Amgen (AMGN) Files Patent Infringement Suit Against Sanofi (SNY), Regeneron (REGN)

October 17, 2014 9:02 AM EDT

Amgen (NASDAQ: AMGN) announced that it filed a lawsuit in the United States (U.S.) District Court of Delaware against Sanofi (NYSE: SNY), Aventisub LLC, formerly doing business as Aventis Pharmaceuticals Inc. (collectively "Sanofi"), and Regeneron Pharmaceuticals, Inc. ("Regeneron")(Nasdaq: REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 ("PCSK9").

By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S.

Amgen previously announced submission of a Biologics License Application to the U.S. Food and Drug Administration for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28, 2014.



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