Amgen Wins Jury Verdict in Patent Dispute with Sanofi Over PCSK9 Cholesterol Drug

By Patricia Van Arnum - DCAT Editorial Director

February 28, 2019

Amgen has received a favorable verdict from a jury from a federal district court in Delaware regarding two patents related to its anti-cholesterol drug, Repatha (evolocumab). Amgen has been involved in ongoing litigation with Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York, biopharmaceutical company, which have a competing anti-cholesterol drug, Praluent (alirocumab). Both drugs are PCSK9 (proprotein convertase subtilisin/kexin type 9) antibodies, a new class of anti-cholesterol drugs.

A jury verdict from the US District Court for the District of Delaware upheld the validity of two Amgen patents related to PCSK9 antibodies. These patents describe and claim antibodies, such as Amgen's Repatha (evolocumab), which bind to a specific region on PCSK9 and reduce low-density lipoprotein cholesterol (LDL-C levels) in the body. This verdict follows a previous trial in March 2016, where a prior jury also upheld the validity of Amgen's patents, according to information from Amgen. That prior jury decision was partially reversed on appeal, and the case was remanded to the district court for a new trial on two validity issues. Now, in this recent verdict, the jury found that the Amgen patents meet the legal requirements of written description and enablement, according to information from Amgen.

“We are disappointed in today’s verdict,” said Karen Linehan, Executive Vice President and General Counsel, Sanofi,’ in a February 25, 2019 company statement. “It is our longstanding belief that all of Amgen’s asserted US patent claims are invalid and we believe the law and the facts support our positions.”

The jury upheld the validity of three of the five asserted claims of the two Amgen US patents covering antibodies targeting PCSK9, but “[t]he jury agreed with Sanofi and Regeneron for two of the five asserted claims, finding they were invalid based on lack of written description,” said Sanofi in its statement. It added that the verdict does not impact US physicians’ and patients’ access to Praluent (alirocumab).

Sanofi and Regeneron said that they intend to file post-trial motions with the district court over the next few months, seeking to overturn the jury verdict and also to request a new trial. The companies also said that, if necessary, that they plan to appeal to the Court of Appeals for the Federal Circuit. The companies report that the district court dismissed Amgen’s claim for willful infringement in a ruling on February 8, 2019.

The jury verdict from the federal district court in Delaware follows recent decisions in the European Patent Office and the Japanese Patent Office, which Amgen says also rejected challenges to the validity of Amgen's PCSK9 antibody patents brought by Sanofi, Regeneron, and other potential competitors. Amgen said it is seeking to enforce these patents in the national courts in Europe and Japan against Sanofi and Regeneron.

Source: Amgen and Regeneron