COMPULSORY LICENSING IN INDIA: A CRITICAL ANALYSIS POST–NOVARTIS V. UNION OF INDIA

AUTHOR – SHAMBHAVI SINGH, STUDENT AT AMITY LAW SCHOOL/AMITY UNIVERSITY PATNA,BIHAR

BEST CITATION – SHAMBHAVI SINGH, COMPULSORY LICENSING IN INDIA: A CRITICAL ANALYSIS POST–NOVARTIS V. UNION OF INDIA, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 5 (13) OF 2025, PG. 218-225, APIS – 3920 – 0001 & ISSN – 2583-2344.

ABSTRACT:

This research paper examines the balance between patent protection and public health through the lens of compulsory licensing (CL) under the Indian Patents Act, 1970. It explores how CL serves as a legal mechanism to ensure affordable access to essential medicines while preserving incentives for innovation. The study traces the historical evolution of India’s CL framework, its alignment with international norms under the TRIPS Agreement and the Doha Declaration, and its practical application in landmark cases such as Bayer v. Natco and Novartis v. Union of India. It further analyzes the post-Novartis landscape, highlighting trends, challenges, and India’s cautious yet principled stance amid global trade pressures. The paper concludes with policy recommendations aimed at strengthening transparency, defining affordability standards, and enhancing institutional capacity. Ultimately, it argues that compulsory licensing remains a vital policy tool ensuring that the patent system functions not only to reward innovation but also to uphold the public’s right to health and equitable access to life-saving medicines.

Keywords: compulsory licensing, TRIPS, Patent act, Doha declaration, commercial, Public health, Patents,