Supreme Court Decision in Skinny-Label Induced Infringement
On June 4, 2026, Justice Jackson wrote for a unanimous Court reversing the Federal Circuit, holding Amarin failed to plausibly allege that Hikma actively induced infringement through its generic.
NDA, ANDA, and “Skinny Labels”
Pharmaceutical companies usually submit a new drug application (NDA) to the FDA with full data on quality, safety, and efficacy for their new brand-name drugs. Under the Hatch-Waxman Act of 1984, a special process is created under the abbreviated new drug application (ANDA) for generic manufacturers to enter the market by establishing pharmaceutical equivalence and bioequivalence of their generic drug to the FDA-approved brand-name counterpart. An DNA holder may seek to exclude others from making, using, or importing their brand-name drug by obtaining patents on the active ingredient, compositions, formulations, and methods of use, etc. A method-of-use patents may claim an approved method of using the drug (indication). For each such patent, the NDA holder submits a short statement describing all patented uses to the FDA, known as the patent “use code”. Upon approval, FDA publishes the use codes in the “Orange Book” as-is without construing the patent claims. For ANDA filers to avoid infringing on the exclusivity of rights maintained by the brand-name drug patents, they could enter the market by either certifying that they are not seeking approval of patented uses via a Section viii statement or certifying that the patent is either invalid or would not be infringed via a Paragraph IV certification. The former is typically used when the patent use codes do not cover all methods of use due to listed patents claiming too vaguely or too narrowly. If the patent narrative is too broad, the ANDA filers may seek the latter action to argue the unenforceability of the listed patent and resolve the boundary of the claimed indications in federal court. With a Section viii statement, the ANDA filers may carve out the still-patented uses in their proposed labeling while seeking approval only for non-patented or patent-expired uses, resulting in the so-called “skinny labels”. Nevertheless, the remaining language may still point toward the protected medical indications. Together with external factors such as marketing as the generic equivalent, skinny-labels may lead to unavoidable off-label prescriptions of the generic drug by doctors for still-patented, carve-out indications, raising the question whether such conduct constitutes induced infringement.
Hikma v. Amarin
Amarin Pharma, Inc. developed the brand-name drug Vascepa®, originally approved for the treatment of severe hypertriglyceridemia (the “SH indication”) in 2012 and later for reducing cardiovascular risk in hypertriglyceridemia patients (the “CV indication”) in 2019. Hikma Pharmaceuticals USA Inc. sought to manufacture a generic version of Vascepa® initially via a paragraph IV certification challenging the validity of the SH-indication patent. After a district court affirmed the invalidity claim, Hikma applied for and was approved for a skinny label for the “SH indication”, carving out the still-patented “CV indication” in 2020. Amarin sued Hikma thereafter, alleging induced infringement through Hikma's skinny label omission, the patient information leaflet, press releases, and marketing statements. In 2024, the Federal Circuit found it at least plausible that a physician could read the relevant statements as an instruction or encouragement to infringe. On June 4, 2026, the Supreme Court unanimously ruled that Amarin had not plausibly alleged that Hikma actively encouraged infringing use. The Supreme Court reversed the Federal Circuit judgment of “whether doctors could plausibly read the alleged statements as instructions to infringe” as the central question.
The supreme court holds that this case concerns with whether Amarin has sufficiently alleged that Hikma has taken active steps in encouraging direct infringement. The Supreme Court reasoned that statements on Hikma’s actions to comply with the “duty of sameness” law or standard industry practice, i.e., retaining identical clinical study in the skinny label for non-carved out use, and description as the generic equivalent, do not support liability. Secondly, mere omissions, inactions, and nonfeasance, such as the omission of the more common CV use in the skinny label approved for the less common SH indication, do not constitute affirmative statements or actions to induce liability. Lastly, Amarin may not rely on vague statements in patient information leaflet, Hikma’s website description, and the sale figures in Hikma’s press releases combined with speculation as probative evidence of affirmative inducement. In addition, the Court emphasizes that active inducement need not be express. Although the Court raises the bar on the requirement for affirmative actions in alleging induced infringement, this ruling does not relieve the burden of generic manufactures to adopt clear language in skinny labels, marketing, and sales to focus only on non-patented use while complying to regulatory standards.
