The US Federal Trade Commission (FTC) has filed an amicus brief in an antitrust case entailing allegations that a pharmaceutical manufacturer illegally leveraged monopoly power over a blockbuster autoimmune drug.
As the primary federal antitrust enforcer in the pharmaceutical industry, the FTC reviews pharmaceutical patent settlement agreements, conducts studies, hosts listening sessions, and collaborates with other agencies to promote drug competition, including competition in the biologic marketplace.
The filing, submitted to the US Court of Appeals for the First Circuit, argues that courts should evaluate monopolization claims based on the effects of a company’s conduct on competition – not on whether the company specifically intended to harm competitors.
The underlying lawsuit was brought by CareFirst of Maryland, Inc, which alleges that Johnson & Johnson (J&J) unlawfully preserved its monopoly over Stelara (ustekinumab), a widely used treatment for psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.
According to the complaint, J&J acquired Momenta Pharmaceuticals and then used Momenta’s patent portfolio to delay or block biosimilar competition, extending Stelara’s market exclusivity beyond what federal law allows.
In the case, J&J argues that its conduct surrounding Stelara was lawful because it was exercising legitimate patent rights, not engaging in exclusionary behavior. In its view, acquiring Momenta’s patents and enforcing them was normal competitive activity, and CareFirst must show more than lawful patent use to prove monopolization.
In its brief, the FTC told the court that requiring plaintiffs to prove a monopolist’s specific intent to harm competition would contradict decades of Supreme Court precedent. The agency emphasized that Section 2 of the Sherman Act focuses on whether conduct actually harms competition and consumers, not on a company’s subjective motivations.
Section 2 of the Sherman Act makes it illegal for any person or entity to monopolize, attempt to monopolize, or conspire to monopolize any part of trade or commerce among the states or with foreign nations.
Imposing a heightened intent requirement, the FTC warned, would weaken antitrust enforcement and make it more difficult to challenge exclusionary practices in pharmaceutical markets.
“The district court’s misstatement of well-settled monopolization doctrine has the potential to undermine future antitrust law enforcement efforts, impede competition, and harm consumers in the form of higher prices or lower quality goods or services,” the FTC said in the brief.
The Commission said it filed the brief because of its strong interest in ensuring that federal antitrust laws are applied correctly, particularly in industries where consumers face high prices and limited alternatives.
In this case, Stelara was a major blockbuster for Johnson & Johnson, generating nearly $11 billion at its 2023 peak, but its sales sharply declined after losing patent protection and facing a wave of lower‑priced biosimilars. By 2025, revenue had fallen by more than 40%, forcing J&J to shift its focus to other growth drugs.
According to BioSpace, the loss of exclusivity on a drug “accounted for 20% of innovative medicine sales in 2023.”
The FTC’s filing does not take a position on the ultimate merits of the case. Instead, it urges the court to reaffirm that antitrust analysis must center on the competitive impact of a company’s actions. The Commission argued that maintaining an effects‑based standard is essential to preventing anticompetitive conduct that can raise costs for patients, insurers, and public health programs.
“[Longstanding] Supreme Court precedent has clearly and consistently held that antitrust law is focused on the impact of anticompetitive conduct, not on the intent to harm competition,” the regulator asserted in a press release.
In its conclusion, the brief argues “by requiring an antitrust plaintiff to prove that a biosimilar drug manufacturer intended to exclude rivals when it made an allegedly anticompetitive acquisition in violation of Section 2 … ‘makes nonsense of’ the Sherman Act.”
“Such an intent-based test makes nonsense of the Sherman Act, contradicts precedent, and risks undermining vigorous market competition and effective government enforcement if left unchecked. Great for monopolists, bad for American consumers.”
The appeal is ongoing, and the First Circuit has not yet scheduled oral argument.