Amgen Wins Patent Case for Its Repatha PCSK9 Against Sanofi and Regeneron's Praluent PCSK9

March 16, 2016—Amgen announced that a Delaware jury delivered a verdict in the company’s favor in a trial on the validity of two Amgen patents that describe and claim monoclonal antibodies to the company’s Repatha (evolocumab), which is a proprotein convertase subtilisin/kexin type 9 (PCSK9) biologic molecule that reduces low-density lipoprotein (LDL) cholesterol. Amgen brought the patent infringement action in Federal Court in Delaware against Sanofi and Regeneron Pharmaceuticals, Inc. 

Amgen stated that before the trial, Sanofi and Regeneron acknowledged infringement of seven patent claims in US Patent Numbers 8,829,165, and 8,859,741. The trial proceeded on Sanofi and Regeneron’s challenges to the validity of those seven claims. The jury found that Sanofi and Regeneron had failed to prove the patents invalid for lack of written description and enablement. Before the case went to the jury, the court dismissed Sanofi and Regeneron’s case on obviousness.

In a joint press release from Regeneron and Sanofi, the companies stated that they strongly disagree with a US District Court jury verdict. The companies believe that the Amgen patent claims are invalid and plan to appeal the judgment.

The companies noted that the next steps on damages are to be determined and that the judge will hold a hearing to consider a permanent injunction in the near future. They intend to take their case to the Federal Circuit Court of Appeals, the United States appellate court that hears all biopharmaceutical patent appeals.

Regeneron and Sanofi advised that the decision is the first step in this ongoing litigation and does not impact Praluent (alirocumab) injection or the companies’ ability to deliver it to physicians and patients at this time. 

In August 2015, Amgen announced that the US Food and Drug Administration approved the company’s Repatha injection to lower LDL cholesterol. 

In July 2015, Regeneron and Sanofi announced that Praluent was approved for use in the United States. It is indicated for use as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL cholesterol.