Summary
Recently, the U.S. Supreme Court unanimously reversed the Federal Circuit in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., holding that a brand-name manufacturer failed to state a claim for induced patent infringement against a generic competitor marketing under a “skinny label,” which omits or “carves out” FDA-approved indications of a brand-name drug protected by unexpired method-of-use patents.
The Upshot
- The Court held that the proper inquiry under 35 U.S.C. § 271(b) is whether the generic manufacturer took “active steps” designed to encourage infringement—not merely whether physicians or others could plausibly interpret its statements as instructions to infringe.
- The June 4, 2026, decision allows generic drug manufacturers who follow the skinny-label pathway to avoid claims of inducement liability, provided the generic company does not “actively encourage infringement through its statements….”
- For brand-name manufacturers, the ruling requires allegations of affirmative conduct purposefully designed to induce infringement rather than speculative claims of infringement about how third parties might interpret a generic manufacturer’s communications.
- The Court explicitly rejected the Federal Circuit’s recent approach as applied in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021), and further supported by Hikma v. Amarin, 104 F.4th 1370 (Fed. Cir. 2024), of analyzing inducement through the lens of how medical providers might understand a manufacturer’s statements.
The Bottom Line
Routine labeling, standard industry terminology, and investor-facing communications alone will not be enough to give rise to inducement liability for infringement of a patented indication where the generic’s label is limited to indications not protected by the brand’s patents. However, under the Supreme Court’s ruling in Hikma, “clear” and “affirmative” encouragement, whether express or implicit, may create the basis for such inducement liability.
When bringing an action for inducement-based infringement when the generic company files an abbreviated new drug application (ANDA) for an indication not covered by the brand’s patents, brand-name manufacturers will need to point to inducement that is “clear” to the relevant audience and “affirmative” rather than relying on ambiguous statements or omissions.
Vascepa®, a brand-name drug containing icosapent ethyl, was developed by Amarin and approved by the FDA first in 2012 for treating severe hypertriglyceridemia (the SH indication), and again in 2019 for a second indication, reducing cardiovascular risk in hypertriglyceridemia patients already taking statins (the CV indication). Amarin’s method-of-use patents for the SH indication were previously invalidated by a district court; however, patents for using Vascepa® for the CV indication remained in force.
Hikma obtained FDA approval in 2020 to market generic icosapent ethyl under a “skinny label,” which was limited to only the SH indication without reference to the CV indication. Amarin sued, alleging that the totality of Hikma’s communications including its label, patient leaflet, website, and press releases actively induced physicians to prescribe Hikma’s generic drug for the patented CV indication. The District of Delaware dismissed the complaint, but the Federal Circuit reversed. The Supreme Court granted certiorari.
Writing for a unanimous Court, Justice Jackson held that the Federal Circuit applied the wrong standard by asking whether Hikma’s statements “could be ‘plausibly underst[oo]d’” as encouragement to infringe, rather than whether Hikma itself took “‘affirmative steps to bring about the desired result’ of infringement.”
Applying this standard, the Court found that the content of Hikma’s label was compelled by statute and therefore had an “obvious alternative explanation,” and that omissions such as not including the CV indication of use cannot constitute the “affirmative” conduct required for inducement.
Further, the Court noted that the website’s “AB” rating did not plausibly constitute encouragement because, as defined in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320, 1335 (Fed. Cir. 2011), an AB rating means the generic is equivalent to the brand-name drug only “under the conditions specified in the generic's label,” which, in this case, excluded the patented methods of use.
As for the remaining statements on the website and in press releases, the Court found these were too vague to plausibly allege that Hikma designed them “to stimulate others to commit” infringement.
For generic manufacturers, the decision confirms that routine skinny-label compliance, standard industry terminology, and investor-facing communications should not give rise to inducement liability absent affirmative steps to actively encourage infringement. Brand-name manufacturers, meanwhile, must identify specific affirmative acts designed to promote infringing use, rather than relying on vague statements or omissions combined with speculation about physician behavior.
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