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ARTICLE · 01 JULY 2026

Practical Tips After U.S. Supreme Court’s Hikma v. Amarin Case

Upadhye Tang
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The Supreme Court's unanimous decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. fundamentally reshapes the legal landscape for generic drug manufacturers pursuing skinny-label strategies under Section viii carve-outs. By rejecting the Federal Circuit's reader-focused approach and requiring affirmative, purposeful conduct to establish induced infringement, the Court provides substantial new protections while leaving critical questions about implicit inducement and commercial communications pr

United StatesIntellectual Property
Shashank Upadhye
Shashank Upadhye
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Executive Summary

On June 4, 2026, the U.S. Supreme Court unanimously reversed the Federal Circuit in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., holding that Amarin failed to plausibly plead induced infringement under 35 U.S.C. §271(b).

The decision represents the most significant Supreme Court guidance on skinny-label induced infringement since Caraco and provides substantial protection for generic manufacturers pursuing Section viii carve-outs. Most importantly, the Court rejected the Federal Circuit’s recent trend of focusing on what physicians, pharmacists, or other readers might infer from a generic manufacturer’s statements. Instead, the Court held that the proper inquiry is whether the generic manufacturer itself engaged in affirmative, purposeful conduct designed to encourage infringement.

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