Declaratory Judgment Jurisdiction Despite Covenant Not To Sue

Holding that jurisdiction existed under MedImmune's "all the circumstances" test, the U.S. Court of Appeals for the Federal Circuit recently reversed a lower court's finding of no jurisdiction in a Hatch-Waxman declaratory judgment action in which the pharmaceutical patentee had provided the Abbreviated New Drug Application (ANDA) filer a covenant not to sue for the patent-in-suit. Caraco Pharm. Labs., LTD. v. Forest Labs., Inc., Case No. 07-1404 (Fed. Cir., April 1, 2008) (Gajarsa, J.; Friedman, J. dissenting).

As part of obtaining Food and Drug Administration (FDA) approval for its anti-depression drug Lexapro^®, Forest listed U.S. Patent Nos. Re. 34,712 and 6,916,941 in the FDAs Orange Book. After Caraco filed its May 2006 ANDA for generic Lexapro^®, which included Paragraph IV certifications for both patents, Forest responded by suing Caraco for infringement of only the '712 patent. Caraco