Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc.

This is an action brought under the Declaratory Judgment Act, 28 U.S.C. §§ 2201, 2202, and the provision of the Hatch-Waxman Act establishing civil actions for patent certainty, 21 U.S.C. § 355(j)(5)(C). Plaintiff-Appellant Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”) appeals a decision of the United States District Court for the Eastern District of Michigan dismissing its declaratory judgment action for noninfringement against Defendants-Appellees Forest Laboratories, Inc., et al., (“Forest”). Caraco’s action was dismissed for lack of Article III jurisdiction on the grounds that it had been rendered moot when Forest unilaterally granted Caraco a covenant not to sue for infringement of the patent-in-suit, U.S. Patent No. 6,916,941. However, in the context of the Hatch-Waxman framework, Forest’s covenant not to sue did not eliminate the controversy between the parties. Accordingly, we hold that Caraco’s declaratory judgment action presents a continuing Article III controversy, and reverse and remand for further proceedings.

Download the decision.