Hikma Pharmaceutical USA Inc. v. Amarin Pharma Inc.
In a unanimous decision of June 4, 2026 in Hikma Pharmaceutical USA Inc. v. Amarin Pharma Inc., authored by Justice Jackson, the Supreme Court clarified the pleading requirements for claims of induced patent infringement when a generic drug manufacturer receives approval to market a drug for a nonpatented use while other uses of the drug remain patented. In doing so it reversed a decision of the Court of Appeals for the Federal Circuit that had held that Amarin’s pleadings had asserted sufficient facts to make it plausible that Hikma had induced doctors to infringe patents on the patented use and so had reversed a district court’s dismissal of the action based solely on the pleadings without any discovery having taken place.
In the United States marketing of a pharmaceutical product requires authorization from the Food and Drug Administration (FDA). Grant of such authorization requires consideration of the safety and efficacy of the drug for its intended use and the labelling that is intended to be used for the drug. Additionally, the applicant must provide information on relevant drug patents. After initial approval of a drug for a specific use, a generic drug manufacturers may seek approval for the same use of the drug relying on the originator’s safety and efficacy data if it shows its product to be the biological equivalent of the drug that has already been approved. In this case, however, FDA approval will require consideration of the patent position relating to the drug or the specific use for which marketing approval is sought. In its application for marketing authorization, the generic drug manufacturer must do one of the following: 1) agree not to enter the market until the relevant patent has expired; 2) make a statement that it does not believe its product infringes the patent or the patent is invalid, in which case the law provides that the patent owner can immediately sue for infringement; or 3) where some uses of the drug are patented but others are not (for example because a patent on the drug itself or a specific use has expired or been held invalid), agree that it will market the drug only for the unpatented use. In general, a generic drug manufacturer is required to label its drug in the same way as the originator drug. However, in cases where marketing approval is limited to unpatented uses while other uses remain patented, the generic manufacturer is required to carve out references to the patented use from the label and use only what is referred to as a “skinny label” on its generic product.
In Hikma v. Amarin, Hikma’s drug was marketed with such a “skinny label”.
Because such skinny labels will often contain medical information that is applicable to both patented and unpatented use of the drug and because the generic version of the drug is the biological equivalent of the original drug, the question of whether such a skinny label could be considered as a contributing factor to induce physicians to prescribe the generic version of the drug to treat a condition for which its use is still patented has arisen before. For example, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. the Federal Circuit’s initial decision was read by many as saying that the contents of a skinny label was an inducement to physicians to write off-label prescriptions of the generic drug for patented uses of the drug. Following a petition for rehearing the Federal Circuit emphasized that its conclusion on induced infringement was based on several other factors, including the activities of Teva’s marketing representatives.
35 USC 271(b) provides that
Whoever actively induces infringement of a patent shall be liable as an infringer.
In Hikma v Amarin, Amarin’s pleadings in support of its claim that Hikma had induced infringement of its patents set out the following facts: 1) Hikma’s skinny label included information about a clinical study that related to a use that was still patented; 2) Hikma’s patient information leaflet warned against possible side effects that might be countered by the use that remained patented; 3) Hikma’s web-site listed the drug as “AB” rated, indicating its biological equivalency to the innovator dug whose use for some indications was still patented and 4) issue of press releases stating that the drug Hikma was marketing was the generic version of Amarin’s innovator drug without stating that the generic version had been authorized for use by the FDA only for unpatented uses.
The Supreme Court addressed two issues: 1) what was required to establish active induced infringement and 2) what had to be pleaded in support of an allegation of actively inducing infringement to avoid dismissal of the lawsuit without proceeding to discovery.
On the first issue, notwithstanding that the Grokster case referred to was a copyright case, the Court summarized its relevant case law as follows:
A trio of our patent cases illuminates the required elements of an induced-infringement claim. First, there must be direct infringement by a third party. Limelight Net works, Inc. v. Akamai Technologies, Inc., 572 U. S. 915, 920–921 (2014). Second, the inducer must know that “the induced acts constitute patent infringement.” Global-Tech Appliances, Inc. v. SEB S. A., 563 U. S. 754, 766 (2011). Third, and most relevant here, the inducer must take “active steps . . . to encourage direct infringement.” Metro-Goldwin-Mayer Studios Inc. v Grokster Ltd, 545 U. S., at 936.
As to the pleading requirements, the Court summarized the requirements as follows:
In order to proceed to discovery, a plaintiff must “state a claim to relief that is plausible on its face.” Bell Atlantic Corp. v. Twombly, 550 U. S. 544, 570 (2007). That plausibility standard “asks for more than a sheer possibility that a defendant has acted unlawfully.” Ashcroft v. Iqbal, 556 U. S. 662, 678 (2009). If the complaint “pleads facts that are merely consistent with a defendant’s liability, it stops short of the line between possibility and plausibility of entitlement to relief. … Instead, to nudge a claim “across the line from conceivable to plausible,” a plaintiff must plead facts that, if true, “allo[w] the court to draw the reasonable inference that the defendant is liable for the misconduct alleged,” id., at 678, 680 … and to rule out “obvious alternative explanation[s]” for the defendant’s conduct, Twombly, 550 U. S., at 567.
The Court accepted that the pleadings had set out enough to meet the plausibility requirement for the first two elements of the induced infringement claim and so turned to the question of whether the facts set out above made it plausible that Hikma had taken active steps to encourage direct infringement.
Relying on its decision in the Grokster copyright case Justice Jackson pointed out that —”
Active steps involve “purposeful, culpable expression and conduct,”, i.e., “affirmative,” as opposed to passive, actions “to bring about the desired result” and that the Court had defined “active steps” to exclude “ordinary acts incident to product distribution,” Grokster, 545 U. S., at 937; those are insufficient to support liability. Hikma had been wrong to urge that active inducement must be express, because a defendant can achieve active inducement through implicit encouragement, but implicit or explicit, the necessary inducement must be “clear” to the relevant audience and “affirmative”.
In the present case, she saw the information contained in the skinny label as being required to meet FDA requirements and much of the other information relied on as “normal industry practice” or “vague” so that, although the facts set out by Amarin in its complaint set out a possible chain of events that could support a claim for induced infringement, they did not allege “more than a sheer possibility” that Hikma actively induced infringement In this context Justice Jackson pointed out that it was not enough to show that it was plausible that various statements that could be read by medical practitioners as an instruction to infringe and the Federal Circuit had been wrong to encourage this line of thinking. Consequently, Hikma failed to meet the pleading standards set out by the Supreme Court in Ashcroft v. Iqbal that the complaint should set out a “plausible” cause of action.
The district court had therefore been correct to dismiss the action.