5 Cited authorities

  1. Palmer v. BRG of Georgia, Inc.

    498 U.S. 46 (1990)   Cited 229 times   8 Legal Analyses
    Holding an agreement between bar review course providers dividing market territories for the purpose of raising prices was per se illegal
  2. Ranbaxy Labs., Ltd. v. Burwell

    82 F. Supp. 3d 159 (D.D.C. 2015)   Cited 8 times   3 Legal Analyses

    Civil Action No. 14–1923 BAH 03-11-2015 Ranbaxy Laboratories, Ltd, et al., Plaintiffs, v. Sylvia Mathews Burwell, Secretary, United States Department of Health and Human Services, et al., Defendants, v. Dr. Reddy's Laboratories, Inc., Endo Pharmaceuticals, Inc., Ivax Pharmaceuticals, Inc, Teva Pharmaceuticals USA, Inc. Defendant–Intervenors. John Kevin Dolan Crisham, Robert Anthony Gretch, Stephen S. Schwartz, Kirkland & Ellis LLP, New York, NY, Michael D. Shumsky, Kirkland & Ellis, LLP, Washington

  3. AstraZeneca AB v. Impax Laboratories Inc.

    490 F. Supp. 2d 368 (S.D.N.Y. 2007)   Cited 5 times
    Holding that the language of 35 U.S.C. § 271(e) is clear and “[o]nly the most extraordinary showing of contrary intentions in the legislative history will justify departure from the plain and unambiguous language of the statute”
  4. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,252 times   340 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"
  5. Section 355a - Pediatric studies of drugs

    21 U.S.C. § 355a   Cited 68 times   12 Legal Analyses

    (a) Definitions As used in this section, the term "pediatric studies" or "studies" means at least one clinical investigation (that, at the Secretary's discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies. (b) Market exclusivity for new drugs (1) In general Except as provided in paragraph (2), if, prior to approval of an application