A Review on Evolution and Challenges of Pharmaceutical Patent Protection in India

Review Article

Abstract

The Indian pharmaceutical patent system has undergone substantial changes through amendments to the Patents Act of 1970, particularly with the 2005 TRIPS compliance modifications. The system's cornerstone, Section 3(d), prevents patent extensions through minor molecular modifications unless significant therapeutic benefits are demonstrated. This provision gained global attention during the Novartis Glivec patent dispute, establishing India's firm stance on patentability criteria. India maintains specific safeguards within its patent framework, including a dual-opposition system and compulsory licensing provisions, which have proven crucial in maintaining medicine affordability. The Bayer-Natco case involving the cancer drug Nexavar highlighted the practical application of compulsory licensing to address public health needs. Patent office modernization efforts have targeted prolonged examination timelines and application backlogs, though administrative challenges persist. While multinational pharmaceutical companies express concerns about innovation protection, India's approach has enabled a robust generic drug industry that supplies affordable medicines globally. The patent system continues to evolve, balancing domestic healthcare requirements with international patent obligations. Recent technological upgrades in patent offices and refined examination guidelines demonstrate India's commitment to efficient patent administration while maintaining its public health priorities.