New trial ordered in cholesterol drug patent case

Sanofi and Regeneron Pharmaceuticals said the US Court of Appeals for the Federal Circuit ordered a new trial and vacated the permanent injunction in the dispute concerning Amgen’s asserted patent claims for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).

The ruling means that Sanofi and Regeneron will continue marketing, selling and manufacturing cholesterol-lowering drug Praluent in the US.

Sanofi and Regeneron said: “The Federal Circuit affirmed the trial court’s ruling that Amgen’s patents were non-obvious, which was one of Sanofi and Regeneron’s several challenges to validity of Amgen’s patents.

“Because of the improper exclusion of evidence, the court considered the record to be incomplete and concluded at this time that Sanofi and Regeneron are not entitled to judgment as a matter of law (JMOL) on the issues of written description and enablement.”

The schedule for the new trial has not yet been determined.

The companies do not anticipate any new trial proceedings to start in 2017.

“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,” said Karen Linehan, General Counsel, Sanofi.

“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.”

Regeneron general counsel Joseph LaRosa said: “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.

“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.”

Amgen told Reuters it was disappointed by the court’s action, saying: “We firmly believe in the validity of our patents and we look forward to reasserting our rights in court.”