Today, a unanimous Supreme Court dismissed Amarin Pharma, Inc.’s suit against generic manufacturer and ANDA applicant Hikma Pharmaceuticals USA Inc., premised on active inducement of patent infringement by encouraging uses for indications outside the “skinny label” carve out sought by Hikma. Amarin alleged that the skinny label along with website and press release information, amounted to the “active inducement” required for infringement under 35 U.S.C. § 271(b). Writing for the Court, Justice Jackson held that the Federal Circuit’s reversal of the district court grant of dismissal was error and that active inducement required more than “whether doctors could plausibly read the alleged statements as instructions to infringe.” Hikma Pharms. USA Inc. v. Amarin Pharma, Inc., 24-889, Slip op. at 2 (June 4, 2026).
Under the Hatch-Waxman regulatory scheme, a generic manufacturer may seek approval for fewer than all approved indications of a branded pharmaceutical. Such “skinny label” submissions carve out the indications for which approval is not sought from the proposed label. See 21 U.S.C. § 355(j)(2)(A)(viii). Strategically, as recognized by the Supreme Court, generic manufacturers know that there is a high likelihood that a generic drug approved under the skinny label scheme for one of multiple indications of such a branded pharmaceutical will nevertheless be substituted for the brand drug for all indications under generic drug laws throughout the United States. But, as the Court noted, “mere knowledge” alone is insufficient to cross the line to active inducement. Slip op. at 4.
The Court restated the requirements for active inducement infringement from earlier cases. There must be direct infringement by a third party (citing Limelight Networks, Inc. v. Akamai Technologies, Inc., 572 U.S. 915, 920-21 (2014)); knowledge by the inducer that the induced acts constitute patent infringement (citing Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 766 (2011)); and “active steps” by the inducer “to encourage direct infringement (citing Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936 (2005). Today’s decision focuses on the third element, and the Court found that Amarin could not demonstrate that Hikma took the active steps necessary to induce infringement.
The Court revisited the interactions between Amarin and Hikma. In 2016, Hikma filed an ANDA with a Paragraph IV notice to market a generic version of Vascepa, which then had a single indication, severe hypertriglyceridemia or SH. Amarin sued Hikma under the Hatch-Waxman Act, and the district court found Amarin’s asserted patents invalid. During the pendency of the action, Amarin obtained approval for a second indication, the use of Vascepa to reduce cardiovascular risk while taking statins, the “CV indication.” Hikma amended its ANDA and carved out the CV indication and moved forward with a skinny label. After FDA approval of the skinny label, Hikma began marketing its generic drug.
Amarin then brought suit against Hikma, alleging that certain actions demonstrated the “active steps” necessary to assert infringement: (1) including certain clinical testing in the label; (2) information provided in a patient’s leaflet that discussed cardiovascular risk (an area near the CV indication); and (3) website posting that designated Hikma’s product as AB rated for Vascepa generally; and (4) press releases that described the drug as “generic Vascepa.”
The Court rejected this pleading and found that it was insufficient to plausibly allege the active steps necessary for inducement infringement. In a key footnote, Justice Jackson cites to a “trend” at the Federal Circuit where an allegation that asserted a physician “could” read a label in a particular way was sufficient to state a claim for active inducement. The Court rejected that trend and “emphasize[d] that the key question is whether a defendant actively encouraged infringement through its statements, not merely how others may understand those statements.” Slip op. at 9, n.3.
Examining the asserted facts under the Court’s standard, the opinion held that Amarin’s assertions failed to state a claim for active inducement infringement. Regarding the labeling and inclusion of a particular clinical study, the Court recognized that Hikma properly relied on the “duty of sameness” for labeling, even under the carve out rules. Similarly, the Court found that the “generic Vascepa” claims were literally true. Turning to statements about the overall Vascepa sales on the Hikma website, the Court again found that there was at best a vague link, but that such a link was insufficient to demonstrate active steps.
The Hikma opinion sets the stage for further use of the skinny label – much as Congress intended. For generic manufacturers, the fears raised by the Federal Circuit’s decision in Hikma and in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. should be set aside by this opinion. Generics should, for multi-indication products, identify the indication(s) with a “weaker” patent protection covering one of the indications and pursue invalidity or noninfringement of those patents. For branded manufacturers, care must be taken in seeking approvals for new indications with potentially weaker patent protection but that are therapeutically close to an approved but vulnerable indication. By isolating and strengthening those protections at the earliest stage, some of the strength of skinny labels can be lessened. Undoubtedly, this opinion will create additional risk for branded manufacturers.