21 C.F.R. 314.107 - Date of approval of a 505(b)(2) application or ANDA
| Cite as | 21 C.F.R. 314.107 |
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92 practice notes
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Mylan Laboratories, Inc. v. Thompson, No. CIV.A.04-1049(RBW).
...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......
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In re Ciprofloxacin Hydrochloride Antitrust Lit., No. 2008-1097.
...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 ......
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In re Tamoxifen Citrate Antitrust Litigation, Docket No. 03-7641.
...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......
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In re Omeprazole Patent Litigation, No. M-21-81 (BSJ),
...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
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Mylan Pharmaceuticals Inc. v. Henney, Civil Action No. 99-cv-862(RMU).
...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......
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In re Ciprofloxacin Hydrochloride Antitrust Lit., 2008-1097.
...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 ......
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Teva Pharmaceuticals Usa, Inc. v. Sebelius, Civil Action No. 09-1111 (RMC).
...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......
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Dr. Reddy's Laboratories, Inc. v. Thompson, Civil No. 02-452(WGB).
...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
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Requirements, Benefits, And Possible Consequences Of Listing Patents In FDA's Orange Book
...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......
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The FTC's Continuing Challenge to Reverse Payment Patent Settlements in the Pharmaceutical Industry By Helen Cho Eckert
...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......
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Know the Rules! FDA’s New Regulations Change Responsibilities For ANDA Filers
...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......
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Hatch-Waxman and BPCIA Developments in June 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
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Notice and Prefiling Considerations
...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......
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Remedies
...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, ......
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Summary Judgment
...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......
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The War on Drugs: How KSR v. Teleflex and Merck v. Integra Continue the Erosion of Pharmaceutical Patent Protection
...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......