Bayer loses another Nexavar compulsory licence appeal in India

The Mumbai High Court has upheld India-based Natco Pharma’s compulsory licence on Bayer’s kidney cancer drug Nexavar (sorafenib).

It is the second time Bayer has lost an appeal against Natco’s compulsory licence on Nexavar. The compulsory licence allows Natco to make and sell a generic version of Nexavar before Bayer’s patent on the drug expires. So far it is the only compulsory licence to be issued in India.

The Indian Controller of Patents granted Natco the compulsory licence in March 2012, finding that Bayer had not made the drug available at a reasonable price in India.

Bayer charges 280,000 rupees ($4,650) for a month’s supply of Nexavar, while Natco can sell the same number of doses for 8,800 rupees ($146) a month.

Under the licence terms, Natco was required to pay Bayer a six percent royalty.

In September 2012, Bayer sought to have the compulsory licence revoked, but the Indian Intellectual Property Appellate Board (IPAB) rejected its appeal the following March. Bayer appealed to the Mumbai High Court last October.

In a statement, Natco said that it was pleased with the Mumbai High Court’s decision to uphold the IPAB’s decision.

Bayer told LSIPR in a statement: “We are disappointed by the decision of the High Court. We will continue to defend our intellectual property rights and appeal this decision.”

According to FiercePharma, Nexavar generated sales of $1 billion in 2012.