21 C.F.R. 314.107 - Date of approval of a 505(b)(2) application or ANDA

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92 practice notes
  • Mylan Laboratories, Inc. v. Thompson, No. CIV.A.04-1049(RBW).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • August 17, 2004
    ...patent itself will not bar FDA's approval of the ANDA; rather, it is eligible for immediate approval. 21 U.S.C. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(f)(2). "The patent holder is, of course, free to sue the applicant for infringement ... after the 45-day window expires. The 30-month stay......
  • In re Ciprofloxacin Hydrochloride Antitrust Lit., No. 2008-1097.
    • United States
    • United States Courts of Appeals. United States Court of Appeals for the Federal Circuit
    • October 15, 2008
    ...right to the 180-day exclusivity period on a "successful defense" of its Paragraph IV ANDA against the patent holder. Id.; see 21 C.F.R. § 314.107(c)(1) (1998), revoked 63 Fed.Reg. 59710, 59711 (Nov. 5, 1998). However, Barr acknowledged in the consent judgment both its infringement and the ......
  • In re Tamoxifen Citrate Antitrust Litigation, Docket No. 03-7641.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (2nd Circuit)
    • November 2, 2005
    ...IV certification, but only if the ANDA filer successfully defended against a lawsuit for infringement of the relevant patent. See 21 C.F.R. § 314.107(c)(1) (1995). This so-called "successful defense" requirement was challenged in 1997 in two separate lawsuits. In each, the circuit court rej......
  • In re Omeprazole Patent Litigation, No. M-21-81 (BSJ),
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • May 31, 2007
    ...patent holder files suit within forty-five days of receiving notice of a Paragraph IV certification. 21 U.S.C. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(f)(2) (2006). If a patent infringement action is timely brought, final marketing approval of the ANDA cannot occur before expiration of thi......
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74 cases
  • Mylan Pharmaceuticals Inc. v. Henney, Civil Action No. 99-cv-862(RMU).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • March 31, 2000
    ...within 45 days of the date the pioneer maker receives notice of the Paragraph IV certification. See 21 U.S.C. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(f)(2).1 If a patent action is brought within 45 days, however, the ANDA will not be approved until at least 30 months from the date the affe......
  • In re Ciprofloxacin Hydrochloride Antitrust Lit., 2008-1097.
    • United States
    • United States Courts of Appeals. United States Court of Appeals for the Federal Circuit
    • October 15, 2008
    ...right to the 180-day exclusivity period on a "successful defense" of its Paragraph IV ANDA against the patent holder. Id.; see 21 C.F.R. § 314.107(c)(1) (1998), revoked 63 Fed.Reg. 59710, 59711 (Nov. 5, 1998). However, Barr acknowledged in the consent judgment both its infringement and the ......
  • Teva Pharmaceuticals Usa, Inc. v. Sebelius, Civil Action No. 09-1111 (RMC).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • July 31, 2009
    ...ANDA, and the approval may be effective immediately despite the unexpired patent, provided that other conditions have been met. Id.; 21 C.F.R. § 314.107(f)(2). Under certain circumstances, the statute provides a 180-day exclusive marketing period vis-a-vis other ANDA applicants to the first......
  • Dr. Reddy's Laboratories, Inc. v. Thompson, Civil No. 02-452(WGB).
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • September 15, 2003
    ...drug or the date of "a decision of a court" finding the patent invalid, unenforceable, or not infringed. 21 U.S.C. § 355(j)(5)(B)(iv); 21 C.F.R. 314.107(c)(1) & With respect to the omeprazole drug products, patent infringement issues have been adjudicated in the New York litigation and are ......
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6 firm's commentaries
  • Requirements, Benefits, And Possible Consequences Of Listing Patents In FDA's Orange Book
    • United States
    • Mondaq United States
    • July 20, 2018
    ...are met." 81 Fed. Reg. at 69,606 (citing sections 505(c)(3)(C) and (j)(5)(B)(iii) of the Federal Food, Drug, and Cosmetic Act; 21 C.F.R. § 314.107). Second, if a patent owner or NDA holder brings a patent infringement suit against a generic drug applicant, "the applicant may asser......
  • The FTC's Continuing Challenge to Reverse Payment Patent Settlements in the Pharmaceutical Industry By Helen Cho Eckert
    • United States
    • JD Supra United States
    • June 26, 2009
    ...the Debate Over Reverse-Payment Settlements in the Wake of the Medicare Modernization Act of 2003 and In re Tamoxifen Citrate 12 21 C.F.R. § 314.107. Litigation, 93 IOWA L. REV. 1015, 1031 (2008) (while the cost of 13 E.g., Christopher M. Holman, Do Reverse Payment researching, developing a......
  • Know the Rules! FDA’s New Regulations Change Responsibilities For ANDA Filers
    • United States
    • JD Supra United States
    • October 13, 2016
    ...or license date if the ANDA applicant submits “written consent” obtained from the patent and/or NDA holder for that approval. See 21 C.F.R. § 314.107(b)(3)(vi). FDA describes acceptable “written consent” as “[a] letter to FDA from the patent owner(s) or exclusive patent licensee that provid......
  • Hatch-Waxman and BPCIA Developments in June 2018
    • United States
    • JD Supra United States
    • July 9, 2018
    ...had provided written consent, “the proper course is for Deva to submit that consent to the FDA, which would have the authority under 21 C.F.R. § 314.107(b)(3)(vi) to terminate the stay and grant approval of Deva’s No OTDP for Firazyr®Shire Orphan Therapies LLC v. Fresenius Kabi USA, LLC, 06......
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4 books & journal articles
  • Notice and Prefiling Considerations
    • United States
    • ABA General Library ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...NDA owner should compare the time to trial in various jurisdictions, as well as 89. 21 U.S.C. § 355(j)(5)(B)(iii). 90. Id.; see also 21 C.F.R. § 314.107(b)(3)(i)(A). 91. 21 U.S.C. § 355(j)(5)(B)(iii); see also 21 C.F.R. § 314.107(b)(3)(i)(B)(ii). 92. While it may be possible to obtain a pre......
  • Remedies
    • United States
    • ABA General Library ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...837 (1984). 130. See 59 Fed. Reg. 50,338, 50,367 (Oct. 3, 1994) (adopting successful defense regulation as a final rule, codified at 21 C.F.R. § 314.107). 131. 955 F. Supp. 128 (D.D.C. 1997). 132. See 63 Fed. Reg. 59,710, 59,711 (Nov. 5, 1998); see also, e.g., Mova Pharm. Corp. v. Shalala, ......
  • Summary Judgment
    • United States
    • ABA General Library ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...of the paragraph IV certification, i.e., that listed patents are invalid or not infringed or unenforceable. Id. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(b)(3) (2009). 3. FED. R. CIV. P. 56. dor54588_13_ch13_279–320.indd 279 5/5/16 4:50 PM 280 CHAPTER 13 but because of the unique circumstanc......
  • The War on Drugs: How KSR v. Teleflex and Merck v. Integra Continue the Erosion of Pharmaceutical Patent Protection
    • United States
    • Capital University Law Review Nbr. 36-4, July 2008
    • July 1, 2008
    ...2006 WL 2008962, at *49 (E.D. Va. July 17, 2006). 239Aventis, 499 F.3d at 1295. 240Id. at 1301–02. 24121 U.S.C. § 355(j) (2000). 24221 C.F.R. § 314.107(c)(1) (2007). 243Congressional Budget Office, How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceu......

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