524 U.S. 417 (1998) Cited 503 times 5 Legal Analyses
Holding that "the power to enact statutes may only be exercised in accord with a single, finely wrought and exhaustively considered, procedure" outlined in Article I
Holding that a declaratory judgment action as to one of the listed patents would "clear the path to FDA approval that [the NDA holder's] actions would otherwise deny [the generic pharmaceutical]"
Affirming the district court's dismissal of an action filed by Spectronics under the Declaratory Judgment Act, 28 U.S.C. § 2201, alleging, inter alia, invalidity and non-infringement of a patent owned by Fuller because Fuller filed a covenant not to sue Spectronics for infringement of the patent at issue and therefore Fuller was "forever estopped from asserting the [patent at issue] against Spectronics"
21 U.S.C. § 355 Cited 2,241 times 334 Legal Analyses
Granting the court discretion to change the date on which an ANDA may be approved if "either party to the action failed to reasonably cooperate in expediting the action"