The Supreme Court granted certiorari to review whether a generic drugmaker that fully carves out a patented use from its label can nonetheless be held liable for induced infringement based solely on marketing its product as a generic version of a branded drug and referencing public information about the branded product, without promoting the patented use.

In Amarin Pharma v. Hikma Pharmaceutical USA, Case No. 23-1169 (Fed. Cir. June 25, 2024), the US Court of Appeals for the Federal Circuit concluded that Amarin adequately pleaded induced infringement based on allegations that Hikma marketed its product as a “generic” version of Vascepa and cited publicly available information about Vascepa, even though Hikma’s label carved out the patented indication pursuant to Section viii of the Hatch-Waxman Act.

In its petition to the Supreme Court, Hikma argued that the Federal Circuit’s ruling threatened the statutory balance struck by Hatch-Waxman by exposing skinny-label generic manufacturers to inducement liability based on conduct unrelated to the carved-out use. According to Hikma, permitting inducement claims under these circumstances would effectively nullify Hatch-Waxman Section viii by allowing plaintiffs to rely on generic marketing statements that do not instruct or encourage use of the patented method.

The questions presented are:

• 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?
• 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?