FTC urges Fourth Circuit to reject Amgen plea to shield Roche patent acquisition: deal “threatens to upend” long-settled antitrust framework

Context:

• In 1998, Immunex Corporation (acquired by Amgen in 2002) launched Enbrel in the U.S. to treat inflammatory diseases like rheumatoid arthritis. Roche, however, had already described etanercept in its own patent applications, so Immunex obtained a non-exclusive license to the relevant patents from Roche. The drug’s patents (known as the Brockhaus patents) were initially set to expire in 2012 but, after acquiring Immunex, Amgen restructured the 1998 license agreement, including obtaining control over the prosecution of two pending Roche patent applications. The USPTO issued the patents in 2011 and 2012, extending Enbrel’s protected lifespan to 2029, and Amgen used those issued patents to block its competitors from marketing Enbrel biosimilars, obtaining permanent injunctions against Sandoz (July 1, 2020 Amgen press release) and Samsung Bioepsis ( November 3, 2021 Amgen v. Samsung Bioepsis District of New Jersey decision) in July 2020 and November 2021, respectively.
• In August 2024, non-profit health insurance provider CareFirst filed a class action antitrust complaint against Amgen in the United States District Court for the Eastern District of Virginia, asserting that the pharma company’s acquisition of Roche’s patent applications was anticompetitve, and unlawfully delayed competition for its blockbuster drug. “Amgen engaged in a long-running and successful scheme to build and buttress its monopoly power over Enbrel, reaping billions in profits while denying purchasers and patients access to the lower prices they would have paid in a competitive market,” CareFirst alleged at the time. Amgen moved to dismiss the case, arguing that its transaction was immune from antitrust scrutiny because it had later obtained injunctions enforcing the issued patents, but the Eastern Court of Virginia disagreed, concluding that although the later litigation was protected by Noerr-Pennington, the overall scheme – beginning with the acquisition of Roche’s patent rights – remained actionable. In March, Amgen filed an appeal with the Fourth Circuit.