On June 4, 2026, a unanimous Supreme Court in Hikma Pharms. USA Inc. v. Amarin Pharma, Inc., No. 24-889, clarified the standard for pleading induced patent infringement under 35 U.S.C. § 271(b). Although Hikma dealt specifically with an inducement claim against a “skinny label” generic drug maker, the Hikma opinion is broadly applicable to all inducement claims. According to Hikma, it is not sufficient for an inducement claim to allege that an accused party’s statements plausibly could be read to induce infringement; rather the accused statements must plausibly constitute affirmative steps to bring about direct infringement by others, and there cannot be an “obvious alternative explanation” for those statements.
Background
In Hikma, the branded drug maker Amarin obtained two sets of method-of-use patents for its Vascepa® (icosapent ethyl) drug product: one for the treatment of severe hypertriglyceridemia (the “SH” indication) and a second for reducing cardiovascular risk in hypertriglyceridemia patients on statins (the “CV” indication). After a district court invalidated Amarin’s SH patents, generic drug maker Hikma filed a so-called section viii statement, representing to FDA that it would seek approval for its generic icosapent ethyl product with a “skinny label” that included only the now-unpatented SH indication. After Hikma began marketing its generic product, Amarin sued Hikma for § 271(b) inducement, arguing that various statements by Hikma induced physicians directly to infringe the CV patents, including in:
- Hikma’s skinny label, which omitted a limitation on the CV indication and retained information about a clinical study involving patients on statins;
- Hikma’s patient information leaflet, which warned against side effects in the target population for the CV indication and noted that medicines are sometimes prescribed for purposes other than those mentioned in the leaflet;
- Hikma’s website, which described its generic product as “AB” rated and listed its therapeutic category as “hypertriglyceridemia,” a category broader than just SH; and
- Hikma’s press releases, which described its generic product as “generic Vascepa” or a “generic equivalent” of Vascepa®, did not mention that its approved use was limited to SH, and included U.S. sales figures attributable to both SH and CV indications.
Hikma moved to dismiss Amarin’s § 271(b) inducement claim under Fed. R. Civ. P. 12(b)(6), which the District Court for the District of Delaware granted. But the Federal Circuit reversed, explaining that it was “at least plausible” that a physician could read the above statements to encourage the prescription of Hikma’s generic product for any Vascepa®-approved indication, including the patented CV indication.
The Supreme Court Opinion
The Supreme Court’s June 4, 2026 opinion (by Justice Jackson) held that the Federal Circuit erred. It noted that the Federal Circuit, when analyzing inducement claims, had followed a recent trend of focusing on whether the accused statements “could be read by medical providers as instructions to infringe.” The Supreme Court rejected that trend, explaining that the key question on inducement is whether the defendant “actively encouraged” infringement through its statements, not merely how others may have understood those statements.
Drawing on its prior decisions—primarily Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) and Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913 (2005)—the Supreme Court in Hikma set forth the following guidance on how a § 271(b) inducement claim can pass muster at the pleadings stage.
First, the Supreme Court reaffirmed the three essential elements of a § 271(b) inducement claim: (i) direct infringement by a third party; (ii) knowledge by the accused inducer that the induced acts constitute patent infringement; and (iii) as required by Grokster, “active steps” taken by the accused inducer to encourage direct infringement.
Second, the Supreme Court clarified that, under Twombly, a claim for relief must be “plausible on its face”—a pleading standard that requires “more than a sheer possibility that a defendant has acted unlawfully” and instead demands that a plaintiff plead facts that, if true, rule out any “obvious alternative explanation” for the defendant’s accused conduct.
Third, putting together Grokster and Twombly, the Supreme Court held that to adequately plead a § 271(b) inducement claim, “the question is not merely whether the [accused] statements could be plausibly understood to induce infringement, but whether they plausibly constitute affirmative steps to bring about the desired result of infringement.” (emphasis added; internal citations omitted). Moreover, to survive a motion to dismiss, the plaintiff must rule out “obvious alternative explanations” for the accused statements.
The Supreme Court concluded that Amarin’s § 271(b) inducement claim against Hikma fell short of those standards. As an initial matter, the Supreme Court noted that there was an obvious alternate explanation for the contents of Hikma’s label and the “AB” rating statement on its website: Hikma was simply following the law and normal industry practice in copying the contents of Amarin’s Vascepa® label and in describing its product as a “generic equivalent” of Vascepa®. The Supreme Court explained that it would not “put generic manufacturers between a rock and a hard place by turning adherence to the law and industry standards into building blocks for illegal conduct.” The Supreme Court next determined that, because a plaintiff may not rely on “mere omissions, inactions or nonfeasance” to plead inducement, the absence of express disclaimers against the CV indication in Hikma’s label and press releases could not constitute “affirmative statements or actions” encouraging infringement. Last, the Supreme Court characterized the remaining accused statements in Hikma’s patient information leaflet and website as “implausibly roundabout ways to induce medical providers to infringe” and too “vague” to constitute active inducement.
Final Thoughts
Although the Supreme Court’s Hikma opinion brings important clarifications to the pleading standard for § 271(b) inducement claims, it is important to understand that it provides no per se immunity for “skinny label” generic drug makers like Hikma. The opinion expressly states that the skinny label laws “do not foreclose the possibility” that a generic drug maker “may still interfere with a patented method of use,” and that a generic drug maker “can cross the line into liability” if it actively induces infringement. The opinion also cautions that, while active steps are needed to trigger inducement liability, they need not be express: instead, “[a] defendant can achieve active inducement through implicit encouragement” of direct infringement. Thus, the opinion leaves open the question of what kinds of conduct, including by skinny labelers, can cross the line to constitute “active inducement.”
