"The Solicitor General has recommended that the Supreme Court grant certiorari in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, to resolve whether a generic manufacturer's FDA-compliant carved-out labeling and basic commercial statements can constitute active inducement of patent infringement. The government's December 2025 brief argues that the Federal Circuit's decision threatens to undermine the Hatch-Waxman Amendments' balance between promoting generic competition and protecting patent rights."
"Although the statute does not create immunity per se, the brief argues that the appellate panel erred by treating communications integral to the section viii skinny label pathway as evidence of culpable inducement -- and thus created a substantial disincentive for generic manufacturers to invoke a mechanism that Congress explicitly designed to prevent method-of-use patents from creating de facto monopolies on entire drug compounds."
The Solicitor General urges the Supreme Court to decide whether FDA-compliant carved-out labeling and basic commercial statements by a generic manufacturer can amount to active inducement of patent infringement. The government contends the Federal Circuit's ruling risks upsetting the Hatch-Waxman balance between promoting generic competition and protecting patent rights. The brief states the statute does not grant blanket immunity but faults the appellate panel for treating communications integral to the section viii skinny-label pathway as evidence of culpable inducement. The brief warns that the ruling deters generics from using the skinny-label mechanism that prevents method-of-use patents from monopolizing entire drug compounds. The case concerns Hikma's generic of Vascepa, where the compound patents expired, certain method-of-use patents were invalidated, and a cardiovascular-risk use patent remains at issue.
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