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References
1.
482 F.3d 1330 (Fed. Cir. 2007 ).
2.
527 F.3d 1278 (Fed. Cir. 2008 ).
3.Andrx Pharms., Inc. v Biovail Corp. , 276 F.3d 1368, 1371 (Fed. Cir. 2002 ).
4.
21 U.S.C. §355(b)(1), (c)(2).
5.
Available online at http://www.fda.gov/cder/ob/default.htm.
6.
21 U.S.C. §355(j)(2)(A)(vii).
7.
35 U.S.C. §271(e)(2).
8.
21 U.S.C. §355(j)(5)(B)(iv).
9.Id. .
10.
The statute relating to these events was amended in 2003. Accordingly, the ‘court trigger’ law applies to all ANDAs for a product if any Paragraph IV certification was submitted prior to 7th December, 2003, and the ‘forfeiture event’ law applies if the first Paragraph IV ANDA was submitted on or after 7th December, 2003 .
11.
21 U.S.C. §355(j)(5)(C).
12.
35 U.S.C. §271(e)(5).
13.
See, for example, Capo, Inc. v Dioptics Metal Products, Inc. , 387 F.3d 1352, 1354–57 (discussing declaratory judgment jurisdiction satisfied under the ‘reasonable apprehension of suit’ standard).
14.
127 S.Ct. 764 (2007 ).
15.
482 F.3d at 1344.
16.Caraco , 527 F.3d at 1288.
17.Caraco Pharmaceutical Laboratories Ltd v Forest Laboratories Inc. , Case No. 2007–1404, petition for rehearing and rehearing en banc denied (Fed. Cir., 23rd June, 2008 ).