Patient versus patent: How Indian law enables affordable medicine production without patent law violation

On March 20, 2026, Novo Nordisk’s patent over semaglutide, the active ingredient in Ozempic and Wegovy, expired in India. Within hours, over 40 Indian pharmaceutical companies announced plans to launch generic versions of the blockbuster weight-loss and diabetes drug.

Natco Pharma, the same company at the centre of India’s most celebrated compulsory licensing dispute, announced a price of just ₹1,290 per month. In the United States, where the patent holds until at least 2032, a monthly supply costs close to $936.

This is not a coincidence; it is the design a deliberate, constitutionally grounded, internationally compliant legal architecture that India has built over decades to ensure that patents serve people and not just profits. The Ozempic moment crystallises a truth that Indian patent law has long embodied: exclusivity over a life-altering medicine is not an absolute right. It is a conditional privilege, subject to the demands of public health.

Just months before, the Delhi High Court in F Hoffmann‑La Roche AG & Anr v. Natco Pharma Ltd gave precedence to the rights of patients to access affordable healthcare, over the patent rights of big pharma corporations. The case involved a patent on the drug “Risdiplam” used for treating spinal muscular atrophy, a disease that is both fatal and rare at the same time. The Court held that when a drug is the only one available in India for a rare disease, its availability at an affordable price is a material factor while deciding on interim injunctions.

There has been a continuous war between the right to access affordable healthcare and the rights of big pharma companies over their own inventions through patents. This war is particularly acute and evident in developing countries such as India, where a majority of the population lacks comprehensive health insurance and is heavily dependent on affordable generic medicines. Although the access to affordable healthcare is a cornerstone of social justice, its meaning is defeated when big companies exercise patent rights over inventions that could be life saving for the common man.

Patents incentivise innovation by ensuring financial rewards for research and development. However, they often end up restricting the common man’s access to life saving drugs due to high costs. To counter these issues, India, the “pharmacy of the developing world," has developed a unique legal mechanism that reconciles these competing interests.

In India, the framework to combat this kind of a situation begins in the Constitution itself, wherein under Article 21, the Supreme Court has consistently interpreted it to include the right to health and access medical treatment. It can be reasonably interpreted that denial of essential medicines due to an unaffordable price may result in the denial of right to life contained in Article 21 itself.

India’s historical experience with pharmaceutical patents reinforces this concern. As documented by the the Ayyangar Committee (1959), prior to the enactment of the Patents Act, 1970, a vast majority of pharmaceutical patents were held by foreign entities, most of which were not worked in India. The Committee made suggestions which later took the form of legislation through the Patents Act, 1970.

The foundation for compulsory licensing in India lies in Sections 84 to 92 of the Patents Act, 1970, which was amended in 2005 to comply with the provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Section 84 of the Act allows any interested person to apply for a compulsory licence after three years from the grant of a patent if the reasonable requirements of the public are not satisfied, the patented invention is not available at a reasonably affordable price, or the invention is not worked in India.

In addition, Section 92 allows the Central government to issue compulsory licenses in case of national emergency, extreme urgency, or public non-commercial use, such as during health crises like pandemics. It constitutes the most explicit provision that recognises public interest as an independent ground for denying and overriding patent exclusivity.

Section 92(A) further expands the public interest-oriented approach of compulsory licensing by allowing for the grant of export licenses of patented pharmaceutical products to countries that lack sufficient manufacturing capacity.

Equally critical is Section 3(d), which bars the grant of patents for new forms of known substances unless they demonstrate significantly enhanced efficacy. This provision directly targets “evergreening”, the practice by which pharmaceutical companies file successive minor modifications to extend monopoly protection beyond the original patent term. It is Section 3(d) that has historically prevented “big pharma” from gaming the system in India. It is this provision that now limits Novo Nordisk’s ability to rely on secondary patents to delay generic semaglutide.

Despite a significant history of compulsory licensing, the first and most significant compulsory licence in India was granted much later, in 2012, when Natco Pharma sought permission to manufacture a generic version of Bayer Corporation’s cancer drug Sorafenib Tosylate (Nexavar). Bayer was selling the drug in India at around ₹2,80,000 per month, making it unaffordable for most patients.

The Controller General of Patents, Designs and Trademarks ultimately decided to grant the compulsory license after carefully analysing the ground conditions and realities of a low income country such as India. In light of these factors, Natco was allowed to manufacture and sell its generic version of the drug at ₹8,800 per month, representing an extraordinary price reduction of about 97%, while still compensating Bayer through a 6% royalty on net sales. This case went on to become a global precedent and demonstrated how India’s patent system balances patent protection with public health needs, in line with the international covenants and treaties such as the Doha Declaration on TRIPS and Public Health (2001).

The TRIPS agreement 1995 established minimum standards of intellectual property protection for all World Trade Organization (WTO) member countries, including India. The Doha Declaration (2001) clarified that the TRIPS does not prevent member countries from taking measures to protect public health. The compulsory licensing provisions, as they operate in India, are considered to be within the framework of international law and, therefore, ensure that affordable production of generic medicines does not lead to patent infringement.

Through its compulsory licensing regime, India has set a benchmark for the world in balancing intellectual property rights and right to health for every citizen. India's patent regime has long been criticised by Western pharmaceutical lobbies as being hostile to innovation. The Ozempic moment puts that criticism to rest. Decades of deliberate legislative choices, from Section 3(d)'s bar on evergreening to the Ayyangar Committee's foundational insistence that patents must be worked for the public good, ensured that monopolies could not be stretched indefinitely.

Five major Indian manufacturers are now entering the semaglutide market at a fraction of the originator's price, placing a drug that treats diabetes, obesity and cardiovascular disease within reach of hundreds of millions of Indians who would otherwise never have seen a prescription. As global health challenges continue to evolve, the Indian model offers a blueprint for other developing nations striving to ensure that patents serve people, not profits.

Harsh Seouran is a 3rd Year B.A.LL.B. student at Faculty of Law, Jamia Millia Islamia.