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 |
-
- This document is available in original version only for vLex customers
View this document and try vLex for 7 days - TRY VLEX
- This document is available in original version only for vLex customers
4 books & journal articles
-
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......
-
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, ......
-
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......
-
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......