INTELLECTUAL PROPERTY LAW RESEARCH PROJECT

ON
“PERSPECTIVE ON EVERGREENING PATENT”

In Partial Fulfilment of the degree of Bachelors in Law

SUBMITTED BY SUBMITTED TO
MS. LAVANYA
AADVIK SINGH
BHANGRA

ASSISTANT
07051103819 PROFESSOR
 CHAPTER 1- INTRODUCTION

“The history of patents includes a wealth of attempts to reward friends of the government
and restrict or control dangerous technologies.”

— James Boyle

The title for the proposed project is “PERSPECTIVE ON EVERGREENING PATENT”

Intellectual property rights have been a source of discussion and worry around the practice of
patent evergreening, notably within the pharmaceutical sector. When a company uses a
patent evergreening approach, they modify or make modest changes to an existing product in
order to prolong the exclusivity of their patents without necessarily giving significant
therapeutic advantages. This strategy has prompted concerns about how to strike a balance
between encouraging innovation and ensuring that everyone has access to cheap medicines.

The idea of patent evergreening, its ramifications, and the steps taken to remedy this issue
are all examined in this essay. It investigates the possible effects of patent evergreening,
including increased drug costs, lessened market competitiveness, and restricted access to
necessary medications. It also examines the existing legal and regulatory structures.

The paper also analyses the ongoing debates and difficulties regarding patent evergreening,
highlighting the necessity to strike a delicate balance between defending intellectual property
rights and advancing public health. It emphasizes the significance of encouraging innovation
while ensuring people around the world have access to inexpensive life-saving
pharmaceuticals. This paper seeks to further the discussion of intellectual property,
pharmaceutical innovation, and equitable healthcare delivery by critically analyzing the
problem of patent evergreening. For governments, policymakers, and international
organizations to navigate this complicated terrain and develop a balanced strategy that
benefits both innovation and public health, it calls for ongoing investigation, research, and
cooperative efforts.
 REVIEW OF LITERATURE

““The COVID- 19 vaccine patent: A right without rationale ” is a Nabeel Mahdi

Althabwi & Ali Adil Kasheef AL-Gheet article that emphasizes on the extent to which the
waiver application contradicts the theoretical justification of the patent system. It concludes
that the concerns raised over the conflict between the waiver proposal and the patent right
philosophy are indefensible.1
2
“The role of patent waivers and compulsory licensing in facilitating access to COVID-19
vaccines’’: Adigwe OP, Oturu D authored a paper that examined there is a need for
intellectual property rights waiver and compulsory licensing of all novel COVID-19
commodities including vaccines, as this is an important strategy that can improve access to
relevant products in developing countries.

STATEMENT OF PROBLEM

The numerous difficulties that the public face by evergreening of pharmaceutical drugs.

1 Abeel Mahdi Althabwi & Ali Adil Kasheef AL-Ghee t(2020). The covid vaccine patent: A right without rationale, National
Library of Medicine, 28(1), 36-65.

2 Adigwe OP, Oturu D (2022)The role of patent waivers and compulsory licensing in facilitating access to COVID-19
vaccines,National Library of Medicine, 19(1), 24-39.
 HYPOTHESIS

In regard to assuring the protection of intellectual property, taking action to eradicate the
effect of evergreening of pharmaceutical drugs.

RESEARCH QUESTION

The proposed project focuses on the following problems:-

How evergreening affects health? What measures can be taken in order to cope with
the challenges faced by the public at large ?

PLAN OF STUDY

Chapter 2 – The Idea Of Evergreening

Chapter 3 – Potential Advantages & Disadvantages Of Evergreening

Chapter 4 – NG Novartis v. Union Of India Case Analysis

Chapter 5 – Conclusion

OBJECTIVES OF STUDY

● The goal of the proposed project is to understand how evergreening is detrimental

● What measures are taken by legislator to combat the problem of evergreening of
pharmaceutical drugs
CHAPTER 2–THE IDEA OF EVERGREENING
Intellectual property rights are essential for encouraging innovation and safeguarding the
rights of innovators and inventors. Patents, which fall under the category of intellectual
property, provide inventors exclusive ownership over the use, creation, and sale of their
inventions for a set amount of time. Politicians, activists, and healthcare organizations have
all expressed disagreements and worries about the evergreening of patents.In order to reward
pharmaceutical businesses for their creative research and development efforts, the drug patent
system was set up. Patent protection encourages businesses to invest in the pricey and time-
consuming process of finding new treatments and bringing them to market by granting a
monopoly right for a set amount of time. The goal of this system is to progress medical
research and raise the standard of living. However, the idea of "evergreening" has come to be
seen in the pharmaceutical sector as a contentious practice.
Any aspiring inventor is aware of the difficulty in creating something that has never been
seen before. On the other hand, it is a lot simpler to tweak something old and call it fresh.

Evergreening is the term used in the pharmaceutical industry to describe when well-known
corporations patent what they claim are "new inventions" but are really merely minor changes
to existing medications. And some who have investigated the practice claim that it doesn't
really accomplish much to improve people's health.

"Typically, when you evergreen anything, no meaningful therapeutic benefit is expected. You
are examining a company's competitive edge, claims Dr. Joel Lexchin, a professor at York
University in Toronto, Ontario's School of Health Policy and Management. It is the process
of prolonging the life of a patent by securing new patents that protect little modifications or
variants of an already-existing invention. This tactic enables patent holders to keep their
monopoly and stave off competition, potentially preventing consumers from accessing low-
cost generic alternatives and stifling innovation.
Evergreening is a strategy used by pharmaceutical firms to extend the life of their patents by
adding minor changes or enhancements to an already-patentable product or process. The
therapeutic efficacy or value of the original invention may only be slightly increased by these
modifications, which could involve a tiny change in formulation, dosage method, or route of
administration. Evergreening is used to extend the window of market exclusivity and
preserve a competitive edge by limiting generic competition and raising prices.
The phrase "evergreening" is derived from the idea of evergreen trees, which keep their
leaves all year long, signifying the ongoing extension of patent protection. It is frequently
faulted for stifling innovation, restricting access to affordable medications, and erecting
obstacles to competition.Pharmaceutical corporations can easily extend their monopoly and
exclusivity by securing additional patents for minor tweaks or alterations of existing
products, which prevents the entry of generic alternatives into the market. Particularly in
relation to healthcare access, affordability, and the harmony between intellectual property
rights and public health concerns, this practice has been the focus of discussion and close
examination.The goal of regulatory frameworks, such as patent laws and regulations, is to
find a balance between fostering public access to necessary medicines and stimulating
innovation. However, by utilizing loopholes and prolonging the monopoly term past what is
required for fostering true innovation, evergreening undermines the purpose of these
frameworks.
Stricter patentability requirements, such as the need to show appreciable advances in efficacy
or therapeutic advantages, are one measure used to address evergreening. These rules are
intended to prevent the issuance of patents for trivial changes and promote genuine
innovation that benefits patients and society at large.
Overall, evergreening is a contentious technique that poses critical issues about the harmony
between patent rights, medical access, and healthcare affordability. Policymakers, healthcare
providers, and advocates who fight to guarantee equal access to necessary pharmaceuticals
continue to discuss and examine it.

.
CHAPTER 3- Some potential advantages & disadvantages of evergreening
patents include the following:

1.1 Potential advantages of evergreening

Patents with a longer life span: Evergreening patents give businesses the option to keep their
patents active after their initial expiration date. For corporations and inventors who have
spent a lot of time, money, and resources developing their discoveries, this may be
advantageous. They can continue to benefit solely from their discoveries and more fully
recover their investment in research and development by prolonging the term of their patents.

Maintain market dominance: By using evergreening, businesses can safeguard their market
share and competitive advantage. Companies can keep one step ahead of rivals and prevent
new entrants from duplicating their inventions by constantly enhancing and expanding their
patented products or technologies.
Added legal defense: Evergreening may give innovators and patent owners greater legal
defense. Due to the lengthened window of potential infringement, extended patent life may
result in higher damages in infringement cases. Additionally, since a corporation has more
protection and exclusivity over its patented technology or product, evergreening might help
them in licensing discussions.
Evergreening patents can encourage businesses to continue making investments in R&D,
which will foster innovation. Companies are more willing to invest in innovation and work to
improve their existing ideas when they are aware that they can extend their patent protection
through minor adjustments or alterations. This need for constant improvement may result in
technology innovations, product improvements, and better consumer solutions.Evergreening,
the practice of extending the life of patents, can help to increase employment and the
economy. Long-term patent protection allows businesses to continue operating or grow,
which can increase employment prospects and boost the economy. Local economies and
communities may benefit from this.

These are just a few possible advantages of evergreening patents, but it's also vital to think
about their potential disadvantages and restrictions. Evergreening, according to its detractors,
might limit access to affordable alternatives, discourage competition, and prevent others from
improving on previously developed technologies. In order to create effective intellectual
property policies that support both innovation and the general welfare, the advantages and
disadvantages must be balanced.For a number of reasons, the Indian judiciary opposes
patents from being renewed indefinitely. In the first place, it aids in preventing
pharmaceutical companies from abusing patent rules to prolong their monopoly over a drug
without offering any significant innovation or improvement. The judiciary guarantees that
genuine inventions are rewarded by forbidding the issue of patents for minor adjustments,
while avoiding the grant of patents for mere variations that do not considerably improve the
medicinal efficacy of the drug.
Furthermore, preventing evergreening encourages competition in the pharmaceutical
industry. It hinders the entry of generic medication producers, who can provide more cost
alternatives once the patent expires, when patents are repeatedly extended for small
adjustments.
This competition results in lower prices, greater accessibility to medications, and better
patient affordability. The Indian judiciary favors innovation and encourages pharmaceutical
corporations to make genuine investments in research and development for new and
improved pharmaceuticals by discouraging evergreening. Companies constantly innovate and
create more potent therapies out of a concern of losing their monopoly on the market once the
patent expires. This encourages a climate of true innovation and guarantees that patients have
access to better treatments that actually provide therapeutic advantages.
The Novartis case was crucial in establishing the Indian judiciary's opposition to
"evergreening." In light of the Supreme Court's decision, it is crucial to sustain patent
regulations that strike a balance between encouraging innovation and defending the interests
of public health. It sends a clear message to pharmaceutical companies that little tweaks to
already-approved medications will not result in new patents.

1.2 Drawbacks of Evergreening Patents

Impairs competition and innovation: Evergreening patents can hinder innovation by
barring other businesses from releasing upgraded or alternative iterations of currently
available products. As a result, there is less market competition, which may result in
fewer options for consumers and higher prices.

Extended market monopolies: Businesses can extend their market exclusivity

beyond the original patent term by securing additional patents for minor adjustments.
This may lead to monopolistic behavior, enabling the patent holder to set prices and
restrict access to necessary goods and services.

Access to affordable alternatives is hampered by evergreening, which can

postpone the release of generic or substitute medications on the market. This reduces
the availability of low-cost healthcare solutions. In underdeveloped nations where
access to life-saving pharmaceuticals is crucial, this can have catastrophic
repercussions.
Evergreening patents, which give their owners exclusive rights and allow them to
demand greater prices for their products, might raise healthcare expenses. This may
put a strain on healthcare systems, insurers, and people who can't afford basic medical
care.
Lessens the incentive to invest in new research and development: If businesses can
continuously renew their patent rights through evergreening, there might be less of an
incentive to do so. This may hamper the development of novel therapies and
technology and impede scientific advancement.
Legal hazards and patent tangles: Evergreening can produce intricate patent
landscapes with overlapping patents, resulting in a costly and time-consuming legal
process. Companies may use strategic patenting techniques to grow patent thickets,
making it challenging for rivals to navigate the patent landscape without running the
risk of being caught.
Access to generic medications may be delayed as a result of evergreening; generic
medicines typically cost less than branded ones. Patients who depend on affordable
therapies for chronic diseases may be significantly impacted by this.
In general, the negative effects of evergreening patents include stifling competition,
restricting access to low-cost alternatives, raising healthcare prices, decreasing
incentives for innovation, escalating legal complications, and delaying the availability
of generic medications. The public's interest in promoting cheap access to necessary
medications and encouraging innovation in the pharmaceutical business must be
carefully balanced with the necessity for policymakers and regulatory bodies to
safeguard patents.
CHAPTER 4- Novartis AG V. Union of India

In fact, the Supreme Court of India's decision in the Novartis AG v. Union of India case is
noteworthy and has had a considerable effect on the nation's patent laws, particularly in the
pharmaceutical industry. In this instance, Novartis filed a patent for an altered form of the
cancer medication "Imatinib mesylate," often known as Gleevec.
The interpretation of Section 3(d) of the Indian Patents (Amendment) Act, 2005, which
outlines the requirements for the patentability of medicinal compounds, served as the
foundation for the Supreme Court's conclusion in this case. The court ruled that a new form
of a recognized chemical must have increased therapeutic effectiveness or enhanced efficacy
in order to The court's decision not to give Novartis a patent was noteworthy because it
stressed how crucial it is to stop patent from becoming evergreen. Evergreening is the
practice of obtaining multiple patents for incremental or minor changes to already-existing
goods or substances with the goal of extending monopolistic dominance and patent protection
past the original patent's expiration date.
The Supreme Court upheld the purpose of Section 3(d) to prevent evergreening and advance
access to cheap medications by rejecting Novartis' patent application. The decision has been
hailed as a turning point in the fight to protect the public's health and guarantee that Indian
pharmaceutical patents are only issued in the wake of significant scientific and medical
advancement.India's dedication to striking a balance between intellectual property rights and
public health issues is best demonstrated by the Novartis case. It emphasizes the value of
inexpensive access to important medications and dissuades patents from being granted for
insignificant changes that do not significantly advance therapeutic outcomes.

Overall, the Supreme Court's decision in the Novartis case has influenced Indian patentability
laws, notably those pertaining to the pharmaceutical industry, and it has added to the ongoing
global discussion about how to strike a balance between patent rights and the availability of
inexpensive healthcare.
FACTS
Glivec (commonly known as Gleevec or imatinib mesylate), an anticancer medication. The
reason for the rejection was that the medication's beta crystalline form (imatinib mesylate),
which had previously been patented outside of India, did not show any appreciable variations
in therapeutic efficacy.Imatinib mesylate's beta crystalline salt form, which Novartis created,
was said to represent a substantial advancement over the medication's existing form. The
Indian patent authorities disagreed, nevertheless, and came to the conclusion that the
medicine did not fulfill the requirements for an innovative step.
It is significant to remember that pharmaceutical and agrochemical products were not eligible
for patent protection at the time of the patent application in 1997.Novartis filed two writ
petitions with the Madras High Court in May 2006 following the Madras Patent Office's
rejection of the company's patent application for Glivec. According to one of the petitions,
Section 3(d) of the Indian Patents Act is invalid and unconstitutional since it is arbitrary and
goes against Article 14 of the Indian Constitution. The other petition invoked Article 226 of
the Indian Constitution to contest the Madras Patent Office's ruling.
The Madras High Court, however, rejected Novartis' writ petitions. The court ruled that it
lacked the competence to decide whether domestic law violated international treaties, hence it
was unable to make a determination about the legality of Section 3(d) of the TRIPS
agreement. Along with Novartis, NATCO Pharma Ltd. and the Cancer Patients Aid
Association also filed Special Leave Petitions (SLPs) against the IPAB's decision in favor of
Novartis. All of these SLPs were given permission to appeal by the Supreme Court of India,
which meant that it would evaluate the case on its own and not be constrained by the IPAB's
or the lower court's findings.
The controversy surrounding the Glivec patent application in India has had a considerable
impact on the country's patent laws, access to medications, and understanding of intellectual
property rights. It spurred intense discussion on how to strike a balance between
pharmaceutical companies' interests and the demand for reasonably priced medicines,
particularly in developing nations like India.
JUDGEMENT
According to the Supreme Court, the purpose of Section 3(d) is to prohibit the idea of
"evergreening," therefore an invention will not be granted a patent if it does not pass the
Section 3(d) test.The court continued by saying that this ruling shouldn't be interpreted as
indicating that all incremental inventions (d) are prohibited under Section 3. The Supreme
Court further ruled that patent applicants must demonstrate an improvement in therapeutic
efficacy in animals based on the results of in vivo research.The Supreme Court of India
dismissed Novartis' lawsuit in April 2013 and found that the beta crystalline form of imatinib
mesylate is a distinct formulation of the well-known drug, whose efficacy was well-
established. All other drug-related characteristics, according to the Supreme Court, are
useless in

CHAPTER-5 CONCLUSION
In conclusion, the idea of patent evergreening has been a hotly debated topic in the world of
intellectual property rights, especially in the pharmaceutical business. The term "patent
evergreening" is the technique of prolonging a patent's exclusivity by making modest
adjustments or enhancements to an already-marketable product—without necessarily
providing major therapeutic benefits.

When patent evergreening is used to unreasonably extend market exclusivity and restrict
competition, concerns are raised, even if intellectual property protection is necessary to
promote innovation and support research and development. Critics contend that these actions
may result in higher drug prices, limited access to necessary medications, and impede the
development of generic substitutes.For instance, Section 3(d) of the Indian Patents Act
prohibits the issuance of patents for minor tweaks or adjustments that do not considerably
improve the efficacy of a substance that is already recognized. This clause has been the focus
of discussion and legal challenges, highlighting the fine line that must be drawn between
encouraging innovation and ensuring that everyone has access to reasonably priced
medications.

The problem of patent evergreening is still under consideration and discussion in the world of
intellectual property. It's still difficult and constantly changing to strike the right balance
between defending intellectual property rights and advancing public health.