Case: Hikma Pharmaceuticals USA Inc., et al. v. Amarin Pharma, Inc., et al., No. 24-889
Lower Court: Federal Circuit
Docketed: 2025-02-19
Status: Granted
Question Presented: 1. 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? 2. 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?
On April 13, 2026, Hikma filed its reply brief, completing merits briefing in this closely watched generic drug dispute. The reply arrives alongside a substantial amicus showing. Briefs filed on March 27 from brand manufacturers including Sanofi, Regeneron, AbbVie, and PhRMA, as well as from former Federal Circuit Chief Judge Paul R. Michel and a group of academic medical centers, reflect the breadth of industry concern about how the Court resolves the “skinny label” question. The SCOTUSBlog case page tracks the full filing record.
The underlying dispute centers on whether a generic drugmaker that fully carves out a patented use from its label can nonetheless face induced infringement liability. Amarin sued Hikma, pointing to marketing materials describing its product as a “generic version” of the branded drug and citing the branded drug’s sales figures. Hikma argues this approach effectively nullifies the skinny-label mechanism Congress built into the statutory framework. Amarin responds that deliberate free-riding on a brand’s reputation can constitute inducement.
The Court’s answer will set the outer boundary of induced infringement liability for generic manufacturers across the pharmaceutical industry. If brand-referencing marketing alone suffices, the skinny-label pathway becomes considerably less reliable as a tool for bringing lower-cost generics to market while respecting valid patents.