On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid in all 17 UPC contracting States, based on lack of inventive step. This is the first patent revocation decision issued by the UPC.
Amgen’s EP3666797, related to antigen binding proteins to proprotein convertase subtilisin/kexin type 9 (PCSK9) including evolocumab, is marketed by Amgen as Repatha®. Sanofi and Regeneron market a PCSK9 inhibitor, alirocumab, under the brand name, Praluent®.
Sanofi filed its UPC revocation case on 1 June 2023, the day of the UPC’s commencement. Regeneron’s revocation action was filed as a counter-claim to an infringement action brought by Amgen, also on 1 June 2023.
On 18 May 2023, the US Supreme Court invalidated antibody genus claims in two Amgen patents relating to Repatha® (evolocumab). Judgment in an opposition by Sanofi to Amgen’s corresponding Australian patents is pending.