The Supreme Court granted certiorari in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889) on January 16, 2026, to address when induced-infringement liability can attach to generic drugs launched under a 'skinny label' that carves out patented uses23
The case centers on whether a generic drug manufacturer's marketing of its product as a generic version and public statements about a branded drug constitute induced patent infringement when the generic label omits the patented indication13
The Federal Circuit reversed a district court dismissal in 2024, finding that Amarin's inducement claims were plausible when considering the totality of Hikma's label and public statements together23
Hikma argues the Federal Circuit's approach effectively nullifies the FDA's skinny label carveout pathway under 21 U.S.C. § 355(j)(2)(A)(viii)24
After the Supreme Court requested the views of the United States, the Solicitor General submitted a brief supporting Hikma's petition for review2
The Supreme Court must decide whether allegations that a generic drugmaker calls its product a 'generic version' and cites public information about the branded drug are sufficient to plead induced infringement when the label fully carves out the patented use3
Sources:
1. https://www.bipc.com/client-update-supreme-court-takes-up-skinny-labels-granting-certiorari-in-hikma-v.-amarin
2. https://www.mcguirewoods.com/client-resources/alerts/2026/1/skinny-facts-may-limit-supreme-courts-decision-in-skinny-label-generic-drug-approval-case/
3. https://www.duanemorris.com/alerts/ussupremecourtgrantscertiorarihikmaamarinplacingskinnylabelinducementfocus0126.html
4. https://www.biosimilarsip.com/2026/01/20/supreme-court-to-address-skinny-label-patent-disputes/