UCB challenges Teva generic drug application

Belgian pharmaceutical company UCB SA has sued drug-maker Teva Pharmaceutical Industries to stop it manufacturing a generic version of epilepsy drug Vimpat.

In May 2013 Teva filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market generic lacosamide tablets.

UCB holds a patent (‘551) that covers uses of Vimpat’s active ingredient lacosamide to be administered as a tablet, an intravenous solution or as an oral solution. In 2004 the US Patent and Trademark Office issued the patent, which is due to expire in March 2022.

In the complaint filed at the US District Court for the District of Delaware on June 28, UCB claimed that by filing an ANDA with a view to market a Vimpat generic before the ‘551 patent expires, Teva was committing an act of infringement.

UCB is seeking a declaration that its patent is valid and enforceable, a permanent injunction keeping Teva from marketing the Vimpat generic, and unspecified damages.

Teva has until July 22 to file a counterclaim, said Jeremy Oczek, partner at Bond Schoeneck & King PLLC, as that date matches 21 days after the case was served – the maximum time period for responding.

“At that time, as with all of these cases [prompted by ANDAs], I would expect a counterclaim,” he added.

He continued: “When a company files the ANDA with the FDA, it has to say whether it’s contesting either the invalidity of the patent or whether it thinks it does not infringe,” he said.

“Teva said both – that the patent is invalid and/or it does not infringe.”