Contextualizing Patent Linkages in the Indian Pharmaceutical Sector: Lessons from the Bayer Corporation Case
Dr. V.K. Unni, Assistant Professor, Indian Institute of Management, Kolkata
Patent linkage, which refers to the practice of linking the marketing approval for any regulatory approval for a generic drug to the status of a patent which might be covering that product, is a controversial issue all over the world. Those who argue for patent linkage in India and elsewhere have the firm opinion that a robust patent protection needs the linkage of a state's drug regulatory regime with its patent regime. However, with respect to India, linking its separate and independent drug regulatory and patent regimes might eliminate the flexibilities for research and experimentation protected under TRIPS Article 30 and § 107A of India's Patents Act. The Delhi High Court had to deal with the patent linkage question in Bayer Corporation v. Union of India during the year 2010. This talk will give a brief analysis of the global regulatory regime dealing with patent linkages and highlights the Indian scenario along with its implications.