21 C.F.R. §314.53 - Submission of patent information

Cite as21 C.F.R. §314.53
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33 firm's commentaries
  • Requirements, Benefits, And Possible Consequences Of Listing Patents In FDA's Orange Book
    • United States
    • Mondaq United States
    • July 20, 2018
    ...asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug." 21 U.S.C. § 355(b)(1); see also 21 C.F.R. § 314.53(b)(1) (construing "drug" as "drug product"), (d)(1). If a patent issues after the NDA is filed but before it is approved, "the applicant s......
  • U.S. Supreme Court To Weigh In On Reverse Payment Deals
    • United States
    • Mondaq United States
    • April 5, 2013
    ...of any patent that a generic manufacturer would infringe by making or selling the NDA applicant's drug. 21 U.S.C. § 355(b)(1); 21 C.F.R. § 314.53(b). If the FDA approves the NDA, the drug and patent information is published in a book commonly known as the "Orange To obtain FDA approval of a......
  • Litigation Alert: U.S. Supreme Court to Weigh In on Reverse Payment Deals
    • United States
    • JD Supra United States
    • April 3, 2013
    ...of any patent that a generic manufacturer would infringe by making or selling the NDA applicant’s drug. 21 U.S.C. § 355(b)(1); 21 C.F.R. § 314.53(b). If the FDA approves the NDA, the drug and patent information is published in a book commonly known as the “Orange Book.” To obtain FDA approv......
  • A Modest Proposal for Protecting the Laws of Nature from Being Burdened by Patents, and Making them Free to All Men and Reserved Exclusively to None
    • United States
    • LexBlog United States
    • December 31, 2013
    ...file a New Law of Nature Application, or more mellifluously, N-LoNAs. The relevant Code of Federal Regulation provisions, principally 21 C.F.R. § 314 (New Drug Applications) and § 321 (Investigational New Drug Applications) will need to be revised to include a requirement that the respectiv......
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14 books & journal articles
  • Antitrust
    • United States
    • ABA General Library ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...injunction issues; and (4) the effect (if any) of the court’s ruling on the public interest.”). 122. 21 U.S.C. § 355(a). 123. Id. 124. 21 C.F.R. 314.53(b). 125. 21 U.S.C. § dor54588_16_ch16_377-404.indd 402 5/5/16 5:42 PM III. Remedies 403 when the NDA holder lists additional patents in the......
  • Regulatory and Enforcement Framework
    • United States
    • ABA Antitrust Library Pharmaceutical Industry Antitrust Handbook. Second Edition
    • December 8, 2018
    ...74. See infra Chapter VI, Part D.1. 75. Which patents must be listed in the Orange Book is subject to regulation by the FDA under 21 C.F.R. § 314.53. 76. 21 C.F.R. § 314.53. 77. See 21 U.S.C. § 355(j). 78. Id. at § 355(j)(2)(A)(vii)(I)-(IV). 79. Id. at § 355(j)(2)(A)(vii)(I). 80. Id. at § 3......
  • Notice and Prefiling Considerations
    • United States
    • ABA General Library ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...whether a patent is properly listed in the Orange Book.18A Generic may write to the FDA challenging the propriety of a 13. 21 C.F.R. § 314.53(b); 59 Fed. Reg. 50,338, 50,345 (Oct. 3, 1994). 14. 21 U.S.C. § 355(b)(1)(G). 15. 21 C.F.R. § 314.53(d)(1). 16. 21 U.S.C. § 355(c)(2). 17. 21 C.F.R. ......
  • The Statutory and Regulatory Scheme
    • United States
    • ABA General Library ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...by the manufacture, use, or sale of the drug for which the ANDA applicant seeks approval.72The 66. 21 U.S.C. § 355(b)(1)(G). 67. See 21 C.F.R. §§ 314.53(c)(2)(ii)(P)(3), (e); Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670, 1672 (2012). 68. 21 C.F.R. § 314.53(b)(1). 69. 21 U.......
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