturers
 Supply is prioritized for high-income countries through advance purchase agreements.
5. India’s Policy Response
COVID-19 Example:
India has:
The TRIPS waiver proposal by India and South Africa (2020) sought temporary suspension of IP
 Supported the TRIPS waiver at WTO.
  Amended export restrictions to prioritize domestic needs.  Cannot mislead regarding use or efficacy (Section 9(2)(a)).

 Faced challenges in negotiating voluntary licenses (e.g., for Pfizer vaccine or Moderna  May face stricter scrutiny due to potential public health risks from confusion.
mRNA tech).
4. Judicial Approach in India
Yet, lack of decisive action on compulsory licensing limited India’s ability to ramp up
Courts in India adopt a high standard of scrutiny for pharma mark disputes, especially involving
production of critical drugs early in the pandemic.
deceptive similarity.

Cadila Health Care Ltd. v. Cadila Pharmaceuticals Ltd. (2001) 5 SCC 73

UNIT8: A. Background & Facts:

Trademarks and the Pharmaceutical Industry  Cadila Health Care launched a drug called "Falcigo" for treating malaria (Plasmodium
falciparum).
Topic: Protection of Pharmaceutical Brand Names
 Cadila Pharmaceuticals had launched a drug named "Falcitab" for a similar purpose.
1. Introduction  Both drugs were anti-malarial injectables, prescribed for similar treatments.

Pharmaceutical trademarks serve a dual purpose: they act as commercial identifiers and play a The dispute arose over the similarity in the brand names — Falcigo vs. Falcitab — potentially
causing confusion in the minds of doctors, chemists, or patients, especially in rural or semi-
public health role by preventing confusion between drugs. Unlike general trademarks, pharma
literate populations.
brand names must meet strict regulatory and legal standards, balancing IP rights with patient
safety. B. Legal Issues:
2. Nature of Pharmaceutical Trademarks  Whether "Falcitab" was deceptively similar to "Falcigo", risking consumer confusion?
 What standards of similarity and public interest should be applied in pharmaceutical
Pharmaceutical brand names are classified into:
trademark cases?
 Proprietary (brand) names: Protected under trademark law (e.g., Lipitor).
C. Judgment:
 Non-proprietary (generic) names: Such as Atorvastatin, which cannot be monopolized.
The Supreme Court ruled in favor of Cadila Health Care, emphasizing:
These brand names must:
“Even a possibility of confusion between medicinal products can be fatal and must be
 Be distinctive and non-deceptive (Section 9, Trade Marks Act, 1999 – India). avoided.”

 Avoid phonetic or visual similarity with existing drugs to prevent medication errors. Key Legal Principles Laid Down:

3. Legal Protection of Pharma Trademarks in India 1. Higher standard of care is required in pharmaceutical trademarks due to public health
implications.
Pharmaceutical trademarks are governed by the Trade Marks Act, 1999 and must also comply
2. Courts must consider phonetic similarity, visual similarity, target consumer base,
with Drugs and Cosmetics Rules, 1945 and DCGI (Drug Controller General of India) norms. illiteracy, and language diversity in India.
3. Likelihood of confusion is sufficient; actual damage or evidence of confusion is not
Key Requirements:
necessary.
 Must not be descriptive of the drug’s composition. 4. Medicines sold over-the-counter or on prescription in India must avoid similarity due
to low literacy and lack of proper guidance from medical professionals in rural areas.
Sun Pharma v. Cipla (2015):  Regulatory agencies like FDA (US) and EMA (EU) run Name Simulation Studies to avoid
A. Background & Facts: confusion that may lead to misprescription or medical errors.

 Sun Pharma had a skin-care product branded as "Venusia". 6. Brand Value and Competitive Edge
 Cipla launched a product named "Venosan" in the same or overlapping therapeutic
Pharmaceutical companies invest heavily in brand recognition, especially for over-the-counter
space (topical formulations).
(OTC) drugs. Trademarks build consumer trust, brand loyalty, and commercial value—even
Sun Pharma alleged trademark infringement and passing off, claiming Venosan was after patent expiration.
deceptively similar to Venusia.
Example:
B. Legal Issues: After patent expiry of Zantac (ranitidine), GSK continued to benefit from trademark protection
over the brand name.
 Was Cipla’s mark “Venosan” deceptively similar to “Venusia” under the test of passing
off? 7. Challenges and Best Practices
 Whether there was a likelihood of confusion among medical professionals and
consumers?  Challenge: Clashing public health regulations and brand protection.

C. Judgment:  Best Practices:

o Conduct thorough trademark searches.

The Delhi High Court granted an injunction in favor of Sun Pharma.
o Avoid use of suffixes similar to therapeutic class (e.g., "stat" for statins).
Key Observations:
o Align branding with regulatory naming guidelines.
1. Although the medications were not identical, both belonged to dermatological
products, and the target consumers overlapped.
2. Phonetic similarity was considered important.
3. The Court followed the Cadila precedent: UNIT 9

“In pharmaceutical cases, the possibility of confusion must be eliminated, not Trademarks and Pharmaceutical Industry
merely minimized.”
Sub-topic: Conflict between Trade Marks and INN Names (Section 13) & Coined Names
4. Even if drugs treat different skin conditions, the similar sounding names might lead to
1. Introduction
prescription errors or chemist confusion.
In the pharmaceutical industry, naming drugs involves a complex interaction between
5. International Perspective and the Role of INNs
trademark law, public health policy, and global standardization norms. This becomes
 International Nonproprietary Names (INNs) are generic names assigned by WHO (e.g., particularly sensitive when proprietary drug names conflict with International Nonproprietary
paracetamol). Names (INNs) prescribed by the World Health Organization (WHO).
Pharma companies cannot register INNs or deceptively similar variants as trademarks.
2. INNs vs Trademarks: Understanding the Conflict
 Reading (2019) explains how myths about easy pharma trademarking overlook strict
INNs (International Nonproprietary Names):
scrutiny by both trademark and drug regulators in the EU, US, and India.
  Globally recognized generic names for active pharmaceutical substances (e.g.,  Zyrtec (for cetirizine)
paracetamol, ibuprofen).
 Lipitor (for atorvastatin)
 Ensure universal recognition and safe prescription practices across countries and
 Viagra (for sildenafil citrate)
languages.
These coined names are:
 WHO bans the registration of INNs as trademarks to prevent monopolization and
confusion.  Easy to register as trademarks
3. Indian Law: Section 13 of the Trade Marks Act, 1999  More memorable to consumers
 Section 13 explicitly prohibits registration of names that are:  Legally defensible against infringement
“Identical with or deceptively similar to an INN declared by the World Health Organization.” 6. Regulatory Caution and Best Practices
 Objective: To prevent pharma companies from claiming exclusive trademark rights over  Coined names must still undergo scrutiny by DCGI, FDA, and EMA to avoid phonetic or
essential drugs, thereby protecting public health and generic access. therapeutic confusion.
4. Legal and Regulatory Standpoint  Pharma companies must avoid:
 Why this matters: If a pharma company trademarks a name identical or similar to an o Names ending in commonly used drug suffixes (-cillin, -mab, -statin)
INN, it could mislead doctors and patients, restrict competition, and threaten access to
affordable medicine. o Similarity to existing brand or INN names

 Example: An attempt to trademark “Amoxillin” (similar to Amoxicillin, an INN) would be 7. Case Example: India
refused under Section 13.
 In SmithKline Beecham v. Sun Pharma, registration of similar-sounding drug names was
 Indian courts and the Drug Controller General of India (DCGI) also play a crucial role in challenged due to likely confusion and infringement.
rejecting such deceptive brand names.
 Cadila Healthcare case (2001) laid down rigorous standards to prevent confusion in
5. Coined Names in Pharma Branding medicinal products, even where the products differ in composition or purpose.

To avoid INN conflicts, companies create coined or invented names—completely new words
with no prior meaning.
Unit 10:
Features of Coined Names:
Trademarks and Pharmaceutical Industry
 Distinctive and non-descriptive
Sub-topic: Trade Dress & Shape of Pharmaceutical Medicine
 Offer stronger trademark protection
1. Introduction
 Can convey brand image or efficacy subtly without making unproven claims
In the highly competitive pharmaceutical industry, brand identity is not limited to names or
Examples: logos. "Trade dress"—the overall visual appearance of a product—and the shape of
pharmaceutical products like pills and tablets are crucial for consumer recognition, particularly failed, it opened doors for considering shape and color of tablets as part of get-up or
among patients relying on look-alike generics. trade dress.

2. What is Trade Dress? 5. Challenges in Protecting Medicine Shapes

Under Section 2(1)(zb) of the Trade Marks Act, 1999, trademark includes the shape of goods,  Many tablets have functional shapes (e.g., for swallowing), which cannot be
packaging, combination of colors, and any visual aspect that can distinguish goods. trademarked under Section 9(3) of the Trade Marks Act.

Trade dress refers to:  Need to prove distinctiveness and secondary meaning (i.e., public associates the shape
with the brand)
 The visual appearance of packaging (color, design, graphics)
Example: Pfizer’s attempt to trademark the diamond shape of the blue Viagra pill was
 The shape of the product itself
successful in some jurisdictions because the shape and color had acquired distinctiveness.
 Sometimes even sound or smell (though less common in India)
6. Importance in the Pharma Sector
3. Legal Protection of Trade Dress in India
 Prevents look-alike generics that may confuse patients.
While Indian law does not explicitly define "trade dress", courts have interpreted it as part of
 Enhances brand recall and patient safety.
non-traditional trademarks.
 Particularly important in jurisdictions with low literacy rates, where patients identify
Case Law:
medicine based on shape and color.
 Colgate Palmolive v. Anchor Health & Beauty Care (2003) – Court recognized packaging
7. Global Context
as protectable trade dress.
 In the EU, the shape of the medicine can be protected under EU Trademark Regulation,
 Gorbatschow Wodka KG v. John Distilleries Ltd. (2011) – Shape of a vodka bottle was
subject to distinctiveness.
protected as trade dress.
 In the US, under the Lanham Act, trade dress is protectable if non-functional and has
These principles apply to pharma as well.
acquired distinctiveness.
4. Shape of Pharmaceutical Medicines as Trademark

The shape of pills, tablets, or capsules may be registered as trademarks if:

UNIT 11:
 The shape is distinctive
Trademarks and Pharmaceutical Industry
 Not functional (i.e., not required for the medicine to work)
Sub-topic: IP for Business - The Fall and Rise of Pharma Brand Names & Counterfeiting of
 Not generic (like standard round or oval tablets) Pharmaceutical Drugs

Case Reference: 1. Introduction

 Glaxo Group Ltd. v. Clover Remedies Pvt. Ltd. (2004) The pharmaceutical industry relies heavily on brand names and intellectual property (IP)
Glaxo’s use of a particular color and shape of Zantac tablets was considered by the protections, especially trademarks, to distinguish their products in a competitive market. Over
court in deciding confusion between competing products. Though ultimately the claim time, pharmaceutical branding has seen both ups and downs in terms of consumer trust,
regulatory scrutiny, and market dynamics. One of the significant challenges is counterfeiting,  This led to a rise in mellifluous names like Symbicort (AstraZeneca) and Zestril
which undermines the effectiveness of IP protection and endangers public health. (AstraZeneca), which were more pleasant and non-confrontational.

2. IP for Business: The Fall and Rise of Pharma Brand Names 3. Counterfeiting of Pharmaceutical Drugs and Trademarks

2.1. Early Development of Pharma Brand Names 3.1. The Threat of Counterfeit Drugs

 In the early stages of pharmaceutical marketing, brands often had chemical names or  Counterfeit drugs are one of the biggest threats to public health globally, and India is no
generic names (e.g., "Aspirin" from the German company Bayer). exception.

 Brand names initially reflected the chemical composition of the drug or the therapeutic  These fake medicines are often sold under the guise of brand-name drugs but contain
purpose. incorrect or dangerous ingredients.

2.2. The Rise of Aspirational Branding  The World Health Organization (WHO) estimates that 10% of global drugs are
counterfeit, and in certain regions, this number can be as high as 30%.
 With the advent of direct-to-consumer advertising, pharmaceutical companies began to
move away from purely descriptive names to more consumer-friendly ones that 3.2. Role of Trademarks in Combating Counterfeiting
conveyed an emotional appeal or lifestyle benefits.
 Trademarks are critical in ensuring that consumers can distinguish between genuine
 Examples: and counterfeit products.

o Viagra (Eli Lilly) – A name that evokes strength and vitality.  Brand names and logos are one of the most reliable indicators of authenticity,
especially in markets where literacy levels may be low, and consumers rely on visual
o Prozac (Eli Lilly) – Conveys a positive, uplifting connotation to treat depression.
cues.
o Celebrex (Pfizer) – Suggests celebration and wellness, aligning with consumer
 Pharmaceutical companies spend millions on IP protection, and trademarks are
aspirations.
essential tools in safeguarding their market identity.
2.3. Regulatory Scrutiny and Challenges
3.3. Counterfeit Drugs and Public Health Risks
 As the industry grew, regulatory bodies like the FDA in the US and EMA in Europe
 Counterfeit medicines may contain incorrect dosages, impurities, or harmful substances
imposed stricter guidelines on naming to avoid confusion between similarly named
that can have dangerous health effects.
drugs.
 For example, counterfeit versions of antibiotics or antiretroviral drugs can lead to drug
 The Paradox of Pharma Naming: The name must be distinctive but not so flashy that it
resistance, creating more complicated health problems for patients and undermining
over-promises or misleads consumers about therapeutic benefits.
global health efforts.
 The balance of creativity versus safety became central to the evolution of pharma
 In India, counterfeit versions of common medicines such as paracetamol or cough
brand names.
syrups have been linked to serious health crises.
2.4. The Shift Toward Neutral and Safe Branding
3.4. Legal Mechanisms to Combat Counterfeiting
 Over time, brands began using softer, more neutral names to avoid negative
 India’s Trade Marks Act (1999) provides a robust framework for IPR enforcement and
perceptions, especially after scandals related to high-profile drugs.
protection against counterfeiting.
  Customs officials are empowered to seize counterfeit goods, and IPR infringement 1.2. The Effect of Generic Medicines on Branded Medicines
actions can lead to severe penalties for counterfeiters.
 Competition and Price Reduction: The introduction of generic versions of branded
 International Cooperation: drugs leads to increased market competition, causing prices of branded drugs to
decrease. This is especially true in countries like India, where generic medicines are
o The Anti-Counterfeiting Trade Agreement (ACTA) aims to enhance global
more readily available and widely used.
cooperation on IPR enforcement, including against counterfeit pharmaceutical
goods. o Example: After the expiration of the patent for the HIV/AIDS drug Efavirenz,
generic manufacturers, particularly from India, began producing Efavirenz at a
o Countries are encouraged to share information and coordinate actions to curb
fraction of the branded price, thereby improving access for low-income
the cross-border movement of counterfeit drugs.
populations.
3.5. Technological Solutions to Fight Counterfeiting
 Loss of Market Share for Branded Drugs: Branded medicines typically hold a monopoly
 With the rise of digital technologies, pharmaceutical companies and regulatory bodies in the market during their patent term, but the entry of generic competitors can
are increasingly adopting track-and-trace systems such as QR codes and barcodes. diminish their market share once the patent expires. For example, when the patent for
Lipitor (atorvastatin) expired, generic alternatives flooded the market, causing a
 Smart packaging and authentication apps allow consumers to verify the authenticity of dramatic decline in Lipitor's sales.
a drug before purchase, adding an additional layer of protection.
 Impact on Innovation and Research: The presence of generic alternatives can have both
 Companies are also exploring blockchain to create secure, transparent supply chains for positive and negative effects on innovation. While generics make drugs more affordable
pharmaceuticals. and accessible, pharmaceutical companies may face reduced incentives to invest in new
research and development (R&D) due to declining profits from off-patent drugs.

1.3. Legal and Regulatory Barriers to Generic Medicines

UNIT 12:
While generic medicines contribute to affordability, they often face legal hurdles from the
Introduction
branded drug manufacturers:
The global pharmaceutical industry is characterized by two major types of medicines: generic
 Patent Challenges: Branded companies may engage in patent litigation to delay the
medicines and branded medicines. Both play crucial roles in ensuring the availability and
entry of generics into the market, often through "evergreening" strategies, where they
affordability of healthcare products, but their interplay has significant implications on
make minor modifications to their existing drugs to extend their patent life.
accessibility, pricing, and overall public health. This case study explores the impact of generic
medicines on branded medicines and the effect of medicine branding on the accessibility and  Regulatory Hurdles: Regulatory bodies like the FDA in the U.S. and CDSCO in India
affordability of these drugs. impose rigorous standards for the approval of generic drugs, which, while ensuring
safety and efficacy, can delay market entry.
1. Impact of Generic Medicines on Branded Medicines
2. Impact of Branding of Medicines on Accessibility and Affordability
1.1. What are Generic Medicines?
2.1. Role of Branding in Pharmaceutical Industry
Generic medicines are drugs that contain the same active ingredients, in the same dosage
form, and strength as the branded version of a medication. They are off-patent and are Branding in the pharmaceutical industry is not just about advertising but also about creating a
marketed under their chemical names rather than a brand name. In most cases, generics are unique identity for a particular drug. A strong brand can convey quality, reliability, and
sold at a significantly lower price compared to their branded counterparts. trustworthiness to consumers, healthcare providers, and pharmacies.
  Brand Loyalty: Consumers and doctors tend to trust well-established branded medicines o Example: When generic versions of the blood pressure drug Losartan entered
due to their perceived quality and safety. Pharmaceutical branding can create a sense the market, the price of the branded version also dropped, making it more
of confidence in a drug, which may not always be present with generics, even if they are affordable for patients globally.
chemically identical.
2.4. Potential Risks of Overbranding in the Pharmaceutical Industry
 Branding and Market Perception: Branded drugs often have higher prices, as part of
 Overpricing: Some companies may engage in overbranding, which involves creating a
the price premium is attributed to marketing costs, brand equity, and consumer
premium image for a drug that may not offer additional benefits compared to existing
perception of superior quality or efficacy.
alternatives. This practice can result in the overpricing of essential medicines and
2.2. Impact on Accessibility and Affordability exacerbate inequalities in healthcare access.

 Accessibility: While branded medicines may be more easily available in developed o Example: The EpiPen price controversy illustrated how branded medicines
markets due to widespread pharmacy networks and healthcare systems, they may be could be marked up significantly, despite the lack of major improvements in the
inaccessible in low-income regions due to their high cost. This can limit access to product's composition.
essential medicines for those who need them the most.
 Reduced Competition: Strong pharmaceutical branding can also act as a barrier to entry
o Example: In developing countries, the high cost of branded insulin and for generics, as consumers may be more reluctant to switch to cheaper alternatives,
antibiotics can make it unaffordable for patients, leading to inequitable access especially when there is a strong association between the brand and quality.
to life-saving drugs.

 Affordability: Branded drugs are typically sold at a premium price, which can limit their
UNIT 14:
affordability for large sections of the population, especially in low- and middle-income
countries. Introduction
o For example, the price of brand-name chemotherapy drugs can be prohibitively The pharmaceutical industry, like many other sectors, is deeply intertwined with intellectual
expensive, leading to poor health outcomes in many regions. property (IP) law, particularly copyright. While patents often take center stage in
pharmaceutical protection, copyright plays an important role in the protection of creative
2.3. The Role of Generic Drugs in Enhancing Accessibility and Affordability
works such as research papers, databases, software, and marketing materials. This case study
 Lower Prices: Generic drugs are a cost-effective alternative to branded drugs. They are explores copyright licensing for pharmaceutical companies, the impact of electronic copying,
usually priced 30-80% less than branded medicines due to the absence of marketing and the role of copyright in pharma research journals.
expenses, R&D costs, and patent protections.
1. Copyright License for Pharmaceutical Companies
o Example: In India, the availability of generics has dramatically improved the
1.1. What is Copyright Licensing?
accessibility of essential drugs for chronic conditions like diabetes and
hypertension. A copyright license is a legal agreement between the copyright holder (author, creator, or
publisher) and a third party that grants permission to use the copyrighted work. Pharmaceutical
 Increased Competition: The widespread availability of generics can lead to increased
companies typically rely on copyright licenses for various types of creative works, including:
market competition, which can drive down the prices of both generics and branded
medicines.  Software Licensing: Pharmaceutical companies often use proprietary software
programs for data analysis, clinical trials, and R&D processes. These software programs
 are protected by copyright law, and pharmaceutical companies must acquire licenses to copying entire research papers or using proprietary data without permission can result
use them. in significant legal consequences.

 Research Publications: Pharmaceutical companies may require licenses to access and  Digital Distribution: Pharmaceutical companies must ensure that any digital
use research journals, academic papers, and clinical trial reports protected by distribution of their proprietary research or clinical trials is properly licensed.
copyright. Licensing ensures that they have the legal right to reference, reproduce, or Unauthorized reproduction or distribution of pharmaceutical research can negatively
distribute these works. affect the company's revenue model and competitive edge.

 Marketing and Advertising: Copyright protects promotional content, such as brochures, 2.2. Impact on the Pharmaceutical Industry
websites, and advertisements. Pharmaceutical companies often enter into licensing
 Increased Risk of Piracy and Counterfeiting: With the increased use of electronic
agreements with designers, photographers, or production companies to use such
formats, the pharmaceutical industry faces a growing risk of digital piracy and
content.
counterfeit medicines. Copyright infringement can occur when research papers,
1.2. The Importance of Copyright Licensing in the Pharma Industry formulations, or even marketing materials are copied without proper authorization.

 Innovation and Access: Licensing facilitates the sharing of knowledge and data,  Data Security: Electronic copying increases the risks associated with data breaches,
essential in the pharmaceutical research and drug development processes. This ensures where confidential clinical trial data or proprietary pharmaceutical research could be
that pharma companies can legally access key research without infringing on intellectual accessed and copied by unauthorized entities.
property rights.
 Cost of Copyright Enforcement: Protecting digital works through copyright law can be
 Risk Mitigation: By obtaining proper copyright licenses, pharmaceutical companies costly for pharmaceutical companies, especially when they need to invest in monitoring
avoid potential legal disputes over unauthorized use of copyrighted material. This is and enforcement mechanisms to prevent unauthorized copying and distribution of their
particularly crucial when dealing with clinical research or data analysis software. works.

 Revenue Generation: Copyright licensing can also be a source of revenue for 3. Copyright in Pharma and Research Journals
pharmaceutical companies if they are the holders of copyrighted content. For example,
3.1. The Role of Copyright in Pharmaceutical Research Journals
a pharma company may license out its proprietary databases or educational resources
to other firms or research institutions. Research journals are essential sources of scientific knowledge, and pharmaceutical companies
rely on them for updates on clinical trials, new drug discoveries, and medical advancements.
2. Electronic Copying and Its Impact on the Pharma Industry
Copyright plays a vital role in protecting the originality of these works and ensuring that
2.1. Electronic Copying and Pharmaceutical Research authors and publishers are compensated for their contributions.

With the rise of digital technologies, the pharmaceutical industry has increasingly shifted to  Access to Research: Pharmaceutical companies need to access copyrighted research
electronic formats for storing and sharing research materials, clinical trial data, and product journals to stay updated with the latest findings in their fields. However, these journals
information. This shift has brought about various concerns and opportunities related to often require a subscription or purchase to access the full text.
copyright law:
 Fair Use and Licensing: While some uses of research papers may fall under the fair use
 Research Accessibility: The electronic format allows researchers to easily access doctrine, pharmaceutical companies often need to negotiate licensing agreements with
pharmaceutical databases, journals, and clinical trial results. However, unauthorized journal publishers for broader use, such as reproducing content in marketing materials
copying of these materials poses a significant copyright infringement risk. For example, or internal training resources.

3.2. Challenges with Copyright and Pharma Research

  Cost of Subscriptions: Many academic publishers charge high fees for access to research emerging technologies such as 3D printing and concerns like bio-piracy shape the way the
journals, which can be a barrier to access for smaller pharmaceutical companies or pharmaceutical sector evolves. This case study explores the influence of various IP rights on the
research institutions. The high cost of subscription-based access to journals is a pharmaceutical industry, covering healthcare equipment and devices, pharmaceutical
significant concern for those in developing countries or with limited research budgets. machines, herbal folklore, and more.

 Open Access Movement: The open access model has gained momentum in recent 1. Health Care Equipment and Devices
years, with researchers and academics pushing for free or low-cost access to scientific
1.1. Design Patents in Health Care Devices
literature. However, the shift toward open access can lead to tensions over how to
protect the intellectual property of researchers and publishers while making knowledge Healthcare devices and medical equipment often involve complex designs, making design
more accessible. patents essential in protecting their aesthetic and functional features. In the pharmaceutical
industry, these devices range from drug delivery systems (such as inhalers and insulin pens) to
 Impact on Drug Development: The lack of easy access to key research due to copyright
medical diagnostic equipment.
restrictions can slow down the pace of drug development, as pharmaceutical
companies may be unable to use certain studies or findings that could accelerate their  Protection of Innovation: Design patents protect the unique visual elements of a
R&D processes. product. Pharmaceutical companies patent the design of devices to prevent competitors
from creating similar products that could confuse consumers or infringe on their market
3.3. Impact of Copyright on Pharmaceutical R&D
share.
 Patent and Copyright Interplay: Pharmaceutical companies often hold patents on their
 Examples:
drug formulations while the research data or clinical trial results may be copyrighted.
The protection of both patents and copyrights ensures that companies can o Inhalers used for asthma or chronic obstructive pulmonary disease (COPD) often
commercialize their innovations without fear of imitation or unauthorized use by have patented designs that enhance user experience and effectiveness.
competitors.
o Syringes and injectors have unique features designed to optimize the delivery of
 Collaborative Research: Copyright law can affect collaborative research efforts medicines, with design patents protecting these features.
between pharmaceutical companies, universities, and other institutions. Copyright
ownership must be clearly defined at the beginning of any collaboration to avoid 1.2. Impact of Design Patents on the Industry
disputes later on.
 Market Differentiation: Design patents enable companies to differentiate their products
in the market and create a distinctive brand identity for their healthcare equipment.

UNIT 15:  Incentivizing Innovation: By securing design protection, manufacturers are encouraged
to invest in innovative healthcare devices, enhancing patient outcomes and healthcare
Impact of Other Related Intellectual Property Rights on the Pharmaceutical Industry efficiency.
Introduction 2. Pharmaceutical Machines
The pharmaceutical industry is influenced by various types of intellectual property (IP) 2.1. Patent Protection for Pharmaceutical Machines
protections, each playing a crucial role in maintaining competitive advantage, safeguarding
innovation, and ensuring the effective delivery of healthcare products. While patents and The machinery used in pharmaceutical manufacturing processes, such as tablet compressing
trademarks often dominate the discourse around IP in pharma, other IP rights, including machines, capsule filling machines, and packaging equipment, is crucial for ensuring the mass
designs, trade secrets, and undisclosed information, also have significant impacts. Additionally,
production of medicines. These machines often require patent protection to secure their 4. Herbal Folklore to Modern Medicine
unique mechanical designs or technological advancements.
4.1. Protecting Traditional Knowledge and Herbal Products
 Technology & Efficiency: Patents can protect innovations in automated pharmaceutical
The transition of herbal folklore into modern pharmaceuticals involves the integration of
machines, ensuring that companies retain a competitive edge in manufacturing
traditional medicinal knowledge into scientific drug development. This has created a unique
efficiency, quality control, and speed of production.
intersection of intellectual property and cultural heritage.
2.2. Impact on Pharma Manufacturing
 Geographical Indications (GIs): Herbal products, especially those with traditional
 Cost Reduction: Innovative machinery can significantly reduce production costs by significance, can be protected through Geographical Indications (e.g., Indian Ayurvedic
improving efficiency and reducing human error. herbs, Chinese herbal medicines). GIs protect products linked to a specific region,
ensuring that only products from that region are entitled to the GI label.
 Market Access: Owning patented pharmaceutical machinery can also allow companies
to have more control over production capabilities, reducing dependency on third-party  Traditional Knowledge Protection: The UN Convention on Biological Diversity (CBD)
manufacturers and enhancing vertical integration. and the Nagoya Protocol aim to protect traditional knowledge related to biological
resources, especially regarding bioprospecting and the commercial use of indigenous
3. 3D Printing in Pharmaceuticals
knowledge.
3.1. 3D Printing: Revolutionizing Drug Delivery and Production
4.2. Impact on Pharma
The advent of 3D printing technology has the potential to revolutionize pharmaceutical
 Patentability: Traditional knowledge is increasingly being used to identify new drug
manufacturing. 3D printing can create customized drug delivery systems, such as personalized
candidates. However, patentability can be controversial, especially if the knowledge is
pills with specific doses, sizes, and shapes. It can also be used to print biodegradable implants
derived from public domain or indigenous communities without proper consent or
and prosthetics, as well as enable the on-demand production of drugs.
compensation.
 Patent Opportunities: The pharmaceutical industry can file patents for the technology
 Ethical Concerns: The appropriation of traditional knowledge without acknowledging
used in 3D printing, as well as for innovative drug forms that are printed using this
indigenous communities or providing fair compensation has led to the issue of
technology.
biopiracy.
3.2. Impact on the Pharmaceutical Industry
5. Trade Secrets in Pharmaceuticals
 Personalized Medicine: 3D printing allows for the development of personalized
5.1. Importance of Trade Secrets
medication, creating pills with specific doses or combinations tailored to an individual’s
needs. Trade secrets play a critical role in protecting confidential business information that is not
publicly disclosed, such as formulation processes, clinical trial data, manufacturing techniques,
 Cost Reduction: 3D printing can reduce the cost of producing small batches of
and marketing strategies.
medicines and customized medical devices, making healthcare more affordable and
accessible.  Protection via Non-Disclosure Agreements (NDAs): Pharmaceutical companies often
require NDAs from employees, suppliers, and research collaborators to protect
 Disrupting Traditional Models: The flexibility of 3D printing technology allows for more
proprietary trade secrets.
agile production models, enabling small-scale production of drugs, especially in remote
areas or during health crises.  Examples: The formula for a drug or drug delivery system, the production process of a
vaccine, and clinical trial data.
5.2. Impact on Pharma 7.2. Combating Bio-Piracy

 Market Advantage: Trade secrets enable companies to keep core technologies and  Access and Benefit Sharing (ABS): Under international agreements like the Nagoya
strategies confidential, ensuring that competitors cannot replicate their innovations. Protocol, countries are encouraged to ensure that any access to genetic resources is
preceded by prior informed consent and that benefits from bioprospecting are shared
 Longevity: Unlike patents, which have a limited duration (typically 20 years), trade
fairly.
secrets can potentially last indefinitely, as long as the secret is kept confidential.
 IP Rights: Pharmaceutical companies must balance the protection of IP (through patents
6. Role of Undisclosed Information
and trademarks) with ethical practices, ensuring that the use of biological resources
6.1. Undisclosed Information and Regulatory Protection respects the rights of indigenous communities.

In the pharmaceutical industry, certain information related to clinical trials, drug formulations,
and testing data can be protected as undisclosed information. This plays a critical role in
ensuring that companies can maintain an edge in the marketplace before the official patenting
process or regulatory approval occurs.

 Regulatory Protection: Regulatory agencies, such as the FDA and EMA, offer protection
for undisclosed information submitted in support of new drug applications or market
authorizations.

6.2. Impact on Pharma

 Competitive Edge: By safeguarding proprietary information, pharmaceutical companies

can prevent competitors from using or copying their research findings.

 Innovation Incentive: Protection of undisclosed information provides companies with

incentives to invest in long-term research and development.

7. Bio-Piracy and the Pharmaceutical Industry

7.1. Bio-Piracy and Its Impact

Bio-piracy refers to the unauthorized or unethical use of biological resources or traditional

knowledge from indigenous communities for commercial purposes. In the pharmaceutical
industry, bio-piracy typically involves the extraction of herbal or genetic material from
biodiversity-rich regions, often without sharing benefits with the local communities or countries
of origin.

 Bioprospecting: Pharmaceutical companies conduct bioprospecting to discover new

compounds from plants, microorganisms, or other organisms that could lead to new
drugs. However, the lack of proper informed consent and benefit-sharing agreements
can result in bio-piracy claims.