Episode
Oral Argument Re-Listen: Hikma Pharmaceuticals v. Amarin Pharma | Generic Drug Beats Patent Trap
- Podcast
- The High Court Report
- Published
- Jun 11, 2026
- Duration seconds
- 3738
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Summary
Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. | Case No. 24-889 | Docket Link: Here | Argued: 04/29/2026 | Decided: 06/04/2026 Oral Advocates: Petitioners (Hikma): Charles B. Klein of Winston & Strawn LLP Amicus Curiae (United States): Malcolm L. Stewart of the Department of Justice Respondents (Amarin Pharma): Michael R. Huston of Perkins Coie LLP Overview: Amarin's cardiovascular drug patent faced challenge when generic maker Hikma launched a skinny-label version and marketed it through statements Amarin claimed encouraged doctors to prescribe the generic for the still-patented heart indication. Question Presented: Whether a generic drug maker's marketing statements plausibly constitute "active steps" inducing patent infringement under 35 U.S.C. §271(b). Posture: District Court dismissed; Federal Circuit reversed; Supreme Court reversed and remanded. Main Arguments: Petitioner (Hikma): (1) Statements fully consistent with lawful skinny-label marketing cannot constitute active inducement under §271(b); (2) Federal law mandated the label's contents, making legal compliance an obvious alternative explanation that forecloses liability; (3) The Federal Circuit's physician-reading standard would destroy the Hatch-Waxman section viii pathway and expose generics to devastating litigation risk. Respondent (Amarin): (1) Hikma's totality of statements — repeatedly invoking "generic Vascepa," using an overbroad therapeutic category, and touting Vascepa's billion-dollar sales — plausibly encouraged infringing use; (2) Amarin spent $300 million discovering the cardiovascular indication and patent law must protect that investment from free-riders; (3) Seven other generic manufacturers avoided liability by accurately describing only their narrow approved uses, demonstrat…