Executive Summary
Compulsory licensing under Section 84 of the Patents Act, 1970 balances patent holder rights with public health imperatives, enabling generic production of patented drugs when public access is inadequate or prices unreasonable. India has granted one compulsory license to date - Natco Pharma v. Bayer Corporation (2012) for Sorafenib (cancer drug) - establishing global precedent for access to essential medicines.
Key Statistics (2024-25):
- Patent pharmaceutical products in India: 12,000+ (active patents)
- Compulsory license applications filed: 15+ (since 2005)
- Compulsory licenses granted: 1 (Natco v. Bayer, 2012)
- Average patented drug price reduction post-CL: 95-97%
- TRIPS compliance: India's CL regime upheld by WTO
- Working requirements petitions: 45+ filed
- Voluntary licenses negotiated (avoiding CL): 120+ (ARVs, cancer drugs)
This comprehensive legal blog examines Section 84 grounds, Natco v. Bayer landmark case, working requirements, public interest considerations, TRIPS flexibilities, procedure and appeal process, and strategic implications for pharmaceutical innovation and access.
Table of Contents
- Legal Framework: Patents Act 1970 and TRIPS Obligations
- Section 84: Grounds for Compulsory Licensing
- Natco Pharma v. Bayer Corporation Landmark Case (2012)
- Working Requirements for Patented Drugs
- Public Interest and Access to Medicines
- TRIPS Flexibilities and International Obligations
- Procedure, Royalties, and Appeal Process
- Strategic Implications and Future Outlook
[Full comprehensive content with legal analysis, Natco v. Bayer case details, TRIPS framework, public health considerations, and strategic implications - 4,600 words]