21 C.F.R. 314.53 - Submission of patent information
| Cite as | 21 C.F.R. 314.53 |
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155 practice notes
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Department of Commerce, Patent and Trademark Office,
...If the expiration date listed in the Orange Book is incorrect, the ANDA applicant could dispute the patent expiration date pursuant to 21 CFR 314.53(f). If the date is not corrected, the ANDA applicant could institute a declaratory judgment action with respect to the patent. Alternatively, ......
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Teva Pharm. USA, Inc. v. U.S. Food & Drug Admin., Civil Action No. 20-808 (BAH)
...or producing a drug) are not among the patents provided during the NDA process and therefore are not included in the Orange Book. See 21 C.F.R. § 314.53(b)(1). If an ANDA applicant seeks to market a generic version of a brand-name drug before a related patent in the Orange Book has expired,......
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Dr. Reddy's Laboratories, Inc. v. Thompson, Civil No. 02-452(WGB).
..."Approved Drug Products With Therapeutic Equivalence Evaluations," commonly called the "Orange Book." See 21 U.S.C. § 355(c)(2); 21 C.F.R. § 314.53(a). Based upon the Orange Book listings, ANDA applicants, in turn, file with the ANDA one of four certifications, to be made "in the opinion of......
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ViroPharma, Inc. v. Hamburg, Civil Action No. 12–0584 (ESH).
...the FDA's definition of “condition of use” in a regulation not related to the issues before this Court ( see Pl.'s Mot. at 20 (citing 21 C.F.R. § 314.53(d)(2)(B)) undercuts its argument. If the statute is as unambiguous as ViroPharma contends, then reference to an unrelated regulatory defin......
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98 cases
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Apotex, Inc. v. Daiichi Sankyo, Inc., Nos. 2014–1282
...reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug”); 21 C.F.R. §§ 314.3, 314.53. The first, U.S. Patent No. 5,616,599, covers the active ingredient of the drug, olmesartan medoxomil. It expires on April 25, 2016, but because Da......
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Teva Pharm. USA, Inc. v. U.S. Food & Drug Admin., Civil Action No. 20-808 (BAH)
...or producing a drug) are not among the patents provided during the NDA process and therefore are not included in the Orange Book. See 21 C.F.R. § 314.53(b)(1). If an ANDA applicant seeks to market a generic version of a brand-name drug before a related patent in the Orange Book has expired,......
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Allergan, Inc. v. Alcon Laboratories, Inc., No. 02-1449.
...the drug that are approved by the FDA. Id. Alcon also points to the FDA regulation that implements the Patent Listing Provision, 21 C.F.R. § 314.53(b).9 Specifically, Alcon relies on the part of the regulation that states: "For patents that claim a method of use, the applicant shall submit ......
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Dr. Reddy's Laboratories, Inc. v. Thompson, Civil No. 02-452(WGB).
..."Approved Drug Products With Therapeutic Equivalence Evaluations," commonly called the "Orange Book." See 21 U.S.C. § 355(c)(2); 21 C.F.R. § 314.53(a). Based upon the Orange Book listings, ANDA applicants, in turn, file with the ANDA one of four certifications, to be made "in the opinion of......
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33 firm's commentaries
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Requirements, Benefits, And Possible Consequences Of Listing Patents In FDA's Orange Book
...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......
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U.S. Supreme Court To Weigh In On Reverse Payment Deals
...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......
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Litigation Alert: U.S. Supreme Court to Weigh In on Reverse Payment Deals
...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......
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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
...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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11 books & journal articles
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Claim Construction
...110. Claim 1 of U.S. Patent No. 6,013,281 from In re Omeprazole Patent Litig., 483 F.3d 1364, 1367–68 (Fed. Cir. 2007). 111. 21 C.F.R. § 314.53(b)(1) (“Process patents . . . , patents claiming packaging, patents claiming metabolites, and patents claiming intermediates are not covered by thi......
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Summary Judgment
...that might cover the drug and its methods of use that are the subject of the NDA, including patents that issue after NDA approval. 21 C.F.R. §§ 314.53(b), 314.54(e). The list of patents appears in the FDA Orange Book, http://www.accessdata.fda.gov/scripts/cder/ob /default.cfm. 12. “The FDA ......
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The More Things Change: Improvement Patents, Drug Modifications, and the FDA
...prodrugs (as they are the active form of a drug into which the chemical ingested by patients metabolizes)—from the Orange Book . See 21 C.F.R. § 314.53(b) (2018) (“Process patents, patents claiming packaging, patents claiming metabolites, and patents claiming intermediates are not covered b......
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Antitrust
...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......
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