US Federal Circuit Court of Appeals rules in favour of Regeneron + Sanofi in Praluent patent litigation

Regeneron Pharmaceuticals, Inc. announced that the United States Court of Appeals for the Federal Circuit upheld the decision by the U.S. District Court for the District of Delaware that Amgen’s asserted patent claims directed toward PCSK9 (proprotein convertase subtilisin/kexin type 9) antibodies are invalid based on lack of enablement.

The Federal Circuit ruling means that Regeneron and Sanofi have successfully invalidated all five of Amgen’s asserted claims relevant to Praluent (alirocumab).

This decision follows the October 2020 ruling by the European Patent Office’s (EPO) Technical Board of Appeal that also invalidated certain functional claims of Amgen’s European patent directed to PCSK9 antibodies.