Authorities Cited: United States Patent and Trademark Office U.S. Patent No. 4,804,663 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)(iv) 21 U.S.C. § 355(j)(2)(B) 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)(bb) 21 U.S.C. § 355(j)(5)(C) 21 U.S.C. § 355(j)(5)(C)(i)(II) 21 U.S.C. § 355(j)(5)(D) 21 U.S.C. § 360(cc) 28 U.S.C. § 2201 28 U.S.C. § 2201(a) 35 U.S.C. § 156 35 U.S.C. § 271 35 U.S.C. § 271(e)(2)(A) 35 U.S.C. § 271(e)(5) 35 U.S.C. § 282 Supreme Court 415 U.S. 452, 459 519 U.S. 61 Circuit Courts 787 F.2d 572, 575 77 F.3d 1381, 1388 276 F.3d 1368, 1371 289 F.3d 775, 778-780 354 F.3d 877, 879 385 F.3d 1360, 1371-1372 402 F.3d 1198, 1203 482 F.3d 1330, 1335-1342 495 F.3d 1340, 1344 501 F.3d 1263 527 F.3d 1278 527 F.3d 1296 527 F.3d 1359, 1370 456 F. Supp. 2d 644, 671