- with Inhouse Counsel
Introduction
A disease is not capable of discrimination, however, access to treatment often does discriminate.
Around the world, there are millions stuck in a cycle of poverty, leading to poor nutrition and health, life-long. Just like limited access to food and nutrition, this section of the society has limited to absolutely no access to medical needs or affordable medication. Around the same world, are global pharmaceutical giants, spending large amount of time, effort and money in research and development of new and specialized pharmaceutical products. It is important to understand the interests of these pharmaceutical players and life sciences companies; however, balancing these interests against the needs of millions living in poverty remains a significant challenge. Innovation and access to medicines is therefore, exist in a state of constant tension.
The patent system in India tries to maintain this balance by having patent rules and safeguards that also simultaneously protect public interest. Tools such as compulsory licensing and restrictions on patent evergreening are some of such safeguards. The aim is to make ensure access to affordable medicines and also at the same time, encourage pharmaceutical companies to engage in Research and Development.
Pharmaceutical Patent Architecture & TRIPS
India, as a founding Member of the World Trade Organization (WTO), became bound by the TRIPS Agreement in 1995. India’s commitments to the TRIPS obligations were complete when product patent protection for pharmaceuticals and agrochemicals was introduced in 2005.
The Indian Patent framework has been created to incentivize pharmaceutical research and development since they undertake high risks to create new formulas and compounds1. Thus, the patent laws indeed focus on providing pharmaceutical companies strong protection of and benefits from their innovations. However, to honour India’s TRIPS obligations, all protections are extended keeping in mind public health and the larger scheme, i.e., access to medication to all. These provisions are popularly named “TRIPS flexibilities” and they are used by different countries to ensure a balance between the right to health and patent rights2.
Compulsory Licensing: Prioritisation of Public Health
The protection of public health is of utmost importance, and compulsory licensing is one of the strongest means to do so. Established via the Doha Declaration, compulsory licensing enables third parties to manufacture and sell a patented product even without taking the consent of the patent holder. Article 31 of the TRIPS Agreement codified this process. In India, this mechanism is governed under Sections 84 to 92 of the Patents Act, 1970. Section 84 of the Act3 states that any person may apply to the Controller of Patents for grant of a compulsory license after three years from the date of grant of the patent, provided atleast one of the following conditions is satisfied:
- public requirements are not met;
- patented product is unaffordable;
- patented invention is not worked in India.
Section 92 of the Act4 on the other hand, permits Central Government to issue compulsory licenses during national emergencies, and Section 1005 allows the Government to use the patented product. India’s first and only compulsory license was granted in 2012. Natco Pharma, an Indian generics manufacturer, filed a compulsory license application for Bayer’s cancer drug. This drug was imported only in small quantities and costed approximately rupees 2.8 lakh per month, a staggering price for most families in India. All three conditions of Section 84 were satisfied, and a compulsory license was issued. The drug was subsequently launched at approximately rupees 8,800 per month. Bayer was compensated through a 6% royalty on the net sales by Natco6. This case shows the application of this provision at the ground level to improve access to life saving medicines.
Critics argue that excessive use of this provision may diminish innovation funds. Furthermore, this provision may lead to detriment in global health as companies would be reluctant to manufacture medications that are most urgently needed by developing countries. However, India’s limited use of this provision reflects a balanced approach. While compulsory licensing limits patent rights after they are granted, an equally pressing question is whether certain patents should be granted at all.
Patent Evergreening: Section 3 (d)
While the growth of innovation must be safeguarded, it is equally important that exploitation does not occur in the name of innovation, as seen in the process of evergreening. Evergreening is the process wherein pharmaceutical companies take undue advantage of the patent system by making minute changes in the drug composition – to further increase the term of the patent and continue making profits from it for a longer period of time.
This act is prohibited by Section 3(d) of the Indian Patents Act 19707. Under Indian law, a new version of an old drug will only be granted a new patent if it shows improved functioning and efficacy8. In the case of Novartis AG v. Union of India9, a patent for the cancer drug “Glivec” was rejected under Section 3 (d) because it failed to show better effectiveness than an earlier drug, interpreting “efficacy” as therapeutic effectiveness. By preventing evergreening, Section 3(d) allows the timely entry of affordable generic medicines into the market.
India as the Pharmacy of the World: Generic Drug Access in India
India, often called the “Pharmacy of the world”, is the largest supplier of generic drugs, supplying about 20% of all generic drugs around the world10. It has emerged as a major manufacturer and supplier of cost-effective drugs and vaccines, including drugs for HIV treatment. In a similar fashion, India emerged as a global supplier during the COVID-19 pandemic11. The expiry of Novo Nordisk’s semaglutide patent in India in 2026 and the consequential entry of more than forty manufacturers in the market is in fact, the latest example of the generic medicines’ machinery at work. Domestically, this system has been strengthened by a nationwide network of Jan Aushadhi Kendras that provide medicines at reduced prices for the common masses12.
Conclusion
The tensions between patent protection and access to healthcare that this article discusses are not system failures. It is this constant struggle of different competing interests that ensures no one interest can dominate over the others. This fine balance is enshrined in India’s patent regime with provisions like compulsory licensing and Section 3(d) discussed above, that protect innovation while ensuring affordable healthcare.
Footnotes
1. Nazila Yousefi, ‘New Product Development in the Pharmaceutical Industry: Evidence from a generic market’ (2017) 16 (2) Iran J Pharm Res < https://pmc.ncbi.nlm.nih.gov/articles/PMC5603895/> accessed 5 June 2026.
2. Montgomery Dunn, ‘TRIPS flexibilities help change policy and practice to increase access to medicines: evidence from 2001 to 2024’ (2026) 11(1) BMJ Global Health < https://gh.bmj.com/content/11/1/e021481> accessed 5 June 2026.
3. The Patents Act 1970, s 84.
4. The Patents Act 1970, s 92.
5. The Patents Act 1970, s 100.
6. Bayer Corporation v Natco Pharma Limited, 2014(60) PTC 277 (BOM).
7. The Patents Act 1970, s 3 (d).
8. Roger Collier, ‘Drug Patents: innovation and accessibility’ (2013) 185 (9) CMAJ< https://pmc.ncbi.nlm.nih.gov/articles/PMC3680578/ > accessed 5 June 2026.
9. Novartis AG v Union of India AIR 2013 SUPREME COURT 1311.
10. Ero Partsakoulaki, ‘India’s drugs industry: how one country took over the global medicine market’ (The Bureau of Investigative Journalism, 16 April 2025) <https://www.thebureauinvestigates.com/stories/2025-04-16/indias-drugs-industry-global-medicine-market> accessed 5 June 2026.
11. How Indian Pharma Manufacturers Ensure Affordable and Accessible Healthcare Worldwide’ ( Genesis Biotec, 6 December 2025) < https://genesisbiotec.in/how-indian-pharma-manufacturers-ensure-affordable-and-accessible-healthcare-worldwide/> accessed 5 June 2026.
12. Deepak Kumar Behera, ‘Medicine affordability and access in India: lessons from generic–branded price variation under the Jan Aushadhi Scheme’ (2025) Front Public Health < https://pmc.ncbi.nlm.nih.gov/articles/PMC12715599/> accessed 5 June 2026.
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