Hikma Pharmaceuticals USA Inc. et al. v. Amarin Pharma, Inc. et al.
No. 24-889 · Decided June 4, 2026 · reversed and remanded
Does a claim for active inducement of patent infringement under 35 U.S.C. §271(b) require a plausible allegation that the defendant actively encouraged infringing use? Amarin Pharma, Inc. failed to state a claim for active inducement under 35 U.S.C. §271(b) because it did not plausibly allege that Hikma Pharmaceuticals USA Inc. took affirmative steps to encourage infringement.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR · Argued April 29, 2026
Parties — Petitioner: HIKMA PHARMACEUTICALS USA INC. ET AL. · Respondent: AMARIN PHARMA, INC., ET AL.
Vote & lineupJackson delivered the opinion of the Court (1).
Who prevailed — Hikma Pharmaceuticals USA Inc. et al. prevailed; the Court reversed and remanded the judgment below.
⚠ summary flagged: missing/empty section: DISSENT SUMMARY
The question
Does a claim for active inducement of patent infringement under 35 U.S.C. §271(b) require a plausible allegation that the defendant actively encouraged infringing use? Or is it sufficient to allege that a third party could plausibly read the defendant's statements as instructions to infringe? This case specifically examines whether a generic drug manufacturer's "skinny label," website, and press releases constitute such active encouragement.
Petitioner's argument
Petitioner Hikma Pharmaceuticals USA Inc. sought the dismissal of the induced-infringement claim under Federal Rule of Civil Procedure 12(b)(6). It argued that its statements across the skinny label, website, and press releases did not constitute active steps to encourage infringement. Petitioner further urged that active inducement must be "express" to support liability.
Respondent's argument
Respondent Amarin Pharma, Inc. sought to survive the motion to dismiss and proceed to discovery. It argued that it only needed to allege a "plausible chain of events" through which Hikma's statements could lead a healthcare provider to prescribe the drug for the patented cardiovascular risk indication. Respondent relied on *National Rifle Association of America v. Vullo* and *Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd.* to support this pleading threshold.
The decision
The Court held that Amarin failed to state a claim for active inducement under 35 U.S.C. §271(b). To establish active inducement, a plaintiff must allege direct infringement, knowledge of infringement, and "active steps . . . to encourage direct infringement" under *Metro Goldwyn Mayer Studios Inc. v. Grokster, Ltd.*. The Court clarified that "active steps" require "affirmative" actions and exclude "ordinary acts incident to product distribution" per *Grokster*. Applying *Bell Atlantic Corp. v. Twombly*, the Court found that Hikma's label had an "obvious alternative explanation" because 21 U.S.C. §355(j)(2)(A)(v) requires generic labels to