Authorities Cited: United States Code 21 U.S.C. § 355(a) 21 U.S.C. § 355(b) 21 U.S.C. § 355(b)(1) 21 U.S.C. § 355(c)(2) 21 U.S.C. § 355(j)(2)(A) 21 U.S.C. § 355(j)(5)(B) 21 U.S.C. § 355(j)(5)(B)(iv) 35 U.S.C. § 271(e)(2)(A) Code of Federal Regulations 21 C.F.R. § 314.94(a)(12) Supreme Court 467 U.S. 837, 842 503 U.S. 519, 534 Circuit Courts 88 F.3d 1075, 1088 140 F.3d 1060, 1069 162 F.3d 1201, 1204 269 F.3d 1077, 1080 296 F.3d 227 347 F.3d 1335 354 F.3d 877, 883 469 F.3d 120, 124-126