Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.

Hikma Pharmaceuticals versus Amarin Pharma, decided June 4th, 2026. A unanimous Supreme Court, in an opinion by Justice Jackson, reversed the Federal Circuit and held that Amarin failed to state a claim that Hikma induced infringement of its method-of-use patents by selling a generic drug under a so-called skinny label. Under section 271(b), the question is whether the defendant actively encouraged infringement — not whether doctors could plausibly read its statements as encouragement. Here's the brief.

Amarin makes Vascepa, whose active ingredient is icosapent ethyl. The FDA first approved it in 2012 for severe hypertriglyceridemia. In 2019, the FDA approved a second, far more common use — reducing cardiovascular risk in patients already taking statins — and Amarin obtained two method-of-use patents covering that cardiovascular indication.

Hikma wanted to sell a generic. After earlier litigation invalidated Amarin's patents on the original indication, Hikma took Hatch-Waxman's section viii pathway: it filed a statement that it would not seek approval for the patented use, and proposed a skinny label — a label limited to the older, now-unpatented indication, carving out the patented cardiovascular use. The FDA approved it in 2020 with an "AB" rating, meaning therapeutically equivalent to Vascepa when used according to its labeling.

Amarin sued in the District of Delaware for induced infringement. It conceded the skinny label standing alone did not induce. Instead, it relied on the totality of Hikma's statements: the label retained data from a clinical study involving patients on statins; the patient leaflet warned of side effects in people with cardiovascular disease and noted that medicines are sometimes prescribed for other purposes; Hikma's website listed the therapeutic category as hypertriglyceridemia and noted the AB rating; and press releases called the product "generic Vascepa" while touting sales figures spanning both uses.

The district court dismissed the complaint. The Federal Circuit reversed, holding it "at least plausible that a physician could read" those statements as encouragement to infringe.

The question presented: do those allegations state a claim for active inducement of infringement?

The statute is one sentence: whoever actively induces infringement of a patent shall be liable as an infringer. The Court's precedents supply three elements.

First, direct infringement by a third party. Second, knowledge that the induced acts constitute infringement. Third — the element in dispute here — active steps to encourage direct infringement. And because the case arose on a motion to dismiss, the ordinary Twombly and Iqbal standards applied: the complaint must allege facts making liability plausible, not merely possible, and must rule out obvious alternative explanations.

The Court held, unanimously, that Amarin's complaint failed.

Active steps, under Grokster, mean purposeful, culpable expression and conduct — affirmative, not passive — and they exclude ordinary acts incident to product distribution.

The reasoning came in three moves. First, most of Hikma's statements had an obvious alternative explanation: legal compliance and industry practice. By statute, a generic's label must match the brand's except for the carved-out use, and describing a generic as equivalent to the brand-name drug is, under Inwood Laboratories, normal industry practice.

Second, omissions — what the label and press releases failed to say — cannot show active inducement. Citing Twitter against Taamneh, the Court held that mere omissions, inactions, or nonfeasance do not qualify. Third, the remaining statements were simply too vague: a leaflet that warns patients with cardiovascular disease is an implausibly roundabout way to induce that very use, and investor-directed sales figures required a chain of events the Court called possible, but not plausible.

One calibration on the other side: the Court rejected Hikma's argument that inducement must be express. Implicit encouragement can qualify — but it must be clear, and it must be affirmative.

Hikma is the Supreme Court's first decision on skinny labels since Hatch-Waxman created them, and it realigns section 271(b) with the Grokster line: inducement is measured by what the defendant affirmatively did to encourage infringement, not by how an audience might read its statements. In a footnote, the Court expressly rejected the Federal Circuit's contrary trend, exemplified by GlaxoSmithKline against Teva. The case stands for this rule: compliance with the labeling statute and industry-standard statements of equivalence, without affirmative promotion of the patented use, do not plead active inducement.

Hikma Pharmaceuticals against Amarin Pharma, 608 U.S., decided June 4th, 2026. I'm John Goodhue. Thanks for watching.