The United States Supreme Court hears oral arguments this week in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889). The Cyberlaw Clinic filed an amicus brief in the case on behalf of the Public Interest Patent Law Institute (PIPLI). The case concerns whether induced infringement liability can attach to a generic drug launched under a “skinny label” when the generic drugmaker refers to its product as the “generic version” of the brand-name drug and cites public sales data about the brand-name drug. The brief supported neither party and highlighted potential impacts of the case on the drug market and the public’s access to affordable health care. In the brief, PIPLI urged the Court to preserve: (1) the balance between encouraging pharmaceutical innovation and ensuring timely public access to lower-cost drugs; and (2) Congress’s requirement of specific intent to find induced infringement of a patent under Section 271(b) of the Patent Act.
This case concerns Hikma Pharmaceuticals’ use of the skinny label pathway, which allows generic manufacturers to obtain FDA approval for a generic drug before all patents for a brand-name drug have expired. If a brand-name drug company has a patent for a certain use of a drug compound, a generic company can enter the market for other non-patented uses of that same drug compound using a skinny label. In this case, Amarin (the brand-name company), had a patent for icosapent ethyl to treat patients with a certain blood-triglyceride level. Hikma (the generic company) obtained a skinny label patent for icosapent ethyl to treat patients with a different blood-triglyceride level. Amarin alleged that Hikma induced infringement of Amarin’s patent, primarily based on public statements in which Hikma referred to its drug as the “generic version” of Amarin’s drug.
Amarin argued that Hikma’s language induced infringement by promoting Hikma’s drug for all possible uses of the compound, including uses covered exclusively by Amarin’s patent and not included Hikma’s skinny label patent. The United States Court of Appeals for the Federal Circuit held that Amarin’s allegations plausibly stated a claim for induced infringement. Hikma filed a petition for a writ of certiorari, which the Supreme Court granted on January 16, 2026.
In the brief, amicus curiae PIPLI argues that when Congress authorized the skinny label pathway through Section VIII of the Hatch-Waxman amendments, they relied on the settled understanding that Section 271(b)’s specific intent requirement for induced infringement is critical to balance innovation and low-cost drug access. Inducement liability has long required that the alleged inducer purposefully encourage infringement. If generic manufacturers could face liability for engaging in truthful marketing and lawful competition, they may delay or even abandon the pursuit of skinny label patents altogether. This risks further entrenching monopolistic practices and rendering the Section VIII skinny label pathway effectively meaningless.
PIPLI’s brief highlights several harmful market effects that could result from a finding of induced infringement in this case. These market effects risk reducing access to significantly cheaper generic versions of drugs. Of particular note, uncertainty as to which marketing statements are permissible will raise compliance costs for generic manufacturers. Uncertainty about liability may chill lawful speech by generic manufacturers. And, less clear and less effective communication from generic manufacturers may decrease uptake of generic drugs due to confusion. All of these impacts on generic manufacturers will ultimately increase the cost of drugs for American patients.
Several amici filed briefs weighing in on the scope of inducement liability in the Hatch-Waxman skinny label context. The United States, appearing as amicus curiae in support of the Petitioners, argued that the Federal Circuit’s decision threatens the statutory framework Congress created to enable generic competition. According to the Solicitor General, inducement under 35 U.S.C. § 271(b) requires affirmative encouragement of infringement, and a generic manufacturer that lawfully carves out patented uses from its FDA-approved label should not face liability merely because physicians might prescribe the drug for those uses. Former Congressman Henry A. Waxman—co-author of the Hatch-Waxman Act—likewise supported the Petitioners, contending that the Federal Circuit’s approach undermines the legislative compromise embodied in the Act by effectively penalizing generic manufacturers that rely on the statutory carve-out mechanism. A group of seventy-six scholars in law, business, economics, and medicine also filed in support of Petitioners, emphasizing that inducement should require clear, affirmative conduct encouraging infringement and warning that a broader rule would discourage use of skinny labels and reduce generic competition.
Other amici filed in support of neither party, urging the Court to clarify the governing doctrine. Patent law professors Paul Gugliuzza and Jacob Sherkow (working with Stanford Law School’s Juelsgaard Intellectual Property and Innovation Clinic) focused their brief on the Federal Circuit’s reliance on drug labeling: they assert that treating FDA-mandated labeling as evidence of inducement improperly expands § 271(b) because labeling primarily reflects regulatory compliance, not promotional encouragement. Industry groups including the Intellectual Property Owners Association and the New York Intellectual Property Law Association likewise filed briefs supporting neither party but emphasizing doctrinal clarity from a different perspective: they urged the Court to preserve traditional inducement principles while providing clearer guidance on how those principles apply in the Hatch-Waxman setting, warning that uncertainty about when labeling or other communications constitute “encouragement” risks destabilizing both patent enforcement and the regulatory framework for generic drugs.
Spring 2026 Cyberlaw Clinic students Millie Kim, Alex Curylo, and Maya Arora worked on the brief alongside Alex Moss, Executive Director of the Public Interest Patent Law Institute. The students were supervised by Christopher Bavitz and Michael Rosenbloom at the Cyberlaw Clinic. The Supreme Court is set to hear oral arguments on April 29, 2026. The Clinic looks forward to the Supreme Court’s decision in this case.