Amgen Wins Patent Case on PCSK9 Inhibitor

A jury in Delaware yesterday delivered a verdict in favor of Amgen in the trial against Sanofi and Regeneron Pharmaceuticals.

The case involved the validity of Amgen’s 2 patents on evolocumab (Repatha) for antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9).

“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 Chairman and Chief Executive Officer at Amgen, Robert A. Bradway.

Amgen brought the patent infringement action to the Federal Court in Delaware. Before the trial, Sanofi and Regeneron acknowledged the infringement of 7 patent claims for US patent numbers 8,829,165, and 8,859,741.

The jury ruled that the defendants failed to prove the patents were invalid for lack of written description and enablement.

This decision is the first step in the ongoing United States patent infringement litigation, but it does not impact the PCSK9 inhibitor alirocumab (Praluent). In July 2015, Praluent became the first PCSK9 inhibitor approved in the United States.

Unlike current statins that are taken orally and have less costly generic alternatives, PCSK9 inhibitors are self-injected monoclonal antibodies that block the PCSK9 protein from inhibiting removal of LDL from the liver.

Sanofi and Regeneron said they plan to appeal the judgment.

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

In the future, the judge will hold a hearing to consider a permanent injunction.

“This is a complex area of law and science, and we believe the facts and controlling law support our position,” said Senior Vice President, General Counsel and Secretary at Regeneron, Joseph LaRosa. “We look forward to taking our case to the Federal Circuit Court of Appeals, the United States appellate court that hears all biopharmaceutical patent appeals. Praluent was developed with Regeneron’s proprietary science and technology and represents an important medical advance for patients.”