NATIONAL UNIVERSITY OF STUDY AND RESEARCH IN LAW,

RANCHI

SUBJECT: IPR-2

Analysing the existing situation and difficulties relating to access to drugs, it is essential to
comprehend the Indian healthcare system. India's patent regime on access to medicines,
highlighting the importance of policy decisions and legal provisions and Alternative
models to investigate to address the issues with patent protection and drug access

SUBMITTED BY : SUBMITTED To:

ASHIRWAD DR. M.R.S MURTHY

SEMESTER – VII A ASSOCIATE PROFESSOR

ROLL NO. 1097 NUSRL, RANCHI

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Table of Contents

I. Abstract ................................................................................................................................... 3
II. Introduction: .......................................................................................................................... 4
Key provisions of the Indian Patents Act ............................................................................... 5
III. Impact of the Indian Patents Act on Pharmaceutical Innovation ......................................... 6
IV. The WTO and TRIPS Agreement: Implications for India's Patent Regime ......................... 6
1. The TRIPS Agreement and its relevance to India's patent regime ..................................... 6
a. Patent Protection under TRIPS: ...................................................................................... 6
b. Flexibilities and Public Health: ...................................................................................... 7
India's Obligations under the TRIPS Agreement ................................................................... 7
3. The Impact of the TRIPS Agreement on India's Patent Regime ........................................ 8
V. Access to Medicines in India: Current Scenario and Challenges .......................................... 8
1. Overview of the Healthcare System in India ..................................................................... 8
2. Burden of Disease and Access to Essential Medicines ...................................................... 9
3. Challenges to access to affordable medicines in India ..................................................... 10
Implications of India's Patent Regime for Access to Affordable Medicines ........................... 11
Recommendations for Effective Compulsory Licensing: ........................................................ 13
Recommendations for Effective Patent Pools: ........................................................................ 13
Summary of Key Findings ....................................................................................................... 16

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ABSTRACT
The consequences for public health and intellectual property rights are highlighted as this
research investigates the interaction between India's patent system and access to medications.
The report offers a thorough review of the TRIPS Agreement, India's patent system, and the
difficulties in guaranteeing accessible, cheap healthcare. In order to address these issues, it also
examines possible remedies and policy possibilities. The introduction of the article provides a
summary of the historical evolution of India's patent regime, noting significant turning points
and reforms that have influenced the contemporary intellectual property landscape. It then
looks into the provisions of the Indian Patents Act, paying particular attention to Sections 3(d),
84, and 92A and analysing how they affect the requirements for patentability and patient access
to medications. The report analyses India's commitments under the TRIPS Agreement and how
they would affect patent protection and access to pharmaceuticals. It also looks at the effects
of the TRIPS Agreement on India's patent regime. It examines the complex interplay between
intellectual property rights and public health while taking into account the agreement's
flexibility. An extensive examination of the existing situation and difficulties relating to access
to pharmaceuticals in India is a crucial component of the article. It draws attention to the
prevalence of disease, the condition of the healthcare system, and the particular issues
preventing easy access to affordable medications. The report offers a number of policy
suggestions to deal with these difficulties.

This study also advances knowledge of the intricate connection between access to medicines
in India and the country's patent system. It includes legislative suggestions to find a balance
between intellectual property rights and inexpensive access to necessary pharmaceuticals as
well as insights into the effects of patent protection on public health. Policymakers, healthcare
professionals, and stakeholders will benefit from the research's findings as they develop
strategies that prioritise both innovation and public health outcomes.

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 INTRODUCTION:
A key element of maintaining the public's health is ensuring that people have timely,
inexpensive access to necessary pharmaceuticals. Given the numerous healthcare issues and
economic inequities that the nation of India faces, the accessibility and cost of medicines are
key factors in determining the general well-being of its population. The Indian patent system,
which is governed by the Indian Patents Act, significantly affects the availability and cost of
medications, especially those that are life-saving.
This article tries to critically analyse the effects of India's patent regime on the general
public's access to reasonably priced medications. The World Trade Organization's (WTO)
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)1 and the
issue's larger global intellectual property rights framework are both taken into consideration
as it examines the legal, economic, and social aspects of the matter. A thorough structure for
patent protection in India was provided by the Indian Patents Act2, which underwent
considerable revisions in 2005 to comply with TRIPS obligations. But the Act also contained
particular restrictions meant to protect public health and guarantee that everyone has access
to reasonably priced medications. One such clause is Section 3(d)3, which raises the bar
for incremental changes to qualify for patent protection and forbids the issuance of patents
for just altering current medications without demonstrating improved efficacy. Under
specific circumstances, Section 844 of the Act permits the granting of compulsory licences,
enabling the production of generic versions of proprietary medications to meet public health
emergencies and provide access to affordable medications. The export of patented
pharmaceutical items to nations with insufficient manufacturing capacity is also permitted
by Section 92A, improving those nations access to reasonably priced medications.
Although these clauses were designed to strike a compromise between patent holders' rights
and public health concerns, they have been the topic of discussions and objections from a
number of parties. Some contend that the patent system is excessively liberal, which
undermines incentives for pharmaceutical innovation and puts the rights of patent holders in
jeopardy. Others claim that maintaining the current system is necessary to encourage
competition, lower costs, and guarantee that the general public has access to life-saving

1
Malbon, Justin, Charles Lawson, and Mark Davison. The WTO Agreement on Trade-Related Aspects of
Intellectual Property Rights: A Commentary. Edward Elgar Publishing, 2014.
2
Indian Patents Act, No. 39 of 1970.
3
Indian Patents Act, No. 39 of 1970, § 3(d).
4
Indian Patents Act, No. 39 of 1970, § 84.

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pharmaceuticals.

Key provisions of the Indian Patents Act

a. Section 3(d)5
The Indian Patents Act's Section 3(d) made a significant adjustment to the requirements
for patentability. It raises the bar for incremental advances to qualify for patent protection,
especially in the pharmaceutical industry. According to this clause, a novel formulation of a
known material must show improved efficacy over the original formulation in order to be
patentable. This clause tries to stop the patenting of just therapeutically inferior derivatives
or modifications of already approved medications6. Several issues have been raised
regarding Section 3(d), including objections from both domestic and foreign pharmaceutical
firms.

b. Section 84
The Indian Patents Act's Section 84 permits the granting of compulsorily granted licences
under specific situations. It gives the government the authority to approve the manufacturing
of generic versions of medications that are covered by patents without the patent holder's
permission403. This clause is essential for handling public health emergencies, providing
cheap access to medications, and balancing the rights of patent holders with the needs of the
general public. However, there has been debate and ambiguity around the standards and
processes for issuing forced licences.

c. Section 92A7
The export of pharmaceutical items with patents to nations with limited manufacturing
capacity is covered by Section 92A of the Indian Patents Act. It makes it possible to produce
and export generic copies of copyrighted medications to meet those regions' healthcareneeds,
especially when they are dealing with public health issues. This clause
acknowledges the significance of global collaboration in providing access to cheap
medications.

5
Indian Patents Act, No. 39 of 1970, § 3(d).
6
Suresh Koshy, The Effect of TRIPS on Indian Patent Law: A Pharmaceutical Industry Perspective, BUJ Sci. &
Tech. L. 1 (1995): 123.
7
Indian Patents Act, No. 39 of 1970, § 92A.

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 3. IMPACT OF THE INDIAN PATENTS ACT ON PHARMACEUTICAL INNOVATION
Indian pharmaceutical innovation has been significantly impacted by the Indian Patents
Act and its essential clauses. The creation of Section 3(d) has been viewed as an effort to
promote higher standards of invention by preventing the grant of frivolous or insignificant
patents. Instead of depending on little adjustments, this clause has encouraged local
producers to concentrate on research and development for new and more potent medications.
However, there is continuous discussion regarding how the Indian Patents Act will affect
future pharmaceutical innovation. Critics contend that by limiting the extent of patent
protection, the tighter patentability requirements under Section 3(d) may deter innovation.
They contend that the Act ought to find a balance between encouraging access to inexpensive
medications and rewarding innovation8.
Overall, the Indian Patents Act and its major features have been instrumental in reshaping
the country's pharmaceutical industry. It is critical to comprehend the effects of these rules
on drug access, pharmaceutical innovation, and the nation's broader healthcare environment.

IV. THE WTO AND TRIPS AGREEMENT: IMPLICATIONS FOR INDIA'S PATENT
REGIME

1. The TRIPS Agreement and its relevance to India's patent regime

The World Trade Organisation (WTO) is a global organisation that oversees the Agreement
on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It establishes minimal
requirements for intellectual property protection across all WTO members, including
patents, copyrights, trademarks, and trade secrets. The TRIPS Agreement offers a
framework for intellectual property protection and enforcement, making it significantly
relevant to India's patent system. Being a WTO member, India is required to abide by the
TRIPS Agreement's requirements and incorporate them into its national legislation.

a. Patent Protection under TRIPS:

Patentable Subject Matter: The TRIPS Agreement specifies the range of inventions that are
covered by the definition of patentable subject matter. In accordance with TRIPS, India's

8
George T. Haley & Usha C.V. Haley, "The Effects of Patent-Law Changes on Innovation: The Case of India's
Pharmaceutical Industry," 79 Technological Forecasting & Soc. Change 607 (2012).

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patent system provides patent protection to a number of industries, including
biotechnology, pharmaceuticals, and technological advancements.
Patent duration: TRIPS requires that patents have a minimum duration of 20 years beginning
on the filing date. The 20-year patent term in India's patent system complies with this
condition.

b. Flexibilities and Public Health:

Protections for Public Health: The TRIPS Agreement enables nations to include specific
flexibilities to guarantee access to medications and preserve public health. Compulsory
licencing, patent revocation for non-operation, and parallel imports are a few of these
flexibilities.
E.g. 1: Doha Declaration on TRIPS and Public Health: In 2001, the Doha Declaration was
released, affirming that countries should not be prevented by the TRIPS Agreement from
adopting actions to protect the public's health. The rights of WTO members to make
advantage of TRIPS flexibilities, such as mandatory licencing, to advance access to cheap
medicines were made clear.
E.g. 2: Indian Patents Act Amendments: In order to include TRIPS flexibilities, India
amended its Patents Act in 2005. This included enacting laws requiring compulsory
licencing, allowing the government to grant permits for the manufacture of copyrighted
products in generic form under specific conditions, and guaranteeing that everyone could
afford medications.

India's Obligations under the TRIPS Agreement

India's patent system saw considerable changes as a result of its admission to the TRIPS
Agreement. India was required to enact product patents in all areas of technology, including
pharmaceuticals, in order to comply with its TRIPS responsibilities. This signalled a change
from the earlier framework, which mostly issued process patents. India was also required to
implement systems for the protection of intellectual property rights, including patent review
and enforcement procedures, and to grant a minimum 20-year patent term.
The TRIPS Agreement also sets duties in relation to the standards for patentability,
modifications to the length of patent terms, specifications for patent disclosure, and
procedures for patent enforcement. These requirements are meant to strike a compromise
between the needs of the general public, such as access to affordable medications, and the
interests of patent holders.

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3. The Impact of the TRIPS Agreement on India's Patent Regime
The TRIPS Agreement significantly influenced the legal system, laws, and practises
governing patents in India. Changes to the Indian Patents Act, which previously exclusively
permitted process patents in the pharmaceutical industry, were required by the introduction
of product patents for pharmaceuticals under TRIPS. Increased patent protection for
pharmaceutical inventions as a result of the TRIPS Agreement has prompted multinational
pharmaceutical corporations to apply for patent protection in India. In turn, this has sparked
worries about the possibility of rising prescription prices and restricted access to affordable
medications.9
It is crucial to emphasise that the TRIPS Agreement also gives member nations flexibility to
protect the interests of public health. In order to guarantee access to affordable medications,
particularly in situations of national emergencies or public health crises, it permits the use of
mandatory licencing, parallel imports, and other procedures.
India has made use of these flexibilities in its patent system because it values public health.
Aiming to protect public health and advance access to cheap medicines, provisions like
Section 3(d) and Section 84 of the Indian Patents Act might be interpreted as reactions to the
TRIPS Agreement's requirements.
Thus, the TRIPS Agreement was crucial in influencing India's patent system and bringing it
in line with global standards for intellectual property. While the Agreement places duties on
India, it also offers flexibility to safeguard the interests of the public health. In order to
evaluate the balance between intellectual property protection and access to affordable
medications in the nation, it is essential to comprehend the impact of the TRIPS Agreement
on India's patent law.

V. ACCESS TO MEDICINES IN INDIA: CURRENT SCENARIO AND CHALLENGES

1. Overview of the Healthcare System in India
For evaluating the existing situation and difficulties relating to access to drugs, it is essential
to comprehend the Indian healthcare system. India has a diversified healthcare system with
a mix of urban and rural healthcare facilities, public and private healthcare providers, and
government-funded programmes. The public healthcare system, which includes district
hospitals and basic health centres, attempts to offer the general public access to reasonably
priced medical care. However, issues like limited resources, shoddy infrastructure, and

9
Martin J. Adelman & Sonia Baldia, "Prospects and Limits of the Patent Provision in the TRIPS Agreement:
The Case of India," 29 Vand. J. Transnat'l L. 507 (1996).

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geographical inequities continue to limit access to medications.
2. Burden of Disease and Access to Essential Medicines
India has a heavy disease load, including neglected tropical diseases, non-communicable
diseases, and communicable diseases. Effective management and treatment of certain health
issues depend on having access to necessary medications. However, there are still large gaps
in access despite efforts to close them. Due to issues including high prices, weak supply
chains, and restricted access of particular prescriptions, many people, especially those in
lower-income neighbourhoods, have trouble getting necessary medications.
The difficulties in securing timely and cheap access to life-saving pharmaceuticals are
highlighted by a number of examples and scenarios while studying the burden of disease and
availability to necessary medicines in India. Here are a few noteworthy instances:

a. HIV/AIDS Medications: India has a sizable HIV/AIDS problem, and getting access to
antiretroviral medication (ART) is essential for treating the illness. Patented HIV/AIDS
drugs were excessively expensive in the early 2000s, which prevented many patients from
accessing them. A wider range of people now have access to reasonably priced ART thanks
to the development of generic versions through voluntary licencing and domestic production.
This illustration demonstrates how generic medications help increase access to necessary
therapies.

b. Cancer Treatments: In India, cancer is a growing public health issue. Patients who need
many therapies for effective treatment have a substantial hurdle as a result of the high cost
of copyrighted cancer medications. It's important to notice the patent dispute involving the
cancer medicine imatinib. Imatinib's original patent application was denied by the Indian
Patent Office, allowing generic producers to create cost-effective substitutes. This choice
was crucial in guaranteeing access to imatinib, which in turn made other cancer medications
more readily available and more reasonably priced.

c. Tuberculosis (TB) Medications: In India, tuberculosis is still a common infectious disease,

making it essential to ensure access to affordable and efficient TB drugs for the management
and control of the illness. It has been controversial to employ fixed-dose combinations (FDC)
of medications to treat tuberculosis. While some contend that FDCs make treatment plans
simpler and increase adherence, others express concerns about their effectiveness and
potential for overuse. The Indian government has made measures to control the use of FDCs

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and promote the availability of cost-effective, high-quality generic TB drugs.

d. Vaccines: The COVID-19 pandemic made clear how crucial it is to have prompt access to
vaccines. As one of the top vaccine producers in the world, India had to balance meeting
domestic demand with guaranteeing fair access. The importance of striking a balance
between intellectual property rights and the requirement for quick and reasonably priced
vaccine availability was highlighted by the instance of COVID-19 vaccine manufacture and
distribution in India. In order to increase vaccine production and handle access difficulties,
flexibilities like mandatory licencing or technology transfer agreements have been
considered as potential solutions.
These instances highlight the complexity and practical effects of India's high disease load
and limited access to life-saving medications. They emphasise the crucial role that policy
choices, patent laws, generic manufacturing, and international partnerships play in ensuring
that the public has timely and cheap access to life-saving pharmaceuticals.

3. Challenges to access to affordable medicines in India

a. High Drug Prices:
The price of medications in India is a significant access barrier. A sizable portion of the
population cannot afford many necessary medications, especially patented and cutting-edge
ones. Research and development expenses, distribution margins, and markups along the
supply chain are some of the factors that affect medicine prices.10 Furthermore, the issue is
made worse by the absence of effective pricing control measures and the fact that patients
are burdened with a substantial out-of-pocket expense burden.

Cancer drugs: Access to proprietary cancer medications like trastuzumab (used to treat breast
cancer) and imatinib (used to treat leukaemia) has been severely hampered in India due to
their high cost. These medications are frequently too expensive for many patients to afford,
making them unavailable and unaffordable.
Rare disease treatments: The high cost of medications for rare disorders frequently prevents
patients from accessing them. For instance, the majority of patients in India cannot afford
the medication eculizumab, which is used to treat the rare blood condition paroxysmal
nocturnalhemoglobinuria (PNH).

10
Anand Grover & Brian Citro, "India: Access to Affordable Drugs and the Right to Health," 377 Lancet 976,
976-977 (2011).

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b. Limited Access to Generic Medicines:
Despite the fact that India is regarded as the "pharmacy of the developing world" due to
the strength of its generic drug production sector, there are still barriers to acquiring generic
medications there. The efficient use of generic medications is hampered by problems like
poor distribution networks, restricted availability in remote areas, and knowledge gaps
between healthcare professionals and patients. This restricts the cost reductions and
improved access that generic medications may offer in the future.
Pharmaceutical patent disputes: The difficulties in obtaining generic versions of proprietary
medications are highlighted by cases like Novartis vs. Union of India (Glivec case). Patients'
access to treatment was restricted as a result of the imatinib patent battle, which delayed the
release of cost-effective generic substitutes.

IMPLICATIONS OF INDIA'S PATENT REGIME FOR ACCESS TO AFFORDABLE

MEDICINES
The Indian Patents Act, which established India's patent system, has both beneficial and
detrimental effects on people's access to low-cost medications. One the one hand, the
implementation of more stringent patentability requirements, including Section 3(d), has
assisted in preventing the granting of patents for minor changes with minimal therapeutic
effect. This clause has compelled local pharmaceutical firms to concentrate on creating novel
medications with substantial clinical advantages.
However, the patent system has also made access more difficult. Due to the monopoly power
granted by patents, patented medications are frequently more expensive and therefore out of
reach for many patients, particularly those from low-income groups. These elements combined
have an impact on access to vital medications, especially for marginalised groups that are most
vulnerable to high healthcare expenses.

3. Case studies and examples

a. The Glivec Case:
Background: Imatinib mesylate (marketed as Glivec) is a cancer medication for which
Novartis submitted a patent application in India in 1998. The patent application was
nevertheless denied by the Indian Patent Office in 2006 due to a lack of innovation and
inventiveness.

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On access aftermath: Imatinib could now be produced at reasonable prices in India thanks to
the patent application's denial11. Imatinib's cost consequently dropped considerably, making
it more affordable for patients. This instance illustrated how India's patent system helps to
increase access to reasonably priced medications.
b. Compulsory Licensing of Sorafenib:
Background: A mandatory licence to manufacture a generic version of the cancer medication
sorafenib (brand name Nexavar) was given to Indian generic producer Natco Pharma in
2012. Bayer possessed the Sorafenib patent, and the price of the patented medication was
very high.
On access aftermath: The granting of the mandatory licence enabled Natco Pharma to
manufacture and market a less expensive generic form of sorafenib in India. Patients with
kidney and liver cancer who would otherwise have had trouble affording the patented version
now have much easier access to the medication.
c. Anti-Retroviral Therapy (ART) Access:
Background: In order to give patients both domestically and abroad access to inexpensive
ART, India has been a significant producer of generic HIV/AIDS drugs. India's ability
toproduce generic drugs at reasonable prices has been essential in increasing access to these
life-saving drugs.
On access aftermath: Affordable generic HIV/AIDS drugs are now widely accessible in India
and other nations, allowing more people to get ART and receive treatment. This instance
demonstrates how India's patent policy and its capacity for generic manufacture have
improved access to necessary medications for a serious public health issue.
These case studies provide as an example of how India's patent system has affected access
to medications. They show how decisions regarding patents, forced licencing, and generic
manufacturing have been crucial in increasing access, lowering drug costs, and enhancing
patient outcomes. These case studies and examples show how the patent system in India, the
availability of medications, and the state of the public health are all dynamically related.
They emphasise how important it is for laws, regulations, and the patent system's flexibility

11
Ravinder Gabble & Jillian Clare Kohler, "To Patent or Not to Patent? The Case of Novartis' Cancer Drug
Glivec in India," Globalization and Health 10.1 (2014): 1-6.

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to shape access to affordable medications. Policymakers, healthcare professionals, and other
stakeholders can identify areas for improvement and create strategies that strike a balance
between the protection of intellectual property rights and ensuring affordable access to
necessary medications by analysing the effects of India's patent regime on access to medicines.

RECOMMENDATIONS FOR EFFECTIVE COMPULSORY LICENSING:

Supportive International Frameworks: Nations should be encouraged to use compulsory
licencing as necessary through international organisations and agreements. In order to solve
issues with public health, this includes encouraging the use of the flexibility afforded by
international accords, such as the Doha Declaration on TRIPS and Public Health.

- Streamlining the Process: For the purpose of issuing compulsorily issued licences, maintaining
transparency, and reducing delays, governments should develop precise norms and procedures. This
could hasten the release of generic versions of patented medications.

-Balancing Public Health and Innovation: While the goal of compulsory licencing is to
increase access to medications, it should be administered carefully to strike a balance
between promoting innovation and public health needs. The unique circumstances and public
interest at stake should be carefully taken into account.

- Fair Compensation: When a compulsory licence is granted, patent owners should get just
remuneration. The economic worth of the patented invention and the accessibility of the
medication should be taken into consideration when determining what fair royalty rates
are.

b. Enhanced International Collaboration:

Collaboration with Patent Holders: Before using forced licencing, governments and patent
owners should consult one another and look into voluntary licencing arrangements. A
approach that fosters access while upholding intellectual property rights is voluntary
licencing, which can be advantageous to both parties.

RECOMMENDATIONS FOR EFFECTIVE PATENT POOLS:

Broad Participation: Encourage as many relevant patent owners to participate as possible to
guarantee widespread access to critical technology. The potential for innovation and the

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creation of new goods or services increases with the number of patents included in the pool.

Transparent Licensing Terms: To provide fair and equitable access to the pooled patents,
establish explicit and clear licencing terms. This promotes involvement of licensees,
particularly those from developing nations, and helps prevent monopolistic practises while
guaranteeing affordability.

Flexibility and Non-Discrimination: Create the patent pool with flexibility in mind, allowing
for various licence types and fee structures to satisfy the various requirements of licensees.
Non-discrimination provisions must be in place to guarantee that all licensees are treated
equally.

Encouraging Collaboration and Innovation:

Technology Transfer: Encourage technology transfer within patent pools so that licensees
can access the skills, knowledge, and production methods related to the pooled patents. This
promotes regional manufacturing and broadens consumer access to reasonably priced goods.
Research and Development (R&D) Collaboration: In order to boost innovation, meet unmet
medical needs, and advance the creation of new technologies, encourage cooperative R&D
efforts inside patent pools. Sharing best practises and research findings among pool
participants can result in more effective resource use.

Ensuring Public Health and Access:

Addressing Geographic Coverage: Geographic coverage should be given priority in patent
pools, particularly in low- and middle-income nations where access to necessary medical
treatments and technological advancements is frequently constrained. Licence agreements
must take into account the unique requirements and difficulties of each region.
Public Interest Safeguards: Put safeguards in place for public health interests in patent pools.
In the event of excessive pricing or supply shortages, this may include measures for cheap
pricing, technology transfer to local producers, and access to generic competition.
These suggestions emphasise the potential advantages of cooperative licencing agreements
in encouraging access to protected technologies, along with the examples of patent pools.
Patent pools can aid in the creation and accessibility of cost-effective goods and services by
promoting broad involvement, open licencing terms, and collaborative research and

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development.

Voluntary Licensing:
Increased access to medications may be facilitated through voluntary licencing agreements
between patent holders and producers of generic versions. Through these agreements, patent
owners permit generic medicine producers to create and market their patented medications
for less money or with certain restrictions. Promoting voluntary licencing can help remove
access hurdles and promote cooperation between innovators and generic producers,
especially for essential and life-saving pharmaceuticals.

Promoting Competition and Generic Medicines

a. Importance of Competition Laws for Access to Medicines:
By encouraging fair market competition, competition laws play a crucial part in guaranteeing
access to cheap medications. These rules support a competitive market by banning
anticompetitive behaviour, which increases the availability of low-cost generic medications
and encourages innovation in the pharmaceutical industry. In order to balance intellectual
property rights with the need to prevent patents from becoming obstacles to accessing
lifesaving medications and treatments, strong competition regulations are necessary.

b. Cases Highlighting the Need for Strengthened Competition Laws:

The significance of strong competition rules in the context of access to medications is
illustrated through real-world situations. For instance, there have been concerns raised about
restricting access to more cost alternatives in the case of pharmaceutical corporations
participating in pay-for-delay deals, when brand-name medication producers pay generic
manufacturers to postpone the arrival of cheaper generics onto the market. Another example
is situations where pharmaceutical corporations use "evergreening" techniques to delay the
release of generic versions by securing secondary patents for little adjustments to extend
their monopolies.

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 SUMMARY OF KEY FINDINGS
This paper has explored the intricate relationship between India's patent regime, access to
medicines, and intellectual property rights. Key findings from the analysis include:
a. The Indian Patents Act has undergone significant changes, influenced by both domestic
and international factors, such as the TRIPS Agreement.
b. The TRIPS Agreement has shaped India's patent regime, introducing product patents and
imposing obligations for patent protection.
c. India's patent regime has had both positive and negative implications for access to
medicines, with challenges arising from high drug prices, limited access to generic
medicines, and patent evergreening.
d. Case studies and examples have demonstrated the impact of India's patent regime on
access to medicines, highlighting the importance of policy decisions and legal
provisions.

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