About this episode

The episode discusses the Supreme Court case involving Hikma Pharmaceuticals and Amarin Pharma regarding patent infringement and generic drug marketing.

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…

People in this episode

Guests: Charles B. Klein, Malcolm L. Stewart, Michael R. Huston

Topics covered

• patent law
• generic drugs
• pharmaceutical marketing
• court cases
• legal arguments

Keywords

• Hikma Pharmaceuticals
• Amarin Pharma
• patent infringement
• generic drugs
• Supreme Court

Mentioned in this episode

Organizations: Hikma Pharmaceuticals USA Inc., Amarin Pharma, Inc., Winston & Strawn LLP, Department of Justice, Perkins Coie LLP

Books & works: Hatch-Waxman

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