On June 4, the Supreme Court unanimously decided Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.¹ This case concerns the requirements for induced infringement, specifically in the context of “skinny labels” for generic drug products, where a generic drug company copies the label of a branded product but “carves out” or omits one or more indications covered by a patent.

Hikma related to whether a branded drug patent owner could allege induced infringement by a generic manufacturer based on statements outside of a proposed skinny label where that label “carved out” the patented indication. The Supreme Court held that at the pleading stage, Amarin did not allege sufficient facts to show that Hikma actively induced infringement. The Court rejected what it called a “trend” in Federal Circuit decisions such as GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.,² focused on “whether the relevant statements could be read by medical providers as instructions to infringe.” The Court emphasized that “the key question [for induced infringement] is whether a defendant actively encouraged infringement through its statements, not merely how others may understand those statements.”³

Background

Amarin manufactures Vascepa (icosapent ethyl), which is approved to treat severe hypertriglyceridemia (the “SH indication”) and reduce cardiovascular risk in hypertriglyceridemia patients who already take statins (the “CV indication”). The CV indication makes up over 75% of Vascepa sales⁴ and is covered by method-of-use patents.

Hikma sought approval of a generic under a “skinny label” with only the SH indication, and “carved out” the CV indication. Amarin nonetheless sued Hikma for induced infringement of the CV patents. It pleaded that other parts of Hikma’s label and Hikma’s public statements would induce physicians to use its generic product for the CV indication.

On Hikma’s motion, the Delaware District Court dismissed Amarin’s inducement claims under Rule 12(b)(6) in 2022. It found that “none of Hikma’s statements constituted active steps to encourage infringing Amarin’s method-of-use patents for the CV indication.”⁵ In 2024, the Federal Circuit reversed, holding that “[i]t is at least plausible that a physician could read Hikma’s press releases … as an instruction or encouragement to prescribe that drug for any of the approved uses of icosapent ethyl, particularly where the label suggests that the drug may be effective for an overlapping patient population.”⁶

The Supreme Court’s Decision

The Supreme Court’s decision first explained three elements required to show induced infringement under 35 U.S.C. § 271(b). First, there must be at least one direct infringer (e.g., a third party like a doctor). Second, the party inducing infringement must know that the induced acts constitute patent infringement. Third, the party inducing infringement must take active steps to encourage the direct infringement.⁷ It explained that to survive a motion to dismiss, the complaint must plead facts that, if true, allow the court to plausibly infer that the defendant is liable and rule out obvious alternative explanations.⁸

The Court explained that active inducement requires affirmative—not passive—steps, statements, or actions.⁹ It thus stated that the inducer’s efforts may be “implicit or explicit,” but “must be ‘clear’ to the relevant audience and ‘affirmative.’”¹⁰ For example, “ordinary acts incident to product distribution” are insufficient.¹¹ “The classic instance of inducement” is an “advertisement or solicitation that broadcasts a message designed to stimulate others to commit violations.”¹² The Court distinguished “statements designed to stimulate others” from “statements that could stimulate others” to infringe. It thus stated that “inducement cannot be based only on ‘vague’ language ‘combined with speculation about how others may act.’”¹³

Applying these principles to the facts of the case, the Court focused on whether the acts identified by Amarin were sufficient to allege Hikma took active “steps to bring about the desired result” of patent infringement.¹⁴ It found that in this case, they were not. Specifically:

• Though Hikma’s label “retained information about a clinical study involving patients taking statins,” the Court found that did not adequately support active inducement of others to use the drug for the patented CV indication. The Court noted “Hikma’s label must be identical to Amarin’s except for the carved-out use,” and declined to find that reference in the label a “building block[] for illegal conduct.”¹⁵

• The Court found Hikma’s public statements were also insufficient to show active inducement. It found that a warning “against possible side effects for ‘people who have heart (cardiovascular) disease’—the target population for Vascepa’s patented CV-indication method of use”—and a statement that “medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet” were not enough to support an allegation of induced infringement. It found such statements were “vague” and insufficient to encourage infringing use, despite Amarin’s argument that medical providers “would plausibly understand” them to encourage use for the CV indication.¹⁶

• Though the Court noted sales figures in Hikma press releases included sales “attributable to both the SH-indication and the CV-indication methods of use,” it found that because those figures were “directed to investors rather than doctors and pharmacists,” they were too vague to support “a ‘plausible’ scenario of active infringement.”¹⁷ The Court also disagreed that the “omission” of statements that Hikma’s product was only approved for the lesser-used SH indication supported inducement. It found “mere omissions, inactions, or nonfeasance” are not enough “to allege active inducement.”¹⁸

• The Court also held Hikma’s website statements characterizing the drug as “AB” rated and listing the drug’s therapeutic category more broadly than just the non-patented SH indication were not designed “‘to stimulate others to commit’ infringement.”¹⁹

In this context, the Court found that Amarin “fail[ed] to allege ‘more than a sheer possibility’ that Hikma actively induced infringement of Amarin’s CV-indication patents.”²⁰

Conclusion

After Hikma, patent owners alleging induced infringement will need to consider whether their allegations are sufficient to show active inducement, for example, by pointing to defendant’s clear, affirmative statements or actions that actively encourage direct infringement, which show it is more than conceivable that the alleged conduct was intended to bring about infringement.