Hikma Pharmaceuticals v. Amarin

Congress passed the Hatch-Waxman Act "[t]o facilitate the approval of generic drugs as soon as patents allow." Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S , 566 U.S. 399, 405 (2012). Recognizing that many drugs are approved for both patented and unpatented uses, Congress sought to ensure "that one patented use will not foreclose marketing a generic drug for other unpatented ones." Id . at 415. The statutory mechanism is a "skinny label": Generic drugmakers "carve out" patented uses from their labels, leaving only instructions to use generic drugs for their unpatented uses. See 21 U.S.C. § 355(j)(2)(A)(viii). Congress designed this carve-out mechanism to encourage competition and to protect generic drugmakers from allegations that marketing a generic drug for an unpatented use "actively induces infringement." 35 U.S.C. § 271(b). After all, active inducement requires "clear expression or other affirmative steps taken to foster infringement"-there is no "liability when a defendant merely sells a commercial product suitable for some lawful use." Metro-Goldwyn- Mayer Studios Inc. v. Grokster, Ltd. , 545 U.S. 913, 936-937 & n.11 (2005). The questions presented are: 1. When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a "generic version" and cites public information about the branded drug (e.g., sales) enough to plead induced infringement of the patented use? 2. Does a complaint state a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use?

Amarin Pharma markets icosapent ethyl under the brand name Vascepa. In 2012, the FDA approved Vascepa for treating severe hypertriglyceridemia (the SH indication), which affects patients with blood triglyceride levels of at least 500 mg/dL. In 2019, following additional research and clinical trials, the FDA approved Vascepa for a second use: reducing cardiovascular risk in patients with triglyceride levels of at least 150 mg/dL (the CV indication). Amarin listed two patents covering the CV indication in the FDA’s Orange Book. In 2016, Hikma Pharmaceuticals submitted an Abbreviated New Drug Application seeking approval for a generic version of icosapent ethyl. When the CV indication was approved in 2019, Hikma filed a “section viii statement” seeking FDA approval only for the SH indication by “carving out” the patented CV indication from its label—creating a “skinny label.” The FDA approved Hikma’s ANDA in May 2020. Throughout 2020, Hikma issued press releases referring to its product as the “generic version” or “generic equivalent” of Vascepa, describing Vascepa as indicated “in part” for the SH indication, and citing Vascepa sales figures (over $1 billion annually) that were attributable primarily to the CV indication. Hikma also marketed its product on its website under the therapeutic category “Hypertriglyceridemia” and as “AB” rated, though with a disclaimer that it was approved for fewer indications than Vascepa. In November 2020, Amarin sued Hikma for induced infringement of its CV indication patents. The U.S. District Court for the District of Delaware granted Hikma’s motion to dismiss. The U.S. Court of Appeals for the Federal Circuit reversed, finding that Amarin’s allegations—based on Hikma’s skinny label combined with its press releases and marketing materials—plausibly stated a claim for induced infringement.