India’s first compulsory license, granted for Bayer’s Nexavar, is deeply criticized by US House of Representatives and USPTO. The compulsory license was granted to Natco in March and the decision has already been appealed by Bayer.
US has expressed its disapproval on the grant of this compulsory license by threatening to elevate the case to WTO’s dispute settlement panel. It is speculated that by granting this compulsory license in a situation where there has not been a national emergency, India may not be honouring International patent law standards.
Well, through these allegations is US suggesting that a compulsory license may be granted only in case of national emergency and that national emergency is one of the prerequisites for the grant of compulsory license? At present, the Indian patent system does not include national emergency as a prerequisite to the grant of compulsory license. Rather, the Indian system provides that the compulsory license may immediately granted, overlooking the requirements and procedural aspects (under section 92(3)), in cases of national emergency. It also provides that the consideration to be made under section 84 (6)(iv) by the patent office for granting a compulsory license may be overlooked in case of national emergencies.
It would be interesting to see how this case develops once it reaches the WTO, if at all it does.