§Why CasetextPricing

Biovail Corporation et al v. U.S. Food and Drug Administration et al

RESPONSE in Opposition re MOTION for Temporary Restraining Order MOTION for Preliminary Injunction

37 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. Granny Goose Foods, Inc. v. Teamsters

    415 U.S. 423 (1974)   Cited 2,115 times   1 Legal Analyses
    Holding that union could not be held in contempt of restraining order

  3. Direx Israel, Ltd. v. Breakthrough Med. Corp.

    952 F.2d 802 (4th Cir. 1991)   Cited 943 times   3 Legal Analyses
    Holding that a court will not grant a preliminary injunction unless the plaintiff first makes a "clear showing" that he will suffer irreparable injury without it, and that the harm "must be neither remote nor speculative, but actual and imminent"

  4. Lilly v. Medtronic, Inc.

    496 U.S. 661 (1990)   Cited 252 times   28 Legal Analyses
    Holding that the statute creates an "act of infringement that consists of submitting an ANDA . . . containing the fourth type of certification"

  5. In re Microsoft Corporation Antitrust Litig

    333 F.3d 517 (4th Cir. 2003)   Cited 442 times   2 Legal Analyses
    Holding "a preliminary injunction is to protect the status quo and to prevent irreparable harm during the pendency of a lawsuit ultimately to preserve the court's ability to render a meaningful judgment on the merits."

  6. Scotts Co. v. United Industries Corp.

    315 F.3d 264 (4th Cir. 2002)   Cited 417 times   4 Legal Analyses
    Holding that when survey questions are leading and suggestive, this "weaken the relevance and credibility of the survey evidence to the point that it sheds no light on the critical question in case."

  7. Blackwelder Furn. Co., Etc. v. Seilig Mfg. Co.

    550 F.2d 189 (4th Cir. 1977)   Cited 937 times   6 Legal Analyses
    Holding that "if a decided imbalance of hardship should appear in plaintiff's favor, then the likelihood-of-success test is displaced by Judge Jerome Frank's famous formulation. . . ."

  8. 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."

  9. Microstrategy Inc. v. Motorola, Inc.

    245 F.3d 335 (4th Cir. 2001)   Cited 318 times
    Holding that the phrase "Intelligence Everywhere" was not used as a mark in part because the word mark was used in "limited, sporadic, and inconsistent" ways

  10. 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

  11. Section 271 - Infringement of patent

    35 U.S.C. § 271   Cited 6,040 times   1050 Legal Analyses
    Holding that testing is a "use"

  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 314.3 - Definitions

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

  15. Section 314.53 - Submission of patent information

    21 C.F.R. § 314.53   Cited 89 times   51 Legal Analyses
    Referring to "those patents that claim the drug product," and those "patents that claim the drug substance"

  16. Section 314.107 - Date of approval of a 505(b)(2) application or ANDA

    21 C.F.R. § 314.107   Cited 66 times   13 Legal Analyses
    Expanding Paragraph IV certification to include "unenforceability" defense in addition to the invalidity and noninfringement defenses stated in 21 U.S.C. § 355(j), because unenforceability is a recognized reason why a generic drug product would not violate a patent holder's rights