The Medicines Co settles with APP over Angiomax

24 January 2012

The Medicines Company (Nasdaq: MDCO) says that it has settled the law suits filed by company in the US District Court for the District of Delaware relating to the Abbreviated New Drug Application filed by APP Pharmaceuticals, a unit of Fresenius Kabi, for a generic version of the anticoagulant Angiomax (bivalirudin for injection).

The settlement, also known as a pay-for-delay deal, includes APP's agreement to dismiss its appeal of the August 2010 federal district court decision holding that MDCO's application for Hatch Waxman patent term extension of the Angiomax composition of matter patent, US Patent No 5,196,404, was timely filed. Upon dismissal of the appeal, all pending litigation regarding the Angiomax composition of matter patent will have been resolved.

As part of the deal, APP admits that the two patents asserted in the law suits related to APP's ANDA are valid and enforceable against, and would be infringed by APP's proposed generic bivalirudin product. These patents are listed in the Orange Book and expire on July 27, 2028.

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