Amarin Corp Plc (AMRN)

[kenyboy]

Below is my OPINION based on my analysis of the oral argument:



SUPREME COURT OF THE UNITED STATES

No. 24-123
Hikma Pharmaceuticals USA Inc., et al. v. Amarin Pharma, Inc.
[Decided: June 2026]

Justice Barrett delivered the opinion of the Court.

Amarin Pharma, Inc. brought this action alleging that Hikma Pharmaceuticals induced infringement of Amarin’s method-of-use patents covering the treatment of severe hypertriglyceridemia. The district court dismissed the complaint at the pleading stage, concluding that Hikma’s generic product—approved only for the treatment of hypertriglyceridemia—could not, as a matter of law, induce infringement because its labeling complied with the FDA’s carve-out regulations. The court further denied Amarin leave to amend.

We conclude that the district court applied an incorrect legal framework. By collapsing the brand-name and generic labels into a single undifferentiated “product,” the court failed to assess inducement under the governing statutory and doctrinal standards. And by resolving factual disputes and drawing inferences against the non-movant, the court departed from the procedural requirements of Rule 12(b)(6). We therefore reverse and remand.


Amarin markets Vascepa, a prescription omega-3 product approved for multiple indications, including the treatment of severe hypertriglyceridemia. Amarin holds method-of-use patents covering that indication. Hikma sought approval to market a generic version of Vascepa with a “skinny label” that carved out the patented indication. The FDA approved Hikma’s product for the treatment of “hypertriglyceridemia.”

Amarin alleges that Hikma’s labeling, marketing, and communications nevertheless encouraged physicians to prescribe the generic for the patented use. In particular, Amarin points to Hikma’s use of the term “hypertriglyceridemia” without the modifier “severe,” which Amarin contends captures the same patient population as the patented indication. The district court dismissed the complaint, reasoning that Hikma’s compliance with FDA labeling rules foreclosed inducement as a matter of law.

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II

The Patent Act imposes liability on one who “actively induces infringement of a patent.” 35 U. S. C. §271(b). We have repeatedly held that inducement turns on intent and affirmative acts—not on regulatory compliance. Global-Tech Appliances, Inc. v. SEB S. A., 563 U. S. 754 (2011). A generic manufacturer may comply with FDA carve-out rules and still induce infringement if its conduct encourages physicians to practice a patented method. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F. 4th 1320 (CA Fed. 2021).

The district court erred by treating FDA compliance as dispositive. The question is not whether Hikma followed FDA regulations, but whether Amarin plausibly alleged that Hikma’s actions encouraged infringement. By collapsing the brand and generic labels into a single “product,” the court sidestepped that inquiry entirely.

At the pleading stage, the court must accept well-pleaded allegations as true and draw reasonable inferences in the plaintiff’s favor. Ashcroft v. Iqbal, 556 U. S. 662 (2009). Instead, the court drew inferences against Amarin, resolved factual disputes about the meaning of Hikma’s labeling, and treated the absence of explicit infringing language as dispositive. That was error.

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III

The district court also abused its discretion in denying leave to amend. Rule 15(a)(2) instructs courts to “freely give leave when justice so requires.” We have emphasized that amendment should be permitted unless it would be futile or cause undue prejudice. Foman v. Davis, 371 U. S. 178 (1962). The court offered no persuasive reason to depart from that standard.

Amarin sought to add allegations regarding Hikma’s marketing materials, sales practices, and communications with physicians. Those allegations bear directly on inducement. The court’s refusal to allow amendment rested on the same legal errors that infected its dismissal.

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IV

We express no view on whether Hikma in fact induced infringement. That question remains for the district court to address on a proper record. Our holding is narrow: the district court applied the wrong legal standard, resolved factual disputes inappropriate for a motion to dismiss, and improperly denied leave to amend.

The judgment of the Court of Appeals is reversed, and the case is remanded for further proceedings consistent with this opinion.

It is so ordered.