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Amgen wins PCSK9 inhibitor patent infringement case vs. Sanofi, Regeneron
Amgen announced that a U.S. District Court jury in Delaware determined that two of its patents related to monoclonal antibodies for PCSK9 inhibition are valid and that Sanofi and Regeneron have infringed those patents.
Amgen brought the patent infringement action against Sanofi and Regeneron in October 2014 over infringement of seven claims from the two patents. According to a press release issued by Amgen, manufacturer of the PCSK9 inhibitor evolocumab (Repatha), Sanofi and Regeneron, manufacturers of the PCSK9 inhibitor alirocumab (Praluent), acknowledged infringement of the claims but charged that the patents were not valid.
The jury found that Sanofi and Regeneron did not prove that the patents were invalid “for lack of written description and enablement,” according to the Amgen release.
According to a press release issued by Sanofi and Regeneron, the companies will appeal the decision and said that this verdict does not impact physician and patient access to alirocumab in the short term.
“We believe the facts and the controlling law support our position,” Joseph LaRose, senior vice president, general counsel and secretary, Regeneron, stated in the Sanofi/Regeneron release. “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. Praluent was developed with Regeneron’s proprietary science and technology and represents an important medical advance for patients.”
In the Amgen release, Robert A. Bradway, chairman and CEO, said, “we are thankful that the jury weighted the evidence carefully and recognized the validity of Amgen’s patents on Repatha, our innovative biologic molecule that reduces LDL.”
The FDA approved Praluent in July 2015 for use in addition to diet and maximally tolerated statin therapy in patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic CVD who require additional LDL lowering. In August 2015, Repatha received FDA approval for the same use in patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia or clinical atherosclerotic CVD who require additional LDL lowering.
Disclosure: Bradway is an employee of Amgen. LaRose is an employee of Regeneron.