New drug product exclusivity
| Currency | Current through May 31, 2023 |
| Citation | 21 C.F.R. §314.108 |
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2 cases
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Watson Labs., Inc. v. Forest Labs. Inc.
...included a Paragraph IV certification--in which case it was permitted to be filed after four years. See 21 U.S.C. § 355(j)(5)(F)(ii); 21 C.F.R. § 314.108. 3. "JA" refers to the Joint Appendix. "Compl." and "Complaint" refer to the Third Consolidated and Amended Class Action Complaint locate......
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CVS Pharm. v. Forest Labs. (In re Watson Labs.)
...included a Paragraph IV certification--in which case it was permitted to be filed after four years. See 21 U.S.C. § 355(j)(5)(F)(ii); 21 C.F.R. § 314.108. [3] "JA" refers to the Appendix. "Compl." and "Complaint" refer to the Third Consolidated and Amended Class Action Complaint located at ......
8 firm's commentaries
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Patent Term Extension for Drugs Not Limited to New Chemical Entities
...PTE for an innovative use or dosage form of cromolyn sodium, which had previously approved by the FDA in inhalation capsule form). 6 21 C.F.R. § 314.108. 7 21 C.F.R. § 314.103. 8 See PhotoCure Asa v. Kappos, 603 F.3d. 1372, 1375-76 (Fed. Cir. 2010) (holding that the drug product with the ac......
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Federal Circuit Focuses On Active Ingredient, Not Active Moiety, For Scope Of Patent Term Extension
...that cause the drug to be an ester, salt ..․ responsible for the physiological or pharmacological action of the drug substance.” 21 C.F.R. § 314.108(a). (The FDA rule cited in Pfizer appears in Part 314, which relates to “Applications for FDA Approval to Market A New Drug.” In contrast, the......
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Federal Circuit Focuses On Active Ingredient, Not Active Moiety, For Scope Of Patent Term Extension
...that cause the drug to be an ester, salt ..․ responsible for the physiological or pharmacological action of the drug substance.” 21 C.F.R. § 314.108(a). (The FDA rule cited in Pfizer appears in Part 314, which relates to “Applications for FDA Approval to Market A New Drug.” In contrast, the......
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President Biden Signs Legislation Boosting Generic and Biosimilar Drugs to Help Foster Price Competition
...1, 1–2 (May 19, 2015), https://www.fda.gov/media/92548/download. 2 21 U.S.C. §§ 355(j)(5)(F)(ii), 355(c)(3)(E)(ii) (2021). 3 Id. 4 21 C.F.R. § 314.108 (2021). 5 21 C.F.R. § 314.3(b). 6 The Ensuring Innovation Act, S. 415, 117th Cong. § 1(a)(1) (2021). 7 Amarin Pharm. Ir. Ltd. v. FDA, 106 F.......
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2 books & journal articles
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The Statutory and Regulatory Scheme
...the District of Columbia district 38. Proveris Scientific Corp. v. Innovasystems, Inc., 536 F.3d 1256, 1265 (Fed. Cir. 2008). 39. 21 C.F.R. § 314.108. 40. 64 Fed. Reg. 47,719, 47,721 (Sept. 1, 1999). 41. See 21 C.F.R. § 314.108(a). 42. 54 Fed. Reg. 28,872, 28,898 (July 10, 1989). dor54588_0......
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The Life Sciences Sector
...investigation exclusivity—three years • Pediatric exclusivity (PED)—six months added to existing patents/exclusivity 22 21. See 21 C.F.R. §§ 314.108, 316.31, and 316.34, and FD&C Act §§ 505A, 505E, and 505(j)(5)(B)(iv). 22. See 21 C.F.R. §§ 314.108, 316.31, and 316.34, and FD&C Act ......