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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

37 Cited authorities

  1. Citizens to Preserve Overton Park v. Volpe

    401 U.S. 402 (1971)   Cited 5,970 times   8 Legal Analyses
    Holding a decision is committed to agency discretion when there is "no law to apply"

  2. Baltimore Gas & Electric Co. v. Natural Resources Defense Council, Inc.

    462 U.S. 87 (1983)   Cited 1,149 times   4 Legal Analyses
    Holding that "a reviewing court must generally be at its most deferential" when examining an agency decision made "within its area of special expertise, at the frontiers of science"

  3. 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

  4. Serono Laboratories v. Shalala

    158 F.3d 1313 (D.C. Cir. 1998)   Cited 247 times   1 Legal Analyses
    Holding deference “is owed to the decisionmaker authorized to speak on behalf of the agency, not to each individual agency employee”

  5. Abbott Lab. v. Andrx Pharmaceuticals

    452 F.3d 1331 (Fed. Cir. 2006)   Cited 179 times   4 Legal Analyses
    Holding that the public interest is best served by denying a preliminary injunction when a party did not establish a likelihood of success on the merits

  6. 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"

  7. Troy Corporation v. Browner

    120 F.3d 277 (D.C. Cir. 1997)   Cited 105 times   1 Legal Analyses
    Holding the agency was not required to include justifications for its self-evident determination that " ‘pulmonary irritation is a serious health effect’ "

  8. Eli Lilly & Co. v. American Cyanamid Co.

    82 F.3d 1568 (Fed. Cir. 1996)   Cited 71 times   1 Legal Analyses
    Holding that importation of antibiotic does not infringe patent claiming method of making intermediate compound where compound was "materially changed"

  9. Henley v. Food and Drug Admin

    77 F.3d 616 (2d Cir. 1996)   Cited 55 times
    Holding that since the question of whether an agency policy is arbitrary and capricious is purely a legal issue, fact discovery is not necessary

  10. Teva Pharmaceuticals, USA, Inc. v. United States Food & Drug Administration

    182 F.3d 1003 (D.C. Cir. 1999)   Cited 42 times   2 Legal Analyses
    Reversing district court's denial of an injunction to require the FDA to recognize the dismissal with prejudice of an infringement suit against a subsequent filer as triggering the first filer's 180-day exclusivity period

  11. Section 706 - Scope of review

    5 U.S.C. § 706   Cited 20,443 times   184 Legal Analyses
    Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

  12. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,245 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"

  13. Section 156 - Extension of patent term

    35 U.S.C. § 156   Cited 202 times   173 Legal Analyses
    Granting five-year extension of patent term based upon regulatory review of the product Abilify® (aripiprazole) by the FDA

  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"

  16. Section 314.105 - Approval of an NDA and an ANDA

    21 C.F.R. § 314.105   Cited 94 times   5 Legal Analyses
    Explaining that a "tentative" approval is the same as a final approval with a delayed effective date

  17. Section 320.24 - Types of evidence to measure bioavailability or establish bioequivalence

    21 C.F.R. § 320.24   Cited 12 times   5 Legal Analyses
    Providing that the FDA may require either in vivo or in vitro studies to demonstrate bioequivalence