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June 30, 2025
Authored by: Maxine An
On May 15, 2025, a federal jury in Delaware district court determined that Defendant Amgen Inc. (“Amgen”) violated antitrust and tort laws, and awarded $406.8 million in damages to Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”).1 The jury found in Regeneron’s favor on all counts but one,2 including Sherman Act claims of monopolization and restraints of trade.3
Regeneron and Amgen are pharmaceutical companies that sell competing PCSK9 inhibitor drugs, which are aimed at lowering cholesterol.4 Regeneron’s product is Praluent® and Amgen’s product is Repatha®.5 Regeneron alleged that Amgen engaged in anticompetitive conduct to “drive Praluent out of the PCSK9 inhibitor market” through exclusive dealings and bundling arrangements.6 Regeneron claimed that Amgen was “giving pharmacy benefit managers (“PBMs”) rebates on other drugs—specifically, its blockbuster drugs Otezla® and Enbrel®—in return for exclusive or preferred formulary placement for Repatha.”7 As a result, Regeneron contended that because all three of Amgen’s drugs, Repatha®, Otezla®, and Enbrel®, had market power in their own respective markets, and due to the high rebate amounts on Otezla® and Enbrel®, PBMs were forced to “accept Amgen’s offer and to exclude Praluent from their formularies.”8
Before the alleged anticompetitive conduct, Praluent® was on the formularies of the “three most dominant” PBMs for the PCSK9 inhibitor market: Express Scripts (“ESI”), United Healthcare/OptumRx (“UHC/Optum”), and CVS Caremark (“CVS”).9 Regeneron alleged that it had collaborated with ESI to increase patient access to Praluent®, that it “had a positive working relationship with UHC/Optum to provide Praluent®, and that “Praluent® was the exclusive PCSK9i for CVS/Zinc Commercial.”10 However, Regeneron claimed that due to Amgen’s high rebate offer to the PBMs for Enbrel®, Otezla®, and Repatha® in exchange for Repatha® exclusivity on their formularies, Regeneron had to match Amgen’s offer or Praluent® would be excluded from the PBMs’ formularies.11 Because Regeneron was unable to match Amgen’s rebate offer or “match Amgen’s bundled rebate by offering an equivalent bundle across its portfolio,” the PBMs entered into exclusive relationships with Amgen’s Repatha® and took Regeneron’s Praluent® off their formularies.12 As a result, Regeneron stated that it was forced to consider exiting the market.13 Regeneron alleged that this conduct violated federal and state antitrust laws14 as well as tortiously interfered with its prospective business relations with the PBMs.15 Regeneron specifically claimed that “[b]ut for Amgen’s interference, Regeneron would have received or would receive the expected economic advantage from its business relations with Third-Party Payors.”16
The district court denied Amgen’s motion to dismiss on February 10, 2023, concluding that Regeneron sufficiently alleged state and federal antitrust claims, such as “anticompetitive conduct under an exclusive dealing theory” and “anticompetitive conduct under a bundling theory.”17 The district court held that the arguments about exclusive dealing and bundling “implicate[d] factual disputes” that could not “be resolved at this stage of the case.”18
The district court denied Amgen’s motion for summary judgment on April 10, 2025.19 The court concluded that there were “material factual disputes that prevent[ed] summary judgment,” such that “a jury could find that Amgen offered bundled discounts that restricted Regeneron’s access to portions of the market because it did not have an equally diverse drug portfolio . . . or that Amgen entered into de facto exclusive dealing arrangements that substantially foreclosed Regeneron from the market.”20
A seven-day trial commenced on May 5, 2025.21 During trial, Dr. Leonard Schleifer, Founder, CEO, and President of Regeneron, testified that after ESI received Amgen’s offer, ESI told Dr. Schleifer that it would not matter what Regeneron’s offer was since Regeneron’s offer would not be able to compete with Amgen’s.22 Regeneron’s attorney phrased Amgen and ESI’s arrangement as a “$200 million payoff.”23
On the other hand, counsel to Amgen told the jury that “Amgen outcompeted Regeneron”24 and that Regeneron “knew if it had to compete head on with Repatha, it would lose what it had lost for years.”25 In addition, Amgen’s economic expert, Eric M. Gaier, explained that “Regeneron had not shown that it had been foreclosed from the market or that there was harm to competition.”26 Gaier added that “Regeneron could have competed by lowering its price for Praluent” and stated that “‘evidence of exclusion’ from drug formularies ‘does not prove foreclosure.’”27
On May 15, 2025, a unanimous jury found that Amgen violated federal and state antitrust laws28 as well as tortiously interfered with Regeneron’s prospective business relationships with the PBMs.29 In addition, the jury concluded that Repatha® and Enbrel® had “market power in a relevant product market” and that “Amgen’s anticompetitive conduct substantially foreclosed Regeneron from the relevant market.”30 The jury awarded $135.6 million in compensatory damages and $271.2 million in punitive damages to Regeneron on its tortious interference claim.31 The judge confirmed a total damages amount of $406.8 million.32
On June 12, 2025, Amgen filed a renewed motion for judgment as a matter of law or in the alternative, motion for a new trial.33 On the same day, Regeneron filed a motion for permanent injunctive relief, constructive trust, and prejudgment interest.34 These motions are currently pending.
Pharmaceutical company deals with PBMs that bundle multiple drugs and offer rebates in exchange for exclusive or preferred formulary placement can face antitrust scrutiny. Pharmaceutical companies should carefully consider their formulary offerings even if implemented as a strategy to compete with and outperform rivals. If such a strategy has the effect of excluding competitors, it could pose antitrust risk.