Evergreening Of Patents - Bridging The Gap Between Intellectual Property Rights And Healthcare Law

Author: LawSphereX

Category: Intellectual Property

Published: 2026-08-23T19:43:49.275Z

Updated: 2026-08-30T07:11:34.828Z

EVERGREENING OF PATENTS: BRIDGING THE GAP

BETWEEN INTELLECTUAL PROPERTY RIGHTS AND HEALTHCARE LAW Shilpi Bose & Ishan Dhyani, LLM (IPR), University School of Law and Legal Studies, GGSIP University

ABSTRACT

Evergreening of patents is a contentious practice in the pharmaceutical industry which involves the tweaking of existing patents to extend their lifespan. This is achieved through minor modifications of the patented drugs, such as changes in formulation, dosage, or delivery method. Critics argue that evergreening hinders generic drug entry, maintains high prices for the drugs and limits access to affordable medication. This research paper examines India’s patent evergreening laws, analyses legal precedents, statutes, and the broader implications of evergreening.

1 INTRODUCTION

A patent is a time-limited exclusive right granted by the government to an inventor for their creation. The system aims to strike a balance between rewarding innovation and fostering progress by encouraging the sharing of knowledge through disclosure. The temporary monopoly allows the inventor to profit from their invention, providing an incentive to disclose it. This disclosure, in turn, promotes further innovation. Once the patent expires, others are free to use the invention, with the disclosure making it easier to do so. 1 Innovation and progress rely on sharing knowledge to advance research and development. The patent system’s requirement for full disclosure facilitates this. Once a patent expires (typically after 20 years), the invention becomes public property, freely usable without needing additional innovation.

Unfortunately, some try to extend their exclusive rights by patenting minor, 1 Gaurav Dwivedi & Sharanabasava Hallihosur & Latha Rangan, “Evergreening: A deceptive device in patent rights”, 32 Technology in Society 1 (2010). insignificant changes to the original invention. “Evergreening in a general sense refers to the extension of the duration of an existing temporary monopolistic or market dominant position by various means or strategies. ”2 Patent evergreening is when companies, often pharmaceutical ones, use strategies to extend their patent protection and keep exclusive control over their inventions. They do this by making small changes and filing new patents, which can limit access to affordable medicines and undermine the purpose of patent law, which is to encourage innovation while ensuring public access to important products.

3 “Evergreening can then be accomplished by erecting entry barriers of all sorts or delaying entries or weakening competition and/or strengthening own competitive advantages when the dominant position is threatened. ”4 “In the words of Federal Court of Appeal, it is like “adding bells and whistles to the original products”. Evergreening also results from a new use of a known substance. ”5 “Typically evergreening has been practiced in pharmaceutucal industry when an IP-based temporary monopoly is about to expire, and then IP strategies for evergreening of IP as well as other means have been used to evergreen product sales. ”6

2 SECTION 3(d)

THE INDIAN PERSPECTIVE The Patents Act, 1970, is deeply connected to the country’s vision of prioritizing social welfare over corporate interests. The Indian Constitution, particularly Article 47, mandates the government to improve public health7, while Article 12 of the ICESCR also highlights the right to health8. These principles have influenced India’s approach to intellectual property, ensuring that innovation serves public welfare rather than merely reinforcing monopolistic control. Policymakers in India have sought to balance these obligations while fostering innovation and protecting multinational corporations’ legitimate interests. Striking this balance has been particularly critical in the pharmaceutical sector, where patent policies directly impact access to life-saving medicines.

India’s commitment to ensuring affordable healthcare has shaped its 2 Ove Granstrand & Frank Tietze, “IP strategies and policies for and against evergreening”, 1 Centre for Technology Management Working Paper Series 4 (2015).

3 Keshav Mittal & Shrey Shah, Patent Evergreening Laws in India vs USA (2025).

4 Supra note 1.

5 Shanti Kumar & Dr. Nitin Shukla & Tanushree Sangal, Evergreening of Patents and the Indian Patent Law, 2009.

6 Supra note 1.

7 The Constitution of India, art. 47.

8 International Covenant on Economic, Social and Cultural Rights, art. 12.

patent framework, leading to provisions that prevent the exploitation of patent laws at the cost of public health. 9 The Patents Act, 1970, initially allowed only process patents, not product patents, to prevent foreign companies from monopolizing the pharmaceutical market. This strategic move enabled domestic pharmaceutical companies to develop cheaper, generic versions of essential medicines without infringing on foreign patents. 10 As a result, India emerged as the “pharmacy of the world,” supplying affordable medicines to millions across the globe. However, this approach came under pressure when India joined the World Trade Organization and signed the Agreement on Trade-Related Aspects of Intellectual Property Rights Compliance with TRIPS required India to amend its patent laws, culminating in the 2005 removal of the product patent restriction.

While this shift aligned India’s legal framework with global patent standards, it also raised concerns about the potential consequences for drug pricing and access to medicines. To address these concerns, India introduced Section 3(d) of the Patents Act, a provision specifically designed to prevent the practice of evergreening11 - a strategy used by pharmaceutical companies to extend patent monopolies by making minor modifications to existing drugs. Under Section 3(d), new forms of known substances cannot be patented unless they demonstrate a significant improvement in therapeutic efficacy. 12 This requirement ensures that only genuinely innovative drugs receive patent protection, thereby discouraging attempts to artificially extend exclusivity periods on medicines with no substantial enhancement in medical benefit.

Section 3(d) has been instrumental in preserving India’s status as a key supplier of affordable medicines. The landmark Novartis AG v. Union of India13 case in 2013 reaffirmed the significance of this provision when the Supreme Court denied a patent for the cancer drug Glivec, ruling that the modifications made to the drug did not offer significant therapeutic advantages. This decision set a precedent for how Section 3(d) would be interpreted, 9 Dherya Maheswari, “Exploitation Of Patents: A Study Of Evergreening In The Pharmaceutical Domain”, 1 NLUA Journal of Intellectual Property Rights 155 (2022).

10 Ibid.

11 The Patents Act, 1970, s. 3(d).

12 Ibid.

13 (2013) 6 SCC 1.

reinforcing India’s commitment to preventing undue monopolization in the pharmaceutical sector. Despite its importance, Section 3(d) has faced criticism from multinational pharmaceutical companies, which argue that it discourages investment in drug research and development. However, public health advocates view it as a necessary safeguard against excessive patenting, ensuring that innovation benefits society rather than serving solely as a profit-driven mechanism.14 The provision reflects India’s broader commitment to balancing intellectual property rights with public interest, highlighting its unique approach to navigating the complex intersection of patent law, healthcare, and global trade obligations.

3 THE NOVARTIS CASE

A CHECK ON EVERGREENING The Novartis AG v. Union of India15 case was a landmark judgment that solidified India's commitment to preventing evergreening, a practice where pharmaceutical companies make minor modifications to existing drugs to extend their patent monopoly. The case centered on Imatinib Mesylate, a modified version of Imatinib, an anti-cancer drug used to treat chronic myeloid leukemia and other cancers. In 2006, Novartis applied for a patent for Imatinib Mesylate in India. However, the Indian Patent Office rejected the application, citing three key reasons: • Lack of Novelty – The modified drug was already known in scientific literature. • Obviousness – Any skilled expert in the pharmaceutical field could have arrived at the modification.

• Failure to Meet the Enhanced Efficacy Standard – As required under Section 3(d) of the Indian Patents Act, the drug did not demonstrate a significant improvement in therapeutic efficacy over the existing version. Unhappy with this decision, Novartis appealed to the Madras High Court, arguing that Section 3(d) was unconstitutional and violated the Trade-Related Aspects of Intellectual Property Rights Agreement under the World Trade Organization. The company also claimed

14 Preeti Uttam, “Evergreening Of Patents

Revival Of Colonisation And Monopoly” 7 IJAR 747 (2019).

15 Supra note 13.

that Section 3(d) violated Article 1416 of the Indian Constitution, which guarantees equality before the law, arguing that it was vague and discriminatory against pharmaceutical patents. However, in 2007, the Madras High Court upheld the validity of Section 3(d), ruling that the provision was designed to prevent frivolous patents and promote access to affordable medicines. The court clarified that India, as a sovereign nation, had the right to frame patent laws that protected public health and prevented unjustified monopolies. Novartis escalated the case to the Supreme Court of India, which delivered its historic judgment in April, 2013. The Supreme Court reaffirmed the rejection of Novartis’ patent application, ruling that: • The mere modification of an existing drug does not qualify for a patent unless it shows a significant improvement in therapeutic efficacy.

• The efficacy requirement under Section 3(d) applies specifically to therapeutic benefits—enhancements such as better bioavailability, improved stability, or changes in solubility do not suffice. • Patent law should encourage genuine innovations rather than incremental changes aimed at prolonging patent protection. The Court set key principles for assessing pharmaceutical patent claims, including: • A clear distinction between minor modifications and true innovations – Small, obvious tweaks to existing drugs cannot be patented unless they provide real medical benefits. • The requirement of comparative clinical data – Patent applicants must submit evidence proving that the new form of a drug significantly enhances therapeutic efficacy.

• Exclusion of non-therapeutic advantages – Features such as improved stability, solubility, or ease of production do not meet the enhanced efficacy standard. • Incremental inventions must meet both patentability and enhanced efficacy criteria – Even if an invention is novel and non-obvious, it must still clear the additional hurdle of

16 The Constitution of India, art. 14.

Section 3(d). 17 The impact of the Novartis judgment was far-reaching. It reinforced India's role as a global leader in prioritizing public health over excessive intellectual property protections. The ruling was highly praised by public health advocates, NGOs, and generic drug manufacturers, as it ensured that critical medicines would remain affordable and accessible. However, the decision also drew criticism from the United States and the European Union, which expressed concerns that India’s strict patent regime could discourage pharmaceutical investment and innovation. The Pharmaceutical Research and Manufacturers of America (PhRMA) and other industry bodies claimed that the ruling created an uncertain patent environment, making India a less attractive market for new drug development.

18 Despite such criticisms, several countries—including Brazil, China, Thailand, and South Africa—supported India’s position, seeing it as a model for balancing public health and intellectual property rights. Some nations have even considered adopting similar provisions in their own patent laws to curb evergreening and ensure affordable access to medicines. Ultimately, the Novartis case reaffirmed India’s stance that patent law should serve the greater public good. By upholding Section 3(d), the Indian judiciary sent a strong message that monopolistic practices should not hinder access to life-saving medicines, setting a precedent for future patent disputes in the pharmaceutical industry.

4 POST-NOVARTIS

DID PATENT EXPLOITATION STOP?

Despite the landmark ruling, evergreening tactics persist. A study of pharmaceutical patents granted in India from 2009-2016 found that 72% were secondary patents with marginal improvements.19

17 Supra note 9.

18 John R. Thomas, “Patent “Evergreening”

Issues in Innovation and Competition” CRS Report for Congress (2009).

19 Supra note 9.

5. OTHER CASES

Johnson & Johnson’s Bedaquiline Patent Rejected (2023)20 In a significant decision in March 2023, the Indian Patent Office rejected Johnson & Johnson’s attempt to patent a fumarate salt form of Bedaquiline, a drug used to treat multidrug-resistant tuberculosis (MDR-TB). The patent rejection was based on Section 3(d) of The Patents Act, 1970, which restricts the patenting of new forms of known substances unless they show a significant increase in therapeutic efficacy. 21 The Indian Patent Office found that the new form of Bedaquiline did not meet this threshold and therefore could not be granted a patent. In its ruling, the Patent Office emphasized that the modification of the salt form did not provide any substantial therapeutic benefit over the original version of the drug.

This decision reflected India’s commitment to upholding the provisions of the Patents Act, particularly aimed at safeguarding public health by preventing the extension of monopoly rights on medicines unnecessarily. This case law is an important example of how India is enforcing its stance against patent evergreening, particularly in the context of essential medicines that are critical for treating diseases like tuberculosis, which continue to affect millions of people worldwide. • Rejection of Dolutegravir Patent Application (2024)22 In November 2024, the Controller of Patents, Kolkata, another important decision by rejecting a patent application for Dolutegravir, an antiretroviral drug used to treat HIV/AIDS.

This application sought patent protection for a new form of the drug, but the Controller of Patents, Kolkata, found that the new form did not show any enhanced therapeutic efficacy over the existing formulation. This decision, once again, was based on Section 3(d) of The Patents Act, 1970, which is aimed at preventing the patenting of trivial modifications of known substances that do not offer significant benefits. 23

20 Nandita Venkatesan & Phumeza Tisile v. Controller of Patents & Janssen Pharmaceuticals (Pre-grant

Opposition to Patent Application No. 1220/MUMNP/2009).

21 Supra note 11.

22 ViiV Healthcare Ltd. v. The Controller of Patents, 2024, Indian Patent Application No. 2017/018876.

23 Supra note 11.

The rejection of the Dolutegravir patent is notable because it reflects India’s ongoing commitment to ensuring that essential medications, particularly those for chronic conditions like HIV/AIDS, remain affordable and accessible. The decision also reinforces the legal precedent that patent evergreening—where companies seek to extend the exclusivity of a drug through minor tweaks—will not be tolerated if it does not provide clear and meaningful therapeutic advances. This case law is a part of India’s broader strategy of ensuring that patents on life-saving drugs do not create artificial monopolies that could prevent access to affordable medications. By rejecting such patents, India supports the production of generic versions of essential drugs, which helps to lower the cost of treatment for millions of people.

6 PUBLIC INTERESTS V. PRIVATE RIGHTS

STRIKING A BALANCE Balancing patent protection with public health is a complex challenge. Pharmaceutical companies argue that exclusive rights are necessary to recover research and development costs, but this cannot come at the cost of denying access to essential medicines. The Declaration on the TRIPS agreement and public health24 (Doha Declaration on TRIPS and Public Health) reinforced the right of countries to prioritize affordable healthcare over patent rights. It emphasized that intellectual property laws should not prevent access to medicines, reaffirming that public health concerns should take precedence over commercial interests. 25 In response to the growing concern over the misuse of patent laws, regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have taken steps to curb abusive evergreening practices.

These bodies have introduced rules and guidelines designed to ensure that patents are granted only for true innovations and that patent extensions are not based on trivial or minor modifications. The goal of these reforms is to strike a balance between rewarding genuine innovation and preventing the extension of patent exclusivity for the sake of market monopolization. However, critics argue that while these efforts are steps in the right direction, more robust and transparent mechanisms are 24 World Trade Organisation, “Declaration on the TRIPS agreement and public health”, World Trade Organisation, November 20, 2001, available at: (last visited on March 15, 2025).

25 Supra note 18.

needed to prevent evergreening from undermining the accessibility and affordability of medicines. 26 The conflict between private intellectual property rights and public interests is a central issue in patent law, especially in the pharmaceutical sector. On one hand, patent law grants exclusive rights to inventors, incentivizing innovation and protecting their inventions for a set period. On the other hand, these rights must be balanced against the public interest, especially when it comes to life-saving medicines. A patent system that overly favours private interests can lead to exorbitant drug prices and limit access to essential medicines, undermining public health goals. 27 India’s patent law, particularly through provisions like Section 3(d)28, aims to ensure that the public interest takes precedence over the commercial interests of patent holders.

By preventing patent evergreening, India seeks to make essential medicines affordable and accessible to its large population. India's approach highlights the importance of limiting patent protection to true innovations that benefit society, rather than allowing incremental changes to extend monopolies. However, critics argue that too much restriction on patenting could discourage innovation, especially in drug research and development. Pharmaceutical companies often claim that their investments in R&D require strong patent protections to recoup costs and fund future innovations. Yet, the Indian system has maintained a balance by permitting patents for truly innovative drugs while curbing unnecessary extensions that do not contribute significantly to medical progress.

This delicate balance requires continuous scrutiny and adjustment, ensuring that patent laws protect genuine innovation without stifling competition or hindering access to vital medicines. By focusing on the therapeutic efficacy of drugs rather than minor modifications, India’s patent system sets a global precedent for the equitable distribution of intellectual property rights in the pharmaceutical sector. This balance between public welfare and private rights is crucial in

26 Supra note 2.

27 Uttam K. Shukla, “‘Ever Greening’ Patents”, 1 Science Reporter 31 (2011).

28 Supra note 11.

shaping the future of patent law, not only in India but also in other nations seeking to ensure that patent laws serve both innovation and the greater good.29

7. CRITICISMS

Evergreening has faced significant criticism for a range of reasons, primarily for its negative impact on public health and innovation: • Limiting access to affordable medication: One of the most glaring criticisms of evergreening is its role in keeping drug prices prohibitively high. By strategically modifying existing patents or introducing minor changes to a drug's formulation, manufacturers can extend their patent exclusivity, preventing generics from entering the market. This practice delays the availability of more affordable generic alternatives, thus restricting access to essential medicines for patients, especially in low- and middle-income countries where affordability is a significant issue. In some cases, this results in unnecessary financial burdens on healthcare systems and patients who rely on these medications for their treatment.

• Stifling innovation: Critics argue that evergreening encourages pharmaceutical companies to focus on minor, incremental changes rather than pioneering truly novel treatments. Instead of investing in the development of new and groundbreaking medicines, companies may shift their focus toward tweaking existing drugs in ways that may offer little clinical benefit. This can divert critical research and development resources away from innovations that could lead to more effective or life-saving treatments. As a result, the overall pace of medical progress can be slowed, with an overemphasis on maintaining existing market monopolies rather than fostering genuine innovation. 30 • Undermining fair competition: Evergreening can also be seen as a tactic to maintain monopolistic control over drug markets.

When patent extensions are granted on the basis of trivial modifications or slight improvements, they create an artificial barrier to entry for generic drug manufacturers. 31 This stifles healthy market competition, which could otherwise lead to price reductions, improved drug quality, and faster access to important

29 Marta Radelli, “Patent evergreening

technological advancement and abusive commercial practices.

Availability of essential medicine in the case of access to insulin”, 2 QMLJ 66 (2021).

30 Supra note 9.

31 Supra note 1.

medications for consumers. By blocking generics, evergreening can perpetuate a system where the original patent holder maintains exclusive control over a drug for extended periods, preventing a more open and competitive pharmaceutical marketplace. • Global public health implications: In addition to individual markets, the global implications of evergreening are concerning. Many countries with weaker patent systems or enforcement mechanisms suffer from the consequences of delayed generic drug entry. This is particularly impactful in developing nations where access to life-saving treatments for diseases like HIV/AIDS, tuberculosis, and cancer can be hindered. When pharmaceutical companies use evergreening to prolong patent protections, it not only affects patients in high-income countries but also exacerbates health inequities in regions with limited healthcare infrastructure.

In conclusion, the practice of evergreening raises ethical, economic, and public health concerns, with calls for stronger regulatory frameworks to ensure that patent protections serve the public interest rather than primarily benefiting the financial interests of pharmaceutical companies.

8. SUGGESTIONS

To prevent evergreening and promote access to affordable medicines, the following are recommended: • Enhanced Criteria for Novelty and Utility: Patent offices should scrutinize claims more rigorously, ensuring that only substantial innovations, such as entirely new formulations or methods of action, are patentable.32 • Secondary Patents Scrutiny: When a new patent is filed based on a minor modification, such as a new dosage form or a combination of existing drugs, the novelty of the innovation should be carefully assessed to ensure it offers genuine clinical benefits beyond convenience.33

32 Nerella Srinivas, “Patent Evergreening In Pharmaceuticals

Impact And Ethical Considerations”, 14 International Journal of Intellectual Property Rights 33 (2024).

33 Ibid.

Public Health Impact: In cases where a modification does not provide significant clinical improvement, such as in the case of formulation changes that do not improve efficacy, the patent office should consider the potential harm to public health in delaying generic entry and reducing drug affordability. 34 • Compulsory Licensing: Governments should have the ability to issue compulsory licenses in cases of public health emergencies, which would allow for the production of generic versions of patented drugs without the patent holder's consent. This could be especially important during global health crises, such as pandemics, where timely access to medications is crucial.

35 • Faster Approval Pathways for Generics and Biosimilars: Regulatory bodies should streamline the approval process for generics and biosimilars to ensure they enter the market as soon as the original drug's patent expires, preventing patent evergreening from extending drug monopolies. 36 • Patent Opposition Mechanisms: Countries can establish systems where third parties, including generic manufacturers and public health organizations, can formally challenge patents at the time of filing, particularly when those patents are based on minor or noninnovative changes. 37 • Government-Funded R&D: Encouraging the development of affordable medicines through public funding, tax incentives, and partnerships between the government and pharmaceutical companies.

By implementing these measures, countries can ensure that patent laws serve their intended purpose—protecting innovation while safeguarding public health.

9 CONCLUSION

“The judgment in Novartis case38 has largely been welcomed as it has given precedence to accessibility of life saving drugs at affordable cost over monopoly right of patentee. The

34 Ibid.

35 Ibid.

36 Ibid.

37 Ibid.

38 Supra note 13.

Supreme Court has clarified that it must not be construed as a ban on patent protection to all incremental inventions of chemical and pharmaceutical substances.”39 Evergreening strategies undermine the core purpose of patents: fostering genuine innovation. Instead of investing in groundbreaking research, companies exploit legal loopholes to extend monopolies on existing drugs, delaying the entry of affordable generics. A well-functioning patent system should encourage companies to develop new medicines rather than manipulate legal provisions to retain exclusivity. By closing loopholes, governments can ensure that patent rights serve both innovators and the public interest.

39 Dr. Vijay Oak, “Evergreening of Patent”, 1 Bharati Law Review 101 (2014).

REFERENCES

Articles: v Gaurav Dwivedi & Sharanabasava Hallihosur & Latha Rangan, “Evergreening: A deceptive device in patent rights”, 32 Technology in Society 1 (2010). v Ove Granstrand & Frank Tietze, “IP strategies and policies for and against evergreening”, 1 Centre for Technology Management Working Paper Series 4 (2015). v Keshav Mittal & Shrey Shah, Patent Evergreening Laws in India vs USA (2025). v Shanti Kumar & Dr. Nitin Shukla & Tanushree Sangal, Evergreening of Patents and the Indian Patent Law, 2009. v Dherya Maheswari, “Exploitation Of Patents: A Study Of Evergreening In The Pharmaceutical Domain”, 1 NLUA Journal of Intellectual Property Rights 155 (2022). v Preeti Uttam, “Evergreening Of Patents: Revival Of Colonisation And Monopoly” 7

IJAR 747 (2019). v John R. Thomas, “Patent “Evergreening”: Issues in Innovation and Competition” CRS Report for Congress (2009). v John R. Thomas, “Patent “Evergreening”: Issues in Innovation and Competition”, Congressional Research Service (2019). v Uttam K. Shukla, “‘Ever Greening’ Patents”, 1 Science Reporter 31 (2011). v Marta Radelli, “Patent evergreening: technological advancement and abusive commercial practices. Availability of essential medicine in the case of access to insulin”, 2 QMLJ 66 (2021). v Nerella Srinivas, “Patent Evergreening In Pharmaceuticals: Impact And Ethical Considerations”, 14 International Journal of Intellectual Property Rights 33 (2024). v Dr. Vijay Oak, “Evergreening of Patent”, 1 Bharati Law Review 101 (2014).

The Constitution of India, 1950. • Statutes: v The Patents Act, 1970. • International Instruments: v International Covenant on Economic, Social and Cultural Rights, 1966. • Cases: v Novartis AG v. Union of India, (2013) 6 SCC 1. v Nandita Venkatesan & Phumeza Tisile v. Controller of Patents & Janssen Pharmaceuticals (Pre-grant Opposition to Patent Application No.

1220/MUMNP/2009). v ViiV Healthcare Ltd. v. The Controller of Patents, 2024, Indian Patent Application No. 2017/018876. • Websites: v World Trade Organisation, “Declaration on the TRIPS agreement and public health”, World Trade Organisation, November 20, 2001, available at: (last visited on March 15, 2025).