Compulsory Licensing Of Pharmaceutical Patents In India: A Legal Analysis Of Trips Flexibilities And Public Health
- IJLLR Journal
- 6 days ago
- 1 min read
Arjun C A, LLM IPR, Inter University Centre for IPR Studies, CUSAT
ABSTRACT
This paper examines compulsory licensing of pharmaceutical patents as a key flexibility within patent law, focusing on its role in balancing patent monopoly with public health imperatives. It traces the evolution of compulsory licensing from early international instruments such as the Paris Convention to its structured recognition under the TRIPS Agreement, with particular emphasis on Article 31 and its associated conditions. The study analyses the incorporation of these international obligations into Indian patent law through the Patents Act, 1970, and its subsequent amendments, highlighting Sections 84, 91, 92, and 92A as the principal statutory bases for compulsory licensing. Special attention is given to the pharmaceutical sector, where patent protection directly affects access, affordability, and availability of life-saving medicines, engaging constitutional concerns under the right to health. Through an examination of leading Indian case law, including Bayer Corporation v Union of India, Lee Pharma v AstraZeneca, and BDR Pharmaceuticals v Bristol-Myers Squibb, the paper evaluates how Indian authorities have interpreted grounds such as reasonable requirements of the public, affordable pricing, and working of patents. It concludes that while India’s compulsory licensing framework is robust in principle, procedural complexity, inconsistent application, and limited governmental initiative have constrained its effectiveness in ensuring timely access to essential medicines.
Keywords: Compulsory licensing, pharmaceutical patents, TRIPS Agreement, Patents Act 1970, access to medicines
