Janssen and Grünenthal sue Watson over Nucynta generic

Johnson & Johnson’s pharmaceutical subsidiary Janssen and Germany-based pharmaceutical company Grünenthal have sued Watson Laboratories for infringing patents related to painkiller Nucynta (tapentadol hydrochloride).

Janssen and Grünenthal filed the case at the US District Court for the District of New Jersey on July 23.

They alleged that Watson, a subsidiary of Actavis, infringed US patents RE39,593 and 7,994,364 when it submitted an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration for approval to make and sell a generic version of Nucynta.

Grünenthal holds both patents, which cover both the pharmaceutical compounds and methods of preparing them. Janssen is the exclusive licensee. According to the Orange Book, the ‘364 patent is due to expire in 2025, and the ‘593 patent is due to expire in 2022.

Janssen and Grünenthal asked for judgment that the patents were not proven invalid and unenforceable, and that by filing its ANDA, Watson has infringed the two patents.

They also asked for an injunction stopping Watson from making and selling a generic version of Nucynta.