APP Pharmaceuticals Settles With The Medicines Company on Angiomax(R) (Bivalirudin) Patent Litigation

APP Pharmaceuticals, Inc., a Fresenius Kabi Company, announced today that it has settled its litigation with The Medicines Company relating to APP's Abbreviated New Drug Application for a generic version of the anti-clotting drug Angiomax(R) (bivalirudin for injection).Under the settlement, The Medicines Company has licensed APP to begin selling APP's generic version of Angiomax in the U.S. on May 1, 2019. Furthermore, in certain limited circumstances, The Medicines Company's license to APP would become effective prior to May 1, 2019, and may include the right to market an authorized generic bivalirudin product supplied by The Medicines Company.Additionally, APP entered into an agreement for the manufacture and supply of Angiomax(R) finished product to The Medicines Company. The agreements are subject to review by the Federal Trade Commission and the U.S. Department of Justice.In 2007, APP filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration to manufacture and market a generic version of Angiomax(R). In 2009, APP amended that filing to include Paragraph IV certifications with respect to two Medicines Company patents that were filed in 2009 and issued in 2010 and are listed in the Orange Book in connection with Angiomax(R). In response to these filings, The Medicines Company filed lawsuits against APP alleging that the proposed product would infringe those patents, which expire July 27, 2028. As part of the settlement with The Medicines Company, APP admits that the two patents asserted in the lawsuits are valid and enforceable against, and would be infringed by, APP's proposed generic bivalirudin product. The settlement also includes APP's agreement to dismiss its appeal of the August 2010 Federal District court decision holding that The Medicine Companies' application for Hatch Waxman patent term extension of the Angiomax composition of matter patent was timely filed.