Amgen Wins Patent Lawsuit vs. Sanofi, Regeneron

March 16, 2016

Amgen announced that a Delaware jury ruled in Amgen's favor in a trial on the validity of two Amgen patents that describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9).

Amgen brought the patent infringement action in Federal Court in Delaware against defendants Sanofi and Regeneron Pharmaceuticals. Before the trial, Sanofi and Regeneron acknowledged infringement of seven patent claims in U.S. Patent Numbers 8,829,165, and 8,859,741, according to a press release. The trial proceeded on defendants' challenges to the validity of those seven claims. The jury found that defendants had failed to prove the patents invalid for lack of written description and enablement.

"We are thankful that the jury weighed the evidence carefully and recognized the validity of Amgen's patents on Repatha, our innovative biologic molecule that reduces LDL cholesterol," said Robert A. Bradway, chairman and CEO at Amgen.

Regeneron Pharmaceuticals and Sanofi strongly disagree with the U.S. District Court jury verdict and said in a statement that they believe the Amgen patent claims are invalid in the ongoing U.S. patent infringement lawsuit and plan to appeal the judgment. This decision is the first step in this ongoing litigation and does not impact Praluent® (alirocumab) Injection or the ability to deliver it to physicians and patients at this time.

"It has always been and remains our position that Amgen's asserted patent claims in this matter are invalid," said Karen Linehan, Executive Vice President and General Counsel, Sanofi.

Next steps on damages are to be determined. The judge will hold a hearing to consider a permanent injunction in the near future.