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Hospira, Inc. et al v. Burwell et al

RESPONSE in Opposition re MOTION for Summary Judgment

57 Cited authorities

  1. Kokkonen v. Guardian Life Ins. Co. of America

    511 U.S. 375 (1994)   Cited 19,241 times   5 Legal Analyses
    Holding that absent a reservation of jurisdiction in the stipulated dismissal order, federal courts lack jurisdiction to consider enforcement of a settlement agreement

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

    467 U.S. 837 (1984)   Cited 16,044 times   505 Legal Analyses
    Holding that courts "must give effect to the unambiguously expressed intent of Congress"

  3. Ebay Inc. v. Mercexchange, L. L. C.

    547 U.S. 388 (2006)   Cited 3,833 times   130 Legal Analyses
    Holding that traditional four-factor test applies to injunctions against patent infringement

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

    463 U.S. 29 (1983)   Cited 6,663 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. Barnhart v. Walton

    535 U.S. 212 (2002)   Cited 2,170 times   1 Legal Analyses
    Holding that the “‘ 12 month' duration requirements apply to both the ‘impairment' and the ‘inability' to work requirements”

  6. Wyeth v. Levine

    555 U.S. 555 (2009)   Cited 1,435 times   101 Legal Analyses
    Holding that the FDA's drug labeling judgments pursuant to the FDCA did not obstacle preempt state law products liability claims

  7. Citizens to Preserve Overton Park v. Volpe

    401 U.S. 402 (1971)   Cited 5,978 times   8 Legal Analyses
    Holding a decision is committed to agency discretion when there is "no law to apply"

  8. Fed. Express Corp. v. Holowecki

    552 U.S. 389 (2008)   Cited 1,121 times   12 Legal Analyses
    Holding that the EEOC "acted within its authority in formulating the rule that a filing is deemed a charge if the document reasonably can be construed to request agency action and appropriate relief on the employee’s behalf"

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

    545 U.S. 967 (2005)   Cited 1,180 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. Amoco Production Co. v. Gambell

    480 U.S. 531 (1987)   Cited 2,092 times   1 Legal Analyses
    Holding that a District Court did not err in declining to issue an injunction to bar exploratory drilling on Alaskan public lands, because the district court's decision "did not undermine" the policy of the Alaska National Interest Lands Conservation Act, 16 U.S.C. § 3120, and because the Secretary of the Interior had other means of meaningfully complying with the statute

  11. Section 706 - Scope of review

    5 U.S.C. § 706   Cited 20,543 times   185 Legal Analyses
    Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

  12. Section 271 - Infringement of patent

    35 U.S.C. § 271   Cited 6,069 times   1056 Legal Analyses
    Holding that testing is a "use"

  13. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,253 times   341 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 314.53 - Submission of patent information

    21 C.F.R. § 314.53   Cited 91 times   53 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 67 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

  17. Section 314.92 - Drug products for which abbreviated applications may be submitted

    21 C.F.R. § 314.92   Cited 23 times   1 Legal Analyses
    Noting that, with limited exceptions not relevant here, ANDAs are suitable only for "[d]rug products that are the same as a listed drug," and that "the same as" includes drugs with label modifications made for patent carve-outs