Blog Big Molecule Watch November 05, 2020

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

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.

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