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 March 23, 2026, the Court granted the Solicitor General’s motion to participate in oral argument as amicus curiae and for divided argument. That order signals the federal government’s view that the questions presented carry significant policy weight, particularly for the Hatch-Waxman framework that governs generic drug entry. Amarin filed its respondent’s brief on March 20, 2026, completing the merits briefing and setting the stage for argument.
The dispute arises from Amarin’s branded cardiovascular drug Vascepa. Hikma sought approval for a generic version using a “skinny label” that carved out Amarin’s patented use. The Federal Circuit’s June 2024 opinion held that Amarin had adequately pleaded induced infringement based in part on Hikma’s use of the phrase “generic version” in its marketing and its references to Vascepa’s sales figures. Hikma argues that such allegations, untethered from any instruction to perform the patented method, cannot support an infringement claim.
The two questions presented go to the heart of what induced infringement requires. The Court will consider whether routine commercial communications — ones that never mention the patented use — can satisfy that standard. The 21 amicus briefs, including submissions from patent law professors and industry groups taking no side, reflect genuine uncertainty about where the line falls.
The outcome will affect how reliably generic manufacturers can rely on carve-outs to enter markets before patent expiration. A ruling that ordinary marketing language suffices to plead inducement would deter generic entry and raise costs for patients. More information on the case is available at the Oyez project.