Bayer seeks to block Nexavar generic at Delaware court

Bayer and Onyx Pharmaceuticals have sued generic drug maker Mylan in an attempt to stop it from developing a version of liver cancer drug Nexavar (sorafenib tosylate).

Mylan had sent an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA), asking for approval to make and sell a generic version of the Bayer drug before two patents covering it expire.

The patents in the case are US numbers 8,618,141, titled “aryl ureas with angiogenesis inhibiing activity”, and 8,877,933, called “thermodynamically stable form of a tosylate salt”.

San Francisco-based Onyx is the exclusive licensee of both patents, which are due to expire in 2023 and 2027 respectively.

Mylan notified Bayer in December that it had filed the ANDA.

In the complaint, filed at the US District Court for the District of Delaware on Friday (January 30), Bayer and Onyx asked for a judgment that Mylan would infringe the patents, and an order stating that the effective date of any FDA approval be after the patents expire.

The companies also want a preliminary and permanent injunction stopping Mylan from making and selling its Nexavar generic.

In India, Bayer has unsuccessfully tried to revoke a compulsory licence covering Nexavar. The licence, granted in 2012, allowed local generic drug maker Natco Pharma to make and sell versions of the drug in packets of 120 tablets for 8,880 rupees ($143), rather than the 284,428 rupees Bayer charged (prices based on 2012 market rate).

In the same year the licence was granted, Nexavar generated sales of $1 billion, according to pharmaceutical industry website FiercePharma.