Fresenius SE, Medicines Co. cardiovascular news
The Medicines Co. and Fresenius' APP Pharmaceuticals Inc. generics unit resolved patent litigation related to Angiomax bivalirudin from Medicines Co. Under the settlement, APP admits that U.S. Patent Nos. 7,582,727 and 7,598,343 owned by Medicines Co. covering the small molecule direct thrombin inhibitor are valid and enforceable, and would be infringed by APP's proposed generic. The patents expire on July 27, 2028, but Medicines Co. granted APP a non-exclusive license to launch a generic in the U.S. by May 1, 2019. Additionally, Medicines Co. will supply the bivalirudin active pharmaceutical ingredient to APP, which will pay Medicines Co. royalties. The settlement resolves a 2009 suit filed in the U.S. District Court for the District of Delaware (see BioCentury, Oct. 19, 2009).
The settlement also includes APP's agreement to dismiss an appeal before the U.S. Court of Appeals for the Federal Circuit of the August 2010 federal district court decision that Medicine Co.'s application for Hatch-Waxman patent term extension of the Angiomax composition of matter patent, U.S. No. 5,196,404, was timely filed (see BioCentury, Sept. 13, 2010). ...