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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

28 Cited authorities

  1. Chevron U.S.A. v. Natural Res. Def. Council

    467 U.S. 837 (1984)   Cited 16,020 times   502 Legal Analyses
    Holding that courts "must give effect to the unambiguously expressed intent of Congress"

  2. Citizens to Preserve Overton Park v. Volpe

    401 U.S. 402 (1971)   Cited 5,969 times   8 Legal Analyses
    Holding a decision is committed to agency discretion when there is "no law to apply"

  3. Morales v. Trans World Airlines, Inc.

    504 U.S. 374 (1992)   Cited 1,698 times   11 Legal Analyses
    Holding that the Airline Deregulation Act, which prohibits States from enforcing any law "relating to rates, routes, or services" of any air carrier, preempted fare-advertising guidelines that "would have a significant impact upon" the airlines' ability to charge fares

  4. Trudeau v. Federal Trade Com'n

    456 F.3d 178 (D.C. Cir. 2006)   Cited 887 times
    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

  5. Michigan State Afl-Cio v. Miller

    103 F.3d 1240 (6th Cir. 1997)   Cited 499 times
    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

  6. Wisconsin Gas Co. v. F.E.R.C

    758 F.2d 669 (D.C. Cir. 1985)   Cited 648 times
    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."

  7. Cityfed Fin. v. Office of Thrift Supervision

    58 F.3d 738 (D.C. Cir. 1995)   Cited 345 times
    Holding that a moving party's failure to make a showing of irreparable injury "alone is sufficient" to deny a motion for a preliminary injunction

  8. Mova Pharmaceutical Corp. v. Shalala

    140 F.3d 1060 (D.C. Cir. 1998)   Cited 287 times   5 Legal Analyses
    Holding that danger of loss of market share due to denial of a preliminary injunction satisfied the third Rule 24 factor

  9. In re Barr Laboratories, Inc.

    930 F.2d 72 (D.C. Cir. 1991)   Cited 245 times   1 Legal Analyses
    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"

  10. Transohio Savings Bank v. Director

    967 F.2d 598 (D.C. Cir. 1992)   Cited 168 times
    Holding that court could exercise jurisdiction over statutory and due process claims related to a contract, but not common law contract claims

  11. Section 706 - Scope of review

    5 U.S.C. § 706   Cited 20,440 times   184 Legal Analyses
    Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

  12. Rule 62 - Stay of Proceedings to Enforce a Judgment

    Fed. R. Civ. P. 62   Cited 4,121 times   14 Legal Analyses
    Granting of stay is discretionary

  13. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,244 times   337 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"

  14. Section 314.94 - Content and format of an ANDA

    21 C.F.R. § 314.94   Cited 224 times   37 Legal Analyses
    Explaining that products stemming from Drug Efficacy Study Implementation approvals are subject to today's ANDA regulations

  15. Section 314.3 - Definitions

    21 C.F.R. § 314.3   Cited 144 times   30 Legal Analyses
    Defining "reference listed drug"