Regeneron Pharmaceuticals, Inc., and Sanofi announced they strongly disagree with certain aspects of jury verdict from the U.S. District Court for the District of Delaware. The jury upheld the validity of three of the five asserted claims of two Amgen U.S. patents covering antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). The jury agreed with Regeneron and Sanofi for two of the five asserted claims, finding they were invalid based on lack of written description. The verdict does not impact U.S. physicians’ and patients’ access to Praluent (alirocumab). 

“We will continue to vigorously defend our positions against Amgen’s overly broad patent claims,” said Joseph LaRosa, Executive Vice President, General Counsel and Secretary, Regeneron. “We are considering our next steps in this important case and continue to believe in the differentiated clinical profile of Praluent.” 

Regeneron and Sanofi intend to file post-trial motions with the District Court over the next few months, seeking to overturn the jury verdict and also requesting a new trial. In addition, if necessary the companies plan to appeal to the U.S. Court of Appeals for the Federal Circuit. On February 8, 2019, the District Court dismissed Amgen’s claim for willful infringement. 

“We are disappointed in today’s verdict,” said Karen Linehan, Executive Vice President and General Counsel, Sanofi. “It is our longstanding belief that all of Amgen’s asserted U.S. patent claims are invalid and we believe the law and the facts support our positions.” 

About Praluent 

Praluent (alirocumab) Injection inhibits the binding of PCSK9 to the low-density lipoprotein (LDL) receptor and thereby increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL-C levels in the blood. Praluent was developed by Regeneron and Sanofi under a global collaboration agreement and invented by Regeneron using the company’s proprietary VelocImmune technology that yields optimized fully-human monoclonal antibodies. Praluent is approved in more than 60 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico, Brazil and the European Union. In the U.S., 

Praluent is approved for use as an 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 LDL-C. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.