A March decision from the Indian Patent Office has caught the attention of pharmaceutical patent holders around the world. For the first time in India, a generic drug manufacturer has been granted a compulsory license to manufacture and sell a generic version of a patented drug. Though Bayer Corp., the drug’s manufacturer, has appealed, the decision may provide a framework that supports future efforts at compulsory licensing in India and, perhaps, beyond.
Bayer’s patented drug in India
Natco then brought its application for a compulsory license under Section 84 of the applicable Indian Patent Act. Granting a compulsory license under Section 84 for a patented drug was a matter of first impression in India.
Section 84 outlines the circumstances whereby a compulsory license may be granted. Under Section 84, grounds for compulsory license include a patentee’s failure to:
- Worked in India
Section 84 does not define the term “worked in the territory of India.” Bayer contested Natco’s claims that “worked” meant manufacture. Instead, Bayer argued that deletion of the term “manufacture” from another section of the Patent Act meant that the term should not be interpreted to require manufacture of a drug in India.
Construing the language of the Section 84 for the first time, the controller looked at various international treaties before concluding that “worked” does indeed mean manufacture. The controller rejected Bayer’s argument that the term “worked” could include utilizing imported, patented goods within an operating commercial Indian venture.