Supreme Court Holds That To State A Claim For Inducing Patent Infringement, The Complaint Must Plausibly Allege That The Defendant Took Affirmative Steps To Encourage Infringement

Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889

Introduction

Today, the Supreme Court held in a unanimous 9-0 decision that induced patent infringement requires active steps to encourage inducement; passive steps or actions that merely could lead to infringement are not sufficient. The decision builds on the Court’s recent ruling in Cox Communications v. Sony Music Entertainment, 146 S. Ct. 959 (2026), and its holding will be relevant to copyright-infringement inducement claims as well.

Background

Amarin Pharma manufactures Vascepa, a name-brand drug, for which Hikma Pharmaceuticals manufactures the generic version. Vascepa was initially approved for a particular use for which Amarin had method-of-use patents. After submitting an abbreviated new drug application, Hikma received FDA approval to market its generic version for that use and successfully sued to invalidate Amarin’s patents. While Hikma’s application was pending and before Amarin’s patents were invalidated, Amarin received FDA approval for another use for the drug, obtained a patent for that use, and removed language on Vascepa’s label cautioning that its use for certain purposes had not been determined. Hikma continued selling the generic version of Vascepa and obtained approval for a new label that carved out the still-patented method of use but otherwise mirrored Amarin’s, including by omitting the previous cautionary language.

Amarin sued, claiming that Hikma induced infringement of Amarin’s patents. The district court dismissed Amarin’s complaint, finding that none of Hikma’s actions constituted active steps to encourage infringement. The Federal Circuit reversed, finding that, although the label alone did not encourage infringing uses, it was plausible to read it to do so when the label was viewed in combination with other statements by Hikma.

Issue

Whether Hikma’s statements were sufficient to state a claim for inducing infringement of Amarin’s patents.

Court’s Holding

In an opinion authored by Justice Jackson, the Supreme Court held that the complaint’s allegations regarding Hikma’s alleged actions were not sufficient to state a claim for inducing patent infringement, in violation of 35 U.S.C. § 271(b), because the allegations were not sufficient to support a plausible inference that Hikma “took ‘active steps . . . to encourage direct infringement.’”  

The Court began its analysis by reiterating its prior holdings that a claim for inducing of patent infringement requires proof that the defendant took “active steps” to encourage direct infringement. The Court emphasized that “‘inducement must involve the taking of affirmative,’ as opposed to passive, ‘steps to bring about the desired result’ of patent infringement.” And it stated that “[t]o avoid ‘trenching on regular commerce,’ ‘ordinary acts incident to product distribution’ are insufficient to support liability.” Inducement therefore requires acts “designed” to induce infringement, not merely those that “could” do so.

In particular, “inducement cannot be based only on ‘vague’ language ‘combined with speculation about how [others] may act.’” Inducement need not be “express,” and “implicit encouragement” could suffice, but “implicit or explicit, the necessary inducement must be ‘clear’ to the relevant audience and ‘affirmative.’”

The Court expressly disapproved a line of Federal Circuit decisions that, in the Supreme Court’s view, “increasingly trained its focus on whether the relevant statements could be read by medical providers as instructions to infringe.” It stated: “We reject that trend today, and hereby emphasize that the key question is whether a defendant actively encouraged infringement through its statements, not merely how others may understand those statements.”

Applying these principles, the Court held that Amarin had failed to plausibly allege that Hikma’s actions represented active infringement of Amarin’s patents. The Court explained that, in carving out Amarin’s still-patented use from its label but otherwise copying Amarin’s label, Hikma was simply complying with the drug-labelling laws. It concluded that Hikma’s references to its product as “generic Vascepa” represented normal industry practice, and that Hikma did not actively induce infringement by not affirmatively mentioning in its press releases that its product’s approved use was limited to a lesser known indication. The Court similarly concluded that Amarin’s speculation about how providers might understand various other “vague” statements regarding the generic drug’s side effects, its therapeutic category, and Hikma’s sales figures did not plausibly allege that Hikma took affirmative steps to induce infringement.

The Court’s decision provides “breathing room” for generic drug manufacturers and others accused of inducing patent infringement by requiring allegations of affirmative steps that clearly encourage infringement to plausibly allege a claim of induced infringement.

Finally, although this decision addresses inducement liability in the patent context, the Court’s analysis is equally applicable to inducement claims under the copyright law. Earlier this Term, in Cox Communications v. Sony Music Entertainment, 146 S. Ct. 959 (2026), the Court held that—given the “historic kinship” between patent and copyright law—patent law jurisprudence is highly relevant in analyzing copyright inducement claims. And in today’s decision, the Court cited Cox Communications and relied on the inducement principles adduced in Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913 (2005), which addressed claims of induced copyright infringement.

Read the opinion here.