Sanofi and Regeneron to appeal against Praluent injunction

Sanofi and Regeneron Pharmaceuticals have revealed plans to appeal against an injunction granted to Amgen, which prevents the companies from selling cholesterol-lowering medicine Praluent (alirocumab).

On Thursday, January 5, Amgen obtained the injunction at the US District Court for the District of Delaware.

Amgen had claimed that Praluent infringed claims of US patent numbers 8,829,165 and 8,859,741, covering the drug Repatha (evolocumab).

US District Judge Sue Robinson ordered the permanent injunction, just days after refusing to throw out a ruling upholding the validity of two patents owned by Amgen.

“We are pleased with today’s decision that recognises Amgen is entitled to an injunction against further infringement of our patent rights,” said Robert Bradway, chairman and CEO at Amgen, in an announcement.

However, Sanofi and Regeneron have sprung into action, announcing their intent to appeal the injunction and a prior jury verdict upholding the validity of the two patents.

The court will delay the imposition of the injunction for 30 days, to allow Sanofi and Regeneron the “opportunity to appeal and request expedited review of this ruling by the Federal Circuit, and/or to encourage the parties to reach an appropriate business resolution”.

Karen Linehan, executive vice president and general counsel, Sanofi, said: “It is our longstanding position that Amgen’s patent claims are invalid and that the best interests of patients will be greatly disserved by an injunction preventing access to Praluent.”

Joseph LaRosa, senior vice president, general counsel and secretary of Regeneron, added: “We will continue to vigorously defend our case through the appeal process as we believe the facts and controlling law support our position.”

Praluent continues to be available to patients at this time.