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Docket 24-889October Term 2025 (2025–2026)

Hikma Pharmaceuticals USA Inc., et al., Petitioners v. Amarin Pharma, Inc., et al.

This case considers whether a generic drug manufacturer can be held liable for inducing patent infringement when it excludes a patented use from its label but markets its product as a generic version of the brand-name drug. It also addresses what specific allegations of encouraging the patented use are required for an infringement complaint to survive dismissal.

Case overview

Dispute
This case considers whether a generic drug manufacturer can be held liable for inducing patent infringement when it excludes a patented use from its label but markets its product as a generic version of the brand-name drug. It also addresses what specific allegations of encouraging the patented use are required for an infringement complaint to survive dismissal.
Issue
The Court is deciding whether 1. When a generic drug manufacturer excludes a patented use from its label, can it still be liable for inducing infringement if it calls its product a “generic version” of the brand-name drug and cites publicly available information about the brand-name drug’s sales? 2. Can a patent infringement complaint survive dismissal if it does not allege that the defendant made any statement specifically instructing or encouraging the patented use.
Current posture
Argued Apr 29, 2026.

Question

Question presented

1. When a generic drug manufacturer excludes a patented use from its label, can it still be liable for inducing infringement if it calls its product a “generic version” of the brand-name drug and cites publicly available information about the brand-name drug’s sales? 2. Can a patent infringement complaint survive dismissal if it does not allege that the defendant made any statement specifically instructing or encouraging the patented use?

Plain English

The Court is deciding whether 1. When a generic drug manufacturer excludes a patented use from its label, can it still be liable for inducing infringement if it calls its product a “generic version” of the brand-name drug and cites publicly available information about the brand-name drug’s sales? 2. Can a patent infringement complaint survive dismissal if it does not allege that the defendant made any statement specifically instructing or encouraging the patented use.

Procedural posture

Case AcceptedJan 16, 2026
Arguments HeardApr 29, 2026
Decision ReleasedUpcoming
Originating court
United States Court of Appeals for the Federal Circuit
Supreme Court review
Granted Jan 16, 2026
Argument
Held Apr 29, 2026
Opinion
Not released

Who is watching

Legal area
Patent Law
Institutional path
United States Court of Appeals for the Federal Circuit decision under Supreme Court review
What changes next
The next public milestone is the Court's disposition.
Term context
Awaiting Decision in October Term 2025 (2025–2026)