Authorities Cited: United States Patent and Trademark Office U.S. Patent No. 5,529,791 U.S. Patent No. 6,162,463 United States Code 15 U.S.C. § 2 21 U.S.C. § 355(j) 21 U.S.C. § 355(j)(2)(A) 21 U.S.C. § 355(j)(4) 21 U.S.C. § 355(j)(5)(B) 21 U.S.C. § 355(j)(5)(B)(iv)(II)(dd)(BB) 28 U.S.C. § 2111 Code of Federal Regulations 21 C.F.R. § 314.105(d) 21 C.F.R. § 314.107 21 C.F.R. § 314.107(b) 21 C.F.R. § 314.107(b)(3) 21 C.F.R. § 314.94 21 C.F.R. § 314.94(a)(12) Supreme Court 395 U.S. 100, 126-129 429 U.S. 477, 489 495 U.S. 328, 334 499 U.S. 365, 379-380 Circuit Courts 463 F.2d 934, 939 111 F.3d 956, 958 164 F.3d 671, 675 239 F.3d 1297 253 F.3d 34, 58 256 F.3d 799, 806 276 F.3d 1368 283 F.3d 380, 388 319 F.3d 532, 535 335 F.3d 1079, 1086-1087 355 F.3d 661, 668-670 469 F.3d 120 471 F.3d 124, 132 471 F.3d 158, 165 471 F.3d 169, 173 488 F.3d 1026, 1031 506 F.3d 1070, 1076 525 F.3d 8, 16-17 527 F.3d 1340, 1346-1347 Federal Rules of Civil Procedure Fed. R. Civ. P. 15(c)(1)(B) Fed. R. Civ. P. 15(c)(2) Fed. R. Civ. P. 56(e) Fed. R. Civ. P. 56(f) 81 F. Supp. 2d 30 158 F. Supp. 2d 1318 175 F. Supp. 2d 1362 437 F. Supp. 2d 79, 82-84