Regeneron Triumphs in Landmark Antitrust Case Against Amgen Over PCSK9 Inhibitor Market Practices
In a major legal victory that could have lasting implications for the biotechnology and pharmaceutical industries, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced it has prevailed in an antitrust lawsuit against Amgen Inc. in the U.S. District Court for the District of Delaware. The jury’s decision, handed down after careful deliberation, found that Amgen violated multiple federal and state antitrust statutes, as well as tort law, by employing an illegal bundling scheme that suppressed competition in the PCSK9 inhibitor market—a therapeutic class targeting high cholesterol and associated cardiovascular risks.
At the heart of the case was Amgen’s aggressive strategy to leverage its commercial dominance in other drug categories to secure market exclusivity for its cholesterol-lowering drug Repatha® (evolocumab). The jury determined that Amgen used its strong positions in unrelated but highly profitable anti-inflammatory products—namely Enbrel® (etanercept) and Otezla® (apremilast)—to pressure pharmacy benefit managers (PBMs) into favoring Repatha over Regeneron’s competing PCSK9 inhibitor, Praluent® (alirocumab). This practice, the court found, constituted illegal bundling that violated antitrust statutes including the Clayton Act and the Sherman Act at the federal level, as well as the Donnelly Act in New York, the Cartwright Act in California, and tort law in the state of Delaware.
According to evidence presented during the trial, Amgen effectively threatened PBMs with the withholding of lucrative rebates for Enbrel and Otezla—two drugs with no therapeutic overlap with PCSK9 inhibitors—unless they granted exclusive formulary placement to Repatha. The jury found that this coercive tactic was designed not to benefit patients based on clinical performance or cost-effectiveness but to exclude Praluent from the market for non-medical, commercial reasons. As a result, Regeneron argued, patients were denied access to an innovative alternative therapy that may have been more suitable or cost-effective in certain cases.
The court agreed with Regeneron’s contention, finding Amgen’s actions constituted a concerted and unlawful effort to restrict competition and monopolize the PCSK9 inhibitor market. The jury awarded Regeneron a total of $406.8 million in damages—$135.6 million in compensatory damages and an additional $271.2 million in punitive damages. Punitive damages are reserved for especially egregious conduct and are intended to deter similar future violations not only by the defendant but by other actors in the industry.
“This verdict is a powerful affirmation of the principles that support fair competition, innovation, and patient access in the biotech and pharmaceutical sectors,” said Leonard S. Schleifer, M.D., Ph.D., co-Chair of the Board, President, and Chief Executive Officer of Regeneron. “The biotechnology industry exists to solve the world’s most pressing medical problems, and that mission cannot be fulfilled if powerful companies abuse their market position to suppress competition. Patients deserve access to the best possible treatments, and that access should be determined by clinical evidence and value—not by coercive business tactics.”
Dr. Schleifer emphasized that fair competition is essential for enabling continued scientific progress, fostering innovation, and ensuring that healthcare systems offer diverse, effective treatment options. “When companies compete on the merits of their science—on the strength of their data and the value they deliver to patients and payers—everyone wins. But when anticompetitive behavior is allowed to thrive, it stifles innovation and restricts patient choice.”
The conflict between Regeneron and Amgen dates back several years. Praluent, developed by Regeneron in collaboration with Sanofi, received U.S. Food and Drug Administration (FDA) approval in 2015, just weeks before Repatha, Amgen’s entrant into the PCSK9 inhibitor space. Both drugs work by inhibiting the PCSK9 protein, which interferes with the liver’s ability to remove LDL cholesterol—or “bad cholesterol”—from the blood. The arrival of PCSK9 inhibitors was hailed as a major advance for patients who are unable to reach cholesterol goals with statins or are statin-intolerant.
But while initial excitement was high, the commercial uptake of PCSK9 inhibitors faced challenges, including high costs and restrictive insurance coverage. As both Regeneron and Amgen navigated these hurdles, their rivalry intensified. After an earlier legal battle over patents—which ultimately ended in Praluent’s favor—Amgen, Regeneron alleged, shifted gears and began using its muscle in other therapeutic categories to constrain Praluent’s market access.
This case marked a pivotal test of whether such bundling arrangements—where a dominant firm ties access to one product to preferential treatment of another—could be considered illegal under antitrust laws, particularly in healthcare markets where patient access and insurer decisions are tightly controlled by intermediaries such as PBMs.
Joseph J. LaRosa, Executive Vice President, General Counsel, and Secretary of Regeneron, underscored the broader importance of the jury’s ruling. “Since the launch of Praluent, Amgen has consistently sought to marginalize or eliminate it from the market. After failing to achieve that through the courts with meritless patent litigation, they turned to an anticompetitive bundling scheme that posed a serious threat to competition and innovation,” LaRosa said. “Today’s jury verdict sends a clear signal that such conduct will not go unchecked. It affirms the importance of preserving open markets where innovation can thrive and patients can benefit from choice.”
LaRosa also emphasized that the verdict could influence how other companies, PBMs, and healthcare stakeholders approach market access negotiations in the future. “We believe this decision will prompt a critical reevaluation of how rebate practices and formulary placements are structured in the United States. Patients should never be collateral damage in a pricing war or strategic bundling play. This outcome underscores that antitrust laws remain a vital tool for safeguarding patient interests.”
Legal experts have noted that this case could be a bellwether for the pharmaceutical industry, especially as scrutiny increases over rebate arrangements and formulary exclusivity agreements that some argue reduce transparency and limit treatment options. The decision also contributes to an ongoing national conversation about how to balance innovation, access, and competition in the biopharma space—especially in an era of increasingly complex pricing and reimbursement mechanisms.
Regeneron expressed gratitude to the jury for its time, deliberation, and attention to the details of the case. “We are thankful for the jury’s thoughtful consideration and commitment to justice,” the company stated.
The case was argued by Regeneron’s lead counsel, Jonathan D. Polkes of White & Case LLP, a legal team known for its experience in high-profile antitrust and commercial litigation.
As for what comes next, the implications of the jury’s verdict may extend well beyond the specific products involved. While Amgen is expected to consider options for appeal, the message delivered by the court is likely to reverberate across the pharmaceutical landscape: anticompetitive bundling that leverages unrelated products to limit patient access and suppress innovation will face serious legal consequences.
In the end, Regeneron’s victory marks more than just a financial win—it represents a broader defense of the principles of scientific merit, fair competition, and patient-first innovation that are foundational to the life sciences industry.
