Bayer, Onyx drop Nexavar patent suit

Bayer Healthcare and Amgen subsidiary Onyx Pharmaceuticals have dropped a patent infringement suit against Dr Reddy’s over a planned generic version of cancer treatment Nexavar (sorafenib).

In a joint stipulation of dismissal published Thursday, November 18, both companies requested that all claims and defences against Dr Reddy were to be dismissed with prejudice, with each party bearing their own costs.

Bayer and Onyx filed the lawsuit in July, claiming that Dr Reddy was looking to bring the generic to market before the expiration of US patent 9,737,488 assigned to Bayer Healthcare.

Onyx is an exclusive licensee for the ‘488 patent, according to the original complaint.

The ‘488 patent is titled “Pharmaceutical composition for the treatment of cancer” and has an adjusted expiration date of September 10, 2028.

Dr Reddy had submitted an Abbreviated New Drug Application (ANDA) seeking approval to manufacture and market 200mg tablets of generic sorafenib in May.

The generic manufacturer notified Bayer HealthCare and Bayer HealthCare Pharmaceuticals that it had submitted its ANDA to the US Food and Drug Administration (FDA). According to the complaint, the letter did not contest the infringement of the patent claims.

Both Bayer and Onyx sought a preliminary and permanent injunction barring Dr Reddy from making and selling the generic, as well as a declaratory judgment that the ANDA infringes the ‘488 patent.

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