Recent Developments in Compulsory Licensing of Pharmaceutical Patents in India

On March 9, 2012, under Section 84(1) of the Indian Patents Act, Controller General of Patents granted country’s first and only compulsory licence to Natco Pharma to sell Bayer AG’s patented oncology drug Nexavar (Sorafenib Tosylate). Since then, India has not issued any other compulsory licence even though two more such applications have been received. India has also implemented a special compulsory licence regime under Section 92A(1), for the manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity to address public health needs. In view of the recent developments, and given the economic consequences of compulsory licensing, it has become important for multinational pharmaceutical companies procuring patents and doing business in India to understand the country’s compulsory licensing laws and reevaluate their business strategies, while domestic companies pursue alternate options to access patented lifesaving medicines within the legal system.