Biovail Corporation et al v. U.S. Food and Drug Administration et al
Memorandum in opposition to re Second MOTION for Temporary Restraining OrderSecond MOTION for Preliminary InjunctionSecond MOTION for Preliminary InjunctionSecond MOTION for Preliminary Injunction
504 U.S. 374 (1992) Cited 1,710 times 11 Legal Analyses
Holding that guidelines on airfare advertising were "related to" the rates, routes, or services of an air carrier given that every guideline makes "express reference to [air]fares"
Holding APA § 702's waiver applies to claims against an agency for nonmonetary relief regardless of whether the challenged agency action constitutes "final agency action" subject to review under APA § 704
Holding that the Michigan Chamber of Commerce had a substantial legal interest where it was regulated by at least three of the four statutory provisions challenged by plaintiffs
Holding that to establish irreparable harm the movant must "substantiate the claim that irreparable injury is 'likely' to occur. . . . Bare allegations of what is likely to occur are of no value."
Holding that courts generally "have no basis for reordering agency priorities," given that the agency is "in a unique — and authoritative — position to view its projects as a whole, estimate the prospects for each, and allocate its resources in the optimal way"
21 U.S.C. § 355 Cited 2,252 times 340 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"