Regeneron Pharmaceuticals and Sanofi today announced that the companies strongly disagree with a U.S. District Court jury verdict that the asserted claims of two Amgen patents for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are valid.
Sanofi and Regeneron believe these Amgen patent claims are invalid in the ongoing U.S. patent infringement lawsuit and plan to appeal the judgment. This decision is the first step in this ongoing litigation and does not impact Praluent® (alirocumab) Injection or our ability to deliver it to physicians and patients at this time.
“It has always been and remains our position that Amgen’s asserted patent claims in this matter are invalid,” said Karen Linehan, Executive Vice President and General Counsel, Sanofi.
Next steps on damages are to be determined. The judge will hold a hearing to consider a permanent injunction in the near future.
“This is a complex area of law and science, and we believe the facts and controlling law support our position. We look forward to taking our case to the Federal Circuit Court of Appeals, the U.S. appellate court that hears all biopharmaceutical patent appeals,” said Joseph LaRosa, Senior Vice President, General Counsel and Secretary, Regeneron. “Praluent was developed with Regeneron’s proprietary science and technology and represents an important medical advance for patients.”
In July 2015, Praluent was the first PCSK9 inhibitor to be approved for use in the U.S. 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 available in two starting doses that allow physicians to adjust the dose based on a patient’s LDL cholesterol lowering needs. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.