EVERGREENING OF PHARMACEUTICAL PATENTS IN INDIA: A LEGAL ANALYSIS UNDER THE INDIAN PATENT ACT IN THE LIGHT OF TRIPS AGREEMENT
AUTHOR – SEKAR V, LL.M. STUDENT AT AMITY LAW SCHOOL, AMITY UNIVERSITY UTTAR PRADESH (AUUP) NOIDA
BEST CITATION – SEKAR V, EVERGREENING OF PHARMACEUTICAL PATENTS IN INDIA: A LEGAL ANALYSIS UNDER THE INDIAN PATENT ACT IN THE LIGHT OF TRIPS AGREEMENT, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 6 (5) OF 2026, PG. 81-89, APIS – 3920 – 0001 & ISSN – 2583-2344. DOI – https://doi.org/10.65393/V6I511
ABSTRACT
The concept of evergreening in pharmaceutical patents has emerged as a critical issue at the intersection of intellectual property law and public health in India. Evergreening refers to the strategic practice by pharmaceutical companies of obtaining multiple patents on minor modifications of existing drugs, thereby extending their market exclusivity beyond the original patent term. This study undertakes a comprehensive legal analysis of evergreening within the framework of the Indian Patents Act, 1970, particularly focusing on Section 3(d), and examines its compatibility with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
India has adopted a cautious and public health-oriented approach to patent protection, aiming to balance innovation incentives with access to affordable medicines. Section 3(d) serves as a key safeguard by denying patents to new forms of known substances unless they demonstrate enhanced therapeutic efficacy. This provision has been instrumental in preventing the misuse of patent rights through incremental innovations that lack substantial clinical benefit. The landmark judgment in Novartis AG v. Union of India is analyzed to understand the judicial interpretation of Section 3(d) and its role in curbing evergreening practices.
The research further evaluates whether India’s patent regime aligns with its international obligations under TRIPS, which mandates minimum standards of patent protection while allowing member states certain flexibilities. It argues that India has effectively utilized these flexibilities to design a patent system that prioritizes public health without violating TRIPS norms. The study also highlights ongoing debates surrounding the tension between pharmaceutical innovation and accessibility, especially in developing countries.
By critically examining statutory provisions, judicial precedents, and international frameworks, this paper concludes that India’s legal stance on evergreening represents a balanced and pragmatic model. It not only discourages trivial patent extensions but also ensures that genuine innovations are rewarded. The analysis underscores the importance of maintaining this equilibrium to promote both technological advancement and equitable healthcare access in the evolving global patent landscape.Top of Form