On September 30, the U.S. District Court for the Eastern District of Virginia granted in part and denied in part the Motion to Dismiss filed by Amgen, Inc. and Immunex Corporation (“Amgen”) in a class action antitrust lawsuit brought by CareFirst of Maryland, Inc., Group Hospitalization and Medical Services, Inc., and CareFirst BlueChoice, Inc. (“CareFirst”).
The case, CareFirst of Maryland, Inc. v. Amgen Inc., 2:24-cv-00484, was initiated on August 8, 2024. In its Complaint, CareFirst, representing parties “who provide healthcare benefits to millions of Americans,” alleges that Amgen has “unlawfully delay[ed] competition for its blockbuster drug, Enbrel (etanercept)” by “engag[ing] in a long-running and successful scheme to build and buttress its monopoly power.”
Etanercept, developed by Immunex Corp. (“Immunex”), was launched as Enbrel® in 1998 as a treatment for moderate to severe rheumatoid arthritis and later approved to treat additional inflammatory diseases: plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. According to its label, etanercept is a tumor necrosis factor (TNF) blocker fusion protein consisting of a portion of human tumor necrosis factor receptor (TNFR).
Independent of Immunex, F. Hoffman-La Roche AG (“Roche”) also developed TNFR fusion proteins that became the subject of a family of patent applications and issued patents (the “Brockhaus Patents”). Prior to the launch of Enbrel®, Immunex obtained a co-exclusive worldwide license to the “Brockhaus Patent Rights” in order to commercialize etanercept. Under the license, Roche retained the right to make, use, sell, and import etanercept, or to grant co-exclusive rights to a third-party in each country to do so in collaboration with or in lieu of Roche. Roche also retained ownership of the Brockhaus Patents and the responsibility for their prosecution and maintenance.
Amgen obtained Immunex and its etanercept intellectual property in 2002. According to CareFirst, while Amgen “benefited handsomely from Immunex, and thus Enbrel, it saw a cliff ahead” because the “key Enbrel patents” would expire in 2012, allowing competition from biosimilars. To “shore up its defenses to this threat,” Amgen purchased Roche’s remaining Brockhaus Patent Rights in 2004, becoming the exclusive licensee and enabling Amgen to “exclude competitors from the etanercept market” and “to further prosecute (and amend) pending patent applications to ensure maximum protection for Enbrel.” CareFirst alleges that, by amending pending Roche applications, Amgen was able to extend patent protection of Enbrel to 2029, resulting in an “overcharge[] of hundreds of millions of dollars per year” to purchasers due to the absence of biosimilars on the market.
CareFirst asserted four claims against Amgen: monopolization in violation of Section 2 of the Sherman Act, and state law claims for monopolization and monopolistic conduct (30 states, Puerto Rico, and the District of Columbia), violation of consumer protection laws (36 states and the District of Columbia), and inequitable conduct constituting unjust enrichment (48 states).
In considering the Sherman Act claim, the Court determined that CareFirst had sufficiently alleged that Amgen had monopoly power over the etanercept market, Amgen’s conduct was anticompetitive, and that antitrust injury resulted. Regarding Amgen’s alleged anticompetitive conduct, the Court was not persuaded by Amgen’s defense that its actions in purchasing, further prosecuting, and seeking to enforce the Brockhaus Patents were immunized from antitrust liability by the Noerr-Pennington doctrine because, while the prosecution and enforcement, as acts of petitioning the government, were immune, the act of purchasing the Brockhaus Patents was not. Further, the Court found “compelling” that, while it was already “reaping astronomical profits from Enbrel pursuant to its own patents,” Amgen still decided to obtain exclusive rights to the Brockhaus Patents. Regarding the resulting injury, Amgen argued that intervening government actions—permanent court injunctions preventing Sandoz and Samsung from marketing their etanercept biosimilars—broke the “causal chain” between the anticompetitive conduct and the injury. The Court found that while other circuits have accepted this reasoning, the Fourth Circuit applies Noerr-Pennington to antitrust liability, but not to antitrust injury. Therefore, Amgen’s Motion to Dismiss the Sherman Act claim was denied.
The Court looked to the laws of the individual states regarding the state law claims. The state law monopolization and monopolistic conduct claim was dismissed for Puerto Rico, where indirect purchasers do not have standing to bring antitrust claims. The unjust enrichment claim was also dismissed for the seven states and Puerto Rico that require parasitic unjust enrichment claims and lacked an additional state claim. For all other state law claims, Amgen’s Motion to Dismiss was denied.
A similar antitrust Complaint was filed by Sandoz, Inc. on April 11, 2025. The case, Sandoz, Inc. v. Amgen, Inc., 2:25-cv-00218, also is before Judge Arenda L. Wright Allen in the Eastern District of Virginia. A Motion to Dismiss is currently pending.
Stay tuned to Big Molecule Watch for further litigation updates.