Sanofi, Regeneron Offered New Trial in Alirocumab Dispute with Amgen

A federal judge has thrown out the March 2016 ruling in Amgen's favor, which blocked Sanofi/Regeneron's ability to take alirocumab to market.

Sanofi and Regneron Pharmaceuticals, Inc, announced that the US Court of Appeals for the Federal Circuit today ordered a new trial for the company’s dispute with Amgen over patent claims for the PCSK9 inhibitor alirocumab (Praluent).

This decision vacates the previous ruling, in which a US Federal Court judge granted Amgen the rights to sell, market, and manufacture evolocumab (AMG 145). The Federal Circuit ruled that the March 2016 decision was erred by excluding evidence regarding a written description, improperly instructed the jury based on said description, excluding evidence on enablement, and improperly granting a permanent injunction.

"We are pleased with the Federal Circuit's decision to remand for a new trial that allows us to present our complete evidence to the jury," Karen Linehan, the executive vice president and general counsel for Sanofi said in a statement. "It is our longstanding position that Amgen's asserted patent claims are invalid, and we remain confident in the long-term availability of Praluent for patients."

Alirocumab was the first PCSK9 inhibitor approved by the US Food and Drug Administration (FDA) in July 2015, with an indication for use alongside diet and maximum tolerated statin therapy to lower LDL cholesterol in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease. Currently, it is the only available PCSK9 inhibitor that offers 2 doses - 75 mg and 150 mg - to be taken biweekly.

"We continue to believe that the law and facts support our position, and we look forward to presenting our complete evidence at trial to a new jury," Joseph J. LaRosa, the senior vice president and general counsel and secretary for Regeneron, said. "Praluent represents an important medical advancement for patients, and we remain confident in the meaningful value that Praluent provides not only to patients, but to the overall healthcare system."

In February, Sanofi and Regeneron fought to keep alirocumab on the market with an appeal following the original decision. Amgen is expected to continue the battle in court moving forward.