b'SWAINE & MOORE LLP\n\nCRAVATH\nFRCIS P. BARRON\n\nGEORGE ... GILLESPIE, m\nTHOMAS R. BROME\n\nROBERT D. .JOFFE\nALLEN FINKELSON\nRONALD S. ROLF\nPAUL C. SAUNDERS\nDDUGLA D. BROADATER\n\nAL C. STEPHENSON\nMA R. SHULMAN\nSTUAR W. GOLD\n\n.JOHN W. WHITE\n.JOHN E. BEERBOWER\nEVAN R. CHESLER\nPATRICIA GEOGHEGAN\nD. COLLIER KIRKHAM\n\nMICHAL L. SCHLER\nKRIS F. HEINZLMAN\nB. ROBBINS KIESUNG\nROGER D. TURNER\n\nPHIUP A. GELSN\nRORY o. MILLON\nNEIL P. WESTREICH\n\nRICHAD W. CLARY\n\nWILLIA P. ROERS, ..R.\n.JAMES D. COOPER\nSTEPHEN L GORDON\n\nWORLDWIDE PLAZA\n\n825 EIGHTH\n\nAVENUE\nNEW YORK, NY 10019- 7475\nTELEPHONE: (212) 474-1000\n\nDANIEL L MOSLE\nGREGORY M. SHAW\nPETR S. WILSON\n.JAMES C. VARDELL, m\n\nFACSIMILE: (212) 474-3700\n\nROBERT H. BAON\nKEVN .J. GREHA\n\nCnYOINT\nONE RDPEMAKER STEET\nLONDON Eca 9HR\n\nW. CLAYTON .JOHNSON\n\nSTPHEN S. MAEN\n\nC. ALN PARR\n\nTELEPHONE: 44-207-453- 1000\nFACSIMILE: 44-207- 860-1150\n\nMA S. ROENBERG\nWILUAM B. BRANAN\n\nPET T. BABUR\nSADRA C. GOLDSTEIN\nPAUL MICHALKI\n\nJUUE T. SPELLMAN\n\nRONAL CAI\nMAK I. GREENE\n\nTHOMA Go RAFERT\n\nSAKIS .JEBE.IA\n\nRICHAD\n\nELBET L. GRAVER\n\nDAVID R. MAIOTT\nMICHAL A. PASKIN\n\n.JUUE A. NORT\n\nANDRE.J. Pins\n\nSTPHEN L. BURNS\nKATHERINE B. FORRES\n\nANONY L. RYAN\n\nMICHA S. GOLDMAN\n\nKEITH R. HUMMEL\n\nDAIEL SUFKIN\n\n.JES C. WOOLE\nMICHA T. REOLD\n\nGEORGE E. ZOBIT\'\nGEORGE A. STPHAIS\n\n.JEFFR A. SMITH\nROBERT I. TOWNSEND, m\n\nWILLM .J- WHEL, m\n\nSPECIA COUNSEL\nSAMUEL C. BUTLR\nTHOMAS D. BAR\n\nSCOTT A. BAHAV\n\nLES R. STEINBERG\n\nWRITER S DIRECT DIAL NUMBER\n\nSUSAN WEBSR\nTIMOTHV G.\n\nPHIUP.J. BOECMA ,\nROGER G. BROOKS\n\nWlLU V. FOGG\n\nDAVID MERCO\n\nFAiZA .J. SAED\n\nROWAN D. WILSON\n\n(212) 474- 1564\n\n.JOHN T. GAFNEY\n\nRICHAD .J. STARK\nTHOMA E. DUNN\n\nOF COUNSEL\nROBERT ROSENMAN\n\nCHRISTINE BESHA\n\nCONFENTIA TREATMNT REQUESTED\n\nApril 12 ,\n\n2004\n\nCarboplati\nDear Mr. Clark:\n\nPursuat to Section XII , subsection (2) of the Decision and Order dated\nApril 14, 2003 and 16 C.\n, Bristol-Myers Squibb Company ("BMS") submits\nthe enclosed agreement for the FTC\' s review. BMS requests that the FTC issue an\nadvisory opinon fiding that the agreement does not raise issues under Section 5 of the\nR.\n\nFederal Trade\n\nCommssion Act.\n\nBMS and Teva Pharaceuticas USA, Inc.\n\'Teva ) wil resolve an ANA patent litigation conceg the drg Carboplati and\nS. Patent No. 4 657 927 (the "\' 927 patent"). BMS and Reseach Corporation\nTechnologies ("RCT") prevailed in the distrct cour, where ingement and\nThe agreeent, between\n\nenforceabilty were conceded and swnar judgment of no invaldity was entered. The\nFederal Circuit, in a 2- 1 decision, vacated that judgment and diected that the cae be\nremanded to the distrct cour for fuer proceeings. BMS and RCT filed a motion for\nrehearg en bane, and the Federal Circuit is not expected to rue on that motion. The\n927 patent is due to expire on April 14, 2004. However, BMS has filed with the FDA\nfor pedatrc exclusivity, based on havig conducted a pediatrc clincal tral , as requested\nby the FDA. If granted by the FDA , the pediatrc exclusivity would result in a fuer six\nmonths of exclusivity for BMS.\n\nBMS and Teva have agreed , subject to regulatory review, to settle their\ndispute on the tenns set fort in the enclosed agreement. In substance, the agreement\nprovides that the litigation wil be dismissed and , if regulatory approval is granted , Teva\n\nCONFIDENTIAL\n\n\x0cwill distrbute an unbraded , generc verion ofBMS\' s product as of June 24 2004, well\nbefore the six-month pedatrc exclusivity would expire.\nWe repectfy submit tht\n\nths agreeent is both pro-competive\n\nand\n\nfuy consistet with the spirt of Section xn of the Decsion and Order. We therefore\n\nrequest a favorable detertion ftom the FTC.\n\nTo aid the FTC\' s evaluation of ths request, I am enclosing the followig\n\nmaterals:\nS. Patent No. 4 657, 927;\n\nMemorandum Opinon and Order Bristol-Mver Squibb Company\nand Reseach Corporation Technologies. Inc. v. Pharacheme\nA. No. 01- 3751 (MLC) (D. J. July 29, 2002);\n\nB.V..\n\nFinal Judgment Bristol-Myers Squibb Company and Reseach\nCorporation Technologies. Inc. v. Pharacheme B.V.. A. No.\n01- 3751 (MC).(D. J. Oct. 22 , 2002);\n\nBristol-Mvers Squibb Company and Research\nCorporation Technologies. Inc. v. Pharacheme B.V. , Appeal No.\n03- 1077 (Fed. Cir. Mar. 17, 2004);\n\nDecision,\n\nand\n\nCarboplati for Injection Distrbution Agreement (April 8, 2004);\nLetter ITom Robert L. Baechtold to Clerk of U. S. Cour of Appeals\n\nfor the Federal Circuit (April 8 , 2004).\n\nAs time is of the essence, we respectfly request expedted treatment of\nths request. The FTC\' s response is requested as soon as possible and before June 10,\n2004. Due to the tie-sensitive natue of ths agreement, its implementation will not be\npossible without such expedited review.\n\nConfidential treatment of this letter and the enclosed materials is\nrespectfully requested.\n\nCONFIDENTIAL\n\n\x0cIf you have any questions, pleae do not hesitate to ca me at the number\nabove.\n\nThan you in advance for your consideration and assistace.\n\nResectfy,\na;J\n\nRichard J. Stak\nDonald Clark, Seceta\n\nFederal Trade Commssion\nth Street and\n\nPennylvana Avenue, N.\nWashigton, DC 20580\n\nEncIs.\n\nBY FEDERA EXPRESS\nCopy wi Encls. to:\n\nAne Schenof, Esq.\nBureau. of Competition\n\nFederal Trade Commssion\n601 New Jersey Avenue, N.\nWashigton , DC 20580\n\nBY FEDERAL EXPRESS\n\nCONFIDENTIA\n\n\x0c"" e\n\nUnited States ,Patent (19)\n\n(11) Patent Num\n(45) Date of Patent:\n\nCleae et ale\n(54) MANATO PLATI COMPOUNS\n(75)\n\nInventors: Mich\n\nJ. Clea James D.\n\n. Hoeel Batt Rosenbe\nLore Van Cap, aU of Bat\nMich.\n\nLag.\n\n(73) Asgnee:\n\nRe\nY.\n\nCorptiOD, New Yark\n\nU.s. CL .................................................. 514/492\n514/492\n\n(S?\n\nAttomey Agent, or\n\nPres\n\nFirm-Sculy, Scott Murhy &\n\nABCI\ncotion compunds an a\n\nsee\n\noced\n\nRelted U.s. AppUc:tiOD Data\norSer. No. 902,706,\n\n1987\n\nmethod of treag magnt tuors\nto a plna ds pltium (D codition copound or an\nd2s3 platium (I cordtion compound\n\n(22) Filed: \' Ma 25, 1983\n\n(51)\n\nApr. 14,\n\nFid of Sech ........................ 424/287;\nPrma Exminer-Jerome D. Goldrg\n(58)\n\nMaonto plaum\n\n(21) AppL No. : 497,806\n\n(62) Divion\n\n(52)\n\n657,927\n\nMay 4, 1978, abandoned.\n\nInt. CJ4 .......................................... A61K 31/28\n\nan of a solution of theadon\ncompound.\ncompri the paente\n\nCl\n\nNo\n\nDrwi\n\nto an\n\nafecte\n\n\x0c657, 927\nMAONATO\n\nnum(I fors d2s3\n\nPLATI COMPOUNS\n\n. The\n\nTh is a Diviona, of Application Ser. No. 902,\nfied .May 4, 1978, abanoned\n\nBACKGROUN OF TH\n\ncoordtion compounds which\n\nhave an octaed argement in\n\ncooron compounds of the invention in-\n\nof pIa um(l and pIatthe bidentate maonat ligad\nwhich may be substute or\nThe\n\nelude th\n\nINON\n\nci and\n\ntr iser\n\nnum(I which cota\nmaonato ligad may\n\nthe grup constig\n\nUDUbstu\n\ncota substituents seecte from\n\noflowe all, (e.g., methyl, etyl.\n\nchemotherpy.\nSUMY\nINON nylethyl(bl),\n4-o-I-bute,\nThe present invention relates to novel maonato plati-\n\nnum coordition compounds and\n\nto thei us in cacer n-propyl,\n\nispropyl. n-butyl,\n\netc.); arl,\n\n(e.g. , phenyl;\n\n10 lower all- , lower alyl-, hao-, ni, lower\n\nOF TH\n\n2-(I-nhtyl)metyl); alyl,\n\nIS\n\n(P1(D,.OOb-d\n\n), an hydrox. Al\n\nethoxy, et.\n\nsuible ar the 1.1, I-cyclo-\n\ncycloaylenedca1i acds, (e.g"\n\nwherein:\nx=\ny= 1\n1 or\nor 2;\n2:\nci or\n\nalyl) cycloal, (e.g., cyclopropyl, cyclohexl, etc.); cycloaJyl, (e.g., 2-cclopente- yl, 2-cyclohexen- I-yl); atxy, (e.g., meoxy,\n\nCQrdintion com- (e.g"\n\nhavig the formul:\n\nThe invention provides platium\n\npounds\n\naloxy-\n\nsubsttu phenyl and nahthyl); arykyl, (e.g. phe-\n\ntn(P(lA"(oo2-j)yLzI\n\npropaedcaboxylic acd, l, l-cyclobutaedcaboxylic\n\naci, etc) and the l, l-cycloayldicaboxylic\n\n20 (e.g., 1,\n\n1-cyclopropeedcaxylic acid,\n\nacds\n1,\n\ncyclobutenedicaxylic acd, etc)\n\nThe cordtion compounds of the invention\nor heterconta two monodenta amoni or\n\npri\n\nlids\n\nocyclic ame\ni.e., when x in th abve formul\n2S is 2 or one bidentate ame liuid" i.e., when x is 1.\nz=O, 1 or 2, provide tht when, y=2. z=O and when\ne monodentateame ligands incl e lower\ny= 1. z is greate th 0;\n(e.g., Jiethyl-, etyl-, n-propyI-, ISpropyl, Rand RI are selected from the group constig onl, , alyl\netc), arl\nes, (e.g., ane), amlower alyl, arl.\nalenyl, cycloal, cy- , n-\n\narl,\n\ncloalyl, aloxy, OH, or are combined with the\' kyl.\n\nam\nl-aes\n\nbel;e),\netholae,\n\names (e.g.,\n\nhydro\n\nlower\n\nall\n\n8D1ae, etc), hycabon atom\'to form a cycloayl or cycloalkenyl 30 ames (\n(e.g., metoxylalower\nalox~l\names\ndervaties\ngroup, and substitUted\nes (e.g., methox~ethylawhen x= 1, A is HRzN-CHR3-CHRsH and JIe, etc.),\netc.), and h:teocycli anes (e. ., pyn me\nwhen x 2, A i!\nheteocyclic ame or\no acds, Le.,\nazdi). Alo mcl ed ar the\namo acid, wherei R2, R3, R4and Rsare the\n\nthereof; xylae, xyl\nan II\nsae\n\nH:z a\n\nall\n\nor diert and are seected from the group con- 35 R7-cZ-COOH wherem R7 IS H, lower\n(e.g., metyl, ispropyl, etc.), hydrxy lower alyl (e.g.,\nfH, CIl, C:zs, hydrxy and lower\nsig\nprovided tht R2 and Rs\n\nmay also be arl\n\naloxy\n\nor\n\nkyl, an eab Rs is the sae or dierent\n\naryl (e.g., be-\n\nar- hydroxyethyl , hydroxyethyl, etc.\n\nand is\n\nzyl, e,tc.\nIt IS, to be\n\n. the cor\n\ntio com-\n\nl\'oo tht\nmvention may mclude two Identica or\n\'\now\noxy\nlhd\nxyl ames aloxyJalaes where,a1 dierent monoentate liga\n\nselec frm ,the group consistig of H, lower\nl h\n\nl gro\n\nS8d\n\nlow\n\nps\n\nI 40 poundS of the\n\ner\n\npr\nCo\n\n\' Sutale bidentate am ligads\nheterocy- tute\nan UDubs.\n\nd ,\n\nalls\n\nd.\n\ninclude th suti-\n\nand seda\n\nclic subst\ncludg S8\n. a nng member\nethylenedes. One or both of the cabon atoms of\nwhen z= 1, L !5 a bldentate amom\nsubstDents such as\n45 the ethylenede may\nwhen. z=2, .L IS a monodentate amomc li\nlower\n(e.g., methyl, etyl), hydrxyl, aloxy (e.g.,\nts\n\nd, and\n\nall\non\' and methox,\netylenes\nethoxy, et).\nors setive to a where\nsubone or more of the ame grup\npla dsp2 plaum(l coordtion\nato of the\nsttuts suh as1i abve for the\ntium(I codi\ned dZs\nmpoun 50\n(, e.g,\name and arl (e.g., phenyl) mid\nm.\ncom\n. an\nTh mvention . also\n\ng ma\n\nmethod for\n\nSec co\nca arl\npr\nadg\nto\nuti sped her\nt tuor a solution\ncordion\n\nate to a co\n\ncopoun or\n\nan\n\nconta\nan\n\ng paent\n\nected\n\num\n\nap\n\nfied hereiove\n\ncord\n\nsuch a\n\nbel) may also be\nThe Pt(l\n\nn C?mpound as\' de-\n\ndo not\n\ncompounds\n\nex as geometr iser; however, the\n\nex as ci an tr isme It is to\nunderoo tht the inventin is inlusve of\nth cis an tr is\nThe\ncordaton compounds may al con-\n\nm an amount s1iClent to cause re- Pt(I coPQunds\n\ngreson of the tuor.\n\nTH\nINNTION\nS5\n\nDETAIED DESCRON OF\n\nbe fuer\n\nPt\n\nmonodentate or one bidentate anonc liga\ni.e., wher\npounds and metod for where ony on maonato ligad is\nthCU proucon are descnbe by J. C. Bai, Jr., The 60 y=1 in the abve\nChemi of the CordlUtin Compond\nSJble monodentate anonic ligas include chloPublig Co., N.Y., 1956, Chap. 2; J: Lewi et al, ride, bromde, iode, nitrte, hydroXde, nitrte suMOt Cordnaton Chemistr: Prcip1e and Method\nmae, etc. Among the bidentate anonic ligads which\nInteience Publier, Inc., N.Y., 1960 and\nmay be prest are oxate pyrophosphate ditboxaInorgan Synthes\n7, McGrw-Hi Book Co., Inc., 65 late\nta two\n\nlatium ~ordiation\n\nReiold\n\nforul\n\nY., 1963.\n\npret,\n\nKaufan\n\nPlatium(l forms\n\ndsp2 coordition\n\nwhich have a liquie pla argement\n\nIt is to be unertoo tht the invention includes\ncompounds those cordition compounds contag mied mono-\n\nin space. Plati- denta anonic ligads\n\n\x0c3\'\n\nThe preferr compounds ar thos\n\n657, 927\n\ndilved\nneutr with a soluton ofKOH\ne.,\nin wat\nrestig pota\nethyl- (- 13 g in 30 ml) to pH\n\nwherein R and Maonic acid (13 g-a twofold exce)\n\nRl in the above formula ar Ii methyl or\n\nethyl, i.\n\nmaonatoplatium methylmonatoplatium and\n\nwas\n\n(30 m1 and\n\nS-. The\n\nmalonap1aum cordaton compounds The most maouate soluton was added to the platium contag\ncompounds ar those maonato- 5 fitrte and the mitu wa cafuy wared (to avoid\nof th\nunti whte\nbumping ) on the hot\nplatium(I compoun of the above formul\nto form in\nproduc\nqu. Th\nx;= 1 and R:z R3, R4and Rs ar eab H, Le.,\n\nprefer Pt(l\n\nwher " st\nmana\nthylenede platium(l, mety1monato wa then\n\ncooled to\n\ncr\nplgr\nrom tepetu and ihe prouct\n\nthylenedep1aum(l an ethy1m0nato fiteed off The fitrte was reeaed for 5- 10 mite\nthylenediAmineplaum(I and , wher x=2 and eah 10 an cooled to O\' C. to collec a fuer cr. The crde\nwas 20. 5 g (93%).\nR6 is Ii ie., maonato tiiAmmin eplatium(I, methyl- yield at th\n\nstwas\nby dilvig in boDepltium(l and ethyl-ingTheor prouct\nnea boilg wate. The above yield (20.\nboilg wate for comple\nPt compounds are those wherein reui\nis H an y=2, ieo bisonato (or bisc- 15 diolution. Maonic acid\n\nrec\n\neplatium(I.\n\nmaonatodiAmmmin\nmaonatodiAmmin\n\n(I.\nThe prefered\nx=2, eah R6\n\nthylm0n or bisylmonao)\n\ndie\n\n5 g)\n\nabout 3 lite of\n\ngI was dilved in\nplatium- wate to suppres any hydrolys-. The fitered solution\n\nwa coled to O.\n\niIll\nneglgi\n\nC. to give white\n\nnufy neees (18.25\n\nThe cordition compounds of the invention may be f,- 83%).\ncoducvity slWes have shown th hydrlys\npreped by one of a vaty of wel-known methods A . U. vi\n20\ngener method of prepaon of the Pt(I\n5 . Th\ncompounds hav- The crytas decmpose be\ntion compounds is as fonows:\nstrtu o e prouct wa !enfi CIa an 1. r. ecis\nI,\nCI\nor\ning th formul ci(P a()iJ wherei Ha\nroduct IS low m cold wate, I.e.,\nSolubilty of the\nDr an A is one bidentate or two monodenta\n. C. and\n20\nmg/l00\nmls\nat\n20\nligads (preared by the method of S. C. Dha India : mplOO O:s\n37 C; b\n93 (1970)) ar reted wi siver 25 hi\n: Cbem., Vol. 8, p.\nwa (:O\'\nr I00\'\n, .C )- 0 65 g/100\ner\nm\nnea\nthe diaquo . complex. Th latt !S\nmtrate to .\n. mi.\nrecte WIth the maonate Ion to form the coordon\ntiedy bemen\nel\ntion wa ven\n. os\'\nmethod is repre- e. emp comp\ncompoun. of the invention.\nanysIS:\nsen y e 110 noWlg rection sc\nMaonato di"mmineplatium(U(P(N3n(C31204))\nCaculted for C3HaN204PC: 10.88; H: 2.43; N: 8.46:\ncist\nS4; Pt 58.\nPt 58. 9. Found C: 10. 67; H: 2. 35; N:\n\ncordi-\n\nSt\n\name tr.\n\nfor\n\nTh\n\nte b th\n\neme: 30\n\n0g\nTh ir\n\nACI2I+ZAgN03+2H20)A(H20b)(N03n+ZAgC\n\nc:Pt A(H20)z(N03n+H2C-COO!21P\n+2H20\nA(OOCJ2CH2I+2N03\n\nwher A is one bidentate ame\n\ndentae ame ligads.\n\nee\n\nEXLE\n\n35 (Peu)(CI0.))(en = H2N(CHmNH:z\n\nligand or two mono- C40;- = 02CCCHvo-\n\ninvention.\n\nThe fonowing non-litig exples ar ilustratve Silver nitrte (3. 64 g) was dilved in 20 ml of wate\nof the methods for preparg the compounds of the and added to (P2)2(CH2bCL2J (3. 5 g) supeed in\n\n40 wate (30 mI) in a coni flas The mitue was\non a war hot pla for . 5-10 miute unti al the yel-\n\nEXALE\n\nlow platium complex\n\ntw\n\npreitcl\n\n(P(N3n(C3HzO.))\n\nReactions: .\n\nlP3nCI2I + ZAgN03\n\n+\n\nha dilved to give a yelow\n\nliquor plus a copious white sive choride prepitte\nThe mire was fiteed thugh a fie pore fiter and\n45 the\nwith sm volum of hot\nwasbed\nwas adde to an\nfitrte plus\nwate. The\naqueo solution of methy1monc acd (2 g in 20 ml).\nwhich ha bee adjuste to\' pH 5-6; The mie wa\nheate to about SO\' C. for fie miute and then coled\n50 to O\' C. The shy whi\nwhich formed wer\n\nep1aum(l\n\nMaonatoiAmm\n\nwags\n\ncry\nwat an actone\n\n2H20)--\n\nfied and wased with cold\n\n(Yied\n\n(P3n(H20b)(N03) + ZACl 2. 65 g). The mother liuor plus aqus wags wa\nreduce to about ha its Drgi volume (- 30 ml) to\n\nII\n\n2-\n\n(P(N:!(H20)i!(N03n + CJH20.\n\nyield a seond crop on cooli\n\n55 Tota\n\n(P3)Z(CJHzo.)) + 2N03\n\n- + 210. wa reryli\n\ng-sghtly les th the stoicho- pore\n\nto O\' C. (Yeld\n\nfrom a mium volume of boilg\n\nwater (around 250 ml) with fitrtion\n\nmetrc amount in order to avoid silver,\n\nwas dilved\n\npror to coolig to O.\n\ncontaon) leaets 2.96 g (74%).\nin waer (50 mI) and added to 60\n\nSilver nitrte (22.55\n\nThe\nfl\nwi\n\n85\n\nCre yid wa 3. 50 gm (88%). The colex\n\nfite\n\nthough a\n\nC. Yield of\n\nshy white\n\nCacuiteforC612 1204PC:19.4IH3. 26N:7. 5S.\n\nFound C: 19. 11 H 3. 61 N: 7.89.\nte\nrapid A send crp (0. 33 g-8%) wa obtaed by reducig\ned (60. C?) on a\nents were w\nCCn\nunti the siver chlonde precpittion was\nthe bul of the mother liquor.\n\n(P(N3)2C12J (20 g) in a 250 ml conica\n\nstg\n\nplet and the mother liquor\n\ncom-\n\nwas alost colorles. \'Ie\n\nsiver choride wa fitere off usg a fie\n\npore sintered 65\n\nglas fiter and the preipitate was wased sever\nwith hot water to give a tota fitrte volume of\n\nEXLE\n\nties\n\n10020\n\nInJP IV(N3n(ma\n\n\x0c657, 927\nSilver nite\n\n(5.45\n\ndilved in watr (30 ml) of solvent. a fie dion\n\ng)\n\nan\n\nan adde to U\'S (P(N3nC4)\n(30 ml) contag\n\nwas prear\n\nof the dose\n\n(3 g) suended in neeed for the tet. Thus some of our tes rests were\nnitrc acd (3 obtaed on\nwher a slur of the compoun\n. ml). The conte wer wared on a hot pla (70. - SOo. Was injecte. Tbes ar so note in Table I below. In\nC.) an\nfor at lea one hour. Th\nwas S addition, for some of the copounds, ther wa injecte\n\nconce\n\nmie\n\nfitered though a fie poe site gl fite\nmove th siver chloride. Th precpitate wa\n\nto re-\n\nI ml of solutiou, either in one\nwaed inabut2 injecons\ngiven a few hour ap of I ml eah.\n\nsigle injection or\n\ncl fi-\n\ngi\n\ntwce with a sm volume of hot wa. The\nin 4 diert dos\nThes injections were intiy\nofb 1M KCI level for eah neW compound with 6 mice in ea dos\nwasgs was tete with a\nif exce siver chorde was pre- 10 level. Th te cover, a doS rage frm a low ineCsolutons to\nent. (I the te is\nsufcient KCJ is added drop- fecve dos to an uppe dos level which prouce\nthe bul solutin unti no siver choride is pre- . some\nwie\nwith the tie peod of the experent.\nand the fitrte The reults ar set fort in Table I.\ncipitate) Th soution was\nreuce to 2030 mJ in volume and cooled to O. C. to TABLE I\nyield ple yelow crsts (preumly\nr Actvity (for\n&0 a I!\nmr\n(P3n(N03)4D. Thes wer waed with a litte. Tes(Dof\ncopouad or aD oced d\nplum (I\n.\nporon\nCO d wate and en actone\n(Yeld\ncoiD copo ofMato an Sl1tolc MaonalO\nth yid (1 g) was diolved in a mium of\n\' CoiDli Coplce ofPIum\nSw white\nTumr-5 180 Ao.FeintrPCtoney\nto which soum nitrte (0.2 g) ha be added.\nSie inleons on daYS noted\ninto an aquens soluton of maonic 20\nsoluton was\nNo. or\nacid (0. g-a slght exce) which ha be adjuste to Cordon\ny o.f\nTIC\nIDJecn Dos\nof\npH 5-6 with sodium hydrxide. Whe\n10\nthe complex qucky form on colig. These were\nIS mglg\n(II)\ntere off and wased with cold wate and actone.\n20 mgg\n2S mgg\n(Yield 0.7 g1/6\n30 mgg\nCaculted \'Cor\nloN20sP C: 16.63 H 2. 33 N: 6.47.\n616\n40 mgl\nFound a 16. 60 a 2,64 N: 6.80, \'\n5/6\nSO mslg\n6/6\n60\nCONFORMTION\ntrte plus\n\ndr\n\ndee\npoe,\n\nde\n\nrefte\n\ntr\n\nTh\n\nIe\n\ncord\n\nhot wate\n\nfite\n\nCompl\nnucrst fi- Mllo,nod.\n\n76\n38\n64\n31\n\n30-%).\n\nGEN STUCT\n\nTh maonate group is shown to be \'cordiated\n\nthe platium by the obsed\n\ndays 1-\n\ncha in the elonic\n\nspe on going from the aquo to the maonate spees. MeI 1m\nstrtuconf\n\':\':\n(I\nda Simly,\nHI0)\n\nsuch as (P(N3)2(H20)z2(H2C304))\nThus,\nthe anytca\nar rued out\nsupport a neutr 3S\nze-tie conductivity\ncompound. The Lr. spectra show the prece of coor-\n\nmeaents\n\ndiat caxyl grups (1601650 em and 140\ncm- l) with no C02H grups (whih would show at\n\nstes.\nte\n\n17001750 em). Finy the carboxyl grup vibrations\n\nar copab"ble\n\nwi a che1te strctu\n\noxaate complexes of kno\n\nas\n\n(SohniOD in\n\nsa\nco\n\nth teg\n\ndite\n\ngr si tr\n\nplated by\n\nousy, in new\n\nax leon,\n\nsutae-\n\nmi The mice were, on the averge S5\non\n\ny 10. The\n\nweghed and the rati\nmice in the trea\n\nprpylea\n::\n\nmin\n\npla (D\n\n\';;1:;\n\n, 3S\n\n3D\n\n)um\n\nratio in Table i.\n\nfi\n\'wa freshly diolved in st\nthe\n\nTIC\n\nFor the\n\nan\n\ncompound maonatoylenedialati (l\n\nditied wate and\n\nin-\n\njec intrperitoeay on day 1 iltO eah of the te 6S\nmice Tbe volume of the iJection was usuay i ml. In\nin order to get an active dose into the ansome\nwas not soluble in th amount\nma wher the\n\nca\n\nchem\n\nSO\n\n60\n\nmgg\n\n90\n\n3D\n\n40\n\nmgl\n\nSO\n\n60 mgl\n\n70 mgg\n\nby 100, is given as\n\nset of tets the codition\n\n40\n\n70 mglg\n\ntuors m (soloton_1I\nin HI0)\n\nto the cool set of\n\nwa obtaed Th ratio, multilic;\n\n138\n\nplum (D\n\nors wee exciBld\n\nof the Weights of the\n\n616\n\n100\n110\n120\n\napproxitey four wee old an weied 18-20\nTakg day 0\' as th day of implat. th\n\ngrsace\n\n3/6\n\nO:\':"Pla tium\n\napproxitey 10 mImelYIm\n\nil the lef\n\n60\n\n100\n120\n\nund usg our\n\nth im-\n\nmg\n\nmgl\n70 mgg\nSO mgg\n\ndilalium (U\n\nfor\n\nas set by the Natona Cace Intute\nfor\n(Cancer Chemthy Rep.. 2S (1962)). ,\nFor these te an S ISO tuor taen from a sariced SO\nfree of supuous tiue and cut\nmouse was\nunder sterie COdion intO\npiec Thes tie pice wer\n\n40\n\nmaoDBIoeylene.\n\n180 tuor in maonl,2\ntuor, soli\nstda scrg\nwhite mice, foUowig stdad protocols\n\nfeme Swi\n\n7 mglg\n\n30 mglg\n\n124\n\nThe compounds of the mv tion wer\nto a pla ds\nantituor actvity, i., for\nplaum(I conitiou compound or an octaedra\n\nd2s platium(I codition\n\nmgl\n\n6 mgg\n\n80 mglg\n\ncompar to\n\nsetivi\n\nmg\n\nDaiy for\n\n(soluliD in HI0)\n\nto 30\n\n(sotolion in HI0)\n\n80 mgl\n\n10 mglg\n\n20 mgg\n\n40 mglg\n4S mglg\nSO mglg\nS5\n\n60 mgg\n\n80 mslg\n\n3/6\n3/6\n\n\x0c657, 927\nTABLE m-cntiued\n\nTABLE l-cntiue\n\nTes of AD Ac:\n(I cordtion cound or\n\ncordintion c:poun\n\noc\nMao\n\nAcy\n\n(for sevity\nConlirmlory Tes of Antior\nds2 platinm (11) cordtion compo or aD\ncound)\nDlatimn aV)\n\n(for setivity 10 a I!Ia ds plawn\ndZsp3 plaum\nan\nand SubslDled Maonalo\nof\n\n., Inbon\nDo coon\n\nCordon\nCoplex\nI-clobutca- I\n\nSinRi injecns on dayS nole.\n\nSirde iniecn Dav Iin\n\nintrlOeaY\n\nNo. of\n\nDay or\n\nilection\n\nDos\n\nTIC\n\n20 mgl\n\n40\n60 mg/g\n\nboxyla\n\nplti (U)\n\nSO\n\n100\n120\n\nmi/\nmgl\n\n160 mg/g\n80 mglg\n\nmanalob\n\n(metylae) platium\n\n100\n\nms/\n\nISO\n\nmgl\n\n120 mglg\n140 mglg\n160 mglg\n\n71\n60\n38\n42\n69\n18\n62\n58\n53\n28\n15\n17\n19\n\npla\n\n15\n20 100\n40\n94\n20\n100 100\n\nCompJces or Platium\nConln\n180 Anl-Feme Sw while mice\n\nTuor-Sma\n\n10 a\n\noced d2s\n\n0i Inpeeay\n\nSO\n\n160\n\nTum ADIPC6 - An\n\nSlnlde\n\n- Mous\n\ninie Day 15 in ou Intreay\n\n500\n\ne an maon\ncomplexes of plaum(I were subdie\n20 ethylene\nmi to the Drug Resh an Development Brach\nSamples of the\n\nrli"mmin\n\nmaonato\n\nsc\n\nfor antiof the Natonal Cacer Intute for\nIn addition to th day 1 injections des"bed above, in\ntuor\nin\nmice.\nThe rethe\nL1210\nmor\nactvity\na number of cae injections were delyed unti day 8 of\nth tumor syste are shown in Table\nobtaed\non\nsuits\nusualy\nat\ntuor\nwas\nthe\nthese\ntuor. grwt. In\nthe acvity of the compounds of the\nleat lager tha ! gm, as estite by palpation. The 2S IV. They\ninvention.\nwere then injecte and observed for a perod of\nby the, \'\nTABLE IV\n. approxiately 60 days. Activi was\nwhose tuors ha regresed to the\nnumber of\nCoumory Tes of AntilDor Acvity (for sevity 10 a JlIa\n\naga\n\nca\n\nan\n\nconf\n\nmeur\n\nII\n\nanal\n\nthe\nvang point, whie sti alowig\nte results ar desn\'bed 30\nvive for th tie perod Such\n\nto sur-\n\nin TABLE n below.\n, TABLE n\nTcs of Lae Sama ISO Reesas by MaoD8o Coinon\nComplexes or Pltium.\n\nCoorn\nComplex Do\nmaDBdi- mgg\n\nTuor-Sarma 180 . Anal-Fee Swi while\nSinlde iniecons on Day Ii intrpelonealy in H20 solutions\n\nTota Numbe\nof\n\nReons\n\nmgl\n18mg\nmg/g\nmaonbylene- 40 mg/g\nmgl\nmg/g\nameplatum (n)\n\nCoon\nCoplcx\n3S\n\nDos\n12.5\nSO\n\ndiaeplanum (U)\n\n15\n\n% Incr in\n\nmgl\nmgl\n\n115\n101\n\n160\n\nMaonloylele-\n\n37. 5\n\n(re te)\n\n16. mgl\n\n151\n121\n\nmglg\n\n15 mgl\n11\n\nLies\n\n163\n133\n\n12.5 mgg\n\ndieplaum (I\n\n45\n\nIntrlOealv\n\n50 mgl\n15 mgl\n\nMalonaloi-\n\nMaonaylen\n\n14\n16\n\nAD - Mi\n\nDaiy iniecons Days 1-9.\n\n, ameplllum CD\n\nDeth\n\nIi mgl\n\nplatium\n\nTuor: LI210\n\n20\n\ndilatium (I\n\noced d2s\ncompoun\n(I\neonln\nal th Nation Cace lnlDe.\n\nds2 platinm (I cordion compom or aD\n\n196\n\nIQJ\n\nmgl\n\n145\n\nSO\n\ncordition compoun of\nar preferly dilved or sused\nThe rets decn"bed in Tables I and n indicate\ny acptale\nr or other phanuti\nthe compounds of the invention are ver Potet antito- \'Y\ncopotion\nwbite mice. 6qmds The par\n\nCa\n\nmor agents agait\n\nthe S 180\n\ntht\n\nThe maonatolaum\n\nthe invention\n\nadble\n\ntuor in Sw\n\nabut 0.5 mg to abut 10\nactivity agt\nCotory tets of antior\nunder\nth the amout may\nbeg\nmg\nper\nmi,\nit\nin rats and the ADJIPWaler 256\nupn\nthe\npacu copound\ninti\ntes\nva\ngry\ndepg\nC6A tuor in mice were conducte. The\nto\nbe\nan\nemployed\nand\nthe\nresults are shown in Table II and CO the potent The platum cordon compounds of the invenaction of the copounds of the invention agt these\n55 tion are preferbly aded paenteray to an an-\n\nother tuor\n\nsys\n\nmagnt tur seve\nTABLE II\nna ds pltium(D cordtion\n1;la\n\nDos co\nTes or An\n\nor Acvity (for setivity 10 a\n\neonlon COd or an oced d\'s\ncomll)\n(I\n% ln"bti Dea\nOIlommln o:lalium\nAn Tuor: Wal 156\n\n"" plunum (U\nDlatinnm\n\nma afecte with a\noctaed d2sp\n\nto a pl-\n\ncompound or an\n\npJtium(I cordition com\n\nund.\n\ne oron 0 trtment and the do level, of cour\n60 wi dep in eah ca upon the si of the hos an-\n\nRa\nmg 100\n100\n100\nRal\n\nCaosIntr!llOeay .\n20 mg/g\nSinlde iniecon Day I in 0i,\n\n10\n\nthe SO should preferaly\n\n(:nta from\n\n(I\n\nma, nat and si\n\nof the tuor, et. Geeray, howabout 20 to abut 200 mglg\never, a dose level of\nof boy weight, per day wi be sucient. It is to be\n\nfr\n\nundertood, however, tht the\n\nplatium cordion\n\n65 copowlIls compouned with a suitale pbautica caer in the sae proportons as recte abve may\noray at the sae dosage level.\nMalonlhyleaediaep1aum (I aloWebe cla:\n\nTmnor: Walke 256 Caosma\n\n- Anal -\n\nadmed\n\n\x0c, 4, 657, 927\n\nmetod Cor\n\ntreatig\n\nto a pla ds p1aum(l\n\nmagnant tuors\n\nan octaed d2s platium(I\npoun in\n\naoan\n\niserg to - an\na solution\n\ngrup contig of\n\nsenstive\n\ncordion copound or\n\names and aloxyl all\n\ncoordition com.\n\npantey ad-\n\nwhich CQmpries\nafecte with sa magnt tuor 5\ncom-\n\ntion to an\n\npound of the formul:\n\ntive to a\npound , or\n\n(P(IOOcn!J\n\nliad-\n\nan\nafec\npla\n\nwith a maigt\n\nth\n\ntuor sen-\n\ndsp platium(l cordition com-\n\nan\n\noced d2 plaum(l cord- phacay act-\n\nthe formul\n\ntr (P(IA"((OOI),L\n\nz=O, 1 or 2, provide th when\nwhe y= I, Z is greater\n\ncound of\n\n(P"(OOJI\n\ny=2, z=O, and CI or I1 (P(JV)"((ood"L\n\n\'\nerem.\nofH. 20 wh\nx=\n1\nor 2:\nlower all, lil.\naJenyl, cycloal. cy- y=l or\ncloaJyl, aloxy, OH and cOmbine with the\nbon atom to form a cycloayl or cycloalenyl z=O, I or 2, p\n\nRand RI are seeced from the group constig\n\narl,\n\n2:\n\nca-\n\noV1ded tht when y=2, z=O, and\n\nfr th\nthe grUP\noCH,\neny cyc oalkyl, cy-\n\nwhen y= I, Z IS greate\n\nRand RI ar\n\n\': 1, A is HR2N-CHR3-CII-NRsH and 2S\n\nwherin\n\nwhen\n\nam;\n\n10 tion coound comprig a\nable caer and a platium coordon\n\nwher:\nx=1\ny= Ior\nor2;\n2;\n0:\ngrUp\'\nci or\n\nar1,\n\nwhen z= 1, L is a bidenta anoDic\nand\nwhen z=2, L is a monodentate anonc ligad.\n3. A compoon suble for patera\n\ncotag in an amount sufcient to cause\n\nregron of the tumor a platium cordition\n\nH, lower alyl, arl,\n\nhydrxy lower all, hydroxyl- and aloxyl;\n\nselected\nlower alyl. arl, arl,\n\nconstig\n\nwhen x=2, A is H2NR or an amino acd;\nR:z R. R4 and Rs ar the sae or dierent and are cloal.Yl, aIoxy, QH an cobme With the cabon\nto form a cycloall or eyeloayl\nseecte from the gronp Consg\noC\nC2Hs-. bycloxand lower aloxy, provided tht group:\nNRsH IId\n:z-CHR3R2 and Rs may al be arl or aryl and each R6 30 when x= I, A IS\nwhen x=2, A IS H2NR or an amo aCd; where\nis the sae or diferent and is selec frm\nR:z R3, R4 an Rs ar the\ne f:r\nerent and\noC H, lower alyl, arl.\ngroup consistig\nseleced from the group cOnsg of H, CH.\nhydroxy lower all, hydroxy- and aloxyl-\n\nH, CH3,\n\n. and aloxyl\n\nthe\naryl.\names\n\nall ames\nligand.\n\nato\n\nC2Hs, hydroxy and lower aloxy, provided tht\n\nbe arl or aryl an each R6\n2 and Rs may\nwhen z= I, L is a bidentBte anonic ligad, and 35\nIS the sae. o! dierent and 18 selecte from the\nwhen z=2, L is a monodentae anoDic\noC H, lower all. arl.\n2. A method for treatig magnant tuors sentive group CODStig\nalkoxylxy lower all, hY\'!xylto a pla dsplatium(l\ncompound or\names an aloxyl all ames;\nan octedr d2s platium(I\nwhen z= 1, L is a bidente anoDic ligad,\npound in,\nwhich compri ory\n\nanaoafec\n\ncotion com40\n\nadteg\na solu- when z=2, L is\n\nmalignant tuor\n\nthe formu1\n\nto an\n\nan arl,\n\ncordon\n\nwith sad\n\nbe\n\nmonod anonic lid,\n\nsad\n\nprest in an amount sucient to\ntion contag\' in an amount sucient to ca reg- compound\ncaus regron of sad tuor.\nsion of the tUor a plaum cordation compound oC\n4S\n\n(PIA.OO-c!J\n\n4. A compoon sutable for or adtrtion\nwith a magnt tuor setie to a\nplan ds platium(l cordtion copoun or an\nan\n\nan afec\n\noctaed d2s3\n\nplatium(I cotion\n\ncomprig a pbauticaY\n\nci or\n\np1aum cordtion compound of the formul\n\ntr (P(OOC)2-CRI),\n\nwherei:\nx=1 or 2;\ny=1 or 2;\nz=O, I or 2, provided\n\ntht\n\nlower 8l1, arl.\n\n(POOh-RRJI\n, or\n\nwhen y=2, z=O, and\n\ngrte th\n\nwhen y= I, z is\nRand Rl arc seec from the grup\n\ncompound\n\nactale caer and a\n\nconsg ofH,\n\ntr (P(I(00-cJ)"L\n\nwherei:\nx=l or 2:\n\naryl, a1yl, eycloal, oy-\n\ncloalenyl, al, OH and cobine with the ca-\n\ny=l or\n\nbon atom to form a cyeloa11 or eycloaenyl 60\n\nz=O, I or 2, provided tht when y=2, z=O, and\n\nwhe y= I, z is grte th\n\ngrup;\nwhen x= 1, A is HR2N-CHR3-C-NRsH and\n\nwhen x=2, A is H2NR or an amo acid; wherin\nR2. R3, R4 and Rs are the sae or dierent and\nseecte from the group\nof H, CH3,\nC2Hs, hydroxy an lower aloxy, provided that\nR2 and Rs may al be arl or arl an eah R6\nis the sae or dierent aud is selec from the\n\nconsg\n\nRand Rl ar\n\ngrup consg\n\nseleced from the\nlower alyl, arl. aryl, a1yl,\n\noCH,\ncyeloal. ey-\n\neloayl, aloxy, OH and combine with the ca65\n\nbon atom to form a cycloa11 or\n\ngroup:\n\ncycloalenyl\n\nNRsH and\nCHacd: wherein\n\nwhen x= 1, A is HR2N-CH3when x=2, A is H2NR6 or an amo\n\n\x0c657,927\nR20 11, R4 and Rs\n\nar the sam or\n\ndierent and are\n\nselecte frm th grup consg of\n\nH, CH3,\n\nC2Hs, hydrxy and lower aloxy, provided\nR2 an Rs may alo be arl or arkyl an eah Re\n\nseec from th\n\nis the sae or dieret and is\ngrup consstg of H, lower all,\n\narl,\n\naryl,\n\nhydroxy lower alyl,\n\nhydroxyl- and aloxyl-\n\names and aloxyl all amesj\nwhen z= I, L is a bideta anonic ligad, and\n. when z=2, L is a monodenta anonc liga sa\ncompound beg pret in an amount sucient to\n\ncaus reeson of sad\n\ntuor.\n\n\x0cfV\n\nUNITED STATES PATENT AND TRADEMARK OFFICE\n\nCERTIFICATE OF CORRECTION\nPATENT NO.\n\n657, 927\n\nDATED\n\nApril 14, 1987\n\nINVENTOA(S) :\n\nMichael J. Cleare\n\net al.\n\nIt is certified that error appears in the above-identified patent and that said Letters Patent is hereby\ncorrected as,shown below:\n\nNo.\n\nOn the title - page, bracket 62: " Division of Ser.\nshould read as\n902, 706, May 4, 1978, abandoned.\n\n--Division of Ser. No. 902, 706" May 4, 1978, abandoned\nN. 778, 955 filed March 18,\nwhich is a divisional of U.\n1977 now Patent No. 4, 140, 707 which is a Continuation of\nN. 260, 989 filed June 8, 1972 now abandoned.\n\nSigned and Sealed thi\nSeventh Day of March, 1989\nAttest:\nDONALD J. QUIGG\nAlestig Offcer\n\nCommissioner of PatenlS and Traemarks\n\n\x0c"\'\'\'1\n.I,\n\nIVI c."\'\'\'\'\'\'T I I. ...J rnA\n\nIo! Io! c: I tI\n\nI-lTPATRICK N,\n\nq::::l\n\nIt 005/011\n\nV.\n\n1.\n\nORIGINAL\n\nUN\' STATES DISCT COURT\n\nJUL 2 9\n\n. FORTBDISCtOFNEWJEY\nT.\n\nWf\\H.\n\nMY SQUIB COMPAN )\n\niNC..\n\nBRISTOL-\n\nan REEACH CORPORATION )\nTEOLOGIB,\nPlaitis,\n\nCIV AciQN\n\nNo. 01-3751 (MC)\n\nENRED\n\nPHACHE B.\n))efdat.\n\n\'JUl\n\n2"\n\nlOO\n\n\\L.\n\nWU T. WAL.\n\n(i)\n\nMEMQRAUM OPINON .A ORDER\n\ntn co\n\nbcfhre the Cour punuat to Deendat Pbaceme\n\n\'Phaacheme ) motion for paal sumuy judgen and\n\n;I.\n\nBrstol:.Myem Sqob\n\nPllli,,\n\ncrss.moton for\nRese Cmption Technologies, 1Dc.1s ("Th\'RCT\')\nCounba\nre an\nof3S\nU.\njudent on \'t Bpcail\np8\nconsder th me1xa of law and supportng docents submtt by RCT U1 BM ao\nCompy\'s\n\nsu\n\nBMS") an\n\nc. i 121.\n\nabve isss. At\nPhcheme. and on Mach 4. 200 th Cour hea ma aren\nri"g. th Courntedin favoofBCT an BMS. 1h mem1:\nconclusion\nOPWOJ se fort th reevt fa1B an concluons unciedyig the Co\'s decisin.\non the\n\nofth\n\nPhcleme a1o moved for sun og1eQt\n1he ar RCT ard BMS apposed Pbatcbe s motioD for pa\non\n\nrcga buf did not\n\nof thes issues unti a\n\n!h patnt-insui\\\n\ncross.moe fo\n\nTh Co wiR, dck reutOl\njudgttb\nhe. coed or\nth an Pbache\' tifor\niss th :rle t1OIe aeed with\'U pre.\nSPmP"\'\n\nis\nin\nlevel of skill in\n\nMa,./r"\n\ntbe retevam ar an, tbe\n\npar suuy judent\n\non\n\nofs1 in\n\nar and\n\nswnarJudgmcm in this\n\nof\n\nar is\n\nto beUerundcd,\n\n$m\n\n\x0cW"\'r\n\nI OJ, c....... I 1.\n\n..0 r fiA\n\nI\': I\': L. ItS\n\nFITPATRICK N.\n\nft 008/011\n\nV.\n\nBACKGROUN\n\nPlaitiff RCT and BM fied a complaitln th\n\nCo on\n\n8 201 al\n\nAu\nPhad1\nofU s. Patet 1-o. 4.651,\ninemt\nth assgn md BM is th\n\n\'97\n. RCT\nexclusve licc oftbe 1927\nTh .claims of th \'97\nto meOds of1teatg\nwith\npla!,nm\ncolexes\nsueb plti-con coex.\n927\n\nby\n\n. is\n\ntuor\n\npat ar\n\npa is\nen\n\npJica\n\npror\n\ncm.f an Abbed New Drg ApPn\n("FDA " seg aproval to ra\nc:DPJa\n\nnt fi oftb w1\nANA\n,itlnfm\n\ntm1iQD\n\nis a\n\npatnt exir.\n\n\'I of\' anY\n\nto exir in Apr 2004; itha not be the sujec\n\n2S sceded\n\nohcn uner the Ha-Waxan Act.\n\npharrru1cb\nprdua\n\nce\n\nce1Diqon\n\nin 1987 an\n\nlitgaon or\n\nFoo 8n Drg\n\npa :oon\n927 C\'te\n\nTha\n\n271(e)(2)(A).\n\nANA" wi 11 U.S. .\na powd for injection\n\nplatium-cordti coex before the \'927\n\nfoam th bass fo\n\nths lawsui\n\npur to 35\n\n. U.\n\nC.\n\nPhheue b,as aserd tht th 1927 pat is fxrvald for\n\nAmong oth deeue,\nobviouSlestype double pati\n\nov u. s. Patet No. 4 130,,707 ("th 707 pat\'j.\n, 1979 anexixd on Aug 24" 1998. The\nThe sae origiaplieati ficd. 0. June 8 . 1972 1h laC ri to th \' 927 p"en\n\npatcisueonz;ebr\'\n\nTh 1 701\n\n707p1htc from\n\nPhheme moved for suar\n\npa\nc;nta.\nergud th 35 V. C. f . 121 do\n\njudgm th th ba to obvusnes-te doube\nnotsply in ths ca. In r\nRCI" an 9MS\nI\'" eme frm\nan prccludes.\npaen\n\nj, 3S u.s.c. A 121 does\n\nas a refeen\n\naply\n\npant. Neith pa:other\n\nagns th\n\nder and does not addr,\n\nus\n\n.uove o\n\nthe\n\n701\n\nand ths Cour ha not\n\nas obviUs-we double\nt 35 U.8.C. ti 121\nPh&nachemc fr usin th 707 pat as a. rqerce ag1he \' \'/7\nPba\nobviousess-ty doube patg defe is precuded in th cae, Phache,u\' s moton is\n\npaentig deen. Beuse th\n\nmeritS ofPharacheme\'s\n\nCOur agees with RCT an BMB\n\npat,\n\ndeni\n\nan RCTs and BMSls mouan is gted. 3\n\nPhuachemie suequcy:fed\n\na second ANAfor an iDecle fo\n\nRCT Bn BMS fied a sepate acon\n1270)\n\ntbs\n\nni re\nwi\n\ntQ\n\nof carbo\nand\naga Phaxhemie in ths dict (Ca\'No.\nOI-CV..\n\nth.AA. Tht acton ha sie bee consoda wi th cas an\n\nis aplile to \'\n\nboth acons.\n\nTh jces enteed into a 10int Stpuon and\nclai\nfr th\n\nce\nes an\n\nelimed\nthe\n\nbeau\n\nde&e, only the ise of\n\nfi defbar\nn 121\n\nOrer"\n\nefve as o Ap2\n\n2002\n\nth ha\n\nlitigan. Du to th\naged to by\nobvonss-tye doUble\n\nPhhes\n\n.igemen remains in ths cae.\n\npag\n\n\x0c, r;.....,\n\nII.\n\nILIL Llti \'f:J:J\n\n..\\3 r n/\\\n\nt-lII"AIRlCK N.\n\nIgOO7l011\n\n1"\n\nPROSECUON HISTORY\n\n!he fats\n\ngc\n\nprseon L1ry of\n\n1ega\n\npares disput\n\nthorough reew\n\nof th\n\nan 1707 paen\n\n9T\n\nprseCUon\n\napplicaty of3S U .\n\ni 121 in\n\n. and\n\nC.\n\n121 at\n\npripa\n\nca\n\nTh invenrs of th 1 927 pa-in-\n\nfa\n\nnecat\n\nOJgi\n\n"tanar\'\n\nppltin on June 8.\nclai\n\npat a\n989. aplicaton\' \'1 con.Wag\nCOmpitOl. In its\nDt\nmethod of\nTratl-JlY\'\\: Ofce (ItPTO") issued a rescton requi\nto!? U.S. Pat an\n\nnube 260 989.\n\n1972 (seal\n\ncounds\n\ncoiltaied in the\n\n1h fact ar unc1sput (thou the\n\neni"ed in 1f pron lU).\ndete the\nis WBan and\n\nbi\n\n\'tis\n\n1I.\n\n3S\n\nto the applcabilit of\n\nsiguica of cer\n\nthe\n\nsut fied\n\nfibeee\n\nphaceca\n\nto\n\nOffce Action"\n\nnovel\nphacal:poti\nfollowi inventil1: 1. Cls 1-8 whch\noter. ("Resct is reui bet\nis\nclasfied\nin\nla 9- whch &t drwn to\nco\'Uds whCh\n\nco\\Dda on 1h on h8n and\ndmwn 1:\n\ncomposition an\n\nmeod of\n\nOf Ac;\nSI Th appli\nEx A to\n\ntr\n\nof1rc:t an\n\nAme.\n\nth pro made\n\ntraten am\n\n13\n\nClass 260. ll.\n\ncacer wbk is clasied in Clas\n\n424." Jan: 11, \' 1913\n\navan Decl. at 2).\n\natt \'\\essfly\nAmndent\n\nFeD. 12; 191)\n(8u\nSx. H to Cavan Dec) in ord to\ne.g.,\n\nti\n\non the:\n\n1he\n\nphcs\noosition\nntinu to cbenge\n"Fin" th restction\n\nRquienent\n\nori\n\nto trver$e the\nrectin\'1equient\nEx. r 10 CaVa Del.; July 13, 1973\nall ofthei\nin a smo pateL\n\ncla\n\nobt\n\nft\n\narng copounds\nmetods of\n(Aprll!8. 197 Off Aet Ex 010 caV\n\nDe.\n(luJy\n13\nreon\n.\n1913\n.\nxeuicnt.\nreson :r\nAmenen Ex H to Cavan:De.). B er""ge\npplicts\npms\nineJy\ncompoun\nclai.\nThe\nth\ne1e\napnc.tsproSe1id\nprvisonay\nat 2):,;te appficats\n\nthe:\n\nof the\n\nted to\n\ncoPOQDi!\n\nclai with the PTO bot did not jrodiatly obt\n\na1\n\nl1 th\n\nfo aDY ofthci\n\nWbe an apeal of the rejecon of applicants compund cla wa\n\npe\n\nclai.\n\nthe applicats chose to fie a coua\na1 numbe 778 955. l\nBo oCPatcn\ntipl1:1tion th apcats\ncontion ; Ex Q 10 Cava Decl. Af fig\nabadone th orgi \' 989 applicaton thus moog th pen apea Beca the\nwith\n\nthe\n\n\'9SS\n\napca\n\ncontion Wo abaDi the 989 apcati "t "955\nef as thugh fi on the Jun 8. , 19 ppodty dae oftbe origi\n\nfied the\n\n, contnuaon ba the sae\n989 apllciatan an ha\nSst!\n\napcaon\n\n35 U.\n\n1977\n\nOn Augu\nAmong oth\n\ne dIec in hr\n\ntb(,,\n\nof\n\nc. i 120 an Dote 4\n\nntiDn;\n\ninfa.\n\nth PT maed its fh\n\nth Offce Action se fort a\n\ngrs\n\nthe praseon:oftht\n\nOfce\n\nAction OD th \'955\n\nconttiOD.\n\nfur r=strcto: reemt. a fOur-Way\n\nof compun. (E R to Cava De!. at 2). ExR1er Helen\nrecton amon\n:pmine\nr of the \' 9.55 cotiuaon.\ntb! Offee AcOD\nwa 1ht PT\nan\namendmen\non\nSeptebe\n7,\n1977,\nin\nwhch\nth prvia1Y\'\naplicants\nat 3-4)\nComPun ft tw of th foar, grups. (Ex. S to Cavan\nproseGUon, the applieats therreivcd a nonce of alowance ofthej compoun\n. Apr 28 1978 (E Vto\n\nsutt\n\nAf reeivi\n\nDe\n\nCavanDel.).\n\nAf.\n\nSne\nclco\n\ncls\n\n\x0c- -- r\n\n"""""""T\n\nI I. U rnl\\\n\nFIT PATRICK N.\n\n1l:1l: l:/t! q:J:J\n\n/tOOS/Oll\n\nclcla.\neX\nplum\n\n:f \'\n\ndi\n\ncompoun\nissue in th \' 707 patt.\napplicants\napplictiQJl to thir nOn\nted\n\'Tis di siGna appllcato se n1l\n902,\n706\nthe\n706 dii lo"\' wa filed,on Ma14\n, 1978.. In th ti Offce Actan in the 706 divi\nne Sn= (who ba\nrtpnAti)\nthe\n9SS\nbeen\nbetee\nCOlnples EU method ofus an\ncomptions.\n(Augu 17, 1978\nAcon; Ex. Z to\nDeal at 2). The\nBefor\n\nst th II(r)estc:\nI\'n\npbautca\nOfe\nCav\naplica ag at.\nUDy\n\'be\nth\nrcStcton teuient\n4a Se.pte\n(E. AA to Ca.va Dec.\nobta cla cagores th weno\naIow\n.A fu precon. apRcats ffed an dioDa apli\n10 ("t \'\nto\n\n1978\n\nin JD Amendment\nin\n\n). so as to\n\nyet\n\nthe\n\nwmber 497\n\nThe \' 806 divion \'W tU on\n1983 (E BB\nCa Dcc.)1 M(I preim amenem wa Bl 0i1u 21\n.\n1983.\nCC\nto Cava\n(E.\nDe.). In a fi Ofce.AcoD date Aug 3.: 1984,. thPTO\n806 divisiona" ).\n\n1D\n\nMa\n\nre that "Rescton. . . is\ncl\ndraw to a pla comlex\ncosiODS. (E DD to\n\nr.ed nnder Secon 121" bet\n" JDtbods ofus 8n\n\nprecof\nme\n\npat\n\n2S.\n\npharace\n\n1: ,phacutca\n198\'.\nth ajUC8 r\n\nan clai drwn to \'\n\nCa De). at 2). Af\n\na IJtice of allo\n\nand\nisued on Apdl 14\n\nSTANAR FOR.\n\ncla.\n\nin e.,Jun 21.\n\ncopositlol1\n\n1985\n\n(E. EB to\n\nOff Acton\n\nCav Dee!.). Th\n\n1 927\n\nS:uY.1GMB\n\nab\n\nllm\n\njwlgJcnt is apprprat where the is an\nof a\nmet an the movi par is cntitle( to judgment as a\nmatt\nof la. FedCi... S6(c);\nCfl reA Corp.\nV. GaITen 477 U. S. 317, 327 (1986).\nWh\nbothpaerMOv." for\nSni1\njudgmentw the coUr mus\nmotion QU, its OWD\nreolvi alheaJile\n\neva ea\n\ninfece agaitb pa\n\nnccar ,prmid.\n\non\n\nmer\n\nwhose moon is 1Ddf\n\n\'199 P.\nv.het Sec 121 apJfes inu.s.\nth\ncais\nmacd facts ar not in disp, tho CoUl deon a matt\nthe fat-\n\n1380 (Fed. Cir. 199). Th\nof law for the Cour Althug\n:131\n\ngeui ise\n\ndc\n\nKiv.\n\nDn of\n\nintene file hitory afth \'97 patc\n\nANALYSIS OF 35 US.C.\n\nCour grts RCTs and BMS\'s\n\n, 121\n\njudgment 1h 3S ,V.s.C.\n\ncrssmotion fO\n\n121 apes on the facts of1b cae to ,\nbar Phaeme.1rom\npatem as a rocruc agans th tg27 patin-sut.\nthe pate aplicaon\nin light of the\nhioty\n\n1b decn 1s\'\n\nrelevt ca Jaw.\n\nSecton 121\n\nsrei in pereni\n\ning the\n\n0:i8, .-tb reew\n\n707\n\npm\n\nIf tw or more .icpent an dict ineDtcs at claied in\none appfcatioD; th (PTO)\nma reir th applicaon to \'b\n\nrescted to on\n\nof"t inventions. If th o1her invetion is mae\ndhision application whtch complis wiCh the \'\nof sectin 120 of ths 1i it sb be entied to ,\nth\n\nth subjcctof a\n\nrcuicat\n\ni\n\n\x0c11.\n\nI U / \'-\n\n;,0 r 1\'/\\\n\n,-\' I"\n\nHTPATRICK N.\n\n"I tI q::::Z\n\nis\n\nfi\n\nth\n\nbefit of\n\nV,\n\n008/0\n\ndate of th origi aplicaon.\nwi tesct- to whch a requien for .\n\nn:\n\nse\n\non an app1icllon\n\n\'lctn UD th\nba be m8 or 01 an\nas a resu ofsu a\nsh no be us as II\n:rerence eith in t1e))at. au Tmd\nOBorm. th\n\nfi\n\naptin\n\ncour aga divioul apJiat\n\nor aay pa\naplica\ndivona\n\napca\non.\n\nor\n\nissud 01 d\n\nis fied before\n\nth\n\nth oth 8.pp\n\n35 U.\n\nC. f 121.\n\nn: st\n\nag\n\nis\n\nr o:t\n\nthe\n\niftbe \'\n\nof th\n\npa\n\norto pm ap1i\n\n\' Cones ened Secon 121 as a\nin\nand\npatetees ftm the\nSee. e.g. gutZy :.pplied\nMaterial.v. Advanced\nInc; 98 P3d\n(Fed Ci.\n1996). Pror to th\nCl wh ha beC3 suect to a I\'Gton\nCGlJld have its latq\non th bas oCme fi issu patt even\nthugh the\nhad intiy sougtto prsee al ofib\nSu, e.g.,\nRBingttmRcm Bu. Sen. v. .AcmsCiJ(/ S)s. . Co. 11 F.2d 628 (4th, Cir i:er\'\n293. U. S. \'\n62 (1934). . SecoD,121 wa\nelmin\n\'1D ,tn es an ODe oftb\nPUIse -oScc1ion 121 is I&to\nvadity WID tbe vapdos ofthcrccton\n\nun\n\nconSeueces ofPTO restcton\n\nSer.lC0dutr MaerIo\n\nreenpa\n\npr\n\nenent\n\nSeon\n\n.4m.,\n\n1563,\n\nIS68-69\n\nof SectiDn 121, a\n\npa.ivac=\n\nclai toge.\n\neu\n\nth\n\nsagu\n\na ove\n\n121\n\npr\n\ndDed\n\nto\n\n.8 th\n\nthe te1mcaties of\n\npote\n\nrection prce\n\nar\n\nnot elevte from thei P1nos of\nCXRq;\nOD. conveence to a\nta,OD th\nty of\npatents"\nApplied M6riQU\nat 15689;\nsee alo\nS.. Rep. No 82-197 (June 27 1952):0\n19S2U. c.C.AN. 2394\nre171ledin\n\n2A13.\n\neng.\n\nIn th cas the\n\nfi pat\n\n(th \'707\n\npa) "issu( ed) on an apcati01 wi xe\nhito as a\n\nwhch a requie:t for resbcton (wa) mae.,14 Fmm a reew ofthpts\nwho it 19 evdentb me ,\nrecli:OIl reuic:D1 A;ae in\nthe applca to pure tbcimethod of1Jtmem an\ncompon\ndivcm applic.oD.\ntescton\ncacee&1 reoke\n\nIb\n\nPhachee 1: not offer\n\npba\n\nrequi\n\nan\n\nJU\n\npeve auoli in suppor of\n\nretrcton requiemen was cl1er excitl or\n\ntr\n\neoauleui\n\ncl\norwi\nit coteon\n197\n\nimplicitly withdmwn by th\n\nin\n\nth th\n\nPTOs:fer\n\nTh is\nfor at lea the xen. th the \' 955 contuaon togeVtth th o\nrd \' 989\naplicaon COtc n one contiou applicaton\ntb mcag of th law.\n68 U.s. 317) 325-26 (1863);\na1$O 7ramo Prods.\nOmtTm:ti\n\nwi\n\nBtes.\n\nfl7\n\n8f\n\n1994) (citi1D\n\n(Fed Cir.\nComnote\nSU\nam conered pa of the sae 1ra\ncons\nlegie\ninca an\n38 F.3d 551.\n\nSS6wS7\n\nth\n\nth a\n\nhiStry of\n\nCourS intee1OD of\n\nGodf)\n\nOD\n\nQD 120 d.oe 1iot\naplicaon\n\nv.\n\n121\n\nGoe:\n\nenct\n\ntb apJUOI1 01 whchit is\none COui ap\n. Th\n\non BD\n\nco\n\nco\n\nPerj"\n("Bef$eon\n\n1n\n\ncongrsson int,tO alte-th\nctc?\' " cer tlene 513 U.S. : 151- U99.S\\\n\n\x0c. "\'VI\n\nI ul ,"",V"t\n\nI I -\n\nr"\'l\\\n\n1.0 1.0 "ItS q\n\nFIT PAT R\n\nrectnr\n\nI.C K N. V,\n\nfg01o/o11\n\nuieD\\en in the \'955 contato an Phanacemie s arguent is beled by the\nwhole\nExamr\'s Sne\' mmen m. the fi Oft Acton on\n106 divion COborate t\' th rection\ncopoim an metoa of11en an\ncoposion\nteJliue in eft thug the " 55 canuaon ("estion. .\nhas\ntw clai drwn to cooum an glai "\ncompon(s) andmes)lI :e z to Cava Dec. at 2,. On at leutfb\noccons, \'te\nreiteat tbJlppUam coound\nneed to be sep fr\nth\ns 1k Cour\n1T_en and\ncopoon\ndiviom\nme1h of\nand phaacutica coposition clms was $ed as a\napplicaon\nof the restrction\nwa not a \' \'voltItaD ac over th\n1h\n\noftl pruton hiry.\n\nbc\n\npNnoa\n\nbe\ncls\nphcal tratt 1a.\npu\nrequen en\n\ndrot\n\nbctequ.\npr\n\nre\n\ncou& th th\n\n, 11repd atts to trVCt the PTO\' restetn\nbi copound\n\nclas \'Wth "metod\n\noftrJment\n\nthe \' 927 paent is fn conson\nFu.\napp1\n\nreui\nphaceutca\n\nme of\n\nye pC1\naplica\ncomposition claims.\n\nbut wer nOt\n\nrestcti lC\n\nofpat\ndrwn exclu.vdy to\nrr7 paeuiu.S\\ co cla\nexJ:.Jly\ndr\noftrateD.t &c phaeu\n\ndencJa\n\nupn by\n\ncontae4\n\nwith tbe\n\nJ973\n\n....nR fl the c)ai of e "97 p nt do not crss ba ov th lie\nto clai subjectma c\nin the\n?07 pat. \'I= 707\n\neali\n\ncompounds. and the\n\nto method\nconsoomce reqre\'as set fort m\n683 (Fed Ci. 1990). is met\n\neomposition. Thus.\n\nGer.her Garent Tech.. Inc.\n\nhe.\n\n\\I.\n\nLectra\n\nl11C.,\n\n916 F.2\n\nupon whh Phachem ba relied do not milta in -favot of a\nCour The Court of Custobl an Pate Appal\' detionS in 1"\n#3 P.2d 12U (C.\n9\'1)\nwifhdialofarescton\nrequient-n a parentapplicaon).\n393 F 2d 1001 (C P.A 1968) (no P1:P In re Scheler 397 F. 2d 350 (C.C.P.A. , 1968) (sach do\nimosed retrction\nthe Coar\' s concluson that Secon 121 aplies in\nnot\ncasc.\nFiny. th caes\n\ncont deoiOD by th\n\nZfegler.\n\nC;P.A\n\nch\n\noffcial\n\n(iotvigthe\n\nln\n\nre Wl\'!ght.\n\nrequiment) an\n\n"t\n\nHer the Pr unqUvocy impo a\n\nsepar tb.acats\'\npharceca composition cbm,\ncoua\nne rescded tb\nand two pate then issued (oue wi otai\nexlusively tQ compoUD and one with clai dmwn exclusvely to ma1hod df1ttmen and\npbsacca compositions). Sccon 121 aplies in th ca to ba th us of.tbe eBerclaims fim\n\nmetod of tratmen\n\nrcuh\n\nrcstiction\n\nand\n\ndr\n\nised 707 paen as .a refence agst the later-isue\n\nSee, e.\n\n11. 1973\n\nm-suit\n\n\'92 paeo-\n\nDel.).\n\nOf. Action (E. E to Cavan Pee. ); Aprl 18. 1913- OBi Acton\n\n(E. G to Cava Deet); Mah 22. 1974 Offce Action (E I to C&V8 DeCL) an1984 Ofce Action (Ex. DD to Cava\n\nugll 3\n\n\x0c,"VV"T\n\nI I . .. I r nl\\\n\nFITPATRICK N.\n\nltI q:l:ll\n\nI.! I.!\n\n0l1/011\n\nV.\n\n1, .\n\nIUER\n2.8 U\n\nC. S\n\nCereatioD\n\n1292(b)\n\ndeon on an\nbu th ha\niDlo0u.basls. RCT BD BMS do not join In Phl\nr.. it Pbitil\noPse ths Cour ceQ!oD, of an inteocury aP. I\ns, fig th Ib cae "ilv cotrllg\nto apea ibs ruli on an\nofr.pion and t1 an\nthe is\npoun for\nquaniatoflaw as to whichoncr\n.t umtey ad 1h ulti fPA ofth\nap:fom an\npJAnnacio h :ruest cecaon so th it may-appe\n\nth\n\ns tB\n\ninocn\n\n. lition."\n\n21 U.S.C. f 12.92(b). 1\n\nby the United\n\nbate\n\nsu\n\nnot ta\n\nherby cafy\n\nSt Cour of Appe fo\n\nCi\n\nI1\n\nmmrlocQ reew\n\nfl follwin queson fo\n\nthe; Fedet\n\nCET1/E QUEION\nWhre (i) th PTO found tht\n\ntw 01 more independet and diltict inenons wee\n\nrequ tb orgil aplicaoD.\norl\nea1iofth invenoDS \\ft reOE\nbefo\nisSUce\nof th eaerori\napplicaon (tii)\npat issued fr co1111nafi: JD\nclvicm appltion which\nth\n_cd pa\n\nclaied iD one\n\n. to be IC\n\naplicaon"). and th PTO\n\napplicaon\n\nteci to 011\n\nn.; Cu)\n\nof the\n\nsubjec of a\n\nvc:on wa\n\nfu rccton\nreen\nieui\nimO$ by no dung prsecuton oftbe diviional apli ("\nreuieDt\'\n1hc other\n\nis pa ("dJvion\nultite mat in\n\'W h\nc:ceed reoke or withwn am\nthe lat-\n\napplication": (iv)\n\nthe\n\nDid the Disct Comt er in holding tht 35\nasa refece\n707\nuse of tM eaer-\n\nis\n\'\npat\nba upn the followig 1eg\n\nrus:\n\nU.\n\n(v) a retion\nJ. rection\n\nC. i 121\n\nag\n\nthe:\n\n8PPUes in th\nissued " 927 p\n\nto bar the\nin-sui\n\nment, .\n\n, (1) The diviiona aplication W8 fied \'Cas a ret of the fi IectOIl\nwith th\nmeing of S\n\non 121;\n\n(2) Th\n\nno\n\n1icit1 or implicitly withdr 1he fist\n\nrent,\n\nrectin requiemen by.\n\nan1he t\'e\nth la restrcln\ncontiue to apply to the divion etplicaon far pUtge ofinwki\ndid not\n\nimo\n\nent .\n\nih 1\'cton\n\nSecon 121; and\n\n(1) The clas or1h eatlier-isueci patet. and 11 clai\' oftb laie..jssu patnt er\nm;Cton\nwith th\nfay\n\ncouat\n\nfi\n\nreuien ,\n\nSO OBEIJi:\n\nMA Y\nt.\n\n.I\n\no2lJ\n\n\x0c;.\' Vul I\n\nUULf\n\n01\n\nI I.\n\nSTERNS &:\n\nFITPATRICK N, V.\n\nHI\n\nr 0\'/\\\n\n002/0"\n\nWEO\'\n\nA Prafesiopal Corporation\n\nqRIGtNALriLE\n\nso Wei Sta Stm\n\n08607\nTt Nl2100\nSuite 140\n\n00\'(2\n\n(609 392-\n\nKC-848\n\n. 0\n\n..:.1 .I\n\n"7\'Ct-t\n\ntn;T r \'1\\\n\nfo Defedat\nPhaceme B.\n\n. 1JIT1 STAms\n\nDlSnucr\n\nFOR THE DISTRICT OF NEW\n\n"":0 --\n\ncOI\n.1Y\n\nBR,TOL-MY SQUI\nCOMPAN -.d\n\nRBCH CORPORATION\n\nTBOLOIB, INC..\n\n:PJaiff\n\nClvIL crONNo.Ol-37\n(Civil Action No. 02 1270\n\npHACHB.Deenda.\nV..\n\n.", I\n\nCQnsJ1da herth)\n\n-I\n\'\n\\\'l1.\nJ\\\nI,\non\n\n\':1.\n\nFIAL JUGME\n\nWHRES.. on July 29t 2002 th\ngr\n\nCo\n\nissued a\n\nMemcm Opn and\n\njudgment for plaintiff on the mvaJd4. defeue af\n\nS\\1\n\natmQUSasty doubl :.\n\ngr1U thaI 35 U-S.C. g 121 baa 1r of U.s. Pa\npat.\') as a refi agait U.S. Paten No. 41)57.921 (tho en 921 pate\nem the\n\nWHB, on Ocber 2\n\nNo.\n\n200 the \' Uuite Staea\n\nCit deed deCen&!t Pbannacheme B.\nappeal &om \'t Cour\n\ns\' (\n\n140 701\n\n(th\n\n10\n\n,i\n\nCa Appaa for th F\nach\nfie\nDC\n\n,i\n\ntiOD 1C "\n\nsaar jud8DC1t otder.\n\nWHE, the onty issue Temnilt in ths case is th -ie ofiI\n\n.t\n\nr\'\n\n\x0c" ..v, I U,\n\nII,\n\nr fill\n\nFITPATRICK N.\n\n11:\n\nI\': I\':\n\nPDArnohemc. in OIer to\n\nW1.\n\nha. With the\n\nwrtt conse DfpIaia\n\nee1i its ri\n\n1a of the "\n\nODe\n\nWl.\nreain to be\n\nDOW\n\ntQ IpJlea1h\n\nfiled an .Aende Auer am\n\nth Pbhenc s fiUng of the AN.As refci\ninmngemenf dr.at\n\nIg 003/011\n\nV,\n\nth tha Amcad-= Aner an\n\n\'twi\n\niss\n\nC011talaJ\n\ncols is an se 0\n\nin tho CODSUda\n\n27 patt md\n\ni 121 ba\n\nafrmve deeJ\n\nits\n\nes .\n\nfilc DO i\n\nCoMcJs hi\n\n0\n\ntr.\n\nWHOn. fi judgment be and heryis cnten as fo1iows:\nJudent is i tavorDf\nBMISquibb Compy on\ndefeadat Pharhe\nV. on its Countelai in tht U.s. Pat\n\nogica mc. 8I\n\nplatis Resh Cortion\n\nth\n\nii\n\nDO\n\nd,\n\nun\n\nas U1:u1,\n\nput to 35 U.\n\nwi the Un St\n\nC.\n\nComplai aa\n\n271( e)(2), and that the\n\nNo. 65./21 is DO\n\nemt of at J.t\n\nmata\n\nor hapomt1on into the UDtec St,\n\nrefe to in the Abbr&k New Dru Applications wod\n\npat\n, It is fwea ordet that the cfecvo date\n\n\'Ue.\n\nof the\n\nin\n\nto 21 U.\n\nC- Section\n\n927 paten\nexpimon of the\n\nsa\n\n01:\n\nOD clam of I.\n\noff fo sae i\n\ncabolat prots\n\' anc clai of\n\nat\n\nnm AppIicaOl Nos. 15-162 . and 76-292 is detcd\n"a Dt Adm&1n exclusvity th may be\nto ptsti\n\ne on\n\nto be the\n\nJ1\n\n3SSa\n\n"Kpy sad exclusivity comiJ into efec up\n\nand" if no such exclusivity is\n\npa1\n\n. a. dat\n\ntht\n\nof Phmemc\n\nof\n\nAbbratd New\nwhlcl Nly Foo\n\nI\n\nfi of1h\n\np\n\npla proct ig an t4t of\n\nNow Drg Applic:an for\ntht pateAt\n\nen\n\nConolida\n\npot eaer\n\nput\n\nGXirat of the .\n\ndu th Ap t4, 200\n\n\x0c--I\n\n. \'O\n\n1-"\n\nI I, -\'-\' 1- nl\\\n\n10 ":J:J\n\nI-llt\'AIK1CI\\ N,\n\nIg 004/011\n\n, 0\n\nI..\n\ntU 0l\n\nn is\n\nIh pd to th\n\ntI\n\no\' I\n\ndalo of\n\nAhbr New \'Dmg Application Nos 76-162 md 76.292, dc Plthem.\nmatin& usin& sdHn J:r oftg for-sde witb th U .\niDto th thtec Sta. dls caJan\ntefe to In \'tsc\n\nenjoied fi tImriay\nSte.. or\n\n, Abbmiated\n\n1icati9na oth\n\n\'New Drug\n\nof\n\nth deyelopeat and\n\nuinf.\n\nUS\n\nth\n\nintou un Fect la whch\n\nor sae of dngs as set fort\n\nin\n\n3S U.\n\nMa L\nDat! Octber\n\n200\n\nreDa rd\n\nte th\n\nc. Secn 271(e)(1). .\n\nle si8 -ct Jud\n\n\x0cto. "\n\nUnited States Court of Appeals for the Federal Circuit\n03- 1077\nBRISTOL- MYERS SQUIBB COMPANY\nPlaintiff-Appellee,\n\nand\nRESEARCH CORPORATION TECHNOLOGIES, INC.,\n\nPlaintiff-Appellee,\n. v.\n\nPHARMACHEMIE B. V.,\n\nDefendant-Appellant.\n\nDavid T. Pritikin ,\n\nSidley Austin Brown & Wood, of Chicago , Ilinois , argued for\nboth plaintiffs-appellees. With him on the\nConstantine L. Trela. Jr. Lisa A.\nSchneider\nMarc A. Cavan\nEUQenia S. Hansen , Sidley Austin Brown & Wood,\nof Dallas , Texas. On the brief for plaintiff-appellee Bristol- Myers Squibb Company, was\nRobert L. Baechtold , Fitzpatrick , Cella , Harper & Scinto , of New York , New York.\nbrief were\n\n; and\n\n, and\n\nFrancis C. Lvnch , Palmer & Dodge , LLP of Boston , Massachusetts, argued for\ndefendant-appellant. With him on the brief was\nLaurie S. Gill.\nAppealed from:\n\nUnited States District Court for the District of New Jersey\n\nJudge Mary L. Cooper\n\n\x0c,i\n\nUnited States Court of Appeals for the Federal Circuit\n\n03- 1077\nBRISTOL- MYERS SQUIBB COMPANY\nPlaintiff-Appellee,\n\nand\nRESEARCH CORPORATION TECHNOLOGIES, INC.\n. Plaintiff-Appellee,\n\nPHARMACHEMIE B.\n\nDefendant-Appellant.\nDECIDED: March 17, 2004\n\nBefore NEWMAN, MICHEL , and BRYSON,\nOpinion for the court\nNEWMAN,\n\nBRYSON,\n\nfiled by\n\nBRYSON,\n\nCircuit Judaes\n\nCircuit Judae\n\nDissenting opinion filed by\n\nCircuit Judae\n\nCircuit Judae\n\nThe question in this patent case is whether the patent in suit is invalid for double\n\npatenting. The district court held on summary judgment that an earlier patent , which\nstemmed from the same application as the patent in suit, could not be used\nreference against the patent in\n\nsuit for double patenting\n\nSquibb Co. v. Pharmachemie. BV. , No. 01-3751\n\nas a\n\npurposes.\n\nBristol- Mvers\n\n(MlC) (D.\n\nJ. July 29, 2002).\n\n\x0cBecause we disagree with a key conclusion on which the district court\' s\n\nsummary\n\njudgment was based, we vacate the district court\' s judgment and remand the case to\nthe district court for further proceedings.\n\nResearch Corporation Technologies, Inc. ,\n\nis the owner\n\nof U. S. Patent No.\n\n657, 927 ("the \' 927 patent" ), and Bristol- Myers Squibb Co. is the exclusive licensee\nunder that patent.\n\nThe patent claims (1) methods for treating malignant tumors with\n\ncertain platinum coordination compounds and (2) compositions containing\n\ncompounds in amounts sufficient to cause regression\nPharmachemie, B.\n\nthose\n\nof those tumors. Appellant\n\n, filed an Abbreviated New Drug Application ("ANDA" ) with the\n\nFood and Drug Administration , seeking FDA approval to market a cancer-treating drug\n\ncovered by the \' 927 patent. Research Corporation Technologies, Inc. ,\nMyers Squibb Co. (collectively " Bristol- Myers\n\nwith patent infringement under 35 U.\n\nC.\n\nand Bristol-\n\n) brought suit charging Pharmachemie\n\n271 (e)(2). As a defense ,\n\nPharmachemie\n\nasserted that the \' 927 patent was invalid for obviousness-type double patenting over\nS. Patent No. 4 140 707 ("the\n\n\'707 patent" ),\n\nwhich was issued in 1979 and expired in\n\n1998.\n\nThe double patenting issue in this case turns on whether Bristol- Myers is entitled\nto invoke section 121 of the Patent Act, 35 U.\n\nclaim of double patenting.\n\nThat issue\n\nC.\n\n121, as a defense against\n\nthe\n\nin turn depends on an interpretation of the\n\nprosecution history of the \'707 and \' 927 patents.\n\n\x0cThe \' 927 patent can be traced\nTrademark Offce in 1972.\n\nto an\n\napplication filed with the Patent and\n\nThat application, Serial No. 260 989 ("the \' 989 application\n\ndisclosed and claimed compounds corresponding generally to the compounds that were\nultimately claimed in the \'707 patent. In addition, the \' 989 application claimed methods\nof treatment and compositions corresponding to the claims that were ultimately included\nin the \' 927\n\npatent.\n\nIn the course of the prosecution of the \' 989 application, the examiners imposed\n\ntwo restriction requirements. The first, imposed in 1973, required\n\nthat the applicants\n\nelect either the compound claims; classified in art class 260, or the method of treatment\nand composltjon \' claims, classified in.,art\n\nclass 424. In\n\naddition\n\n, the \' 1973 restriction\n\nrequirement directed the applicants to elect " a single disclosed species for examination\n\non the merits. " As a result of the 1973 restriction requirement, the applicants elected\n\nthe compound claims and withdrew the non-elected method of use and composition\nclaims from further consideration at that time.\n\nThe examiner then rejected the elected\n\ncompound claims on the basis of lack of utilty.\n\nIn 1974 , adifferent examiner issued a second restriction requirement on the \' 989\n\napplication. That restriction requirement identified four different compound groups\nwithin the compounds claimed in the application as constituting independent and\ndistinct inventions. The four \' groups were: (1) " Organometallc\n\nplatinum compound(s)\n\nclassified in class 260, subclass 429" ; (2) " Platinum compounds containing \' heterocyclic\n\namines \' or (\'heterocyclic substituents \' classified in class 260 , subclass 270R and many\nvarious subclasses ; (3) " Compounds of the above type with 2-valent platinum and no L\n\nmoiety\n\n; and (4) " Compounds with 4-valent platinum containing various \' anionic\n\n\x0cligands."\n\nIn addition , the examiner expressly stated\n\nthat the 1973 restriction\n\nrequirement segregating the compound claims from the method of use and composition\n\nclaims was maintained. The applicants did not file a divisional application in response\n\nto either of the restriction requirements, but instead appealed the final rejection of the\nclaims to the PTO Board of Appeals.\n\nIn 1977, while that appeal was pending,\napplication ,\n\napplication.\n\nSerial No. 778, 955\n\nthe applicants filed a continuation\n\n(" the \' 955 application\n\n), and abandoned the \' 989\n\nThe \' 955 application presented all of the original claims of the \' 989\n\napplication for examination.\n\nrestriction only"\n\nA new examiner examined the \' 955 application "for\n\nand imposed a\n\nnew restriction requirement. The 1977 restriction.\n\nrequirement differed from the 1973 and 1974 requirements that had been imposed in\nconnection with the \' 989 application. The 1977 restriction requirement mandated that\n\nthe claims be separated into four groups, but unlike the 1973 restriction requirement, it\n\ndid not segregate the compound claims from the method of use\nclaims. Instead ,\nreferred to art\n\ncompounds.\n\nand composition\n\nthe first two of the four groups set forth in the restriction requirement\n\ngroups that included methods of use and compositions\n\nThe first group consisted\n\nplatinum compound(s)\n\nsubclass 429 (compounds)\n\nand class 424, subclass 287\n\ncompositions)." The second\n\ngroup consisted of U (p)latinum\n\nclassified in class 260,\n(methods of use and\n\nof U (o)rganometallc\n\nas well as\n\ncompounds containing \' heterocyclic amines \' or (\'heterocyclic substituents \' classified in\n\nClass 260, subclasses 270R and many various subclasses (compounds),\n424 subclass 245 (compositions and methods of use). "\n1977\n\nand Class\n\nThe third group set forth in the\n\nestriction requirement consisted of " (c)ompounds of the above type with 2-valent\n\n\x0cplatinum and no L moiety. " The fourth group consisted of " (c)ompounds with 4-valent\nplatinum containing various \' anionic\' ligands.\n\nThe applicants responded to the 1977 restriction requirement by electing four\nclaims , which corresponded to the claims that were ultimately included in the \'707\npatent that issued two years later.\n\nBefore that patent issued, however, the applicants\n\nfiled a divisional application, Serial No. 902, 706 ("the \'706 divisional application\n\npreliminary amendment, the \'706 divisional application \'ncluded\n\ndenominated claims\n\n5- 20.\n\n). After\n\n16 claims,\n\nClaims 5- 13 were cancelled shortly thereafter.\n\nThe\n\nremaining claims, in slightly rewritten form, claimed the non-elected compound groups\nand\' the\' methods of use and compositions originally claimed in both\' the \' 989 and the\n\n955 applications. Following the filng of the \'706 divisional application, the \'707 patent\nissued, containing the four\n\ncompound claims that had been elected from the \' 955\n\napplication.\n\nThe examiner issued a restriction requirement with respect to the \'706 divisional\n\napplication.\n\nThe office action began with the statement " Restriction has been\n\nrequired. . . between the following\n\ninventions,\n\n" after which the examiner divided the\n\nclaims into three groups: claim 14 which is drawn to Platinum (II) complexes classified\n\nin Class 260, subcla$s 270R" ; claim 15\n\nwhich is directed to platinum (IV) complexes\n\nclassified in Class 260, subclass 429R" ;\n\nand claims\n\n16-20, \' \'which are\n\ncomposition and method (sic) classified in Class 424, subclass 245 , 287. "\n\nIn\n\ndrafted to\nthe same\n\noffice action , the examiner then set forth a second, four-way restriction requirement\n\nwhich replicated the four-way restriction requirement that had earlier been imposed\n\non\n\nthe claims of the \' 955 application. The applicants responded to that office action by\n\n\x0casserting that the two restriction requirements seemed to be "somewhat in conflict" in\n\nthat " any invention elected in a cordance with the requirements (of the first) would\nnecessarily involve election of one or more of the groups set forth (in the second). "\n\nIn\n\nan effort to comply with the requirements, however, the applicants elected claim 14 of\nthe \'706 divisional application.\n\nIn 1983 , after further unsuccessful appellate proceedings ,\n\nthe applicants\n\nfiled\n\nanother divisional application , which again consisted of the original 1972 application. In\npreliminary amendments , the applicants canceled the 13 original claims and added, as\nclaims 14- 19,\n\nthe claims that had been claims 15- 20\n\nof the \'706 divisional application.\n\nAnother examiner was assigned to the application and another\' restriction . requirement\'\nwas issued. This time, the examiner divided the claims into two groups, one consisting\n\nof claim 14 drawn to platinum IV complexes, classified in Class 260, subclass 239E\nand the other consisting of claims 15-\n\nclassified in Class 424\n\ndrawn to methods of use and compositions,\n\nsubclass 245. " In 1987,\n\nthat application matured into the \' 927\n\npatent. The four claims of the \' 927 patent corresponded generally to four of the method\nof use and composition claims of the 1983 divisional application.\n\nThe district court noted that the question whether section 121 of the Patent Act is\n\navailable to Bristol- Myers . depends on whether the applicants were required by a\nrestriction requirement to prosecute the claims that ultimately became part of the \' 927\n\npatent separately from the claims that became part of the \'707 patent. The court\nconcluded that the statutory requirement was satisfied because " it is evident that the\noriginal 1973 restriction requirement remained in effect and required the applicants to\n\n\x0cpursue their method of treatment and pharmaceutical composition claims in a divisional\n\napplication. This restriction requirement was never cancelled, revoked. or withdrawn.\nAccordingly, the court concluded,\n\nthe divisional application pursuing method\n\nof treatment and\n\npharmaceutical composition claims was filed as a result of the restriction\nrequirement and was not a \' \'voluntary \'\' act; over the years, the applicants\nmade repeated attempts to traverse the PTO\' s restriction requirement but\nwere not permitted to combine compound claims with method of treatment\nand composition claims.\n\nBecause the court concluded that section 121 barred the assertion of double\npatenting as a basis for\n\nPharmachemie to assert the invalidity of the \' 927 patent, and\n\nbecause Pharmachemie abandoned any other, defense against Bristol- Myers \' claim of\ninfringement, the court\n\nentered final judgment\n\nof infringement.\n\nPharmachemie\n\nappealed.\n\nSection 121 of the Patent Act provides , in pertinent part , as follows:\nIf two or !\'ore independent and distinct inventions are claimed in\none application, the Director may require the application to be restricted to\n\none of the inventions. If the other invention is made the subject of\ndivisional application which complies with the requirements of section 120\n(of the Patent Act) it shall be entitled to the benefi of the filng date of the\noriginal application. A patent issuing on an application with respect to\nwhich a requirement for restriction under this section has been made, or\nan application filed as a result of such a requirement, shall not be used as\n\na reference either in the Patent and Trademark Office or in the courts\ndivisional application or against the original application or any\npatent issued on either of them , if the divisional application is filed before\nthe issuance of the patent on the other application.\n\nagainst a\n\n35 U.\n\nC.\n\n121.\n\n\x0cAs section 121\n\nhas been interpreted by this court, Bristol- Myers\n\ninvoke the statutory prohibition against the use of the \'707 patent " as\n\nis entitled\n\nto\n\na reference\n\nagainst the divisional application that resulted in the \' 927 patent only if the divisional\napplication was filed as a result of a restriction requirement and is consonant with that\nrestriction requirement.\n\nSee Geneva Pharms.. Inc. v. Glaxosmithkline PLC , 349 F.\nGerber Garment Tech.. Inc. v. Lectra Svs.. Inc. 916\n\n1373, 1378, 1381 (Fed. Gir. 2003);\n\n2d 683, 687 (Fed. Cir. 1990). The district court held that the divisional application\n\nthat led to the \' 927 patent was filed as a result of, and was consistent with, the\nrestriction requirement issued in 1973.\n\nAccording to the\n\ncourt, that 1973 restriction\n\n. requirement resulted in the 1978 divisional application that , ultimately, resulted in the\n927 patent , because the 1973 restriction requirement " remained in effect and required\n\nthe applicants to pursue their method of treatment and pharmaceutical\nclaims in a divisional application.\n\ncomposition\n\nAlthough the 1973 restriction requirement was\n\nissued against the \' 989 application, and not against the \' 955 application , from which the\n\n1978 divisional was filed, the court ruled that the 1973 restriction requirement applied to\n\nthe later application because it " was never cancelled, revoked, or withdrawn.\n\nOur review\n\nof the\n\ndistrict court\' s\n\nsummary judgment\n\norder in this\n\nfactually\n\ncomplex case presents a relatively straightforward question: whether the district court\n\nwas correct to conclude, as a matter of law, that the 1973 restriction requirement was\napplicable to the\n\napplication.\n\n1977 application and therefore\n\nresulted in the\n\n1978 divisional\n\n1 The district court held that it was and that the patent therefore cannol\'\n\nThe dissent appears to take the position that by issuing the \' 927 patent the PTO\nin effect found that the applicant complied with all applicable restriction requirements,\nand that we should not disturb that determination. In fact , however , the question\n\n\x0ccited as a reference against the \' 927 patent for double patenting\n\npurposes.\n\nPharmachemie, on the other hand, argues that the 1973 restriction requirement was not\n\nin effect at the time of the filng of the divisional application that matured into the \' 927\npatent, and that the \' 927 patent therefore cannot be said to have been filed as a result\nof that restriction requirement.\n\nWe agree with Pharmachemie. The \' 955 continuation application , which was\nfiled in 1977 , began a new proceeding in which all of the original claims of the \' 989\napplication were once again presented for examination? In 1977 , when the examiner\nfor the \' 955 application issued the restriction requirement for that application, she did\n\nI"ot reinstate ,or\n\neven \'\n\nadvert to the - 1973 restriction requkement. I n fact ,\n\nthe 1977\n\nrestriction requirement that she issued at the outset of the prosecution of the \' 955\nwhether the requirements of section 121 have been satisfied is a question of law that\nde novo after reviewing the relevant\nSee Geneva , 349\nmaterials.\n\nwe have addressed\n3d at 1377;\n\nIn re BerQ , 140 F. 3d 1428, 1432\n\n(Fed. Gir. 1988). The approach\n\nsuggested by the dissent would be inconsistent with the approach we have employed in\nsimilar cases in the past. In Geneva , and Gerber , for example , we held that applicants\n\nhad failed to satisfy the requirements of section 121 based on our analysis of the\nprosecution history. Even in cases in which we have held that the requirements of\nsection 121 were satisfied, we did so not as a result of deference to the PTO but as a\nresult of our own analysis of the prosecution\nSee Symbol Techs.. Inc. v.\nTex. Instruments Inc. v. U. S. Int\' Trade\nOpticon, Inc. , 935 F. 2d 1569\nComm , 988 F. 2d 1165 (Fed. Cir. 1993).\nhistory.\n\n(Fed. Gir. 1991);\n\n2 Bristol- Myers has not cited any statutory or regulatory basis for concluding that\nthe 1973 restriction requirement was automatically applicable to the \' 955 continuation.\nBristol- Myers cites several cases and a provision (section 201. 07) of the 1972 version\nof the Manual of Patent Examining Procedure (" MPEP" ) for the proposition that\ncontinuation application and its parent are " one continuous application , withih the\nmeaning of the law. Godfrey v. Eames , 68 U. S. 317 , 326 (1864);\naccord Transco\nProds. Inc. v. Performance GontractinQ, Inc. , 38 F. 3d 551 , 556-57 (Fed. Gir. 1994).\nThose authorities, however, do not support the proposition for which Bristol- Myers cites\nthem. The cases deal only with the issue of priority, and not with PTO procedure for\nexamining a continuation application in light of its parent. Likewise , the cited MPEP\n\n\x0c, application\n\nwas different from, and inconsistent with, the 1973 restriction requirement.\n\nThe 1977 restriction requirement, unlike the 1973 restriction requirement ,\n\ngrouped\n\ncompounds together with methods of use and compositions in at least two of the four\ninvention groups, while the 1973 restriction requirement directed that compounds be\nsegregated from methods of use and compositions. Moreover, the examiner examined\n\nthe method of use and composition claims "for subject matter of (the elected groups)\nreadable on the elected species "\n\nas reflected in the subsequent office action.\n\nThis\n\nsuggests that the applicant could have complied with the 1977 restriction requirement in\n\na way that would have been contrary to the categories set forth in the 1973 restriction\n\nrequirement:\' By imposition of a new and\' different restriction requirement and failng to\nmake any reference to the restriction requirements imposed in\n\nconnection with the\n\nparent application , the examiner made clear that the previous restriction requirements\ndid not carry over to the \' 955 application.\n\nBristol- Myers argues that the examiner in effect adopted the 1973 restriction\n\nrequirement ,in the course of the prosecution of the \' 955 application. Bristol- Myers\nsuggests that the four-way\n\nrestriction requirement of 1977 incorporated the two-way\n\nrestriction requirement of 1973\n\nand thus resulted in a\n\nrequirement, part explicit and part implicit.\n\nsix- or eight-way restriction\n\nThere is no indication in the record,\n\nhowever, that the PTO intended one of the two restriction requirements imposed on the\n\n989 application to carry forward to the \' 955 application , but not the other. Moreover\n\nthe record does not indicate that the applicant proceeded under the assumption that the\n1973 restriction requirement continued\n\nin\n\neffect.\n\nDuring prosecution of the\n\n\'706\n\nsection does not address PTO procedure for examining a continuation , but merely sets\n\n\x0cdivisional application, when a restriction requirement similar to the 1973 requirement\n\nappeared in conjunction\n\nwith a\n\nrestriction requirement similar to the 1977 r striction\n\nrequirement , the applicant noted that the two requirements were "somewhat in conflict"\nand that " any invention elected in accordance with the requirements (of the first) would\n\nnecessarily involve election of one or more of the groups set forth (in the second).\n\nThere was, to say the least, some confusion at various points as to how the\nvarious claims should be sorted out for purposes of restriction. But even though at\n\nsome points restriction requirements were imposed that were similar to, or even\nidentical to, earlier restriction\n\nrequirements, each requirement was nevertheless\n\n. separately imposed with respect to each separate application.. The record thus does\nnot support the inference that any of the various restriction requirements automatically\ncarried forward, in part or in whole, from one application\n\nto the next.\n\nFor that reason\n\nwe cannot sustain the district court\' s summary judgment order, which was based on the\ncourt\' s conclusion that the 1973 restriction requirement continued in effect with respect\n\nto the continuation application that was filed in 1977. Accordingly, we reverse\n\nthe\n\ndistrict court\' s judgment and remand for further proceedings.\n\nforth the requirements of a continuation application.\ninting to the examiner s statement, in an office action on the \'706 divisional\napplication, that restriction " has been required" between three categories of inventions,\nBristol- Myers argues that the statement indicates the examiner considered that at least\n\nsome of the restriction requirements from previous applications continued to apply to\nthe later applications. We do not agree with Bristol- Myers \' conclusion in that regard.\nThe examiner s isolated use of the present perfect tense,in\na sufficient basis from which to infer that the examiner\n\nthe 1978 .office\n\naction is not\n\nunderstood , or intended to\n\nconvey, that a restriction requirement imposed five years earlier , in connection with a\ngrandparent application , continued to be in effect for all applications related to the\noriginal \' 989 application because it was never formally withdrawn.\n\n\x0cIn light of the complexity of the factual record in this case, we go no further than\nto address the ground on which the district court ruled. Whether further analysis of the\n\nsequence of applications, restriction requirements , and responses\n\nby the\n\napplicants\n\nmay reveal other grounds for concluding that the protection of section 121 should be\nextended to some or all of the claims of the \' 927 patent is a matter for the district court\nto address in the first instance.\nVACATED and REMANDED.\n\n\x0cUnited States Court of Appeals for the Federal Circuit\n03- 1077\n\nBRISTOL- MYERS SQUIBB COMPANY\nPlaintiff-Appellee,\n\nand\nRESEARCH CORPORATION TECHNOLOGIES, INC.,\nPlaintiff-Appellee,\n\nPHARMACHEMIE: B.\n\nDefendant-Appellant.\n\nCircuit JudQe , dissenting.\n\nNEWMAN,\n\nMy colleagues have peered\nplucked out a\n\ndeep. into the recesses of patent examination\n\nroutine and unreviewable\n\nadministrative procedure -- the " restriction\n\nrequirement" for faciltating examination of , complex cases -- and created\nstandard of\n\na\n\nnew\n\nadministrative review and a new ground of patent invalidity. I must\n\nrespectfully, dissent.\n\nWhether or not the patent applicant here in suit was given proper or consistent\nrestriction requirements by the various examiners,\n\nthe issuance of these\n\nactions was\n\nentirely discretionary with the Commissioner. When the examiners accepted the\n\n03- 1077\n\n\x0capplicantl s elections and the divisional applications filed in compliance therewith, these\nactions are not rulings of law; they are discretionary actions reviewable , if at all, under\n\nthe strictures of the Administrative Procedure Act. It is not disputed that the applicant\nmade the required election for each restriction requirement, and that the divisional and\ncontinuing applications at issue were accepted by the examiner as properly filed. The\n\ndistrict court reviewed these procedures and found that 35 U.\n\nC.\n\n121 protected the\n\npatentee from citation of the earlier patent against the later one:\n35 U.\n\nC.\n\n121. .\n\n. A patent issuing on an application\n\nwith\n\nrespect to which a requirement for restriction under this section has been\nmade, or on an application filed as a result of such a requirement, shall\nnot be used as a reference either in the Patent and Trademark Office or\ntht3 courts against a, divisiona i application or against . the original\napplication or any patent issued on either of them.\n\nThus the district court held that under 35 U.\n\nC.\n\n121 the patent at issue was not an\n\navailable reference.\n\nIf my colleagues on this panel now intend to require that the minutiae of the\nvarious discretionary restriction requirements and the acceptance by the examiners of\nthe applicant\' s\n\ncompliances with those requirements are subject to appellate review , the\n\nstandard of review is that of the Administrative\n\nProcedure Act, not the\n\nde novo\n\nuntangling of internal procedures for which my colleagues remand to the district court.\nSee Dickinson v. Zurko , 527 U. S. 150 (1999).\n\nThe majority opinion , in its footnote 1, misperceives my concern. The\n\nissue is not the standard\n\nof review of the agency s findings of substantive fact\n\nholding that li the PTO is an l agency\' subject to the APA\'\nconstraints, Zurko , 527 U. S. at 1819 , the Court required that matters of agency\nprocedure (such as whether a restriction requirement must be repeated) are delegated\nto the agency. The APA assigns such procedures, which have no substantive impact,\nto internal agency management; the panel majority distorts the administrative process\ndetermining patentabilty. In\n\n03- 1077\n\n\x0cRestriction Requirements are not Appealable within the PTO\n\nThe PTO has myriad procedures to guide and faciltate the conduct of patent\nexamination.\n\nRules of operation are essential to the\n\neffective performance of a\n\ncomplex agency with many employees and an enormous volume of work.\n\nThe PTOl\n\npatent examination procedures fill a three- inch thick Manual of fine print. In addition\n\nPTO regulations fill Volume 37 of the Code of Federal Regulations.\nscientists and engineers apply these procedures\n\nto the most\n\nOver 3500\n\nadvanced science and\n\ntechnology of the age.\n\nEarly in the evolution of patent examination the Patent Office adopted the\nrestricti6i1" practice , to , simplify the \' search , and examination of complex\n\ndiscretionarY\n\ninventions. In electing to require " restriction " the patent examiner requires the applicant\n\nto select a specified aspect of the claimed subject matter , the examiner having first\ndivided the subject matter into groups of cJaims\n\nbased on classification for search\n\npurposes. The applicant then selects the aspect to be examined , and usually also\ntraverses\n\nthe requirement\n\n, a formality grounded in administrative protocols.\n\nExamination then proceeds as to the selected subject\n\nmatter.\n\nThe non-selected\n\naspects are then removed from consideration in that case; they may be rejoined or they\n\nmay be moved into one or more divisional applications for examination. Lest the first\n\npatent be citable as prior art against a divisional application -- an ilogical event that\nin holding that the agency s\n\npractices in complex cases receive\n\n. judicial review and management.\nexamining\n\nplenary\n\nIn 2002 the PTO received 333 688 new patent applications and granted\n162\n\n221 patents.\n\nAccountabiliy\n\nSee 2002 United States Patent & Trademark Offce Performance &\nRep. at 15. The average pendency was twenty-four months id. , and\n\nhundreds of thousands of applications are under examination at any given time.\n\n03- 1077\n\n\x0c121.\n\napparently had occurred -- the 1952 Patent Act precluded this event by enacting\n\nThus the patentee was shielded from this unintended substantive consequence of an\n\nexamination procedural\n\nconvenience.\n\nSemiconductor Materials America. Inc. ,\n\nIn\n\nApplied Materials. Inc.\n\n98 F, 3d 1563\n\nv. Advanced\n\n(Fed. Cir. 1996) this\n\ncourt\n\nexplained:\n\nThe\n\n121 is\n\nto accommodate administrative\nconvenience and to protect the patentee from technical flaws based on\nthis unappealable examination practice. . .. Section 121, viewed overall,\nassures that the technicalities of restriction practice are not elevated from\npurpose of\n\ntheir purpose of examination\n\nconvenience to a\n\npotential taint on the\n\nvalidity of the ensuing patents.\nkl at 1568.\n\nIn the present\n\ncase,\n\nfour different examiners imposed somewhat variant\n\nrestriction requirements, reflecting their divergent views of how the\nshould be divided ,for\n\nsubject matter\n\nsearch and examination. Some examiners grouped all of the\n\nplatinum compounds together and all of the\n\ncancer-treatment\n\nuses together; another\n\nput the compositions with the compounds, another with the uses; another separated the\n\ndifferent kinds of platinum compounds; another included the corresponding composition\n\nand use claims with each type of platinum compound. Some required an election of\nspecies; some did not.\nTo each examiner\n\nrestriction requirement, the applicant made the requisite\n\nelection from among the examiner s categories, while duly " traversing " the requirement.\nNone of the examiners objected to the applicant\' s compliance with any of the restriction\n\nrequirements. None rejected a later filed application on an earlier on.e. None of these\nactions is appealable to the Board of Appeals or the courts. The Court of Customs and\n\nPatent Appeals explained\n\n03- 1077\n\nthat a\n\nrestriction decision is not an actual rejection on\n\n\x0cgrounds of patentabilty, but simply a procedural requirement. The court explained in\nre Henaehold , 440 F. 2d 1395 , 1399 (CCPA 1971):\n\nOn considering 99121 , 132 and 134 and the intent unmistakably\n\nevinced\n\nby the clear language therein , it is evident to us that Congress. . . decided\nnot to regard the procedure involved in matters of " division " or " restriction\nas a " rejection. Instead, section 121 denominates restriction procedure\nIt is apparent, then , that Congress intended to\nas a " requirement." .\ndifferentiate between whatever requirements and objections an examiner\nmight make on the one hand ,\n\nand matters involving actual rejections of\ninsofar\nas its provision of statutory rights of\nclaims on the other, at least\nappeal to the board accruing from such actions in and of themselves.\n440 F. 2d at 1402- 03 (citations\n\nrequirements "\nnature.\n\nld.\n\nomitted). Restriction requirements are like other PTO\n\nthat are " matters of a\n\ndiscretionary, procedural or nonsubstantive\n\nSee also Inre Harnisch , 631 F. 2d 716 (CCPA1980):\n\nat 1403.\n\nIn the PTO, patent applications are examined for compliance with the\nstatutory provisions of Title 35, United States Code, as set forth in\nsections 100, 101 , 102, 103, and 112. These are considered to be\nexaminations " on the merits. " There are also procedural questions arising\nunder section 121 and related PTO rules concerned with " restriction\npractice. "\n!! at 721.\n\nThe only remedy available to an applicant who is dissatisfied with the restriction\nrequirement is a petition to the Director for review:\n37 C.\n\nR. 91.\n\n144. After a final requirement for restriction , the applicant\n\nin addition to making any reply due on the remainder of the action, may\npetition the Director to review the requirement. Petition may be deferred\nuntil after final action- on or allowance of claims to the invention elected\nbut must be filed not later than appeal. , A petition wil not be considered if\nreconsideration of the requirement was not requested (see 91. 181).\nSuch a procedure implements\nactions.\n\nSee generallv\n\nS. 144 , 151\n\n03- 1077\n\nstandard administrative practice relative to agency\n\n.Mn v. Occupa\n\netv & Health Review Comm , 499\n\n(1991) (" Because applying an agency\n\nregulation to\n\ncomplex or\n\n\x0cchanging circumstances, calls upon the agency s unique expertise and policymaking\nprerogatives , we presume that the power authoritatively to interpret its own regulations\nis a component of the agency s delegated lawmaking powers. "\n\n,. Indeed, should there be any imperfections in the agency s\napplications of the regulations with respect to the\n\ncompliance by the applicant, they are not grounds of invalidity.\n\ninterpretations or\n\nexaminer\'s theory of restriction or\nSee Maanivision. Inc. v.\n\nBonneau Co. , 115 F. 3d 956 (Fed. Cir. 1997):\n\nProcedural lapses during examination, should they occur, do not provide\ngrounds of invalidity. Absent proof of inequitable conduct, the examiner\n\nwith the internal rules of patent\nexamination becomes irrelevant after the patent has issued.\n\nor the applicantl s absolute compliance\n\nk! at 960. Such\n\ninternal agency procedures are not judicially reviewable.\n\nSee Hvatt v.\n\nBoone , 146 F. 3d 1348 (Fed. Cir. 1998):\n\nroutine administrative procedures is presumed , and\ndeparture therefrom, should such have occurred, is not grounds of\nRegularity of\n\ncollateral attack. Courts should not readily intervene in the day-to- day\noperations of an administrative agency, especially when the agency\npractice is in straightforward implementation of the statute.\nId. at 1355- 56.\n\nThe presumption\n\nof\n\nvalidity would collapse if the PTOl s\n\nadministration of the\n\nrestriction protocols could be turned into satellte litigation of patent-destroying\nconsequence. In\n\nAmerican Hoist & Derrick Co. V. Sowa & Sons. Inc. , 725 F. 2d\n\n(Fed. Cir. 1984) the court referred to\nthe deference that is due to a qualified government agency presumed to\nhave properly done its job, which includes one or more (patent) examiners\nwho are assumed to have some expertise in interpreting the references\n\nand to be familiar\n\nfrom their work with the level of skil in the art and\n\nwhose duty it is to issue only valid patents.\nk! at 1359.\n\n03- 1077\n\n1350\n\n\x0cRestriction is a Discretionary Requirement\n\nNo statute defines\nauthorization of 35 U.\n\nthe parameters of the examiner\n\nC. 9121, for the subject and scope of this discretion is unrelated\n\nIn re Henaehold\n\nto patentabilty. In\n\ndiscretion beyond the\n\nthe court explained:\n\nThere are a host of various kinds of decisions an examiner makes in the\nexamination proceeding -- mostly matters of a discretionary, procedural or\nnonsubstantive nature -- which have not been and are not now appealable\nto the board or to this court. . . (A) requirement for restriction under\n9121 is now one of those discretionary matters no longer tantamount to a\nrejection of the claims, . . .\n440 F. 2d\n\nat 1339.\n\nThe entrusting of discretionarx agency pr cedures , o agency management is a\n\nclassical administrative practice, requiring\n\njudicial restraint.\n\nSee Vermont Yankee\n\nNuclear Power Corp. v. Natural Res. Def. Council, Inc. , 435 U. S. 519 (1978):\n\n(T)his Court has for more than four decades emphasized that the\n\nformulation o(procedures was basically to be left within the discretion of\nthe agencies to which Congress had confided the responsibilty for\n\nsubstantive judgments.\nId.\n\nat 524.\n\nIn\n\nCitizens to Preserve Overton Park. Inc. v. Volpe , 401 U. S. 402, 410\n\n(1971) the Court ,\n\ninterpreting the Administrative Procedure Act , stated that internal\n\nagency actions are not reviewable if either (1) Congress expressed an intent to prohibit\njudicial review , or (2) the decision is " committed to agency discretion.\'1\nUndoubtedly\' the procedures\n\ncomplex.\n\nsurrounding restriction requirements can be\n\nAn entire Chapter of the Manual of Patenting Examining Procedure , is\n\ndevoted to it. 3\n\nBy statute it is\n\ndiscretionary, for\n\nits purpose is\n\nadministrative\n\nA commentator experienced in the field states: " Many patent examiners\nand patent practitioners are confused by restriction practice and unity of invention\npractice in the (USPTO)." Jon W.\nSome Comments on " Independent and\nHenry,\n\n03- 1077\n\n\x0cconvenience ,\n\nnot\n\npitfalls in substantive validity. The fact that four examiners made\n\nsomewhat inconsistent requirements\n\nfor\n\nrestriction does not change the controllng\n\nweight of the examiners \' steady determination of the applicant\' s compliance with their\n\nrequirements. A discretionary action having no substantive consequence and that is\nunreviewable is not a ground of patent invalidity, and is not subject to collateral attack.\n\nRemand is Inappropriate\nThe panel majority orders the district court to repeat its review of the restriction\n\nprocess , to search for flaws in the procedure, for my colleagues find it too complex for\ntheir appellate decipherment. A complex agency record is not sound reason to discard\nthe required agency deference , or to ask the district court to repeat what the court has\n\nalready done and ruled upon.\n\nWhatever the continuing\n\nforce of the\n\npre-Zurko\n\nconsonance " cases, on which the majority relies, in this case the patents at issue were\nthe product of restriction requirements in which the examiners accepted the applicant\'\n\nelections and the ensuing divisional applications. The courts lack authority to invalidate\n\n(2002).\n\nDistinct" Inventions of 35 U. C. \' 121 and Unity\nTrademark Off. Soc y 745, 748\n\nof Invention\n\n(pt. 1), 84 J. Pat.\n\nThe majority states by footnote that precedent requires de novo review of\n\ncontinuating and divisional applications, but also of the\ncorrectness of the examiner s issuance of restriction requirements and the examiner\nacceptance of the applicantl s response to restriction requirements. That is an inapt\nenlargement of precedent , indeed the case on which the majority relies Geneva\nPharmaceuticals, Inc. v. GlaxoSmithKline. PLC , 349 F. 3d 1373 (Fed. Cir. 2003), states\nthat " requirements for restriction under 35 U. C. 121 are discretionary with the\nCommissioner. " 19 at 1378 quoting MPEP \' 803. 01. The Manual of Patent Examining\nProcedure abjures the examiners to exercise care in making restriction requirements,\nid" but neither the MPEP nor any judicial decision removes the discretion of the\nnot only the lineage of\n\nDirector, formerly termed the Commissioner , nor carves out an exception for restriction\nrequirements into APA review of discretionary actions.\n\n03- 1077\n\n\x0cthe patent on the basis of an asserted flaw in a discretionary procedure, here proposed\n\nafter sixteen years. That these restriction requirements were varied ahd somewhat\ninconsistent cannot now penalize the patentee , who complied with them and whose\n\ncompliance was accepted by all of the examiners involved\n\nSee\n\nin the examination.\n\nNorthern Telecom. Inc. v. Datapoint CorP. , 908 F. 2d 931, 938 (Fed. Cir. 1990) (" rA)ny\n121) does not increase the\n\ndoubt as to whether the examiner lapsed in his duty (under\n\nburden on the applicant. "\n\nThe sequence of restriction requirements was presented to the district court , who\n\ndecided the question. It cannot be correct that when the examiner found no flaw in this\nnon-substantive non- appealable procedure, the\n\ncourts can later conduct a de novo\n\nsearch for some tenuous lapse, and invalidate any patent for which we disagree with\n\nthe agency\n\ns discretionary decision. In\n\nCorp. , 318 U. S.\n\nSecurities & ExchanQe Commission v. Chenerv\n\n80 (1943), the Court discussed such discretionary\n\nadministrative\n\nauthority:\n\nIf the action rests upon an administrative determination -- an exercise of\njudgment in an area which Congress has entrusted to the agency -- of\ncourse it must not be set aside because the reviewing court might have\nmade a different determination were it empowered to do so. But if the\naction is based upon a determination of law as to which the reviewing\nauthority of the courts does come into play, an order may not stand if the\nagency has misconceived the law.\n1! at 94.\n\nCompliance with a restriction requirement is an "exercise of judgment, id. , and is\nentrusted to the\n\nDirector. Each examiner in the case before us determined that the\n\napplicant had complied with the requirement that was imposed.\n\n03- 1077\n\nThe question of\n\n\x0crestriction, its correctness and its compliance, cannot now be collaterally attacked as\ngrounds of patent invalidity. The district court\' s decision should be affrmed.\n\n03- 1077\n\n\x0cAttachment Number 5\n\nREDACTED\n\n\x0cFITZPATRICK. CELLA.\n\nVED\n\nHAER &\n\n30 ROCKEFBLLER PLA\nNBW YORK. NY 1 0 112-o38oaOG APR -6 AM 10:\n\n212-218-2100\n\nJIACSIMILE (212) 218-ZC!OO\n\nWASHINGTON OFFICE\n1900 II MRet. H.\nWAIHltiOTON, O. C. 20011\n\nWW. FITZPATftICKCELLA. COM\n\nUS COURT OF AP\nFEOE RA L\n\nR.Ui.. OFFICE\n\n.cC.;r\nMI! CAUFDIIIA 82818-71:10\nNTEIt DRIVe, SUITE UIOO\n\nCOSTA\n\n(202) &30-1010\n"""SIMILe ( 2) Bao-,O.,.,\n\n(714)\n\nROBERT L 8AECHTOLO\n\n..ACINIUI (7\'41\n\nDIREC DIA C2\'21211WU!13\n\nE-AIL\n\nApril 8 , 2004\n\nVI BA\n\nDELIVRY\n\nThe Honorable Jan Horably\nClerk of the Cour\nu.s. Cour of Appea for the Federa Circuit\n717 Madson Pl., N. W.\n\nRoom 401\nWashington, D. C. 20439\nRe:\n\nBristol-Myers Sqwob Company, et a1.\nv. Phaachemie B.\nAppea No. 03- 1077\n\nDea Mr. Hambly:\n\nBecause there is a pending Motion For Reheag\n\nEn Ban\n\nin the above\n\nappeal I am Wrtig on behaf of all paries to inform the Cour tht the pares have an\nagreement in priciple for reolving the litigation. The pares will submit a Stipulon\n\ndiming the case ealy next week for the Cour\' s approval.\n\nResectfly submitted ,\n\n;tr\nRober L. Baechtold\n\ncc:\n\nDavid T. Pritik ,\n\nEsq.\n\nFracis C. Lynch, Esq.\n\nAMagm\nDC3.tIN 162717,,1\n\n8700\n\n&423\n\n\x0c'