The Supreme Court unanimously held that for a complaint of induced infringement, a patent owner must allege that the accused infringer took affirmative, not passive, steps to encourage direct infringement. Thus, where a generic drug has a skinny label, to induce infringement of the carved-out patented use of the drug, the generic company must have taken steps that were designed to cause others to perform the patented use, not just steps that could cause such conduct.
In Hikma v. Amarin, branded-drug company Amarin initially received approval for Vascepa® to treat severe hypertriglyceridemia. The original label disclosed that the drug’s effect on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia had not been determined (“CV Limitation of Use”). The FDA later approved Vascepa® for reducing cardiovascular risk in certain patients already taking statins (“CV indication”). Amarin revised Vascepa®’s label to remove the CV Limitation of Use. Generic-drug company Hikma sought and obtained FDA approval for a generic version of Vascepa®, but only for the unpatented indication to treat severe hypertriglyceridemia, i.e., Hikma had carved out the patented CV indication from its proposed generic drug and had a skinny label.
Amarin filed a complaint in the District of Delaware, alleging that Hikma had induced infringement of the patented CV indication notwithstanding the skinny label. Specifically, Amarin alleged that Hikma induced infringement through the combined effect of statements in its skinny label, patient information leaflet, website, and prelaunch press releases. The District Court dismissed the complaint for failure to state a claim. On appeal, the Federal Circuit reversed, finding it was “at least plausible that a physician could read” the relevant statements “as an instruction or encouragement to” infringe.
The Supreme Court rejected the Federal Circuit’s approach, emphasizing that the relevant question is not whether healthcare providers could plausibly read those statements as encouraging infringement, but whether Hikma itself took “affirmative” steps to bring about infringement.
The Court listed three elements required to plead induced infringement: (1) a third party has directly infringed the patent; (2) the inducer knew that the induced acts constitute patent infringement; and (3) the inducer took “active steps” to encourage direct infringement. The Court focused on the third element and held that “inducement must involve the taking of affirmative, as opposed to passive, steps to bring about the desired result of patent infringement.” The Court explained that inducement cannot be based only on “vague” language “combined with speculation about how others may act.” The Court distinguished statements that could induce from those that are designed to induce. But the Court stopped short of requiring that the active inducement must be “express,” as Hikma had argued, and instead acknowledged that a party can induce infringement “through implicit encouragement.” The key, according to the Court, was that inducement must be “clear” to the relevant audience and “affirmative.”
Applying these principles, the Court held that Amarin failed to allege “more than a sheer possibility” that Hikma actively induced infringement because Amarin failed to establish that Hikma took any affirmative steps to encourage infringement.
First, statements alleged to be part of Hikma’s inducement had an “obvious alternative explanation.” The Court explained that Hikma had a lawful explanation for omitting the CV Limitation of Use in its label and retaining information about a clinical study involving some patients who were taking statins who were suffering from severe hypertriglyceridemia (the approved indication): The generic label’s text, by statute, must be identical to the reference drug label except for the carved-out use. Similarly, Hikma’s description of its product as “generic Vascepa” in the prelaunch press releases was, according to the Court, “normal industry practice.” The Court declined to penalize adherence to the law and industry standards.
Second, the Court stated that “mere omissions, inactions, or nonfeasance” were insufficient to allege active inducement. While one could imagine a physician reading between the lines and drawing a conclusion based on Hikma’s label and statements, Amarin needed to allege affirmative conduct by Hikma. The Court rejected finding inducement based on a contingent chain of events or attenuated conduct.
Third, the allegations needed to plausibly constitute steps to induce infringement. It was not sufficient that the alleged action could be plausibly understood to induce infringement. As such, for example, Hikma’s mention of an “AB” rating for the generic drug (which signals therapeutic equivalence only under the conditions specified in the generic’s label) was not plausibly designed to encourage others to infringe.
Finally, the Court found that it was too speculative that a physician would read Hikma’s press releases concerning sales attributable to both indications and then be encouraged to prescribe the generic drug for the patented indication.
In sum, in the absence of specific instructions to practice the patented indication, Amarin attempted to gather facts that it hoped would amount to a plausible allegation of induced infringement. However, the Court found that these allegations were not enough to meet the pleading standards. The decision emphasized that pleading inducement requires a showing that a generic manufacturer took clear, affirmative steps to encourage the patented use. Such a showing need not be explicit, but it cannot rely solely on speculation about how others, such as healthcare providers, may act.
Hikma Pharms. USA Inc. v. Amarin Pharma, Inc., No. 24-889, 2026 WL 1593307 (U.S. June 4, 2026)