US Federal Court Upholds Appeal In Favor Of Regeneron, Sanofi On Praluent

(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) Thursday 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 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).

"We are pleased with today's decision by the Federal Circuit, which affirms our longstanding position that Amgen's patents claiming PCSK9 antibodies purely by their function are overly broad and invalid," said Joseph LaRosa, Executive Vice President, General Counsel and Secretary, Regeneron. "Praluent was developed using Regeneron's proprietary technology, and the Federal Circuit validated that Amgen has no claim to Praluent or its development, helping to provide closure on this matter."

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