Benzinga | Feb 11, 2021 05:07PM EST

US Federal Circuit Court Of Appeals Rules In Favor Of Regeneron And Sanofi In Praluent Patent Litigation; Court Upheld Decision That Amgen's Asserted Patent Claims Toward PCSK9 Are Invalid

Upholds decision by U.S. District Court to invalidate Amgen's patent claims directed to PCSK9 antibodies

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today 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(r) (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 (EPO) Technical Board of Appeal that also invalidated certain functional claims of Amgen's European patent directed to PCSK9 antibodies.

Regeneron has sole rights for Praluent inside the U.S. and Sanofi possesses sole rights for Praluent outside the U.S. Each party is solely responsible for funding development and commercialization expenses in their respective territories.