Authorities Cited: United States Patent and Trademark Office U.S. Patent No. 6,916,941 United States Code 21 U.S.C. § 355 21 U.S.C. § 355(a) 21 U.S.C. § 355(b)(1) 21 U.S.C. § 355(j) 21 U.S.C. § 355(j)(2)(A) 21 U.S.C. § 355(j)(2)(A)(i) 21 U.S.C. § 355(j)(2)(A)(ii) 21 U.S.C. § 355(j)(2)(B) 21 U.S.C. § 355(j)(2)(B)(iv)(II) 21 U.S.C. § 355(j)(5)(B) 21 U.S.C. § 355(j)(5)(B)(iv) 21 U.S.C. § 355(j)(5)(B)(iv)(I) 21 U.S.C. § 355(j)(5)(B)(iv)(II) 21 U.S.C. § 355(j)(5)(B)(iv)(II)(bb) 21 U.S.C. § 355(j)(5)(C) 21 U.S.C. § 355(j)(5)(D) 21 U.S.C. § 360(cc) 21 U.S.C. § 2007 25 U.S.C. § 271(e)(2)(A) 28 U.S.C. § 2201 28 U.S.C. § 2201(a) 28 U.S.C. § 2202 35 U.S.C. § 156 35 U.S.C. § 271 35 U.S.C. § 271(e)(2) 35 U.S.C. § 271(e)(5) 35 U.S.C. § 282 35 U.S.C. § 355(j)(5)(C) Supreme Court 300 U.S. 227, 239-241 312 U.S. 270, 273 387 U.S. 136, 149 387 U.S. 167, 171 395 U.S. 100, 124-125 395 U.S. 486, 496-497 438 U.S. 59, 74-78 445 U.S. 388, 397 457 U.S. 957, 962 469 U.S. 70, 76 496 U.S. 661, 676-678 504 U.S. 555, 560 508 U.S. 656, 666 523 U.S. 83, 89-103 538 U.S. 803, 812 Circuit Courts 824 F.2d 953, 956 846 F.2d 731, 735 57 F.3d 1054, 1058-1059 140 F.3d 1060, 1073 148 F.3d 1355, 1360 276 F.3d 1368, 1371 289 F.3d 775, 780 376 F.3d 1339, 1351 395 F.3d 1324, 1328-1332 412 F.3d 1340, 1347-1349 480 F.3d 1372, 1380 482 F.3d 1330 501 F.3d 1263 Federal Rules of Civil Procedure Fed. R. Civ. P. 12(b)(1) 438 F. Supp. 2d 479, 494