Judge Sides With Teva and Strikes Down Actavis’s Atelvia Patents

A federal judge has sided with a Paragraph IV ANDA from Teva and struck down the patents protecting Actavis subsidiary Warner Chilcott’s postmenopausal osteoporosis drug Atelvia.

The New Jersey district court judge ruled in a patent infringement lawsuit filed against Teva that claims on Atelvia’s (risedronate sodium) ‘459 and ‘460 patents were invalid because they would have been obvious for other drugmakers to try. Challenges on the drug’s third patent, the ‘989, had already been dismissed, according to the ruling.

Actavis said it is considering its options for appeal. The drugmaker bought Warner Chilcott in 2013.

The Hatch-Waxman challenge, Warner Chilcott Company, LLC et al v. Teva Pharmaceuticals, is one of several launched against Atelvia, according to an Actavis SEC filing.

Last June, Warner Chilcott settled challenges from Ranbaxy, Amneal and Impax in deals that allowed for generic entry in 2025, several years before the last of Atelvia’s patent protection runs out in 2028, according to the Orange Book. Teva’s successful bid could potentially move up generic entry from the other firms if their infringement settlements included provisions permitting marketing if another firm does so first.

Teva did not respond to a query asking whether it would launch at risk. — Bryan Koenig