On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic bundling rebates, involving its anti-inflammatory drugs Enbrel® (etanercept) and Otezla® (apremilast), to convince pharmacy benefit managers (PBMs) to choose Repatha® (evolocumab) as their exclusive PCKS9 product, instead of Regeneron’s Praluent® (alirocumab). According to Regeneron, Amgen threatened to withhold rebates unless PBMs preferred its cholesterol-lowering antibody, Repatha®, and excluded Regeneron’s Praluent®.
The jury awarded Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages. It is not yet known whether Amgen will appeal the decision.
On 18 May 2023, the US Supreme Court invalidated antibody genus claims in two Amgen patents relating to Repatha® (evolocumab). 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, based on lack of inventive step. Amgen has recently had more fortune in Australia, where, on 23 April 2025, the Federal Court determined that five of Amgen’s evolocumab-related patent applications are valid and should proceed to grant.