Oral Argument: Hikma v. Amarin

Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. | Case No. 24-889 | Docket Link: Here

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

Question Presented: Whether a generic drugmaker that fully carves patented uses from its label actively induces patent infringement through investor press releases and website statements that do not mention, encourage, or instruct the patented use

Overview: Generic drugmaker Hikma followed federal skinny-label law but called its product "generic Vascepa" and touted Vascepa's total sales. Brand manufacturer Amarin claims those statements actively induced doctors to prescribe the generic for a patented cardiovascular use worth over $900 million annually.

Posture: District court dismissed; Federal Circuit reversed; Supreme Court granted certiorari January 2026.

Main Arguments:

• Hikma (Petitioner): (1) "Actively" induces requires affirmative steps encouraging infringement — none of Hikma's statements mention or instruct the patented use; (2) Amarin's theory of liability imputes inferences physicians might draw, not active steps Hikma took; (3) The Federal Circuit's decision effectively nullifies the section viii skinny-label pathway Congress created to speed generic competition

• Amarin (Respondent): (1) Hikma advertised its generic for "Hypertriglyceridemia" — a category encompassing the patented cardiovascular use — going beyond compliant labeling; (2) Press releases calling the product "generic Vascepa" and touting $919 million to $1.1 billion in total Vascepa sales plausibly encouraged prescribers to use the generic for all of Vascepa's indications; (3) Seven other generic manufacturers selling identical skinny-label products avoided suit by accurately limiting their marketing — proving that compliant speech and section viii coexist

Implications: Hikma victory establishes that skinny-label compliance shields generic manufacturers from inducement liability for accurate commercial descriptions, protecting the section viii pathway that delivers billions in consumer drug savings annually. Amarin victory confirms that post-label marketing conduct — even investor communications — can cross the line into active patent infringement inducement, preserving incentives for brand manufacturers to invest hundreds of millions in discovering new therapeutic uses. The Court's answer defines the legal boundary between ordinary commerce and unlawful inducement for the entire pharmaceutical industry.

The Fine Print:

• 35 U.S.C. § 271(b): "Whoever actively induces infringement of a patent shall be liable as an infringer"

• 21 U.S.C. § 355(j)(2)(A)(viii): Permits a generic manufacturer to file a statement seeking approval only for uses not covered by the brand manufacturer's listed method-of-use patents, allowing the generic to carry a "skinny label" that carves out still-patented uses

Primary Cases:

• Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd. (2005): Inducement liability requires "clear expression or other affirmative steps taken to foster infringement" — mere knowledge that a product may reach infringing uses does not suffice; liability demands "statements or actions directed to promoting infringement"

• Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S (2012): Congress designed the section viii skinny-label mechanism to ensure "that one patented use will not foreclose marketing a generic drug for other unpatented ones," expediting generic competition as soon as patents allow

Timestamps:

[00:00:00] Argument Preview

[00:01:41] Oral Advocates

[00:01:58] Argument Begins

[00:02:06] Hikma Opening Statement

[00:04:13] Hikma Free for All Questions

[00:12:50] Hikma Round Robin Questions

[00:13:17] United States Opening Statement

[00:14:29] United States Free for All Questions

[00:24:44] United States Round Robin Questions

[00:30:09] Amarin Opening Statement

[00:32:34] Amarin Free for All Questions

[00:58:56] Amarin Round Robin Questions

[00:59:06] Hikma Rebuttal