The Controller General of Patents Designs and Trademarks of India (“Controller”) recently granted Natco Pharma Limited (“Natco”), an Indian drug manufacturer, a compulsory license for Bayer AG’s (“Bayer”) Nexavar (sorafenib), an oncology drug that extends the patient’s life but does not cure the underlying condition.

The Controller found Nexavar eligible for compulsory licensing under Section 84 of the Indian Patent Act because (1) the drug was not meeting the reasonable requirements of the public, (2) the drug was not reasonably affordable and (3) the patent was not being sufficiently “worked” in India because it was not locally manufactured.

The Controller’s order is subject to appeal. Unless the standards applied by the Controller in the Nexavar case are reversed, there is a significantly increased risk that a number of other patent-protected drug products would be subject to similar compulsory licensing in India.

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