US appeals court confirms Amgen's patent claims on PCSK9 antibodies invalid

The US Court of Appeals for the Federal Circuit has upheld the decision by the US District Court for the District of Delaware that Amgen's (Nasdaq: AMGN) 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 Pharmaceuticals (Nasdaq: REGN) and French partner Sanofi (Euronext: SAN) have successfully invalidated all five of Amgen's asserted claims relevant to their cardiovascular drug 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, at 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," he pointed out.