Section 84 of the Indian Patents Act allows for applications for a compulsory license after three years from the date a patent is granted if just one of three conditions is met: 1. The reasonable requirements of the public with respect to the patented invention are not met; or 2. The patented invention is not available to the public at an affordable price; or 3. The patented invention is not “worked” in the territory of India.
In the first case of its kind in India, Bayer v. Natco, the Controller General of India found all three of these criteria were met, and Bayer now must license its patent for cancer drug Nexavar to Natco for 6% of net sales, and Natco is free to manufacture and sell a generic version.