European Patent Office rules in favor of Sanofi and Regeneron concerning Praluent® (alirocumab)

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On October 29, 2020, the European Patent Office ruled in favor of Sanofi and Regeneron in their dispute concerning Amgen’s Praluent® (alirocumab) patent.  The EPO found invalid certain claims of Amgen’s European patent, EP 2 215 124, which is directed to PCSK9 antibodies.  This 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 that found invalid for lack of enablement, as a matter of law, certain claims of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) directed to antibodies targeting PCSK9.

Following the EPO decision, Praluent® will continue to be available in European countries where it is approved for use and sale.  Currently, Sanofi possesses sole rights for Praluent® outside the United States, while Regeneron has sole rights for Praluent® inside the United States.  Praluent® is not currently available in Germany, following an injunction granted by the Düsseldorf Regional Court in July 2019 on the basis that Praluent® infringes the German part of Amgen’s European patent (EP 2 215 124) directed to antibodies targeting PCSK9.  Sanofi has appealed that injunction, and the court has scheduled a hearing for November 5, 2020.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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