Amgen secures patent win in Repatha case

Amgen secured victory yesterday as a US federal judge refused to throw out a ruling upholding the validity of two patents owned by the company.

In October 2014, Amgen filed a patent infringement lawsuit against Sanofi and Regeneron Pharmaceuticals at the US District Court for the District of Delaware.

Amgen accused the companies of infringing patents covering the drug Repatha (evolocumab), a monoclonal antibody that targets antibody proprotein convertase subtilisin kexin type 9 (PCSK9), preventing PCSK9 from engaging low density lipoprotein receptor protein.

This ultimately lowers the levels of low density lipoprotein (LDL) in the blood.

Amgen had sought to stop Sanofi and Regeneron from selling Praluent (alirocumab), a monoclonal antibody that reduces LDL cholesterol levels in the blood. Amgen argued the drug had infringed the patents.

In February last year, the court entered a stipulated order finding that Praluent infringed claims 2, 7, 9, 15, 19 and 29 of US patent number 8,829,165 and claim 7 of patent number 8,859,741. The following month, a jury returned a verdict finding the asserted claims of the patents-in-suit valid.

Sanofi and Regeneron then presented motions for a new trial and judgment as a matter of law. But US District Judge Sue Robinson refused the motion yesterday, January 3.

“On the record at bar, plaintiffs’ experts provided more than conclusory testimony in order to explain their respective conclusions to the jury. The jury credited such testimony over that of defendants’ experts,” she said.

Robinson added: “The court declines to re-weigh the evidence or the credibility of the experts. Viewing the record in the light most favourable to plaintiffs, substantial evidence supports the jury’s verdict.”

A spokesperson for Amgen said: "The court's ruling today is an important step in this case and confirms the jury's finding that the patents which protect Repatha are valid and infringed by Sanofi."

A Sanofi and Regeneron spokesperson said: "We are disappointed with the district court’s ruling. It is our longstanding position that Amgen’s asserted patent claims are invalid, and we intend to appeal."