US Appeals Court overturns Copaxone patent decision

Israel-based generics giant Teva Pharmaceutical Industries ((NYSE: TEVA) said on Friday (July 26) that the US Court of Appeals for the Federal Circuit has affirmed the judgment of the US District Court for the Southern District of New York in the appeal filed by Momenta Pharmaceuticals (Nasdaq: MNTA), Sandoz (the generics unit of Swiss drug major Novartis [NOVN: VX]) and Mylan Laboratories (Nasdaq: MYL) and Indian drugmaker Natco Pharmaceuticals regarding the validity and infringement of four patents for Teva’s relapsing-remitting multiple sclerosis (RRMS) product, Copaxone (glatiramer acetate injection) that expire in May 2014.

The appellate court, however, reversed the trial court and declared other patents expiring in May 2014 and one patent expiring in September 2015 to be invalid. The appellate court specifically ruled that asserted claims of these patents are invalid for being indefinite.

Teva filed suit against Momenta/Sandoz and Mylan/Natco for infringement of multiple patents covering the chemical composition of Copaxone, methods of using the product and processes for manufacturing the product, the latest of which expires on September 1, 2015. Today’s decision maintains exclusivity for Copaxone until May 24, 2014.