Sanofi and Regeneron will continue marketing, selling and manufacturing Praluent in the United States (U.S.) during their appeal on Amgen’s patent claims.
The companies said on Wednesday that the the U.S. Court of Appeals for the Federal Circuit has confirmed its earlier decision for Praluent Injection, pending the two companies’ appeal.
Karen Linehan, Executive Vice President and General Counsel, Sanofi. “It is our longstanding position that Amgen’s asserted patent claims are invalid and we look forward to moving forward with the appeal process.”
The companies are challenging the injunction ruling and validity judgment during the appeal process, saying that Amgen’s asserted patent claims for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are invalid.
“We continue to believe the facts and controlling law support our position in this case,” said Joseph J. LaRosa, Senior Vice President, General Counsel and Secretary, Regeneron. “We will continue to vigorously defend our case through the appeal process.”
Outside the U.S., Praluent is marketed and sold in 15 countries with anticipated launches in 15 additional countries in 2017