Inducement in a Pharmaceutical, Post-Launch Non-Hatch-Waxman World

Description

On May 15, 2023, the U.S. Supreme Court denied certiorari in Teva Pharms. USA Inc. v. GlaxoSmithKline L.L.C., which brought attention to alleged skinny labels for generics. The Federal Circuit had twice reinstated the jury verdict of induced infringement in a drug patent case that was post-launch and non-Hatch Waxman [GlaxoSmithKline L.L.C. v. Teva Pharms. USA Inc. (Fed. Cir. Oct. 2, 2020)]. The appeals court found to be substantial evidence of inducement Teva's press releases and promotional materials affirmatively, inter alia, promoting its carvedilol tablet as the AB generic equivalent of Coreg®.

The decisions provide guidance regarding what is a skinny label and other evidence such as press releases, promotional materials, and drug classification, such as AB rating, in a post-launch, non-Hatch Waxman pharmaceutical litigation, most notably that the carveout is not a guarantee of avoiding induced infringement under circumstances where the generic label is not truly a skinny label. The Federal Circuit majority agreed with GSK that "precedent makes clear that when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met."

Listen as our authoritative panel of patent attorneys examines the recent decision in Teva v. GSK and GSK v. Teva decision and any other relevant, post-launch, non-Hatch Waxman pharmaceutical litigations, and the implications for post-launch, non-Hatch Waxman induced infringement cases. The panel will also discuss strategies and tactics regarding claim language and label language, as well as types of evidence to adduce to prove inducement of infringement.