The Critical Footnote in the Supreme Court’s Hikma Pharmaceuticals Decision
The recently-concluded Supreme Court term included only one patent case, Hikma Pharms. USA v. Amarin Pharma, 608 U.S. ___, No. 24-889 (June 4, 2026), which involved an allegation of active inducement of infringement. The decision was unanimous, which may lead one to think that this was an easy case. To the contrary, it looks like the Supreme Court took it to change the approach that the Federal Circuit had been taking in active inducement cases.
Active inducement is set forth without elaboration in 35 USC 271(b): ”Whoever actively induces infringement of a patent shall be liable as an infringer.” For active inducement to occur there must be a direct infringer, and the active inducer must act to induce that direct infringement with the knowledge and intent that the direct infringing acts constitute patent infringement.
Hikma brought to market (with FDA approval) a generic version Amarin’s drug Vascepa (icosapent ethyl), used for treatment of severe hypertriglyceridemia (SH). When Hikma applied for approval of its generic version, Amarin already had an issued patent for treating SH using Vascepa, but Hikma succeeded in having that patent invalidated in court. That invalidation paved the way for the approval of Hikma’s application to market its generic icosapent ethyl.
But there was a catch – in the time between Hikma’s application with the FDA and the invalidation of Amarin’s initial patent, Amarin obtained another patent covering methods of using icosapent ethyl to treat another group of patients, to reduce cardiovascular risk in hypertriglyceridemia patients who already take statins. It was undisputed that using Hikma’s generic drug for this purpose would infringe this new Amarin patent, and Amarin sued, accusing Hikma of inducing infringement of the new patent. The complaint based this on the totality of the circumstances, including 1) Hikma’s use of a “skinny label” (identical to Amarin’s) that did not mention any limitation of use; 2) statements in Hikma’s drug leaflet noting the possibility of prescribing medicines for other uses; 3) a Hikma website listing the drug’s therapeutic category as “hypertriglyceridemia”; and 4) a press release describing Hikma’s drug as “generic Vascepa,” without any mention of a limitation of use.
The district court dismissed the suit for failure to state a claim (disagreeing with the recommendation of a magistrate judge), finding that there was nothing about Hikma’s actions that constituted active inducement. Amarin Pharma v. Hikma Pharms. USA, 578 F. Supp. 3d 642 (D. Del. 2022). The Federal Circuit reversed, 104 F.4th 1370 (Fed. Cir. 2024), finding that the totally of the circumstances (but not just Hikma’s label) set out a plausible claim for induced infringement. The court looked to “what Hikma’s label and public statements would communicate to physicians and the marketplace,” which was a question of fact, not law, and therefore not a suitable basis for a motion to dismiss.
The case drew well over a dozen amicus briefs at the Supreme Court, some supporting the Federal Circuit’s decision, and others pushing for its reversal. For example, briefs by the American Intellectual Property Law Association (AIPLA) and by former Federal Circuit Judge Paul Michel (and scholars of law and economics) argued for affirmance. On the other side, briefs by the United States and by former Congressman Henry Waxman (he of the Hatch-Waxman Amendments that allowed greater approval of generic drugs) urged reversal.
A unanimous Supreme Court reversed, and footnote 3 of Justice Jackson’s opinion took direct aim at the Federal Circuit’s approach:
Amarin’s … argument [that it must only “allege ... a plausible chain of events through which statements made by [Hikma] could lead a healthcare provider ... to prescribe or dispense Hikma’s drug” for an infringing use] reflects the recent approach of the Federal Circuit, which has increasingly trained its focus on whether the relevant statements could be read by medical providers as instructions to infringe. See, e.g., GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F. 4th 1320, 1336–1337 (2021). The decision below appears to follow this trend line. See 104 F. 4th, at 1378–1380 (resting reversal on the conclusion that it is “at least plausible that a physician could read” the relevant statements “as an instruction or encouragement” to infringe). 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.
In looking for active inducement, Justice Jackson’s emphasized the distinction between statements and actions designed to stimulate infringement and those that only could produce infringement. Hikma’s use of a legally-mandated “skinny label” didn’t qualify as active inducement, nor did its various “vague statements.”
Going forward, the result in Hikma should provide more certainty and protection for marketers of generic drugs.