European Patent Office rules in favor of Sanofi and Regeneron concerning Praluent.

The European Patent Office (EPO) Technical Boards of Appeal has ruled in Sanofi and Regeneron’s favor, invalidating certain claims of Amgen’s European patent (EP 2 215 124) directed to PCSK9 (proprotein convertase subtilisin/kexin type 9) antibodies relevant to Praluent (alirocumab). Praluent will continue to be available in European countries where it is approved for use and for sale.This affirms that Amgen’s asserted claims against Sanofi in Europe are invalid. The EPO decision follows a ruling in Sanofi and Regeneron’s favor in August 2019 by the U.S. District Court for the District of Delaware which found as a matter of law that certain of Amgen’s asserted patent claims for antibodies targeting PCSK9 are invalid based on lack of enablement. Under a restructured agreement announced in December 2019, Sanofi possesses sole rights for Praluent outside the U.S. Regeneron has sole rights for Praluent inside the U.S. Each party is solely responsible for funding development and commercialization expenses in their respective territories. Praluent is not available in Germany, following an injunction granted by the Düsseldorf Regional Court in July 2019. Sanofi has appealed this decision, and a hearing for the appeal is scheduled for November 5, 2020.neron’s proprietary science and technology and the judge has confirmed our position by issuing this ruling.