Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. | 04/29/26 | Docket #: 24-889
24-889 HIKMA PHARMACEUTICALS V. AMARIN PHARMA, INC.
DECISION BELOW: 104 F.4th 1370
CERT. GRANTED 1/16/2026
QUESTION PRESENTED:
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?
LOWER COURT CASE NUMBER: 2023-1169