FTC Files Amicus Brief Supporting Antitrust Suit Against Johnson & Johnson Over Stelara Monopoly
Key Insights
The Federal Trade Commission (search) filed an amicus brief arguing that antitrust plaintiffs need not prove a company's specific intent to harm competition, only the anticompetitive effects of its conduct.
The brief supports CareFirst of Maryland's class action alleging J&J illegally maintained its Stelara (ustekinumab) monopoly through the acquisition of Momenta Pharmaceuticals (search) and subsequent patent enforcement.
The FTC asserts that requiring proof of specific intent would impede antitrust enforcement, undermine competition, and harm American consumers.
The Federal Trade Commission (search) has filed an amicus brief in a federal antitrust case alleging that Johnson & Johnson illegally maintained a monopoly over the blockbuster autoimmune drug Stelara (ustekinumab), arguing that plaintiffs should not be required to prove a company specifically intended to harm competition in order to pursue monopolization claims.
The brief, filed in litigation brought by CareFirst of Maryland Inc. (search), asserts that longstanding Supreme Court precedent has clearly and consistently held that antitrust law is focused on the impact of anticompetitive conduct on consumers, not on the intent to harm competition.
The Underlying Allegations
CareFirst of Maryland Inc. (search) brought a class action alleging that Johnson & Johnson willfully maintained its monopoly power in the market for Stelara — a drug used to treat several autoimmune conditions, including psoriasis (search), psoriatic arthritis (search), ulcerative colitis (search), and Crohn's disease (search) — through the acquisition of Momenta Pharmaceuticals (search) and the subsequent assertion of its patent portfolio to delay or prevent competition.
Stelara has been one of Johnson & Johnson's largest products, generating billions of dollars in annual sales. The drug's market exclusivity carries significant economic implications for insurers, patients, and rival manufacturers seeking to introduce lower-cost alternatives.
The FTC's Legal Argument
The FTC's amicus brief argues that binding precedent focuses on the effect on competition and harm to consumers, not on proof of specific intent to harm competition. Requiring a plaintiff to show that an alleged monopolist specifically intended for conduct to have anticompetitive consequences "would impede vigorous antitrust enforcement, undermine competition and harm American consumers," the FTC stated in its filing.
The Commission filed the amicus brief given its "strong interest in ensuring the proper application of federal antitrust laws."
Broader Implications for the Pharmaceutical Industry
The case could have significant implications for antitrust enforcement across the pharmaceutical sector, where patent portfolios and acquisitions frequently face scrutiny for their potential to delay lower-cost alternatives and preserve market exclusivity. The FTC framed the case as part of the Trump administration's broader effort to promote competition in prescription drug markets as a means of lowering costs for consumers.
The Commission vote authorizing the issuance of the amicus brief was 2-0.