Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, have scored a victory in ongoing patent litigation with Amgen over Sanofi’s/Regeneron’s Praulent (alirocumab) and Amgen’s Repatha (evolocumab), two new anticholesterol drugs, PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. A federal appeals court has overturned an earlier injunction that had prohibited Sanofi and Regeneron Pharmaceuticals from selling their drug in the US on the basis of patent infringement and has ordered a new trial.

In January 2017, Amgen was granted a permanent injunction by the US District Court in Delaware that prohibited Sanofi and Regeneron from manufacturing, using, selling, or offering Praluent for sale in the US on the basis of Amgen’s claims that the companies infringed two patents that Amgen holds for Repatha. The ruling followed a jury verdict in March 2016 in Amgen’s favor in a trial on the validity of two Amgen patents that describe and claim monoclonal antibodies to PCSK9. 

Sanofi and Regeneron then won a stay on the injunction as they waited for a decision from the federal appeals court. The appeals court has now ruled that the trial court had improperly granted a permanent injunction, had given improper instructions to the jury, and had improperly excluded some evidence that Regeneron and Sanofi wanted to use at the trial in the lower court.

The schedule for the new trial has not yet been determined. In a statement, Sanofi said that the companies do not anticipate any new trial proceedings to start in 2017.

Source: Sanofi