Evergreening Wars: How Big Pharma Tries to Extend Patent Life

Introduction: In the pharmaceutical world, patents aim to reward true innovation. A company that creates a new drug receives a limited period of exclusive rights. After that, competition benefits the public and leads to lower prices. However, this balance is often disrupted by a strategy called evergreening. This strategy involves using secondary patents and making small changes to an existing drug to maintain market control for as long as possible. This issue is important because medicines are not just regular commercial products. When patent protection extends beyond reasonable limits, patients may face higher prices, the entry of generics may be delayed, and public health systems may struggle. Meanwhile, pharmaceutical companies contend that they need strong patent protection to recover the high costs of research and development. This blog examines both perspectives, with a special focus on Indian patent law and the legal response to evergreening.

Main legal provisions and issues

The most important Indian law on this issue is Section 3(d) of the Patents Act, 1970. The rule prevents companies from obtaining a new patent for a small change to a known substance unless that change can be shown to be more effective. In other words, it prevents a new patent being granted on a drug 

simply because it has been changed a little bit. The intent of this rule is to curb the practice of evergreening, and to ensure that patents are granted only for real and significant innovations. This issue also ties into the fundamental requirements of patent law, which include novelty, an inventive step, and industrial applicability.

A drug that has been modified may be technically new, but that does not make it patentable. A drug that has been modified may be technically new, but that does not make it patentable.

If the change does not lead to a significant improvement, especially with regard to the therapeutic effect, the patent claim should be refused. The issue also has implications for India’s obligations under the TRIPS Agreement and the public health safeguards available under the Doha Declaration.

Another important legal question is the extent to which the law should allow improvements to pharmaceutical products. Not all follow-on patents are bad; some changes can actually improve the safety, stability or delivery of a drug. The challenge is to distinguish valuable progress from the strategic extension of patent rights.

Main arguments and legal reasoning

Those who support evergreening say that the pharmaceutical industry is risky and costly. Drugs can take years, and huge expense, to develop, and so companies should be able to protect improvements that help them recoup their investments. They also note that some innovations in late-stage development are practical - better formulations, easier dosing or greater patient compliance. In this case, a rigorous approach could discourage investment in worthwhile improvements.

But critics say many of the evergreening tactics are not really about progress, but are about delaying competition. When companies keep filing patents for minor changes, generic medicines are delayed in the market and prices stay high longer than they need to. This can have dire consequences for patients dependent on affordable treatments. So the law should protect real innovation, but not let small tweaks turn into long-term monopolies.

This balance is well reflected in Indian law. Section 3(d) does not bar all incremental innovation. Rather, it necessitates more than a minor change or an enhancement at the surface. The patent applicant must demonstrate improved efficacy. This standard is important because it promotes meaningful pharmaceutical development, not endless legal layers around the same basic medicine.

Relevant case laws and precedents

The most important Indian case is Novartis AG v. Union of India, (2013) 6 SCC 1. In this case Novartis applied for a patent for the beta crystalline form of imatinib mesylate which is used in treatment of cancer. The Supreme Court dismissed this patent application on the ground that the modified form did not meet the requirement of improved efficacy as defined under Section 3(d) of the Indian Patents Act. This ruling was a significant milestone in the debate on evergreening in India.

The importance of the Novartis case is that it clarifies what is meant by “efficacy” in the patent context. The Court noted that simply changing a known substance is not sufficient, it must provide a real therapeutic advantage. The decision has had a far-reaching effect on the examination and interpretation of the pharmaceutical patents in India and continues to guide the patent examiners and courts in the like cases.

The Doha Declaration on TRIPS and Public Health is also very relevant internationally. It acknowledges that intellectual property rules should not be an obstacle to countries taking the necessary measures to protect public health. The TRIPS flexibilities, including compulsory licensing, are based on the premise that patent laws need to be flexible at times in order to serve the public interest, especially where access to essential medicines is at stake.

Industry relevance and practical implications

Evergreening can be a powerful commercial strategy for pharma companies. It helps companies preserve market exclusivity, protect revenue, and limit competition. But for generic drug makers, evergreening can cause significant delays and legal battles that keep them out of the market even as the original patent is about to expire. This often results in prolonged periods of high drug prices.

The impact on patients and health systems is more direct. Delays in generic drug entry often result in higher out-of-pocket costs and limited access to essential treatments. This is especially important in countries like India, where generic medicines are important in public healthcare at affordable prices. The poor legal response to evergreening may not only hurt access to medicines in India, but also for other developing countries reliant on Indian generics.

Evergreening remains a relevant issue in the global policy debate. The COVID-19 pandemic has demonstrated that there are limits to viewing access to medicines, vaccines and medical technologies purely from a commercial perspective. The patent debates are now increasingly framed by a stronger focus on public health and evergreening is a central part of this ongoing debate.

Conclusion

One of the most controversial practices in pharmaceutical patent law, evergreening, is situated at the very nexus between innovation and access. One side of the debate is the argument that companies deserve protection for their investment in research. On the other hand, there is a worry that patent law should not be a way to prolong monopolies with trivial, meaningless alterations.

India’s Section 3(d) and the Novartis judgment give a strong legal answer to this. They allow real innovation while preventing patents from being used to block affordable medicines. That approach is especially important in a country where access to medicines is closely tied to public welfare. The larger lesson is simple: patent law should reward real progress, not endless repackaging of the same invention.

Author :- Auridraa Chatterjee, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.

Endnotes

1. Prachi Gupta, “Ever Greening of Patents of India,” Manupatra, 10 June 2013.
2. World Intellectual Property Organization, World Intellectual Property Indicators 2022 (2022).
3. Roger Collier, “Drug patents: Innovation v. accessibility,” Canadian Medical Association Journal 185, no. 9 (2013).
4. Reed F. Beall et al., “Is patent ‘evergreening’ restricting access to medicine/device combination products?” PLOS ONE 11, no. 2 (2016).
5. Janice M. Mueller, “The Tiger Awakens: The tumultuous transformation of India's patent system and the rise of Indian Pharmaceutical Innovation,” University of Pittsburgh Law Review 68, no. 3 (2007).
6. Ghily Kirshner et al., “The Impact of an ‘Evergreening Strategy’ Nearing Patent Expiration on the Uptake of Biosimilars and Public Healthcare Costs,” Erasmus Universiteit Rotterdam, EsCHER Working Paper No. 2023001/2023 (2023).
7. Ellen ‘t Hoen, Private Patents and Public Health: Changing Intellectual Property Rules for Access to Medicines (Health Action International, 2023).
8. Matthew B. Stanbrook, “Limiting ‘evergreening’ for a Better Balance of Drug Innovation Incentives,” CMAJ 185, no. 11 (2013).
9. Bryan Mercurio, “Resolving the Public Health Crisis in the Developing World: Problems and Barriers of Access to Essential Medicines,” Journal of Human Rights 5, no. 1 (2007).
10. Andrew Hitchings et al., “Making medicines evergreen,” BMJ 345 (2012).
11. Austin Frakt, “How Patent Law Can Block Even Lifesaving Drugs,” The New York Times, 28 September 2015.
12. Novartis AG v. Union of India, (2013) 6 SCC 1.
13. The Patents Act, 1970, s. 3(d).
14. Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), 1994.
15. WTO, Doha Declaration on the TRIPS Agreement and Public Health, 2001.