Amgen vs. Sanofi – appeals court suspend patent injunction

The United States Court of Appeals for the Federal Circuit has stayed (suspended) the permanent injunction for Praluent (alirocumab) Injection pending Regeneron Pharmaceuticals and Sanofi’s appeal. This ruling means that Sanofi and Regeneron will continue marketing, selling and manufacturing Praluent in the US during the appeal process. 

This is the latest decision in the ongoing legal battle between the pharma giants. In January, the United States District Court in Delaware decided for Amgen, prohibiting Sanofi and Regeneron from infringing two patents that Amgen hold for Repatha (evolocumab) by manufacturing, using, selling or offering alirocumab for sale in the United States.

Appealing the injunction

“This [latest appeals] decision is important for patients in the US who will continue to have access to Praluent during the appeal process giving them a choice in PCSK9 inhibitor treatments to best meet their individual needs,” said Karen Linehan, Executive Vice President and General Counsel, Sanofi.

Following the initial judgement, Amgen released the following statement:

“The US District Court of Delaware denied Sanofi and Regeneron’s motion to stay the injunction pending the appeal in the ongoing PCSK9 patent litigation. By this ruling, the Court has extended the time before the injunction will be imposed by 15 days (from 30 days to 45 days) to allow Sanofi and Regeneron to seek appellate review of the Court’s orders on injunction and denial of stay pending appeal.

Amgen respects the court’s thoughtful deliberations in a situation where a competitor made the choice to launch at risk during the pendency of a patent lawsuit within months of an expedited trial date. The Company remains confident in the validity of its patents.”

Challenging the patent

Sanofi and Regeneron are challenging both the injunction ruling and validity judgment during the appeal process. The companies believe Amgen’s asserted patent claims for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are invalid in the ongoing US patent infringement lawsuit.     

Drug indication

Praluent was the first PCSK9 inhibitor to be approved for use in the US. 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 “bad” (LDL) cholesterol.

Praluent is the only PCSK9 inhibitor that offers two doses (75 mg and 150 mg) with two levels of efficacy, allowing healthcare providers the flexibility to adjust the therapeutic dose based on their patient’s LDL cholesterol-lowering needs.

The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.