Sanofi and Regeneron Pharmaceuticals are going to will appeal to the ban the U.S. District Court for the District of Delaware declared on Friday for the marketing, selling or manufacturing of Praluent in the U.S. during the term of two Amgen patents.
Sanofi and Regeneron said they believe Amgen`s asserted patent claims are invalid and will also appeal a prior jury verdict upholding the validity of those patents. The court has delayed imposition of the injunction for 30 days to allow Sanofi and Regeneron to file a motion for a suspension (stay) of this injunction during the appeal process. Regardless, Praluent is still available for sale at the moment.
“We will immediately appeal today`s ruling, along with the jury`s earlier finding upholding the validity of Amgen`s patents,” said Karen Linehan, Executive Vice President and General Counsel, Sanofi. “It is our longstanding position that Amgen`s patent claims are invalid and that the best interests of patients will be greatly disserved by an injunction preventing access to Praluent.”
Joseph LaRosa, Senior Vice President, General Counsel and Secretary, Regeneron, also confirmed that the companies would appeal.
Praluent is a PCSK9 inhibitor for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease