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On January 16, 2026, the Supreme Court of the United States granted certiorari in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889) to address when induced-infringement liability can attach to a generic drug launched under a "skinny label." The grant centers on review of the Federal Circuit's decision allowing Amarin's inducement claims to proceed notwithstanding Hikma's carveout, and it tees up the relationship between the Food and Drug Administration's (FDA) carveout pathway and 35 U.S.C. § 271(b).
Amarin's Vascepa (icosapent ethyl) is approved for treating severe hypertriglyceridemia (SH indication) with a blood triglyceride at least 500 mg/dL and cardiovascular risk reduction (CV indication) for a patient having a blood triglyceride at least 150 mg/dL. Hikma then obtained the FDA's approval and launched its generic product with a carveout that omitted the CV indication claimed by Amarin's two method-of-use patents, limiting its labeling to the SH indication. Amarin sued Hikma for induced infringement and argued that Hikma's label and public statements instructed physicians to use the generic product for the patented indication. The District Court of Delaware dismissed the inducement claims at the pleadings stage. In 2024, the Federal Circuit reversed, holding that "even if the skinny label alone may not encourage any infringing use for the patented CV indication" the complaint plausibly pled inducement when the label was evaluated alongside the alleged nonlabel materials, allowing the case to proceed. Citing itsGSK precedent on skinny labels, the Federal Circuit noted that it needs to review the totality of allegation of inducement, take the allegations as true and determine the plausibility of the complaint based on the pleading standard adopted by the Third Circuit.
On Hikma's appeal, the Supreme Court has agreed to hear the case. Hikma presented two legal questions:
- When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a "generic version" and cites public information about the branded drug (e.g., sales) enough to plead induced infringement of the patented use?
- Does a complaint state a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use?
The skinny-label regulation, 21 U.S.C. § 355(j)(2)(A)(viii), authorizes FDA to approve generic labels that carve out patented methods. Separately, 35 U.S.C. § 271(b) imposes liability for inducement and requires specific intent, proven by conduct that, in context, encourages, recommends or promotes the patented use and causes infringement by others. The Federal Circuit's ruling in Amarin v. Hikma and the GSK case appears to have added uncertainty to the statutory skinny label practices. In recent years, a lingering question is whether and how a generic company can use a skinny label to fully carve out a patented use without liability of induced infringement.
The Supreme Court's review has immediate implications for launch planning, labeling strategy, marketing strategy and litigation risk for products using skinny label carveouts. A decision that tightens inducement standards in the skinny label context would reinforce the carveout pathway and may support earlier generic entry post-exclusivity; a decision validating broader inducement theories could drive more conservative launches and stricter controls on public statements and medical information responses. In the interim, generic manufacturers intending to use skinny labels may still need to perform both technical and legal analyses to determine whether a skinny label fully carves out a patented use, as well as securitize any public statements and promotional materials to mitigate risk.
For More Information
If you have any questions about this Alert, please contact Jiazhong (Jason) Luo, Ph.D., Frederick R. Ball, any of the attorneys in our Life Sciences and Medical Technologies Industry Group, any of the attorneys in our Intellectual Property Practice Group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.
