Amgen Granted Cholesterol-Drug Injunction, Sanofi to Appeal
Amgen has been granted a permanent injunction by the United States District Court in Delaware that prohibits Sanofi and its partner, Regeneron Pharmaceuticals, from infringing two patents that Amgen holds for its anti-cholesterol drug, Repatha (evolocumab) by manufacturing, using, selling, or offering alirocumab, Sanofi’s and Regeneron’s anti-cholesterol drug, for sale in the US. Amgen’s Repatha (evolocumab) and Sanofi and Regeneron’s Praulent (alirocumab) are two monoclonal antibody drugs in a new class of anti-cholesterol drugs, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.The judge’s decision follows 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 proprotein convertase subtilisin/kexin type 9 (PCSK9).
Sanofi and Regeneron have responded to the ruling, announcing that they will appeal the injunction. The companies said they believe Amgen’s asserted patent claims to be invalid. Sanofi and Regeneron have said they will also appeal the prior jury verdict upholding the validity of those patents.
The injunction will not take effect immediately as the court initially delayed its imposition for 30 days from the date of its ruling on January 5, 2017 to allow Sanofi and Regeneron the opportunity to seek expedited review of this decision.
In an updated statement from Amgen on January 9, 2017, the company said that the court denied Sanofi and Regeneron’s motion to stay the injunction pending an appeal. By this ruling, the court has extended the time before the injunction will be imposed by 15 days, giving Sanofi and Regeneron 45 days from the date of ruling on January 5, 2017, to seek appellate review of the court’s orders on injunction and denial of stay pending appeal.
Both Repatha and Praluent were approved in 2015 and have been forecast by some analysts for potential blockbuster status.