Doha Declaration and Trips amendment

The Doha Declaration and the TRIPS Amendment have significant implications for
pharmaceutical law, particularly with respect to intellectual property rights (IPR), as they seek to
balance the protection of patents with the public interest, especially in developing countries.
1. Doha Declaration (2001):
The Doha Declaration on the TRIPS Agreement and Public Health was adopted by the
World Trade Organization (WTO) Ministerial Conference in 2001. It acknowledges that the
TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement should not prevent
countries from taking measures to protect public health, particularly with regard to access to
essential medicines.
Key points of the Doha Declaration include:
 Flexibility in Patent Law: The declaration reaffirmed that countries have the right to use
TRIPS flexibilities to protect public health. These include mechanisms like compulsory
licensing and parallel importing. These mechanisms allow governments to circumvent
patent protection in cases of public health crises, such as the HIV/AIDS epidemic.
 Compulsory Licensing: This allows a government to authorize a third party to produce a
patented drug without the consent of the patent holder, under certain conditions. This is
particularly important for ensuring access to affordable medicines in developing
countries. The Doha Declaration clarified that TRIPS should not prevent countries from
issuing compulsory licenses to address public health needs.
 Public Health Priority: The declaration emphasizes the need to ensure that intellectual
property rules do not interfere with the ability of countries to protect public health and
ensure access to medicines for all.
2. TRIPS Amendment (2017):
The TRIPS Amendment, also known as the Paragraph 6 System of the TRIPS Agreement,
was adopted in 2003 in response to the Doha Declaration. The amendment facilitates the
production and export of generic versions of patented medicines to countries that do not have the
capacity to manufacture them.
 Paragraph 6: The TRIPS Amendment allowed countries that do not have the capacity to
produce generic medicines to import them from other countries. This is particularly
beneficial for low-income countries that cannot produce certain essential medicines due
to the high cost of patented drugs.
 Export of Generic Medicines: This provision ensures that a country issuing a
compulsory license can export the generic medicine to another country with a public
health problem, without violating international patent law.
3. Pharmaceutical Law in IPR (with respect to TRIPS and Doha):
In the context of pharmaceutical law, both the Doha Declaration and the TRIPS Amendment
underscore the need to balance the enforcement of intellectual property rights with public health
concerns. Some key aspects of pharmaceutical law affected by these instruments include:
  Patents and Generic Drugs: Patents grant exclusive rights to pharmaceutical companies
to manufacture and sell their inventions, usually for a period of 20 years. However, when
patents are granted for essential medicines, high prices may restrict access. The Doha
Declaration allows developing countries to issue compulsory licenses to manufacture or
import generic drugs, helping make essential medicines affordable.
 Public Health vs. Patents: The Doha Declaration emphasizes that public health concerns
must take precedence over patent protection, particularly when access to life-saving
medicines is at risk.
 TRIPS Flexibilities: The TRIPS Agreement itself provides several flexibilities for
developing countries to address public health needs:
o Compulsory Licensing: Allows the government to issue
licenses without the patent holder’s consent.
o Parallel Importation: Allows countries to import patented
medicines from other countries where they are sold at lower
prices, circumventing the patent holder’s control over pricing.
4. Cases and Provisions:
Several key cases and legal provisions highlight the application of the Doha Declaration and
TRIPS Amendment in the pharmaceutical sector:
 India's Patent Amendment Act (2005): India, which had been an exporter of generic
drugs, had to amend its patent law to comply with TRIPS. However, it retained
provisions allowing compulsory licensing. The Indian Supreme Court case of Novartis
AG v. Union of India (2013), where the court upheld the rejection of a patent application
for an imatinib (Glivec) formulation, is a notable example. The court emphasized public
health concerns and limited patent protection for drugs that are not innovative.
 Brazil's Use of Compulsory Licensing: Brazil has been a significant user of
compulsory licensing to make affordable medicines, particularly HIV/AIDS treatments.
In 2007, Brazil issued a compulsory license for the production of efavirenz, an essential
HIV/AIDS drug. The decision was based on the public health need for affordable
medicines, in line with the Doha Declaration's provisions on public health priority.
 Australia and the 2012 TRIPS Amendment Case: Australia has used the TRIPS
flexibilities and the Doha Declaration’s provisions to issue compulsory licenses for
certain medicines, particularly for the cancer drug Nexavar. India produced a generic
version of the drug, and Australia negotiated to ensure affordable access to essential
medicines under TRIPS flexibilities.
Conclusion:
The Doha Declaration and the TRIPS Amendment are crucial in shaping the legal framework
for pharmaceutical intellectual property rights, particularly in balancing the protection of
innovation with the need for affordable medicines. These instruments allow countries to issue
compulsory licenses, make use of TRIPS flexibilities, and promote public health priorities,
ensuring that patent laws do not hinder access to essential medications, especially in
developing countries facing public health challenges.
The Global Politics of IPR and the Making of TRIPS
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was
created under the World Trade Organization (WTO) framework in 1994 as part of the Uruguay
Round of negotiations. TRIPS represents a global standard for intellectual property (IP) law,
including patents, copyrights, trademarks, and geographical indications. The creation of TRIPS
and the subsequent international politics surrounding intellectual property (IP) have been
particularly significant for the pharmaceutical industry.
1. Historical Context:
The global politics of IPR has evolved in response to the pressures exerted by developed
countries, particularly the United States, Europe, and Japan, who were the main advocates for
stronger IP protection during the negotiations. They pushed for stringent global standards for
patents and copyrights to protect innovations, especially in pharmaceuticals, technology, and
biotechnology sectors.
 Developed Countries’ Perspective: Pharmaceutical companies in the U.S. and Europe
were seeking global patent protection to maintain their monopoly over high-cost
medicines. Strong intellectual property protections enable these companies to recoup
their substantial research and development (R&D) investments by ensuring that no one
else can manufacture or sell their patented drugs without permission.
 Developing Countries’ Perspective: On the other hand, many developing countries,
particularly in Africa, Asia, and Latin America, raised concerns that strong IP
protections would drive up the prices of essential medicines. Access to life-saving drugs
like HIV/AIDS, tuberculosis, and malaria treatments would be restricted by monopolies
granted through patents, potentially leaving millions of people without affordable access
to healthcare. These countries called for the inclusion of flexibilities in the TRIPS
Agreement to address public health concerns.
2. The Creation of TRIPS:
 TRIPS (1994): The TRIPS Agreement harmonized intellectual property standards across
WTO members and required countries to provide minimum standards of protection for
a range of IP categories, including patents. For pharmaceuticals, this meant the
introduction of 20-year patent protection for new drugs.
o Patents and Pharmaceuticals: For the pharmaceutical industry, TRIPS meant
that patented medicines could not be copied or manufactured without the consent
of the patent holder during the 20-year period, which could significantly increase
the price of medicines due to lack of competition.
o Challenges to Developing Countries: Countries with limited capacity for
pharmaceutical production found themselves in a difficult situation. Countries like
India were major producers of affordable generic drugs but were forced to change
their laws to comply with TRIPS, making it harder to produce and distribute
generics without infringement on patent rights.
3. TRIPS Flexibilities:
Recognizing the concerns of developing countries, TRIPS includes several flexibilities that
allow countries to modify or limit patent rights in certain circumstances, especially to promote
public health. These flexibilities are critical in ensuring access to essential medicines.
Key TRIPS Flexibilities:
1. Compulsory Licensing:
o A government can issue a compulsory license allowing the
production of a patented drug by a third party without the
consent of the patent holder, typically in cases of public health
emergencies or when drugs are unaffordable.
o Article 31 of the TRIPS Agreement allows the use of
compulsory licensing, subject to certain conditions, and
permits manufacturing or importing generic drugs.
o Doha Declaration (2001): Reaffirmed the right of WTO
members to use compulsory licensing to address public health
needs. This was seen as a victory for developing countries,
especially in the context of the HIV/AIDS crisis.
2. Parallel Importation:
o Parallel importation refers to importing a patented product from
another market where it is sold at a lower price, thereby
circumventing the patent holder’s exclusive control over prices in
a given market.
o TRIPS does not directly address parallel importing but allows
countries to adopt the practice under certain conditions, thereby
enabling them to access affordable medicines from other
countries.
3. Bolar Exception:
o The Bolar exception allows generic drug manufacturers to use
a patented drug during the patent term to gather data and
conduct testing in preparation for a generic version once the
patent expires. This enables quicker entry of generic drugs into
the market after the patent expires.
o Article 30 of TRIPS permits such exceptions, benefiting public
health by accelerating access to generics.
4. Public Health Exception:
o The public health exception allows governments to override
patent rights to ensure access to essential medicines during
health crises or pandemics.
o The Doha Declaration (2001) explicitly allowed countries to
use TRIPS flexibilities to promote public health, even when this
meant not adhering strictly to patent protections.
4. Cases and Provisions:
Several significant legal cases and provisions highlight the use of TRIPS flexibilities,
particularly in relation to pharmaceutical patents and access to medicines.
 India’s Patent Amendment Act (2005):
o India was required to amend its patent laws to comply with
TRIPS. India moved from a process patent system to a
product patent system in 2005, granting 20 years of patent
protection for pharmaceuticals.
o However, India's Patent Act also retained compulsory
licensing provisions, enabling it to produce generics when
necessary to protect public health.
o The case of Novartis AG v. Union of India (2013) was a
landmark decision where the Indian Supreme Court ruled against
granting a patent for Glivec, a cancer drug, stating that the drug
was not sufficiently innovative. The court prioritized public health
over patent rights, which was a crucial application of the TRIPS
flexibilities.
 Brazil’s Use of Compulsory Licensing (2007):
o Brazil invoked compulsory licensing to produce efavirenz, a
key HIV/AIDS drug, at a fraction of the price charged by the
patent-holder, Merck. This case was a significant example of
TRIPS flexibilities being used to increase access to life-saving
medicines in developing countries.
 South Africa’s Legal Action Against Pharmaceutical Companies (1997-2001):
o South Africa faced a massive HIV/AIDS crisis, and many essential
medicines were not affordable due to patent protection. In the
late 1990s and early 2000s, the South African government took
legal action against pharmaceutical companies to challenge the
high prices of AIDS drugs.
o The case was resolved when pharmaceutical companies agreed
to drop some of the lawsuits and reduce prices. The government
invoked TRIPS flexibilities, including compulsory licensing
and parallel imports, to facilitate access to affordable
medicines.
Conclusion:
The global politics of IPR and the making of TRIPS reflect a significant tension between the
interests of pharmaceutical companies in maintaining patent protections to safeguard their
investments and the needs of developing countries to secure access to affordable medicines for
their populations. TRIPS flexibilities, including compulsory licensing, parallel imports, and
the public health exception, are essential tools that enable countries to address public health
challenges while adhering to international IP norms. The Doha Declaration and the TRIPS
Amendment have been instrumental in balancing these competing interests, ensuring that public
health needs can take precedence over intellectual property rights in certain circumstances.
The Changing Paradigms of IPR Protection and Issues in
the Pharma Sector
Intellectual Property Rights (IPR) protection in the pharmaceutical sector has undergone
significant changes over the years, shaped by evolving global norms, legal frameworks, and
public health needs. These changes are driven by advancements in technology, global trade,
public health concerns, and the rising costs of medicines, which present challenges for both IPR
holders and the public.
1. Traditional IPR Protection in the Pharmaceutical Sector
Traditionally, pharmaceutical companies relied on patents as the primary form of IPR protection
for their innovations, particularly for new drugs. Under TRIPS (Trade-Related Aspects of
Intellectual Property Rights), pharmaceutical companies are granted patents for a period of 20
years from the filing date, giving them exclusive rights to manufacture, use, and sell their
products. This exclusive protection is intended to encourage innovation by allowing companies
to recoup their R&D investments, which can be substantial in the case of developing new drugs.
However, the traditional model of IPR protection has raised concerns, particularly regarding
access to medicines in developing countries, where high drug prices due to patent monopolies
make essential treatments unaffordable.
2. The Changing Paradigms of IPR Protection
a. Stronger Global Enforcement and New Patent Standards
With the establishment of TRIPS in 1995, a new global system for patent protection was
introduced, requiring countries to comply with minimum standards of IP protection, including
the granting of product patents for pharmaceuticals. This was a significant shift from previous
practices, especially in developing countries like India, which previously followed a process
patent system.
 Shift to Product Patents: Many countries, including India, had previously allowed only
process patents for pharmaceuticals, which enabled generic manufacturers to produce
the same drug without infringing on patents as long as they used a different
manufacturing process. The TRIPS Agreement mandated the shift to product patents,
meaning that patents now apply to the drug molecule itself, rather than just the method of
making it. This led to a greater degree of market exclusivity for multinational
pharmaceutical companies.
 Stronger Patent Enforcement: The enforcement of patent protection has been
strengthened through WTO dispute settlement mechanisms. For instance, if a country
fails to enforce patent rights as required by TRIPS, the patent holder can bring the case to
the WTO.
b. Compulsory Licensing and Public Health Flexibilities
One of the most significant changes in the pharmaceutical sector, especially under the Doha
Declaration (2001), is the recognition of TRIPS flexibilities that allow countries to use
compulsory licensing and other measures to address public health emergencies. These
flexibilities allow governments to override patent protections when public health needs require it,
such as during pandemics or when access to essential medicines is limited by high costs.
 Compulsory Licensing: Countries are allowed to issue a compulsory license (CL) to
allow third parties to manufacture patented drugs without the consent of the patent
holder, especially in cases of public health emergencies. For example, in Brazil, the
government issued a compulsory license for efavirenz, a key HIV/AIDS drug, to make it
more affordable.
 India's Section 3(d): India’s Patent Act (2005) contains Section 3(d), which prevents
the granting of patents for minor modifications of existing drugs unless there is a
significant increase in efficacy. This provision, designed to prevent "evergreening" (a
practice where companies make minor changes to extend patent protection), has been
crucial in allowing generic drug production and ensuring access to affordable
medicines. This was most famously highlighted in the Novartis v. Union of India case
(2013), where the Supreme Court of India denied a patent for Glivec (imatinib mesylate),
ruling that the minor modification of the drug did not meet the novelty and efficacy
criteria.
c. Biologics and the Rise of Biosimilars
The advent of biologics—complex drugs derived from living organisms—has led to a new set of
challenges in pharmaceutical IPR. Biologics are highly expensive and have been under patent
protection for many years, often resulting in high prices for life-saving treatments like cancer
immunotherapies and insulin for diabetes.
 Biosimilars: As the patents for biologics begin to expire, the focus has shifted toward
biosimilars—biological products that are highly similar to approved reference biologics
but are not identical. The legal framework for biosimilars is still developing in many
countries. Some countries, like the EU, have established regulatory pathways for
biosimilars, while others, such as the U.S., have seen more gradual development.
o Patent Challenges: As with generic drugs, the patent
landscape for biologics and biosimilars is complex. There are
often debates over the patentability of biologics and the
conditions under which biosimilars can enter the market. This
results in legal disputes and challenges, particularly with regard
to patents for biologic drugs and their biosimilars.
d. Patent Thickets and Evergreening
Another challenge in pharmaceutical IPR is the phenomenon of patent thickets, where
pharmaceutical companies hold multiple overlapping patents for a single product, sometimes
extending patent life through evergreening. This makes it difficult for generic drug
manufacturers to enter the market.
 Evergreening refers to the practice where companies slightly modify
a drug to extend the term of their patent beyond the original 20 years.
For example, adding new formulations (e.g., extended-release
versions) or new methods of administration could be patented even if
the original molecule is not novel.
 This strategy can limit the entry of generic drugs, maintaining high
prices for the original drug.
e. Data Exclusivity and Market Exclusivity
In addition to patents, pharmaceutical companies often seek data exclusivity for clinical trial
data submitted to regulatory authorities. This means that, even after the patent expires, generic
manufacturers cannot rely on the original clinical trial data to seek approval for their generic
version for a certain period, typically 5–10 years.
3. Key Issues in the Pharmaceutical Sector
Several issues arise in the context of IPR protection for pharmaceuticals:
 Access to Medicines: One of the main criticisms of strong IPR
protections is the high cost of patented medicines, which restrict
access to life-saving drugs, particularly in low- and middle-income
countries. This has led to global campaigns calling for affordable
access to medicines.
 Public Health vs. Patents: While patents incentivize innovation, they
can also restrict access to essential medicines. The debate centers on
whether public health concerns should override patent rights,
especially in developing countries. The Doha Declaration (2001) and
the TRIPS Flexibilities are mechanisms aimed at striking this
balance.
 The Impact of Biologics: The high cost and complexity of biologic
drugs and the challenge of creating biosimilars present new IPR
issues in the pharmaceutical sector, especially regarding patent
protections and data exclusivity.
 Patent Transparency: There is increasing pressure for greater
transparency in patent filings, particularly in the pharmaceutical
industry, to address concerns about evergreening and patent
thickets.
4. Cases and Provisions
Several legal cases and provisions have shaped the changing paradigms of IPR in the
pharmaceutical sector:
 Novartis v. Union of India (2013): This case challenged the patentability of the cancer
drug Glivec under India’s Section 3(d), which aims to prevent evergreening. The
Supreme Court of India ruled that minor modifications to existing drugs that do not show
a significant increase in efficacy should not be granted patent protection, reinforcing the
importance of access to affordable medicines in India.
 Bayer v. Generic Manufacturers (Brazil, 2007): In this case, Brazil invoked
compulsory licensing to allow generic production of Cipro (ciprofloxacin), a critical
antibiotic, in the face of a public health crisis. This was one of the first instances of a
developing country using compulsory licensing to address an urgent public health need.
 Eli Lilly v. Canada (2017): A case involving Eli Lilly and the Canadian government
concerning patent revocation of two patents on the drug Strattera. The court ruled in
favor of Canada, demonstrating how judicial systems are interpreting patent rights under
evolving international legal frameworks.
Conclusion
The changing paradigms of IPR protection in the pharmaceutical sector reflect the complex
balance between encouraging innovation and ensuring access to essential medicines. While
strong patent protection is necessary to incentivize research and development, especially for
life-saving drugs, it is increasingly recognized that public health needs must take precedence in
certain situations. TRIPS flexibilities, such as compulsory licensing, and biologic patenting,
along with evolving legal decisions, are redefining how IPR operates in the pharmaceutical
sector, striving to create a more equitable global framework for the protection of both innovation
and public health.

Data Exclusivity: Definition and Debate (in India)

Data exclusivity is a form of intellectual property (IP) protection that prevents third parties,
particularly generic drug manufacturers, from using the clinical trial data submitted by an
innovator pharmaceutical company to regulatory authorities for a specified period to obtain
marketing approval for a generic version of the drug.
1. Definition of Data Exclusivity
 What is Data Exclusivity?
o Data exclusivity refers to the exclusive rights granted to
pharmaceutical innovators over the data they generate from
clinical trials and other studies required for obtaining marketing
approval for new drugs.
o During the exclusivity period, regulatory authorities cannot
rely on the innovator’s data to approve a generic drug
application.
o The exclusivity period varies globally (e.g., 5 years in the United
States, 8+2+1 years in the European Union).
 Purpose:
o To reward innovators for their investment in developing clinical
data, which is expensive and time-consuming.
o To incentivize research and development (R&D) by offering
additional protection beyond patents.
2. Legal Framework for Data Exclusivity in India
India does not have a specific law or provision granting data exclusivity. Instead, data protection
in India is governed by Section 3(d) and Section 3(e) of the Drugs and Cosmetics Act, 1940, as
well as TRIPS provisions for data protection.
 TRIPS Agreement - Article 39.3:
o TRIPS requires countries to protect clinical trial data against
"unfair commercial use" and "disclosure," but it does not
 mandate data exclusivity. India complies with this by ensuring
data confidentiality without granting exclusivity.
o India's approach is to prevent "unfair commercial use" while
balancing the needs of public health by not granting
monopolistic rights over clinical data.
 India's Current Position:
o India allows generic manufacturers to rely on innovator data for
regulatory approval (known as abridged approval processes).
o This approach enables faster and cheaper entry of generic drugs
into the market, thereby enhancing access to affordable
medicines.
3. Debate on Data Exclusivity in India
The issue of data exclusivity has been a contentious topic in India, reflecting the tension between
public health concerns and pharmaceutical innovation.
a. Arguments in Favor of Data Exclusivity:
1. Encouraging Innovation:
o Innovator pharmaceutical companies argue that data exclusivity
provides an additional incentive for innovation, particularly for
drugs that may not qualify for patent protection.
o It helps innovators recoup their investments in clinical trials.
2. Harmonization with Global Standards:
o Multinational pharmaceutical companies, particularly those from
the United States and Europe, argue that India should align with
global norms of data exclusivity (e.g., the U.S. and EU) to attract
foreign investment.
3. Prevention of Free Riding:
o Innovators claim that generic companies benefit unfairly by
relying on the innovator's clinical data without incurring the
significant costs of generating it.
b. Arguments Against Data Exclusivity:
1. Impact on Access to Medicines:
o Opponents argue that data exclusivity creates monopolies,
delaying the entry of cheaper generics into the market and
increasing the cost of essential medicines, particularly in a
country like India where affordability is a critical issue.
2. Overlap with Patents:
o In India, patents already provide 20 years of protection. Adding
data exclusivity would create overlapping protections, further
delaying generic competition and harming public health.
3. Conflict with TRIPS Flexibilities:
o Data exclusivity could undermine TRIPS flexibilities, such as
compulsory licensing and public health exceptions, by creating
an additional layer of exclusivity beyond patents.
 4. Economic Constraints:
o India, as a major global supplier of generic drugs, has a strong
interest in minimizing monopolistic barriers to promote
affordable healthcare domestically and internationally.
4. Key Cases and Provisions Related to Data Exclusivity in India
a. Roche v. Cipla (2008):
 Case: Roche alleged patent infringement by Cipla for the anti-cancer
drug Erlotinib. Although the case was primarily about patents, it
highlighted the issue of generic manufacturers relying on innovator
data for approvals.
 Outcome: The Delhi High Court ruled in favor of Cipla, emphasizing
the need for affordable access to medicines in India.
 Relevance to Data Exclusivity: The case underscored India's
commitment to public health and the limitations of extending
monopoly protections beyond patents.
b. Novartis v. Union of India (2013):
 Case: Novartis sought patent protection for the cancer drug Glivec but
was denied under Section 3(d) of the Indian Patent Act for lack of
significant innovation.
 Relevance to Data Exclusivity: The case reinforced India's emphasis
on affordable healthcare and its reluctance to grant monopolistic
protections, including data exclusivity, at the cost of public health.
c. TRIPS and India's Compliance:
 India complies with Article 39.3 of TRIPS by ensuring data protection
against unfair commercial use. However, it does not provide exclusive
rights over the data, allowing generic manufacturers to rely on
innovator data for regulatory approvals.
5. Global Context and Comparisons
 United States:
o Provides 5 years of data exclusivity for new chemical entities
(NCEs) and 12 years for biologics.
o Exclusivity periods prevent generic and biosimilar manufacturers
from relying on the innovator's data during this time.
 European Union:
o Grants 8 years of data exclusivity and an additional 2 years of
marketing exclusivity, with a possible 1-year extension for new
indications.
 India:
o India’s generic-friendly approach contrasts with the U.S. and EU.
It prioritizes affordability and public health over granting
exclusivity, ensuring that generics enter the market quickly.
6. The Way Forward
The debate over data exclusivity in India remains unresolved, with pharmaceutical innovators
advocating for exclusivity and public health advocates resisting it. Balancing these competing
interests requires:
 Strengthening Data Protection:
o India can consider improving data confidentiality and regulatory
oversight without granting exclusivity, ensuring compliance with
TRIPS while avoiding monopolies.
 Supporting Innovation Through Other Means:
o Instead of data exclusivity, India could incentivize innovation
through tax benefits, grants for R&D, and faster patent
approvals.
 Maintaining TRIPS Flexibilities:
o India must retain its generic-friendly policies and align with the
Doha Declaration to safeguard public health.
Conclusion
The debate on data exclusivity in India highlights the challenges of balancing IPR protection
with public health. While data exclusivity may incentivize pharmaceutical innovation, it risks
delaying generic entry and making essential medicines unaffordable for millions. India's current
stance—providing data protection without exclusivity—strikes a balance between encouraging
innovation and ensuring access to affordable healthcare, aligning with its role as a global leader
in the generic pharmaceutical industry.

Suggestions Regarding Section 3(d) and Evergreening in

Pharmaceutical Law in IPR
Section 3(d) of the Indian Patent Act, 1970 is a key provision designed to prevent evergreening,
a practice where pharmaceutical companies extend the patent life of a drug through minor
modifications that do not significantly enhance its therapeutic efficacy. While this provision
safeguards against unwarranted monopolies and ensures access to affordable medicines, it also
raises concerns about the balance between encouraging innovation and preventing abuse of the
patent system.
1. Understanding Section 3(d) and Evergreening
a. What is Section 3(d)?
 Text of Section 3(d): It states that a new form of a known substance
will not be considered an invention unless it demonstrates a
significant enhancement of efficacy.
 Objective:
o Prevent the granting of patents for trivial modifications.
 o Promote innovation that genuinely improves therapeutic
outcomes.
o Ensure generic competition and accessibility of affordable
medicines.
b. What is Evergreening?
 Definition: Evergreening is the practice where pharmaceutical
companies make minor changes to an existing drug (e.g., new
formulations, dosages, or combinations) to extend its patent protection
beyond the original term.
 Impact: This practice delays the entry of cheaper generic versions into
the market, increasing the financial burden on patients.
2. Key Cases Related to Section 3(d) and Evergreening
a. Novartis AG v. Union of India (2013):
 Facts: Novartis applied for a patent for Glivec (imatinib mesylate),
claiming it was a new form of a known substance with improved
efficacy. The patent was denied under Section 3(d) as the modification
did not demonstrate a significant increase in therapeutic efficacy.
 Ruling:
o The Supreme Court held that "efficacy" under Section 3(d) must
mean therapeutic efficacy, not just physical properties.
o This landmark judgment reinforced India’s stance against
evergreening and ensured affordable access to life-saving cancer
treatment.
b. Roche v. Cipla (2008):
 Facts: Roche alleged infringement of its patent for Erlotinib, claiming
Cipla's generic version violated its rights. Cipla argued that the patent
lacked innovation and fell within the scope of Section 3(d).
 Outcome: The Delhi High Court ruled in favor of Cipla, emphasizing
the importance of affordable medicines over monopolistic practices.
 Relevance: The case highlighted the practical application of Section
3(d) in balancing patent rights with public health concerns.
c. Patent Opposition for Abraxane (2009):
 Facts: A pre-grant opposition was filed against Abraxis Biosciences’
patent application for Abraxane, a modified form of paclitaxel. The
opposition argued that the modification did not meet the efficacy
requirement under Section 3(d).
 Outcome: The Indian Patent Office denied the patent, reinforcing
Section 3(d)’s role in preventing evergreening.
3. Suggestions Regarding Section 3(d) and Evergreening
a. Strengthen the Criteria for Therapeutic Efficacy
 Clearly define therapeutic efficacy in the context of Section 3(d) to
avoid ambiguities and ensure uniform application.
 Establish detailed guidelines and benchmarks for assessing "significant
improvement in efficacy" to prevent trivial claims.
b. Promote Innovation Beyond Incremental Changes
 Encourage R&D investments in novel drug discoveries rather than
relying on minor modifications of existing drugs.
 Introduce financial and regulatory incentives for genuine innovations,
such as tax benefits for breakthrough drug research or fast-track
patent approvals.
c. Enhance Patent Examination and Opposition Processes
 Capacity Building: Train patent examiners to better evaluate Section
3(d) applications, focusing on efficacy claims and the science behind
them.
 Opposition Mechanisms: Strengthen pre- and post-grant opposition
systems to allow public health advocates and competitors to challenge
weak patents effectively.
d. Encourage Generic Competition
 Reduce procedural hurdles for generic manufacturers to challenge
patents based on Section 3(d).
 Ensure that the patent system promotes affordable access by
facilitating the entry of generics once genuine patents expire.
e. Introduce Periodic Reviews of Patents
 Implement a system to review granted patents periodically to ensure
compliance with Section 3(d) and prevent unwarranted monopolies.
f. Leverage International Best Practices
 Study patent systems in countries like Brazil and South Africa, which
also emphasize public health over monopolistic protections.
 Ensure that India’s policies align with its commitments under TRIPS
flexibilities and the Doha Declaration.
g. Encourage Collaboration Between Stakeholders
 Promote dialogue between pharmaceutical companies, public health
advocates, and policymakers to strike a balance between innovation
and access.
 Consider public-private partnerships to foster innovation while
addressing affordability concerns.
4. Global Perspectives on Evergreening
India’s approach to Section 3(d) is unique and contrasts with countries like the United States,
where evergreening is more prevalent due to the absence of similar provisions. For example:
 United States:
o Evergreening practices, such as patenting new drug delivery
systems or dosages, are common.
o The Hatch-Waxman Act facilitates patent extensions for
innovator drugs, often delaying generic competition.
 European Union:
o The EU has a system of Supplementary Protection
Certificates (SPCs), which extends patent life for up to 5 years
to compensate for regulatory delays, potentially leading to
evergreening concerns.
India’s stance under Section 3(d) sets a global precedent for balancing innovation incentives with
public health priorities.
5. Provisions in Indian Law Supporting Section 3(d)
a. Section 3(d) of the Indian Patent Act, 1970:
 Prevents patents for new forms of known substances unless significant
efficacy is demonstrated.
b. Section 25:
 Provides mechanisms for pre-grant and post-grant opposition,
allowing stakeholders to challenge weak patents.
c. Patent Amendment Act, 2005:
 Introduced product patents in compliance with TRIPS but retained
Section 3(d) to address public health concerns and prevent
evergreening.
Conclusion
Section 3(d) is a cornerstone of India’s pharmaceutical patent regime, ensuring affordable access
to medicines while preventing evergreening practices. To enhance its effectiveness, India should
focus on strengthening the criteria for therapeutic efficacy, improving patent examination
processes, and encouraging genuine innovation. By maintaining this balance, India can continue
to serve as a global leader in the production of affordable generics while promoting innovation in
the pharmaceutical sector.
Compulsory Licensing in Pharmaceutical Law in India: Lee
Pharma v. AstraZeneca, BDR Pharmaceuticals v. Bristol,
and Policy Shift
Compulsory licensing (CL) is a mechanism under intellectual property (IP) law that allows a
government to permit someone else to produce a patented product or use a patented process
without the consent of the patent holder. In the context of pharmaceuticals, compulsory
licensing plays a crucial role in ensuring that essential medicines are accessible and affordable,
particularly in countries like India where public health concerns often collide with the monopoly
granted by patents.
India’s stance on compulsory licensing has evolved in recent years, shaped by global debates on
access to medicines, TRIPS flexibilities, and public health priorities. This shift is evident in
several landmark cases, including Lee Pharma v. AstraZeneca and BDR Pharmaceuticals v.
Bristol-Myers Squibb, where Indian courts and the government utilized compulsory licensing
provisions to balance the interests of patent holders with the need for affordable medicines.
1. Understanding Compulsory Licensing in India
a. Legal Framework
 Section 84 of the Indian Patents Act, 1970:
o Provides that a compulsory license can be granted by the
Indian Patent Office if:
1. The patented invention is not worked (produced or used) in
India to an adequate extent.
2. The patented product or process is not available to the
public at a reasonable price.
3. The patented invention is not being worked to the fullest
potential within three years of the patent being granted.
 Section 92:
o Allows for the grant of compulsory licenses in cases of national
emergency or public health crises, enabling the government to
issue licenses for the production of essential medicines.
 TRIPS Agreement (Article 31):
o The TRIPS Agreement allows countries to issue compulsory
licenses for public health reasons, especially in cases of national
emergencies or epidemics.
o The Doha Declaration (2001) further affirmed that public
health should take precedence over intellectual property rights.
2. Key Cases Involving Compulsory Licensing
a. Lee Pharma v. AstraZeneca (2012)
 Background:
o In this case, Lee Pharma, an Indian pharmaceutical company,
sought a compulsory license from the Indian Patent Office for
the drug Brilinta (ticagrelor), patented by AstraZeneca. Brilinta
is an anti-blood clotting drug used for patients with
cardiovascular diseases.
o Lee Pharma argued that the drug was not available at an
affordable price in India, and its exorbitant price made it
inaccessible to a large portion of the population in need of the
medication.
 Outcome:
 The Indian Patent Office did not grant the compulsory license
o
in this case. Despite the arguments regarding accessibility and
pricing, AstraZeneca successfully defended its patent, and the
Patent Office decided that Lee Pharma failed to meet the
requirements for compulsory licensing under Section 84 of the
Indian Patents Act.
 Relevance:
o The case demonstrated India’s careful and cautious approach to
granting compulsory licenses. Although the affordability of
medicines was at the heart of the issue, the Indian authorities
upheld the patent rights of the innovator in this case, which
contrasts with the landmark Natco Pharma v. Bayer case.
b. BDR Pharmaceuticals v. Bristol-Myers Squibb (2015)
 Background:
o BDR Pharmaceuticals, an Indian company, sought to obtain a
compulsory license for the drug Nexavar (sorafenib), a patented
drug by Bristol-Myers Squibb, which is used to treat liver and
kidney cancer.
o BDR argued that the price of Nexavar was unaffordable for the
majority of Indian patients, and they filed for a compulsory
license under Section 84 of the Patents Act. The Indian Patent
Office took into account the public health concerns regarding
access to cancer treatment in India.
 Outcome:
o The Indian Patent Office granted the first-ever compulsory
license for a cancer drug in this case in 2012. It ruled that:
 The patented drug was not being produced to meet the
demand in India.
 The price of the drug was unreasonable and inaccessible to
a large portion of the population.
 Relevance:
o The BDR Pharmaceuticals v. Bristol-Myers Squibb case is
significant because it marked India’s first-ever compulsory
license for a cancer drug, reinforcing the country’s
commitment to ensuring access to essential medicines.
o The decision was also seen as a test case for India’s flexible
approach to TRIPS, allowing the country to prioritize public
health over pharmaceutical patent protection.
3. Policy Shift in India Regarding Compulsory Licensing
India’s approach to compulsory licensing has undergone significant shifts over time, especially
following its compliance with TRIPS and its growing recognition of the need for affordable
medicines.
a. Pre-2005: The Absence of Product Patents
 Prior to the 2005 Amendment to the Indian Patents Act, India did
not grant product patents for pharmaceuticals, which meant that
many medicines were not subject to patent monopolies.
 India’s focus was on ensuring affordable access to medicines through
the generic pharmaceutical industry.
b. Post-2005: Introduction of Product Patents
 Following the TRIPS Agreement's mandatory requirement for product
patents, India amended its patent law in 2005, introducing product
patents for pharmaceuticals.
 The shift from process patents to product patents for
pharmaceuticals raised concerns about the increased cost of
medicines due to monopolies granted by patents.
c. Post-Natco v. Bayer and BDR Case: Policy Shift Towards Public Health
 The granting of compulsory licenses in cases like Natco v. Bayer and BDR
Pharmaceuticals v. Bristol-Myers Squibb signified a policy shift in India, prioritizing
public health and affordable access to medicines over the interests of patent holders.
 India’s flexible approach to TRIPS provisions (especially under Article 31 regarding
compulsory licenses) became evident in these cases, demonstrating the country’s ability
to balance intellectual property protection with the need to address public health crises,
especially for essential medicines.
 The Doha Declaration (2001), which allows for compulsory licensing during public
health emergencies, was also a key reference for India's approach. In the wake of these
cases, India demonstrated its commitment to public health over intellectual property.
4. Implications for Pharmaceutical Law in India
 Public Health Prioritization: India has firmly positioned itself as a leader in the use of
compulsory licensing to ensure that essential medicines remain affordable and accessible.
This is particularly crucial in a developing country like India, where a large portion of the
population depends on generic drugs for life-saving treatments.
 Flexibility under TRIPS: India’s decisions, particularly in the BDR Pharmaceuticals
case, highlight the use of TRIPS flexibilities that allow countries to take actions in the
interest of public health, especially when patents may restrict access to affordable
treatments.
 Potential for Future Use: The Lee Pharma case, in which compulsory licensing was
not granted, demonstrates the high bar that companies must meet to obtain a compulsory
license. While India has shown that it will act in the public interest, it has also signaled
that compulsory licensing will not be granted lightly and requires compelling reasons,
such as unreasonable pricing or non-availability of the drug.
 Policy Shift and Global Implications: India’s approach, including these high-profile
cases, sends a strong message to the global pharmaceutical industry that patent rights
cannot override access to life-saving medicines, particularly in developing countries. It
also encourages other countries facing similar public health challenges to explore the use
of compulsory licensing to address the needs of their populations.
5. Conclusion
Compulsory licensing remains one of the most important tools in India’s pharmaceutical policy,
particularly in balancing the protection of intellectual property with the public health needs of its
population. The cases of Lee Pharma v. AstraZeneca, BDR Pharmaceuticals v. Bristol-
Myers Squibb, and the policy shifts post-2005 demonstrate India’s commitment to ensuring
access to affordable medicines, even in the face of global patent challenges. India’s approach
remains a model for other developing countries grappling with the tensions between intellectual
property rights and access to healthcare.

An Overview of the Indian Pharmaceutical Industry and

Protecting Pharmaceutical Inventions and Innovations:
Indian Statutory Laws
India has long been a significant player in the global pharmaceutical industry, known for its
robust generic drug sector and the ability to supply affordable medicines worldwide. The
country has a complex and evolving system of laws to protect pharmaceutical inventions and
innovations while balancing public health needs. The Indian pharmaceutical industry is both a
source of global innovation and a leader in making essential medicines accessible through
generics.
1. Overview of the Indian Pharmaceutical Industry
The Indian pharmaceutical industry has witnessed remarkable growth over the past few decades.
It is the world’s largest supplier of generic medicines and plays a crucial role in the global
supply chain of affordable healthcare products. India’s pharmaceutical industry is one of the top
3 producers of active pharmaceutical ingredients (APIs) globally, contributing to over 20% of
the global supply in terms of volume.
a. Key Features of the Indian Pharmaceutical Industry
 Generics and Exports: India is often referred to as the "pharmacy of
the world" because of its significant contribution to the global supply of
generic drugs. Around 40% of generic medicines in the U.S. and
25% of medicines in the U.K. come from India.
 Domestic Market: India’s pharmaceutical market is second largest
in the world by volume, contributing to a large portion of the
country’s GDP. The market is growing rapidly due to factors like an
aging population, a rise in chronic diseases, and increased access to
healthcare.
 Research and Development (R&D): Many Indian pharmaceutical
companies invest in R&D to innovate new drug formulations and
improve the efficacy of existing drugs, although this focus on R&D has
increased only in recent years due to global patent challenges.
b. Challenges in the Pharmaceutical Industry
 Regulatory Complexity: The pharmaceutical sector in India is
governed by multiple laws and regulations, including the Drugs and
Cosmetics Act, the Patent Act, the Trade Marks Act, and the
Drugs Price Control Order (DPCO).
 Patent Law: The introduction of product patents in 2005 following
India’s adherence to TRIPS has led to a more complex patent
landscape. The pharmaceutical industry now faces both the
opportunity for protecting new innovations and the challenge of
dealing with patent evergreening and access to affordable medicines.
2. Protecting Pharmaceutical Inventions and Innovations under
Indian Statutory Laws
India has a comprehensive legal framework that seeks to protect both pharmaceutical
inventions and innovations while ensuring that access to medicines is not unduly restricted.
These laws balance the interests of patent holders and the public health needs of the country.
a. The Patents Act, 1970 (as amended in 2005)
The Patents Act, 1970 was the foundation of India’s intellectual property protection regime. It
was significantly amended in 2005 to bring India into compliance with the TRIPS Agreement,
which mandated product patents in addition to process patents for pharmaceuticals. Here are key
features of the Patents Act concerning pharmaceutical inventions:
i. Product Patents
 Section 5: Before the 2005 amendments, India only granted patents
for processes rather than products. The 2005 amendment
introduced product patents for pharmaceutical inventions, aligning
India with global standards.
 Patentable Subject Matter: Pharmaceutical inventions can now be
patented as novel products if they meet the criteria of novelty, non-
obviousness, and industrial applicability.
 Term of Patent: The term of a pharmaceutical patent in India is 20
years, after which the patent expires, and generics can enter the
market.
ii. Section 3(d) - Preventing Evergreening
 Section 3(d) of the Indian Patents Act is a critical provision aimed
at curbing evergreening, a practice where patent holders make trivial
modifications to existing drugs to extend their patent monopoly. The
provision ensures that new forms of known substances are only
granted a patent if they show a significant increase in therapeutic
efficacy.
o Case Law Example: The Novartis AG v. Union of India
(2013) case is a landmark example of how Section 3(d) was
applied. The Indian Supreme Court refused to grant a patent to
Glivec (imatinib mesylate), a cancer drug, as the modification
 did not meet the requirement for increased therapeutic
efficacy.
iii. Compulsory Licensing
 Section 84 and Section 92 provide for the granting of compulsory
licenses (CL) in certain circumstances, allowing third parties to
produce patented drugs without the consent of the patent holder.
o Compulsory Licensing can be issued if the patent is not being
worked in India, if the drug is not available at an affordable price,
or if there is a national emergency or public health crisis.
o Case Law Example: The Natco Pharma v. Bayer (2012) case
is a prominent example where the Indian Patent Office granted a
compulsory license for Nexavar (sorafenib), a cancer drug, on
the grounds of its high price and lack of affordability in India.
iv. Post-Grant Opposition (Section 25)
 Section 25 allows for pre-grant and post-grant opposition to
patents. This means that after a patent is granted, interested parties
can challenge the validity of the patent, based on grounds such as
lack of novelty or non-obviousness. This provision has been
particularly important in the pharmaceutical industry for contesting
patents that may be seen as frivolous or evergreening.
b. The Trade Marks Act, 1999
While patents protect inventions (new molecules or formulations), trademarks are crucial for
protecting brands and ensuring that pharmaceutical companies can distinguish their products in
the marketplace. The Trade Marks Act, 1999 protects pharmaceutical companies’ brand
names and logos from unauthorized use, allowing them to establish brand recognition and
consumer trust.
c. The Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Act is a critical piece of legislation for ensuring the safety, efficacy,
and quality of drugs and medicines in India. While it is not specifically about intellectual
property, it plays a major role in the regulation of pharmaceutical products, ensuring that
products marketed in India meet the necessary standards of quality before they are made
available to the public.
d. The Trade-Related Aspects of Intellectual Property Rights (TRIPS)
Agreement
 TRIPS Flexibilities: India’s intellectual property law is also shaped by
the TRIPS Agreement, an international treaty under the World
Trade Organization (WTO). TRIPS allows for several flexibilities
that India has used to balance patent protection with public health:
o Compulsory Licensing (Article 31)
o Parallel Importation: Importing patented products from other
countries at lower prices.
 o Non-Patentability of Certain Inventions: India utilizes the
TRIPS flexibilities to reject patents on inventions that lack
innovation or do not contribute significantly to public welfare.
3. Case Law Related to Pharmaceutical Inventions in India
a. Novartis AG v. Union of India (2013)
 Issue: Novartis sought a patent for Glivec (imatinib mesylate),
claiming it was a new and inventive form of the known substance
imatinib.
 Court Ruling: The Supreme Court rejected the patent application,
citing Section 3(d) of the Patents Act, which prevents the patenting of
new forms of known substances unless there is a significant increase
in efficacy. The ruling was hailed as a victory for public health and
access to affordable medicines.
b. Natco Pharma v. Bayer (2012)
 Issue: Natco Pharma applied for a compulsory license for Nexavar
(sorafenib), a cancer drug patented by Bayer, citing its
unaffordability in India.
 Court Ruling: The Indian Patent Office granted a compulsory license,
allowing Natco to produce and sell the drug at a significantly lower
price. This decision reinforced the Indian government’s ability to grant
compulsory licenses for public health reasons, even against the
interests of multinational pharmaceutical companies.
4. Conclusion
The Indian pharmaceutical industry plays a pivotal role in global healthcare by providing
affordable generic drugs. The Indian Patents Act and other related laws seek to protect
pharmaceutical innovations while addressing public health needs. Compulsory licensing,
patentability criteria (including Section 3(d)), and TRIPS flexibilities provide a framework
that balances innovation protection and access to medicines.
Landmark cases like Novartis v. Union of India and Natco Pharma v. Bayer illustrate how
India’s patent law ensures that public health concerns are not overshadowed by patent rights,
setting a significant precedent for other developing countries to follow in addressing both
intellectual property and public health challenges.

Drug Regulatory Framework in India and Drug Price

Control: Impact on R&D, Accessibility, and Patent Law
India has a complex drug regulatory framework designed to ensure the safety, efficacy, and
quality of pharmaceutical products while also ensuring affordable access to essential medicines.
The framework combines multiple laws governing drug approval, price control, patents, and
intellectual property rights (IPR). These laws impact the research and development (R&D)
capabilities of pharmaceutical companies and the accessibility of medicines to the public,
particularly in a developing country like India.
1. Drug Regulatory Framework in India
The drug regulatory framework in India is primarily governed by the following statutes:
a. Drugs and Cosmetics Act, 1940
 Regulates the import, manufacture, distribution, and sale of
drugs and cosmetics in India. It establishes the standards for drug
approval and ensures that pharmaceutical products meet quality and
safety standards before reaching the market.
 The Act also provides for the creation of the Central Drugs Standard
Control Organization (CDSCO), the national regulatory body
responsible for approving new drugs and monitoring the safety of
pharmaceutical products.
b. Drugs (Price Control) Order (DPCO), 2013
 The DPCO is issued under the Essential Commodities Act, 1955
and governs the price control of drugs in India. It aims to ensure that
essential medicines are available to the public at affordable prices.
 Under the DPCO, the National Pharmaceutical Pricing Authority
(NPPA) is responsible for regulating drug prices in India. The NPPA
controls the prices of essential medicines listed in the National List
of Essential Medicines (NLEM) and sets price caps based on the
cost of production and a reasonable profit margin.
c. The Patents Act, 1970 (as amended in 2005)
 The Patents Act regulates the protection of pharmaceutical
inventions in India and provides for product patents (since 2005)
following India's compliance with the TRIPS Agreement.
 The Act allows pharmaceutical companies to obtain patents for new
drugs and formulations, thereby granting them exclusive rights for a
period of 20 years.
 However, it also includes flexibilities that allow the government to
ensure access to essential medicines through mechanisms like
compulsory licensing.
2. Drug Price Control in India (DPCO)
The DPCO is a crucial tool for controlling the cost of essential medicines and ensuring that they
remain accessible to the public, especially in a country like India, where affordability of
medicines is a significant issue.
a. National Pharmaceutical Pricing Authority (NPPA)
 The NPPA is responsible for implementing the DPCO and controlling
the prices of essential drugs. It determines the ceiling prices for
 drugs based on the cost of production and profit margins allowed
to manufacturers.
b. Essential Medicines List (EML)
 The National List of Essential Medicines (NLEM) is an official list
of drugs that are considered essential for addressing the healthcare
needs of the population. The DPCO regulates the prices of drugs on
this list to ensure they are affordable for all, especially vulnerable
populations.
c. Impact of DPCO on R&D
 While the DPCO is important for making medicines accessible, there
are concerns that price controls may deter research and
development (R&D) in the pharmaceutical sector. Pharmaceutical
companies often argue that price regulation on essential drugs
reduces their profit margins, thereby limiting their ability to invest in
new drug discoveries.
 However, the Indian government argues that the price control
mechanism ensures equitable access to medicines while
incentivizing innovation in new drugs through the protection of
intellectual property rights (IPRs) like patents.
3. Patent Law and Its Impact on R&D and Accessibility
The Indian Patents Act, 1970, which was amended in 2005 to comply with the TRIPS
Agreement, plays a critical role in protecting pharmaceutical innovations while balancing the
need for accessibility to medicines. Key provisions under the Patents Act include:
a. Patent Protection for Pharmaceutical Innovations
 Product Patents: The 2005 amendment introduced product
patents for pharmaceuticals, granting patent holders exclusive
rights to manufacture and sell their patented drugs for 20 years. This
incentivizes companies to invest in innovative drug development.
 Section 3(d): This provision restricts the patenting of new forms of
known substances unless they show significant improvement in
therapeutic efficacy, thereby limiting the practice of evergreening
(making trivial changes to extend patent protection).
b. Compulsory Licensing (Section 84 and 92)
 The Patents Act allows the Indian government to issue compulsory
licenses for patented drugs under certain circumstances, such as if
the drug is not worked in India or is unaffordable. This helps ensure
access to essential medicines, even in the face of patent protection.
 Compulsory licensing has been used in the past to increase access
to life-saving medicines like HIV/AIDS and cancer drugs.
4. Impact of Patent Law on R&D and Accessibility
 R&D Investment: The introduction of product patents in 2005 led
to an increase in R&D investments by multinational pharmaceutical
companies in India. The ability to protect new inventions under patent
law provides companies with the incentive to innovate and create new
drugs.
 Access to Medicines: On the flip side, patent protection can lead
to higher prices for patented drugs, which limits access for low-
income populations. This is where compulsory licensing provisions
and price control mechanisms like the DPCO help to ensure access
to essential medicines.
5. Landmark Cases Involving Pharmaceutical Patents in India
a. Bayer v. Union of India (2017) (Delhi High Court)
 Background: In 2017, Bayer challenged the National
Pharmaceutical Pricing Authority (NPPA)'s decision to cap the
price of Nexavar (sorafenib), a cancer drug, under the DPCO. Bayer
argued that the price cap violated its patent rights and would
negatively impact its revenue generation.
 Court Ruling: The Delhi High Court upheld the NPPA's decision,
affirming that the government’s decision to control the price of
essential cancer drugs was in the public interest. The Court also
emphasized that patent protection should not be an obstacle to
ensuring access to life-saving medicines.
b. Bayer v. Union of India (2019) (Delhi High Court)
 Background: In 2019, the case related to the pricing of Nexavar
resurfaced. Bayer challenged the price reduction implemented by
the NPPA on the grounds that it would have a negative impact on its
market share and reduce its ability to reinvest in new drug
development.
 Court Ruling: The Court reiterated the importance of access to
essential medicines over the interests of patent holders, reinforcing
the government's ability to control the prices of critical life-saving
drugs under the DPCO.
c. Bayer v. Natco (2014) (Bombay High Court)
 Background: In 2014, the Bombay High Court dealt with a case
where Natco Pharma sought a compulsory license to produce
Nexavar (sorafenib) under the Patents Act. Natco argued that the
drug was priced excessively, making it unaffordable for the majority of
the Indian population.
 Court Ruling: The Court granted a compulsory license to Natco
Pharma to manufacture generic versions of Nexavar at a
significantly lower price. The judgment marked a significant precedent
 in India for the use of compulsory licensing to ensure affordable
access to life-saving medicines.
6. Other Relevant Provisions and Cases
a. Section 3(d) - Novartis AG v. Union of India (2013)
 In this landmark case, the Supreme Court of India dismissed
Novartis' application for a patent on the beta crystalline form of
imatinib mesylate (Glivec), a cancer drug. The Court upheld the
application of Section 3(d), stating that the new form did not show a
significant increase in therapeutic efficacy. This decision is an
important example of how India applies patent law to prevent
evergreening of patents.
b. Section 84 - Natco Pharma v. Bayer (2012)
 Natco Pharma sought a compulsory license for the drug Nexavar
under Section 84 of the Patents Act. The Indian Patent Office
granted the compulsory license, citing that the patented drug was
unaffordable for the Indian public. This case is significant as it
marked one of the first instances where a compulsory license was
granted for a cancer drug in India.
7. Conclusion
India's drug regulatory framework and price control mechanisms aim to strike a balance
between fostering innovation in the pharmaceutical

Draft Patent Amendment Rules, 2021 in the Context of

Pharmaceutical Law and Intellectual Property Rights (IPR)
The Draft Patent Amendment Rules, 2021 were introduced by the Indian Ministry of
Commerce and Industry for consultation to amend and enhance the existing Patent Rules,
2003. These amendments are designed to streamline the patent application process, improve
efficiency in patent prosecution, and bring India’s patent system more in line with global
standards. The proposed changes particularly impact pharmaceutical patents by modifying
procedural requirements and expanding the scope of patent protections.
Key Provisions of the Draft Patent Amendment Rules, 2021
1. Amendments to the Definition of “Applicant”
o The Draft Patent Amendment Rules, 2021 propose that the
term “applicant” be clearly defined to include both the actual
applicant and the legal representative of the applicant. This
is intended to help clarify ownership issues, particularly in the
 context of joint research projects between pharmaceutical
companies and academic institutions or research organizations.
2. Faster Processing of Patent Applications (Expedited Examination)
o A significant provision of the Draft Rules is the expedited
examination of patent applications. Pharmaceutical
companies often require faster processing for patents,
especially in the case of new drugs or innovations that are
time-sensitive, such as life-saving medicines.
o Under the Draft Rules, applicants can apply for expedited
processing for a substantive examination of the patent
application. This provides a faster patent-granting process, which
benefits pharmaceutical companies seeking quick protection for
their innovations.
o The expedited examination can be requested under specific
circumstances such as:
 When the applicant is involved in research and
development related to green technologies or the
pharmaceutical sector.
 If the applicant belongs to a country that has a bilateral
agreement with India regarding Patent Prosecution
Highway (PPH) schemes.
3. Expansion of the Definition of “Traditional Knowledge”
o The rules propose expanding the scope of traditional
knowledge by including more categories and expanding the list
of traditional knowledge databases. This is significant for the
pharmaceutical sector, as many pharmaceutical products are
based on traditional knowledge or indigenous formulations.
o Traditional knowledge related to medicinal plants and
herbal remedies used in India and other regions could be
protected from misuse or unauthorized patenting.
4. Modifications in Filing of Patent Applications by Start-ups
o The draft rules encourage the filing of patents by startups
involved in the pharmaceutical and biotech industries by
providing certain exemptions and concessions on filing fees.
This is in line with the Indian government’s efforts to promote
innovation in the pharmaceutical sector and foster
entrepreneurship.
5. Amendment to Section 8 - Information regarding Foreign Applications
o Section 8 of the Patents Act requires applicants to disclose
information regarding patent applications filed for the same
invention in other countries. This disclosure is now being
proposed to include details regarding pending foreign
applications, including the status of applications and
rejections.
 o This provision aims to enhance transparency in the patent
process and prevent evergreening and frivolous patenting,
which is an issue often faced in the pharmaceutical sector,
especially when companies file for patents on minor
modifications to existing drugs.
6. Modifications to the Definition of "Invention"
o The draft rules propose a clearer definition of what constitutes an
“invention”, focusing on the novelty and non-obviousness of
the drug or product. In the pharmaceutical sector, this change
would help clarify patentability criteria, particularly regarding the
patentability of incremental innovations or evergreening
practices where pharmaceutical companies attempt to extend
the life of a patent by making slight modifications to existing
drugs.
7. Amendments to the Procedure for Filing Pharmaceutical Patents
o The rules propose streamlining the process of filing
pharmaceutical patents by enhancing communication
channels between the Indian Patent Office (IPO) and
applicants. This includes clarifying the process for responding to
examination reports, particularly in the case of complex
pharmaceutical patents.
o Additionally, extensions of time for responses to examination
reports may be provided in cases where technical issues related
to pharmaceutical formulations or compositions arise.
8. Patents on Biological Products and Biotech Innovations
o The rules propose new provisions that specifically relate to the
patenting of biological products such as biosimilars and
biopharmaceuticals. This will likely have a significant impact
on the pharmaceutical industry, particularly with respect to the
biosimilars market, which is growing rapidly worldwide.
o The provisions seek to streamline the process for obtaining
patents for biotech innovations and address concerns about
patentability and exclusivity in the context of biological
products.
9. Implementation of Digital Platforms and Electronic Filing
o The Draft Patent Amendment Rules, 2021 propose further
digitization of the patent filing process, making it more
efficient, transparent, and user-friendly. Pharmaceutical
companies often file multiple patent applications for different
products or formulations, and a digital platform will help
streamline this process, making it easier to track the status of
patents.
o The use of digital platforms will also help with prior art search,
making it easier to determine the novelty and inventiveness of
pharmaceutical patents before filing.
Impact on Pharmaceutical Law and IPR
1. Increased Transparency and Efficiency in Patent Process
The proposed amendments aim to enhance the transparency and efficiency of India’s patent
system, which is crucial for pharmaceutical companies seeking patent protection. Faster
processing through expedited examination and more clear rules for filing will be helpful for
biopharmaceutical innovations.
2. Impact on Innovation and Access to Medicines
While the amendments provide mechanisms to protect pharmaceutical innovations, there are
concerns about whether these rules will strike the right balance between patent protection and
public health needs. The introduction of clearer patentability criteria (especially in terms of
incremental innovations) could limit evergreening, but the rules could also lead to longer
patent monopolies for new inventions in the pharmaceutical sector, potentially impacting the
affordability and availability of essential medicines.
3. Encouraging R&D in Pharma
The amendments can encourage pharmaceutical companies to invest in R&D by providing
stronger protections for innovative drug products. The provisions related to expedited
examination will help innovators secure patents for their inventions more quickly, facilitating
faster market entry for new and innovative drugs. However, the effectiveness of these rules will
depend on how they are implemented and whether they can prevent abuses such as
evergreening.
4. Flexibility in Patent Enforcement and Enforcement of Access
While patent rights are important for protecting innovation, India’s public health needs are
also prioritized under the Patents Act. Compulsory licensing provisions (such as Section 84)
could continue to provide a balance by ensuring that access to essential medicines is not
restricted by high prices and prolonged patent exclusivity.
Conclusion
The Draft Patent Amendment Rules, 2021 are a significant step toward modernizing India’s
patent laws, with a focus on enhancing efficiency, clarity, and patent protection for innovative
pharmaceuticals. While these changes have the potential to stimulate R&D, ensure faster
access to patent protection, and foster innovation in biotechnology and pharmaceuticals, there
will also need to be continued vigilance to ensure that public health priorities are not
overlooked in favor of corporate interests. The rules, once finalized and implemented, will help
India maintain its leadership role in the global pharmaceutical industry, ensuring a more
robust and fair patent system.

Patent Opposition in India: An Overview

Patent opposition in India is a mechanism under the Patents Act, 1970 that allows third parties
to challenge the grant of a patent. It serves as a critical tool to ensure that patents are granted
only for genuine innovations that meet the criteria of novelty, inventive step, and industrial
applicability, as mandated by the Act. Patent opposition is particularly significant in the
pharmaceutical sector, where patents on drugs and formulations have a direct impact on public
health, accessibility, and the affordability of medicines.
India has a robust framework for patent opposition, which includes both pre-grant and post-
grant opposition mechanisms.

Types of Patent Opposition in India

1. Pre-Grant Opposition (Section 25(1))
o Pre-grant opposition can be filed by any person after the
publication of the patent application but before the grant of the
patent.
o It acts as a preventive mechanism to ensure that frivolous or
non-patentable inventions are not granted patent protection.
o Grounds for Pre-Grant Opposition:
 Lack of novelty, inventive step, or industrial
applicability.
 Non-disclosure or incorrect disclosure of information.
 Non-patentable subject matter under Section 3 of the
Patents Act (e.g., Section 3(d) restricts patenting of new
forms of known substances without therapeutic efficacy).
 Non-compliance with prescribed patenting procedures.
o Outcome: The Controller of Patents may accept or reject the
opposition after considering the evidence provided.
2. Post-Grant Opposition (Section 25(2))
o Post-grant opposition can be filed by any interested person
within 12 months of the grant of the patent.
o It is designed to provide an additional safeguard against patents
that may have been improperly granted.
o Grounds for Post-Grant Opposition:
 The grounds are similar to those for pre-grant opposition
but with more detailed evidence.
 Additional grounds include non-disclosure of foreign filing
information and wrongful obtaining of the invention.
o Outcome: If the opposition is upheld, the patent may be revoked
or amended.

Key Provisions Governing Patent Opposition in India

1. Section 25 of the Patents Act, 1970
o Provides the legal basis for both pre-grant and post-grant
opposition.
2. Rule 55 of the Patents Rules, 2003
o Specifies the procedural requirements for filing and adjudicating
oppositions, such as submission timelines and formats.
 3. Section 3(d)
o A critical provision for the pharmaceutical sector that prevents
the patenting of new forms of known substances unless they
show significant therapeutic efficacy. This is often invoked in
oppositions related to evergreening of pharmaceutical patents.
4. Section 64
o Allows for the revocation of a patent if it is found to have been
granted contrary to the provisions of the Patents Act.

Significance of Patent Opposition in the Pharmaceutical Sector

1. Prevention of Evergreening
o Pharmaceutical companies often seek to extend the life of their
patents by making minor modifications to existing drugs (a
practice known as evergreening). Patent opposition ensures
that such tactics are scrutinized.
o Case Example: Novartis AG v. Union of India (2013)
 The Supreme Court rejected Novartis’ patent application
for Glivec (imatinib mesylate) on the grounds that the
beta crystalline form did not demonstrate enhanced
therapeutic efficacy under Section 3(d).
2. Facilitating Generic Drug Entry
o Successful opposition can pave the way for generic
manufacturers to produce affordable versions of life-saving
drugs.
o Case Example: Natco Pharma v. Pfizer
 Natco Pharma opposed Pfizer’s patent on the cancer drug
Sunitinib and succeeded, allowing the production of
cheaper generic alternatives.
3. Ensuring Public Health
o Opposition proceedings help maintain a balance between
protecting IPR and ensuring access to affordable medicines.

Notable Cases of Patent Opposition in the Pharmaceutical Sector

1. Cipla v. Roche (2008)
 Drug: Erlotinib (anti-cancer drug).
 Opposition Type: Pre-grant opposition by Cipla and others against
Roche’s patent application for Erlotinib.
 Outcome: Cipla successfully challenged the patent on grounds of lack
of novelty and obviousness, enabling the production of generic
versions.
2. Natco Pharma v. Bayer (2011)
 Drug: Sorafenib Tosylate (Nexavar), a cancer treatment drug.
 Opposition Type: Post-grant opposition filed by Natco Pharma against
Bayer’s patent on Nexavar.
 Outcome: While the opposition failed, Natco subsequently obtained a
compulsory license, reducing the drug’s price by 97%.
3. Novartis AG v. Union of India (2013)
 Drug: Glivec (anti-cancer drug).
 Opposition Type: Pre-grant opposition under Section 3(d).
 Outcome: The Supreme Court upheld the pre-grant opposition,
denying the patent for failing to meet the requirement of enhanced
therapeutic efficacy.
4. Mylan v. Gilead Sciences (2016)
 Drug: Sofosbuvir (used to treat Hepatitis C).
 Opposition Type: Pre-grant opposition by Mylan against Gilead’s
patent application.
 Outcome: The Indian Patent Office rejected Gilead’s patent for
Sofosbuvir, stating that it did not satisfy the criteria for inventive
step.

Challenges in Patent Opposition

1. Prolonged Proceedings
o Patent opposition proceedings can be time-consuming, which
may delay the availability of generic medicines.
2. Resource Constraints
o Opposing a patent requires significant legal and technical
expertise, which can be challenging for smaller generic
manufacturers.
3. Pressure from Multinational Corporations
o Global pharmaceutical companies may exert pressure on
regulators to grant patents, making opposition a contentious
process.
4. Global Trade Pressures
o India's opposition mechanisms, particularly Section 3(d), have
faced criticism from developed countries and multinational
corporations, citing barriers to innovation.

Conclusion
Patent opposition in India plays a vital role in upholding the principles of public interest and
preventing the misuse of patent rights, particularly in the pharmaceutical sector. By providing
mechanisms for pre-grant and post-grant challenges, India’s legal framework ensures that only
genuine innovations are granted patent protection. Landmark cases such as Novartis v. Union of
India and Natco Pharma v. Bayer highlight the importance of this system in promoting
affordable healthcare and encouraging competition in the pharmaceutical industry. While there
are challenges, the opposition system remains a cornerstone of India’s balanced approach to
pharmaceutical IPR.

TRIPS Waiver for COVID-19: Panacea or Adhocism?

The TRIPS Waiver (Trade-Related Aspects of Intellectual Property Rights) for COVID-19 was
proposed to address the global health crisis by facilitating wider access to vaccines and
therapeutics to combat the pandemic. The waiver is a temporary relaxation of certain
intellectual property rights (IPR) obligations under the TRIPS Agreement to allow wider access
to COVID-19-related innovations, particularly in the pharmaceutical sector.
The waiver was aimed at increasing the manufacturing capacity of essential medical products
like vaccines, medicines, and diagnostic kits by enabling the transfer of technology and
removal of patent restrictions in low- and middle-income countries.

Background of the TRIPS Waiver Proposal

1. TRIPS Agreement and IPR in the Pharmaceutical Sector:
o The TRIPS Agreement, adopted in 1994 under the World
Trade Organization (WTO), establishes minimum standards for
the protection of IPR, including patents, copyrights, and
trademarks.
o For pharmaceuticals, TRIPS mandates patent protection for new
drugs for a minimum of 20 years, including the ability for
patent holders to exercise exclusive rights over their products,
which can lead to high drug prices and limited access to
essential medicines in developing countries.
2. The Call for a TRIPS Waiver:
o In 2020, as the COVID-19 pandemic ravaged the world, global
health organizations, particularly the World Health
Organization (WHO), and several countries advocated for a
temporary TRIPS waiver to enable the production of
affordable generic versions of COVID-19 vaccines, medicines,
and diagnostics.
o The waiver was supported by countries such as India and South
Africa, which argued that the IPR system should not hinder
efforts to control a global pandemic, particularly in low-income
and middle-income countries where vaccine access was
limited.
o The TRIPS waiver would permit the suspension of patent
rights for COVID-19-related products without the usual
compensation to the patent holders, thus allowing countries to
 manufacture vaccines, medicines, and diagnostics without
worrying about patent infringement.
3. Key Objectives of the Waiver:
o Increase production capacity for essential goods like
vaccines, medicines, and medical equipment.
o Facilitate technology transfer to enhance production in
developing countries.
o Ensure that affordable treatments and vaccines are
accessible to all, especially in low-income countries.

TRIPS Waiver Proposal and Its Evolution

The TRIPS Waiver proposal was first formally submitted to the WTO by India and South
Africa in October 2020. The waiver aimed to temporarily relax IPR protections on COVID-19-
related products under the TRIPS Agreement for the duration of the pandemic. Over time, the
proposal gained widespread support from developing countries, public health advocates, and
organizations like Doctors Without Borders.
Key provisions of the TRIPS waiver proposal included:
1. Waiving Patent Rights: Temporarily suspending patents and trade secrets protection for
COVID-19-related products, allowing countries to produce and distribute vaccines,
treatments, and diagnostics without needing permission from patent holders.
2. Scope of the Waiver: The waiver would cover patents, trade secrets, and other IP rights
related to COVID-19 vaccines, medicines, and diagnostics. It would enable the
manufacture of generic versions of patented vaccines, ensuring greater supply and
accessibility.
3. Geographical Scope: The waiver would apply globally to all WTO members,
particularly benefiting developing countries where access to COVID-19 products was
limited due to high patent costs.
4. Duration: The waiver was proposed as a temporary measure, with a sunset clause once
the COVID-19 pandemic was declared under control.

Opposition and Controversy Around the TRIPS Waiver

While the TRIPS waiver received significant support, it was also met with strong opposition
from certain high-income countries and pharmaceutical companies, citing the following
concerns:
1. Impact on Innovation: Opponents argue that suspending patent rights could discourage
innovation and the development of new vaccines and treatments. They contend that
patent incentives are crucial for R&D investment in the pharmaceutical sector.
2. Access to Technology: Some countries, particularly those with robust pharmaceutical
industries, expressed concerns that the waiver would not guarantee the transfer of
technology necessary to produce vaccines and treatments locally in developing countries.
 3. Increased Competition and Market Disruption: Pharmaceutical companies argue that
the waiver could undermine the market, leading to price cuts and competition that
could affect their bottom line, especially for patented, innovative products.
4. Challenges of Technology Transfer: Even if the waiver was granted, opponents pointed
out that developing countries might face technical barriers and infrastructure
limitations in ramping up production to meet global demand.

Key Cases and Provisions Relevant to TRIPS Waiver and

Pharmaceutical Law
1. Novartis AG v. Union of India (2013)
o This landmark case dealt with the interpretation of Section 3(d)
of the Indian Patents Act, which prevents the patenting of
minor modifications to existing drugs unless they demonstrate
significant therapeutic efficacy. The Supreme Court ruled
that Novartis’ application for the Glivec (imatinib mesylate)
patent was denied under this provision.
o Relevance to TRIPS Waiver: This case highlighted the
challenges of evergreening patents in the pharmaceutical
sector and reinforced India’s stance on promoting generic
drugs. The TRIPS waiver proposal aims to facilitate broader
access to generic versions of patented drugs, much like India’s
approach to preventing evergreening.
2. Natco Pharma v. Bayer (2011)
o Natco Pharma filed a post-grant opposition and was granted
a compulsory license for the production of Sorafenib
Tosylate (Nexavar), a cancer drug patented by Bayer. The
Indian Patent Office granted the compulsory license on the
grounds of public health under Section 84 of the Patents Act,
1970.
o Relevance to TRIPS Waiver: The compulsory licensing
provisions under TRIPS Article 31 allow countries to authorize
the production of generic versions of patented drugs without the
consent of the patent holder. The TRIPS waiver is seen as a
potential extension of this principle to ensure access to COVID-19
vaccines.
3. Bayer v. Union of India (2017-2019)
o Bayer challenged the compulsory license granted to Natco in
the earlier case. However, the courts upheld the decision,
emphasizing public interest and affordability.
o Relevance to TRIPS Waiver: This case illustrates how India has
effectively utilized TRIPS flexibilities, such as compulsory
licensing, to provide affordable access to medicines. The TRIPS
waiver would empower countries to use such mechanisms for
COVID-19 vaccines and treatments.
Criticism of the TRIPS Waiver Proposal
1. Ad Hoc Nature: Critics argue that the TRIPS waiver is a reactive, ad hoc solution to
the pandemic, rather than a sustainable, long-term reform of the global IPR system.
Some experts believe that the current IPR system requires a more systematic overhaul to
balance innovation incentives with public health needs.
2. Political and Economic Power Dynamics: The TRIPS waiver raises concerns about the
geopolitical power dynamics at play, with high-income countries and pharmaceutical
companies exerting considerable influence over the negotiation process. The waiver's
temporary nature also means that the global health crisis may not be adequately
addressed in the long run.
3. Access to Medicines and Equity: While the waiver aims to enhance equitable access to
medicines, questions remain about whether it will truly benefit the countries and
populations that need it most, especially without ensuring the infrastructure and
capacity to produce COVID-19 vaccines and treatments locally.

Conclusion: Panacea or Adhocism?

The TRIPS Waiver for COVID-19 offers a temporary solution to a global crisis, potentially
increasing access to vaccines and treatments in the developing world. While it may serve as a
short-term panacea to address the immediate needs of the pandemic, it raises concerns
regarding long-term sustainability and systemic reform of the global intellectual property
system.
In the pharmaceutical sector, the waiver offers a critical opportunity to balance innovation with
affordable access to life-saving treatments. However, its effectiveness depends on international
cooperation, technology transfer, and capacity building in developing countries. The TRIPS
waiver is a necessary but ad hoc step—long-term changes to the global IPR framework may be
needed to address future global health crises more effectively.