Pre-Launch Injunctions: Reshaping India's Public Health Vs. Patent Debate

Abstract

Abstract

With the intersection of science and human welfare, the conflict between affordable public access to essential medicines and incentives for pharmaceutical innovation becomes evident. This conflict is a defining feature of global health policy, but it is nowhere more pronounced than in India because of its constitutional commitment to the right to health and its status as a global producer of generic and biosimilar drugs. India serves as a pivotal arena where this delicate balance is continually tested and redefined.

In 2026, the Indian government shifted its focus towards ease of doing business and “trust-based regulatory reforms.” There is a need to examine what impact this shift has on the patent system, particularly in reference to the right to health.

A recent judgment from the Delhi High Court in E.R. Squibb & Sons LLC v. Zydus Lifesciences Limited represents the most significant judicial recalibration of India's patent-health balance in a decade (14). It effectively created a new enforcement paradigm that prioritizes patent certainty over immediate generic competition.

This article analyzes the judgment within India’s complex legal and economic framework and examines the structural conflict between economic incentives and constitutional rights. It argues that alternative innovation models may offer a sustainable solution to balance these competing interests.

References

1. Bandhua Mukti Morcha v. Union of India, AIR 1984 SC 802 (Supreme Court of India).


2. State of Punjab v. Mohinder Singh Chawla, (1997) 2 SCC 83 (Supreme Court of India); Consumer Education & Research Centre v. Union of India, (1995) 3 SCC 42 (Supreme Court of India).


3. United Nations. (1966). International Covenant on Economic, Social and Cultural Rights (Adopted December 16, 1966; entered into force January 3, 1976), 993 UNTS 3, Article 12.


4. United Nations. (1966). International Covenant on Economic, Social and Cultural Rights, Article 15(1)(c).


5. United Nations Committee on Economic, Social and Cultural Rights (UNCESCR). (2000). General Comment No. 14: The Right to the Highest Attainable Standard of Health (Article 12). UN Doc E/C.12/2000/4.


6. World Trade Organization. (2001). Declaration on the TRIPS Agreement and Public Health (Doha Declaration). WT/MIN(01)/DEC/2.


7. World Trade Organization. (1994). Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), Article 33; see also Novartis AG v. Union of India, (2013) 6 SCC 1 (Supreme Court of India).


8. Chaudhuri, S. (2005). Termination of mirror-image patents: The case of pharmaceutical evergreening. Journal of Intellectual Property Rights, 10, 8–11.


9. Novartis AG v. Union of India, (2013) 6 SCC 1 (Supreme Court of India); Lee Pharma Ltd. v. AstraZeneca AB, (2015) 64 PTC 421.


10. BDR Pharmaceuticals International Pvt. Ltd. v. Bristol-Myers Squibb Co., (2013) 55 PTC 34.


11. Bayer Corporation v. Union of India, (2014) 214 DLT 496 (Delhi High Court).


12. Bayer Intellectual Property GmbH v. Alembic Pharmaceuticals Ltd., (2017) 71 PTC 513.


13. Sotefin SA v. Indraprastha Cancer Society, (2022) 289 DLT 582.


14. Zydus Lifesciences Ltd. v. E.R. Squibb & Sons LLC, (2026) 326 DLT 178 (Division Bench).


15. Medicines Patent Pool Foundation. (2010). Statutes of the Medicines Patent Pool Foundation. Retrieved February 26, 2026, from https://medicinespatentpool.org/who-we-are/governance


16. World Health Organization. (2026). COVID-19 Technology Access Pool. Retrieved February 21, 2026, from https://www.who.int/initiatives/covid-19-technology-access-pool


17. Love, J., & Hubbard, T. (2007). The big idea: Prizes to stimulate R&D for new medicines. Health Affairs, 26(6), 1510–1520.


18. World Health Assembly. (2019). Improving the transparency of markets for medicines, vaccines, and other health products (WHA Resolution 72.8).


19. Correa, C. M. (2000). Intellectual property rights, the WTO and developing countries: The TRIPS Agreement and policy options. London: Zed Books.


20. World Trade Organization. (2001). Doha Declaration on the TRIPS Agreement and Public Health.


21. United Nations Human Rights Council. (2008). Human rights guidelines for pharmaceutical companies in relation to access to medicines. UN Doc A/63/263.


22. World Trade Organization. (2020). Communication from India and South Africa: Waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19. IP/C/W/669.