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Ranbaxy Laboratories, LTD et al v. Burwell et al

Memorandum in opposition to re MOTION for Temporary Restraining Order

93 Cited authorities

  1. Winter v. Natural Res. Def. Council, Inc.

    555 U.S. 7 (2008)   Cited 16,781 times   56 Legal Analyses
    Holding that a plaintiff must establish "that he is likely to suffer irreparable harm"

  2. 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"

  3. Bennett v. Spear

    520 U.S. 154 (1997)   Cited 3,687 times   35 Legal Analyses
    Holding that a Final Biological Opinion has "legal consequences," even though the action agency is not legally obligated to accept the opinion's recommendations or conclusions, because the opinion "alter the legal regime to which the action agency is subject"

  4. Motor Vehicle Manufacturers Assoc. of the United States, Inc. v. State Farm Mutual Auto. Ins. Co.

    463 U.S. 29 (1983)   Cited 6,633 times   50 Legal Analyses
    Holding that " `settled course of behavior embodies the agency's informed judgment that, by pursuing that course, it will carry out the policies [of applicable statutes or regulations]'"

  5. United States v. Mead Corp.

    533 U.S. 218 (2001)   Cited 2,593 times   29 Legal Analyses
    Holding that a Customs classification ruling "has no claim to judicial deference under Chevron " but can "claim respect according to its persuasiveness"

  6. Barnhart v. Walton

    535 U.S. 212 (2002)   Cited 2,167 times   1 Legal Analyses
    Holding that the “‘ 12 month' duration requirements apply to both the ‘impairment' and the ‘inability' to work requirements”

  7. Munaf v. Geren

    553 U.S. 674 (2008)   Cited 1,644 times   5 Legal Analyses
    Holding that civilian U.S. citizens held in U.S. military custody in Iraq could petition for a writ of habeas corpus in federal district court

  8. 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"

  9. National Cable Telecom. Assn. v. Brand X Internet S

    545 U.S. 967 (2005)   Cited 1,175 times   41 Legal Analyses
    Holding that an agency is free within "the limits of reasoned interpretation to change course" only if it "adequately justifies the change"

  10. Abbott Laboratories v. Gardner

    387 U.S. 136 (1967)   Cited 5,286 times   9 Legal Analyses
    Holding that plaintiffs subject to a regulation had standing to challenge it even though the Attorney General had yet to "authorize criminal and seizure actions for violations of the statute"

  11. Rule 12 - Defenses and Objections: When and How Presented; Motion for Judgment on the Pleadings; Consolidating Motions; Waiving Defenses; Pretrial Hearing

    Fed. R. Civ. P. 12   Cited 345,885 times   922 Legal Analyses
    Granting the court discretion to exclude matters outside the pleadings presented to the court in defense of a motion to dismiss

  12. 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"

  13. Section 271 - Infringement of patent

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

  14. Section 704 - Actions reviewable

    5 U.S.C. § 704   Cited 4,249 times   31 Legal Analyses
    Granting judicial review over " final agency action"

  15. Section 282 - Presumption of validity; defenses

    35 U.S.C. § 282   Cited 3,896 times   133 Legal Analyses
    Granting a presumption of validity to patents

  16. 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"

  17. Section 331 - Prohibited acts

    21 U.S.C. § 331   Cited 1,512 times   105 Legal Analyses
    Prohibiting the sale of adulterated foods

  18. Section 351 - Adulterated drugs and devices

    21 U.S.C. § 351   Cited 340 times   32 Legal Analyses
    Referencing the U.S. Pharmacopeia's strength, quality, and purity standards

  19. 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

  20. 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

  21. 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

  22. 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"

  23. 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

  24. Section 314.127 - Refusal to approve an ANDA

    21 C.F.R. § 314.127   Cited 62 times   14 Legal Analyses
    Listing reasons the FDA will refuse approval of an ANDA, none of which concern patent litigation under § 271(e)

  25. Section 10.85 - Advisory opinions

    21 C.F.R. § 10.85   Cited 44 times   3 Legal Analyses
    Providing that an FDA employee's written statement, which constitutes "an informal communication," "does not necessarily represent the formal position of FDA," a statement that by its terms contemplates that certain employee statements may do so

  26. Section 20.61 - Trade secrets and commercial or financial information which is privileged or confidential

    21 C.F.R. § 20.61   Cited 25 times   1 Legal Analyses
    Defining trade secret information and confidential commercial information