Supreme Court to Hear Hikma v. Amarin on April 29, Weighing Skinny Label and Induced Infringement

The U.S. Supreme Court will hear oral argument on April 29, 2026, in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, a case that presents the question of whether a generic drug manufacturer can face induced patent infringement liability based on marketing statements describing its product as the “generic version” of a branded drug, even when the generic’s label lawfully carves out all patented uses under the Hatch-Waxman Act framework.

The Product and the Patents

Amarin Pharma holds FDA approval for Vascepa (icosapentaenoic acid), a high-purity omega-3 fatty acid drug approved for two separate indications. The first indication, for severe hypertriglyceridemia in adults with fasting triglyceride levels of 500 mg/dL or higher, received FDA approval in 2012 and is not covered by the patents at issue. The second indication, for reducing the risk of cardiovascular events in adults with elevated triglycerides who are already on a statin, received FDA approval in 2019 and is protected by Amarin’s patents.

Under the Hatch-Waxman Act, a generic manufacturer may obtain FDA approval using a “skinny label” that carves out patented indications, allowing market entry without exposing the generic to infringement liability for the patented uses. Hikma Pharmaceuticals USA Inc. obtained FDA approval for its generic icosapentaenoic acid product using a skinny label describing only the non-patented hypertriglyceridemia indication.

The Disputed Marketing Conduct

The dispute centers on Hikma’s promotional conduct following launch. Hikma issued press releases describing its generic product as “the generic version of Vascepa” and publicly referenced clinical data associated with Vascepa’s cardiovascular indication. That data was derived from a major cardiovascular outcomes trial supporting the patented cardiovascular use. Amarin alleges that this conduct induced physicians and patients to use Hikma’s product for the cardiovascular indication, thereby infringing Amarin’s patents.

The U.S. Court of Appeals for the Third Circuit held that Amarin’s complaint plausibly alleged a claim for induced infringement and declined to dismiss the suit. The Supreme Court granted certiorari in January 2026.

Questions Before the Court

The Court will address two questions. First, when a generic drug label fully carves out a patented indication in accordance with the Hatch-Waxman Act, does a manufacturer’s description of its product as “the generic version” of the branded drug, combined with references to publicly available information about the brand, constitute sufficient allegations to plead active inducement to infringe? Second, can a complaint state a claim for induced infringement when it alleges no specific instruction or statement that directly encourages or mentions the patented use?

Government Participation

The Supreme Court granted the Solicitor General’s motion for leave to present oral argument as amicus curiae and for divided argument time. Three parties will address the Court: Hikma, Amarin, and the United States government. The government’s position is expected to reflect the dual policy interests in preserving access to affordable generic medicines and protecting the incentives for pharmaceutical innovation that patent exclusivity provides.

Industry Implications

The skinny label mechanism is a foundational tool for the generic drug industry, permitting market entry before all of a brand’s patents expire. If the Supreme Court holds that describing a product as a “generic version” of a branded drug can sustain an induced infringement claim, the practical utility of skinny labeling as an entry strategy will be substantially reduced, regardless of what the label itself says. A ruling for Hikma would reaffirm the protection afforded by carve-out labeling when the label itself does not reference the patented use.

Notably, at least seven other generic manufacturers sell icosapentaenoic acid products using materially identical skinny labels, yet Amarin has not sued any of them. The selective nature of Amarin’s enforcement is expected to be a focus of argument, bearing on whether Hikma’s marketing conduct specifically distinguishes its situation from that of the non-sued manufacturers. The Supreme Court’s decision is expected before the end of the October 2025 term in summer 2026.