“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?”
