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Covenant not to sue removes jurisdiction despite lingering Hatch-Waxman exclusivity issues

By McKee, Voorhees & Sease, P.L.C.

In a recent decision, the Federal Circuit affirmed a district court's decision involving declaratory judgment jurisdiction in the context of abbreviated new drug applications (ANDAs) and a related covenant-not-to-sue involving one patent at issue.  The court affirmed a covenant-not-to-sue coupled with a stipulation of validity and enforceability removed any case or controversy required for declaratory judgment jurisdiction.

The Federal Circuit also provided in-depth analysis and explanation about the market exclusivity provisions of the Hatch-Waxman Act as well as the impact of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) passed by Congress amending the Hatch-Waxman Act.  These provisions create unique issues in the context of declaratory judgment actions by potential generic drug manufacturers.
    
More on Janssen Pharmaceutica, N.V. v. Apotex, Inc. after the jump.

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Full post as published by FileWrapper on September 15, 2008 (boomark / email).