Triggering First ANDA Filer’s 180-Day Exclusivity Period Supports Declaratory Judgment Counterclaim of Noninfringement

The court denied plaintiffs' motion to dismiss defendant's noninfringement counterclaims for lack of an actual case or controversy after plaintiffs provided a covenant not to sue. "Plaintiffs’ argument is premised on the assumption that without the actual threat of an infringement lawsuit concerning the [patents-in-suit], [defendant] has no cognizable legal interest in seeking judicial review of whether it has infringed these patents. But this argument fails to account for the reality that as a later ANDA filer, the FDA cannot approve [defendant's] ANDA to market a generic version of [plaintiffs' drug product] until the first filer’s 180-day exclusivity period is either forfeited or runs out. . . . [Defendant's] counterclaims could potentially trigger the first ANDA filer’s 180-day exclusivity period. This would have the effect of expediting [defendant's] ability to market its generic version of [plaintiffs' drug product]. Accordingly, this Court holds that [defendant's] counterclaims present a substantial controversy appropriate for judicial review."

Purdue Pharmaceutical Products LP. et al v. Actavis Elizabeth LLC, 2-12-cv-05311 (NJD April 9, 2014, Order) (Linares, J.)