Supreme Court Raises Bar for Pleading Induced Patent Infringement in Hikma v. Amarin

The Supreme Court’s June 4, 2026, decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. provides critical guidance on what plaintiffs must allege to survive a motion to dismiss an induced patent infringement claim under 35 U.S.C. § 271(b). The unanimous opinion, authored by Justice Ketanji Brown Jackson, clarifies the high pleading standard for inducement claims, which extend liability beyond direct infringement to parties who encourage or facilitate infringement by others.

Under 35 U.S.C. § 271(a), direct infringement occurs when a party makes, uses, sells, or imports a patented invention without authorization. Section 271(b) imposes liability on those who “actively induce” infringement by others, targeting defendants who do not themselves directly infringe but who encourage or instruct third parties to do so.

The Court reiterated that induced infringement requires a specific intent: the defendant must know of the patent and specifically intend to cause infringement. This standard was established in Global-Tech Appliances, Inc. v. SEB S.A. (2011), which held that knowledge of the patent and willful blindness to infringement are necessary to prove inducement.

The case arose from Amarin’s Vascepa®, a drug approved for two uses: treating severe hypertriglyceridemia and reducing cardiovascular risk. Amarin’s patents covering the cardiovascular use generated billions in sales. Hikma sought FDA approval for a generic version with a “skinny label” that excluded the patented cardiovascular indication, seeking approval only for the now-unpatented hypertriglyceridemia use.

Although Hikma’s label complied with FDA regulations, Amarin alleged that Hikma induced infringement through marketing and communications outside the label. Specifically, Amarin pointed to Hikma’s inclusion of cardiovascular clinical data in its label, press releases describing its product as a generic version of Vascepa (whose dominant use was cardiovascular), and citations of Vascepa’s total sales including those driven by the patented use.

The District of Delaware dismissed Amarin’s inducement claim for failure to state a claim. The Federal Circuit reversed, reasoning that Hikma’s statements could plausibly be read by physicians as instructions to infringe.

The Supreme Court rejected the Federal Circuit’s approach, emphasizing that the relevant inquiry is not whether statements could be interpreted as instructions to infringe, but whether the defendant actively encouraged infringement with knowledge it was doing so. The Court stated, “the key question is whether a defendant actively encouraged infringement through its statements, not merely how others may understand those statements.”

Justice Jackson explained that Amarin’s theory—that Hikma’s statements could lead a healthcare provider to prescribe the drug for the patented use—was insufficient without allegations that Hikma affirmatively promoted the infringing use knowing it was infringing.

This ruling signals a tightening of the pleading requirements for induced infringement claims, requiring plaintiffs to allege more than a plausible chain of events leading to infringement. Instead, they must show that the defendant took deliberate steps to encourage infringement with specific intent.

While the facts involve pharmaceutical patents and Hatch-Waxman regulatory frameworks, the Supreme Court’s clarification applies broadly to inducement claims across all patent fields. The decision underscores the importance of precise pleading and evidentiary standards in patent infringement litigation, particularly for claims of indirect liability under § 271(b).