Case: Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889
Lower Court: U.S. Court of Appeals for the Federal Circuit
Docketed: February 14, 2025
Status: Cert granted January 16, 2026; merits briefing commencing March 2026; argument expected April 2026
Questions Presented: (1) Whether, when a generic drug label fully carves out a patented use, allegations that the generic calls its product a “generic version” and cites public information about branded drug sales suffice to plead induced infringement; and (2) whether a complaint states a claim for induced infringement of a patented method when the defendant makes no instruction or statement encouraging, or even mentioning, the patented use.
The Supreme Court granted certiorari on January 16, 2026 in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, taking up its first patent case in nearly three years and squarely presenting the question whether a generic manufacturer’s routine commercial statements can constitute induced infringement of a use excluded from its FDA-approved label. Merits briefing begins in early March 2026, with oral argument expected in April.
Amarin’s drug Vascepa (icosapent ethyl) carries two FDA-approved indications: severe hypertriglyceridemia (SH) and cardiovascular risk reduction (CV). Hikma obtained FDA approval for a generic covering only the SH indication, filing a Section viii carve-out statement to exclude Amarin’s patented CV use. After Hikma launched in 2020, Amarin sued for induced infringement under 35 U.S.C. § 271(b), alleging that Hikma’s press releases describing its product as the “generic version of Vascepa®” and citing Vascepa’s aggregate sales figures—without distinguishing between the two indications—plausibly induced physicians to use the generic for the carved-out CV indication. The District of Delaware dismissed; the Federal Circuit reversed, applying a totality-of-the-circumstances standard drawn from its 2021 decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.
Hikma argues that the Federal Circuit’s approach conflicts with MGM Studios, Inc. v. Grokster, Ltd.’s requirement that a defendant take affirmative steps specifically encouraging the infringing act—a standard not satisfied by market communications that never mention the patented use. The Solicitor General, responding to a December 2025 CVSG, urged the Court to grant and reverse, warning that the Federal Circuit’s rule exposes generic manufacturers to liability based on facially neutral commercial statements. Lead counsel for Hikma is Charles Bennett Klein of Winston & Strawn LLP; Michael Robert Huston of Perkins Coie LLP represents Amarin.
The decision will determine whether the Hatch-Waxman Act’s Section viii carve-out pathway remains viable as a route to early generic entry for multi-indication drugs. The Court’s earlier denial of certiorari in Teva v. GlaxoSmithKline, 143 S. Ct. 2483 (2023)—which raised a comparable post-trial question—makes this grant the industry’s first definitive guidance on skinny-label inducement. For a related Federal Circuit question pending before the Court, see Comcast Cable Communications, LLC v. WhereverTV, Inc., No. 25-820. Additional analysis is available at Patently-O, SCOTUSblog, and Morrison Foerster.