GEORGE ... GILLESPIE, m

THOMAS R. BROME

ROBERT D. .JOFFE

ALLEN FINKELSON

RONALD S. ROLF

PAUL C. SAUNDERS

DDUGLA D. BROADATER AL C. STEPHENSON

MA R. SHULMAN

STUAR W. GOLD

.JOHN W. WHITE

.JOHN E. BEERBOWER

EVAN R. CHESLER

PATRICIA GEOGHEGAN

D. COLLIER KIRKHAM

MICHAL L. SCHLER

KRIS F. HEINZLMAN

B. ROBBINS KIESUNG

ROGER D. TURNER

PHIUP A. GELSN

RORY o. MILLON

NEIL P. WESTREICH

CRAVATH SWAINE & MOORE LLP

FRCIS P. BARRON

RICHAD W. CLARY

WILLIA P. ROERS, ..R.

.JAMES D. COOPER

STEPHEN L GORDON

DANIEL L MOSLE

GREGORY M. SHAW

PETR S. WILSON

.JAMES C. VARDELL, m

ROBERT H. BAON

KEVN .J. GREHA

W. CLAYTON .JOHNSON

STPHEN S. MAEN

C. ALN PARR

MA S. ROENBERG

WILUAM B. BRANAN LES R. STEINBERG

SUSAN WEBSR

TIMOTHV G. 

DAVID MERCO

ROWAN D. WILSON

.JOHN T. GAFNEY

WORLDWIDE PLAZA

825 EIGHTH AVENUE

NEW YORK, NY 10019-7475

PET T. BABUR

SADRA C. GOLDSTEIN

PAUL MICHALKI

THOMA Go RAFERT

MICHA S. GOLDMAN

RICHAD ELBET L. GRAVER

.JUUE A. NORT

STPHEN L. BURNS

KATHERINE B. FORRES

KEITH R. HUMMEL

DAIEL SUFKIN

.JEFFR A. SMITH

ROBERT I. TOWNSEND, m

WILLM .J- WHEL, m

SCOTT A. BAHAV

PHIUP.J. BOECMA ,

ROGER G. BROOKS

WlLU V. FOGG

FAiZA .J. SAED

RICHAD .J. STARK

THOMA E. DUNN

JUUE T. SPELLMAN

RONAL CAI

MAK I. GREENE

SAKIS .JEBE.IA

.JES C. WOOLE

DAVID R. MAIOTT

MICHAL A. PASKIN

ANDRE.J. Pins

MICHA T. REOLD

ANONY L. RYAN

GEORGE E. ZOBIT'

GEORGE A. STPHAIS

SPECIA COUNSEL

SAMUEL C. BUTLR

THOMAS D. BAR

OF COUNSEL

ROBERT ROSENMAN

CHRISTINE BESHA

CONFENTIA TREATMNT REQUESTED

April 12, 2004

Pursuat to Section XII, subsection (2) of the Decision and Order dated

April 14, 2003 and 16 C. R. , Bristol-Myers Squibb Company ("BMS") submits

the enclosed agreement for the FTC's review. BMS requests that the FTC issue an

advisory opinon fiding that the agreement does not raise issues under Section 5 of the

Federal Trade Commssion Act.

TELEPHONE: (212) 474-1000

FACSIMILE: (212) 474-3700

CnYOINT

ONE RDPEMAKER STEET

LONDON Eca 9HR

TELEPHONE: 44-207-453-1000

FACSIMILE: 44-207-860-1150

WRITER S DIRECT DIAL NUMBER

(212) 474- 1564

Carboplati

Dear Mr. Clark:

The agreeent, between BMS and Teva Pharaceuticas USA, Inc.

'Teva ) wil resolve an ANA patent litigation conceg the drg Carboplati and

S. Patent No. 4 657 927 (the "' 927 patent"). BMS and Reseach Corporation

Technologies ("RCT") prevailed in the distrct cour, where ingement and

enforceabilty were conceded and swnar judgment of no invaldity was entered. The

Federal Circuit, in a 2-1 decision, vacated that judgment and diected that the cae be

remanded to the distrct cour for fuer proceeings. BMS and RCT filed a motion for

rehearg en bane, and the Federal Circuit is not expected to rue on that motion. The

927 patent is due to expire on April 14, 2004. However, BMS has filed with the FDA

for pedatrc exclusivity, based on havig conducted a pediatrc clincal tral, as requested

by the FDA. If granted by the FDA, the pediatrc exclusivity would result in a fuer six

months of exclusivity for BMS.

BMS and Teva have agreed, subject to regulatory review, to settle their

dispute on the tenns set fort in the enclosed agreement. In substance, the agreement

provides that the litigation wil be dismissed and, if regulatory approval is granted, Teva

CONFIDENTIAL
will distrbute an unbraded, generc verion ofBMS' s product as of June 24 2004, well

before the six-month pedatrc exclusivity would expire.

We repectfy submit tht ths agreeent is both pro-competive and

fuy consistet with the spirt of Section xn of the Decsion and Order. We therefore

request a favorable detertion ftom the FTC.

To aid the FTC's evaluation of ths request, I am enclosing the followig

materals:

S. Patent No. 4 657,927;

Memorandum Opinon and Order Bristol-Mver Squibb Company

and Reseach Corporation Technologies. Inc. v. Pharacheme

B.V.. A. No. 01-3751 (MLC) (D. J. July 29, 2002);

Final Judgment Bristol-Myers Squibb Company and Reseach

Corporation Technologies. Inc. v. Pharacheme B.V.. A. No.

01-3751 (MC).(D. J. Oct. 22, 2002); 

Decision, Bristol-Mvers Squibb Company and Research

Corporation Technologies. Inc. v. Pharacheme B.V., Appeal No.

03-1077 (Fed. Cir. Mar. 17, 2004);

Carboplati for Injection Distrbution and Agreement (April 8, 2004);

Letter ITom Robert L. Baechtold to Clerk of U.S. Cour of Appeals

for the Federal Circuit (April 8, 2004).

As time is of the essence, we respectfly request expedted treatment of

ths request. The FTC's response is requested as soon as possible and before June 10,

2004. Due to the tie-sensitive natue of ths agreement, its implementation will not be

possible without such expedited review.

Confidential treatment of this letter and the enclosed materials is

respectfully requested.

CONFIDENTIAL
If you have any questions, pleae do not hesitate to ca me at the number

above.

Than you in advance for your consideration and assistace.

Resectfy,

a;J 

Richard J. Stak

Donald Clark, Seceta

Federal Trade Commssion

th Street and Pennylvana Avenue, N.

Washigton, DC 20580

EncIs.

BY FEDERA EXPRESS

Copy wi Encls. to:

Ane Schenof, Esq.

Bureau. of Competition

Federal Trade Commssion

601 New Jersey Avenue, N.

Washigton, DC 20580

BY FEDERAL EXPRESS

CONFIDENTIA
"" e 

. 

United States ,Patent (19)

Cleae et ale

(11) Patent Num

(45) Date of Patent:

657,927

Apr. 14, 1987

(54) MANATO PLATI COMPOUNS

(75) Inventors: Mich J. Clea James D. . Hoeel Batt Rosenbe

Lore Van Cap, aU of Bat Lag. Mich.

(73) Asgnee: Re Y. CorptiOD, New Yark

(21) AppL No.: 497,806

(22) Filed: ' Ma 25, 1983

Relted U.s. AppUc:tiOD Data

(62) Divion orSer. No. 902,706, May 4, 1978, abandoned.

(51) Int. CJ4 .......................................... A61K 31/28

(52) U.s. CL .................................................. 514/492

(58) Fid of Sech ........................ 424/287; 514/492

Prma Exminer-Jerome D. Goldrg

Attomey Agent, or Firm-Sculy, Scott Murhy & Pres (S? ABCI

Maonto plaum cotion compunds an a

method of treag magnt tuors see to a plna ds pltium (D codition copound or an oced d2s3 platium (I cordtion compound compri the paente adon to an afecte an of a solution of the compound. 

Cl No Drwi
,

, .

num(I fors d2s3 coordtion compounds which

have an octaed argement in 

. The cooron compounds of the invention inTh is a Diviona, of Application Ser. No. 902, elude th ci and tr iser of pIa um(l and pIatfied .May 4, 1978, abanoned num(I which cota the bidentate maonat ligad

which may be substute or UDUbstu The BACKGROUN OF TH INON maonato ligad may cota substituents seecte from

The present invention relates to novel maonato plati- the grup constig oflowe all, (e.g., methyl, etyl.

num coordition compounds and to thei us in cacer n-propyl, ispropyl. n-butyl, etc.); arl, (e.g., phenyl; chemotherpy. 10 lower all-, lower alyl-, hao-, ni, lower aloxysubsttu phenyl and nahthyl); arykyl, (e.g. phe- SUMY OF TH INON nylethyl(bl), 2-(I-nhtyl)metyl); alyl,

The invention provides platium CQrdintion com- (e.g" 4-o-I-bute, alyl) cycloal, (e.g., cyclopounds havig the formul: propyl, cyclohexl, etc.); cycloaJyl, (e.g., 2-ccloIS pente- yl, 2-cyclohexen-I-yl); atxy, (e.g., meoxy,

ethoxy, et.), an hydrox. Al suible ar the 1.- cycloaylenedca1i acds, (e.g" 1,I-cyclopropaedcaboxylic acd, l,l-cyclobutaedcaboxylic

aci, etc) and the l,l-cycloayldicaboxylic acds

20 (e.g., 1,1-cyclopropeedcaxylic acid, 1, wherein: cyclobutenedicaxylic acd, etc) 

The cordtion compounds of the invention x= 1 or 2; conta two monodenta amoni or pri or heter- y= 1 or 2: ocyclic ame lids i.e., when x in th abve formul

z=O, 1 or 2, provide tht when,y=2. z=O and when 2S is 2 or one bidentate ame liuid" i.e., when x is 1.

y= 1. z is greate th 0; e monodentateame ligands incl e lower

, Rand RI are selected from the group constig onl, , alyl am (e.g., Jiethyl-, etyl-, n-propyI-, ISpropyllower alyl, arl. arl, alenyl, cycloal, cy- , n- l-aes etc), arl es, (e.g., ane), amcloalyl, aloxy, OH, or are combined with the' kyl. ames (e.g., bel;e), hydro lower all

cabon atom'to form a cycloayl or cycloalkenyl 30 ames (

g., 

etholae, 8D1ae, etc), hygroup, and substitUted dervaties thereof; xylae, lower alox~l ames (e.g., metoxylawhen x= 1, A is HRzN-CHR3-CHR- sH and JIe, etc.), xyl es (e.g., methox~ethylawhen x 2, A i! H:z a heteocyclic ame or an II etc.), and h:teocycli anes (e. ., pyn me 

amo acid, wherei R2, R3, R4and Rsare the sae azdi). Alo mcl ed ar the o acds, Le.,

or diert and are seected from the group con- 35 R7-cZ-COOH wherem R7 IS H, lower all

sig fH, CIl, C:zs, hydrxy and lower aloxy (e.g., metyl, ispropyl, etc.), hydrxy lower alyl (e.g.,

provided tht R2 and Rs may also be arl or ar- hydroxyethyl, hydroxyethyl, etc.

), 

aryl (e.g., bekyl, an eab Rs is the sae or dierent and is zyl, e,tc.

). 

selec frm ,the group consistig of H, lower It IS, to be l'oo tht. the cor tio coml h er l h d I 40 poundS of the 

mvention may mclude two Identica or

, .

' ow

y 

oxy dierent monoentate liga xyl ames aloxyJalaes where,a1 ' Sutale bidentate am ligads include th sutiS8d l gro ps low alls d ,heterocy- tute an UDubs. pr and seda clic subst ts cludg S8 . a nng member ethylenedes. One or both of the cabon atoms of when z= 1, L !5 a bldentate amom d, and 45 the ethylenede may Co substDents such as when. z=2, .L IS a monodentate amomc li d. lower all (e.g., methyl, etyl), hydrxyl, aloxy (e.g.,

Th mvention . also ate to a co on' and methox, ethoxy, et). Sec etylenes

method for g ma ors setive to a where one or more of the ame grup co sub- pla dsp2 plaum(l coordtion copoun or sttuts suh as1i abve for the ca ato of the

ed dZs tium(I codi mpoun 50 pr ame and arl (e.g., phenyl) mid arl (, e.g,

m .an com g paent adg to. an bel) may also be uti

an 

ected such a t tuor a solution The Pt(l cordion compounds sped her conta a p um cord n C?mpound as' de- do not ex as geometr iser; however, the fied hereiove m an amount s1iClent to cause re- Pt(I coPQunds ex as ci an tr isme It is to

greson of the tuor. S5 be fuer underoo tht the inventin is inlusve of

DETAIED DESCRON OF TH th cis an tr is INNTION The Pt cordaton compounds may al conta two monodentate or one bidentate anonc liga

latium ~ordiation pounds and metod for where ony on maonato ligad is pret, i.e., wher

thCU proucon are descnbe by J. C. Bai, Jr., The 60 y=1 in the abve forul Chemi of the CordlUtin Compond Reiold SJble monodentate anonic ligas include chloPublig Co., N.Y., 1956, Chap. 2; J: Lewi et al, ride, bromde, iode, nitrte, hydroXde, nitrte su- MOt Cordnaton Chemistr: Prcip1e and Method mae, etc. Among the bidentate anonic ligads which

Inteience Publier, Inc., N.Y., 1960 and Kaufan may be prest are oxate pyrophosphate ditboxaInorgan Synthes Y., 1963. 7, McGrw-Hi Book Co., Inc., 65 late

It is to be unertoo tht the invention includes

Platium(l forms dsp2 coordition compounds those cordition compounds contag mied monowhich have a liquie pla argement in space. Plati- denta anonic ligads

657,927

MAONATO PLATI COMPOUNS

(P1(D,.OOb-d

ci or tn(P(lA"(oo2-j)yLzI
..,

3' 657,927

The preferr compounds ar thos wherein R and Maonic acid (13 g-a twofold exce) was dilved

Rl in the above formula ar Ii methyl or ethyl, i.e., in wat (30 m1 and neutr with a soluton ofKOH

maonatoplatium methylmonatoplatium and ethyl- (- 13 g in 30 ml) to pH S-. The restig pota

malonap1aum cordaton compounds The most maouate soluton was added to the platium contag

prefer Pt(l compounds ar those maonato- 5 fitrte and the mitu wa cafuy wared (to avoid

platium(I compoun of the above formul wher "bumping ) on the hot pl unti whte cr of th

x;= 1 and R:z R3, R4and Rs ar eab H, Le., mana produc st to form in gr qu. Th thylenede platium(l, mety1monato wa then cooled to rom tepetu and ihe prouct

thylenedep1aum(l an ethy1m0nato fiteed off The fitrte was reeaed for 5-10 mite

thylenediAmineplaum(I and ,wher x=2 and eah 10 an cooled to O' C. to collec a fuer cr. The crde

R6 is Ii ie., maonatotiiAmmineplatium(I, methyl- yield at th st was 20.5 g (93%).

maonatodiAmmminepltium(l and ethyl- The prouct was rec by dilvig in boDmaonatodiAmmineplatium(I. ing or nea boilg wate. The above yield (20.5 g)

The prefered Pt compounds are those wherein reui about 3 lite of boilg wate for comple

x=2, eah R6 is H an y=2, ieo bisonato (or bisc- 15 diolution. Maonic acid gI was dilved in 

thylm0n (I. or bisylmonao) die platium- wate to suppres any hydrolys-. The fitered solution

wa coled to O. C. to give white nufy neees (18.25

The cordition compounds of the invention may be f,-83%).

preped by one of a vaty of wel-known methods A . U. vi iIll coducvity slWes have shown th hydrlys

gener method of prepaon of the Pt(I cordi- 20 neglgi 

tion compounds is as fonows: St compounds hav- The crytas decmpose be ee 5 - . Th

ing th formul ci(P a()iJ wherei Ha is I, CI or strtu o e prouct wa !enfi CIa an 1.r. ecDr an A is one bidentate or two monodenta ame tr. Solubilty of the roduct IS low m cold wate, I.e.,

ligads (preared by the method of S. C. Dha India 20 mg/l00 mls at 20. C. and

: Cbem., Vol. 8, p. 93 (1970)) ar reted wi siver 25 hi: mplOO O:s 37 C; b

(:O' I00' C )-0 65 g/100

mtrate to .for the diaquo. complex. Th latt !S 

. mi. 

er m nea 0 g wa r , .

recte WIth the maonate Ion to form the coordon

, 

Th ir . os' 

 

tied b el compoun. of the invention. Th method is repre- e. emp comp tion wa ven y emen

te b th 11 n

anysIS: sen y e 0 oWlg rection sc eme: 30 Maonatodi"mmineplatium(U(P(N3n(C31204))

cist ACI2I+ZAgN03+2H20)- Caculted for C3HaN204PC: 10.88; H: 2.43; N: 8.46: A(H20b)(N03n+ZAgC Pt 58.9. Found C: 10.67; H: 2.35; N: S4; Pt 58.

EXLE c:Pt A(H20)z(N03n+H2C-COO!21P

A(OOCJ2CH2I+2N03 +2H20

35 (Peu)(CI0.))(en = H2N(CHmNH:z

wher A is one bidentate ame ligand or two mono- C40;- = 02CCCHvodentae ame ligads.

The fonowing non-litig exples ar ilustratve Silver nitrte (3.64 g) was dilved in 20 ml of wate

of the methods for preparg the compounds of the and added to (P2)2(CH2bCL2J (3.5 g) supeed in invention. 40 wate (30 mI) in a coni flas The mitue was 

on a war hot pla for. 5-10 miute unti al the yellow platium complex ha dilved to give a yelow

liquor plus a copious white sive choride prepitte

The mire was fiteed thugh a fie pore fiter and

45 the preit wasbed tw with sm volum of hot

wate. The cl fitrte plus wags was adde to an

aqueo solution of methy1monc acd (2 g in 20 ml).

which ha bee adjuste to' pH 5-6; The mie wa

heate to about SO' C. for fie miute and then coled

50 to O' C. The shy whi cry which formed wer

fied and wased with cold wat an actone (Yied

(P3n(H20b)(N03) + ZACl 2.65 g). The mother liuor plus aqus wags wa

reduce to about ha its Drgi volume (-30 ml) to II 

yield a seond crop on cooli to O' C. (Yeld 85 

g).

55 Tota Cre yid wa 3.50 gm (88%). The colex

(P3)Z(CJHzo.)) + 2N03- + 210. wa reryli from a mium volume of boilg

water (around 250 ml) with fitrtion though a 

Silver nitrte (22.55 g-sghtly les th the stoicho- pore fite pror to coolig to O. C. Yield of shy white

metrc amount in order to avoid silver,contaon) leaets 2.96 g (74%).

was dilved in waer (50 mI) and added to 60 CacuiteforC612 1204PC:19.4IH3.26N:7.5S.

(P(N3)2C12J (20 g) in a 250 ml conica fl The Found C: 19.11 H 3.61 N: 7.89.

CCn ents were w ed (60. C?) on a te wi rapid A send crp (0.33 g-8%) wa obtaed by reducig stg unti the siver chlonde precpittion was com- the bul of the mother liquor.

plet and the mother liquor was alost colorles. 'Ie

siver choride wa fitere off usg a fie pore sintered 65

glas fiter and the preipitate was wased sever ties

with hot water to give a tota fitrte volume of 10020

EXALE 

MaonatoiAmm ep1aum(l

(P(N3n(C3HzO.))

Reactions: .

lP3nCI2I + ZAgN03 + 2H20)--

(P(N:!(H20)i!(N03n + CJH20.2- 

EXLE 

InJP IV(N3n(ma
657,927

Silver nite (5.45 g) dilved in watr (30 ml) of solvent. a fie dion was prear of the dose

an adde to U'S (P(N3nC4) (3 g) suended in neeed for the tet. Thus some of our tes rests were

(30 ml) contag conce nitrc acd (3 obtaed on an wher a slur of the compoun

. ml). The conte wer wared on a hot pla (70. -SOo. Was injecte. Tbes ar so note in Table I below. In

C.) an for at lea one hour. Th mie was S addition, for some of the copounds, ther wa injecte

fitered though a fie poe site gl fite to re- abut I ml of solutiou, either in one sigle injection or

move th siver chloride. Th precpitate wa waed in 2 injecons given a few hour ap of I ml eah.

twce with a sm volume of hot wa. The cl fi- Thes injections were intiy gi in 4 diert dos

trte plus wasgs was tete with a dr ofb 1M KCI level for eah neW compound with 6 mice in ea dos

solutons to dee if exce siver chorde was pre- 10 level. Th te cover, a doS rage frm a low ineCent. (I the te is poe, sufcient KCJ is added drop- fecve dos to an uppe dos level which prouce

wie the bul solutin unti no siver choride is pre- . some de with the tie peod of the experent. cipitate) Th soution was refte and the fitrte The reults ar set fort in Table I.

reuce to 2030 mJ in volume and cooled to O. C. to TABLE I yield ple yelow crsts (preumly tr 

(P3n(N03)4D. Thes wer waed with a litte. Tes of r Actvity (for Ie &0 a I! mr 

(Yeld (D cord copouad or aD oced d plum (I CO d wate and en actone . poron coiD copo ofMato an Sl1tolc MaonalO th yid (1 g) was diolved in a mium of hot wate ' CoiDli Coplce ofPIum 

to which soum nitrte (0.2 g) ha be added. Th Tumr-5 180 Ao.Fe Sw white 

soluton was fite into an aquens soluton of maonic 20 Sie inleons on daYS noted intrPCtoney

acid (0. g-a slght exce) which ha be adjuste to Cordon y o.f

pH 5-6 with sodium hydrxide. Whe nucrst of Compl IDJecn Dos 

the complex qucky form on colig. These were fi- Mllo,nod. 

tere off and wased with cold wate and actone. 

:) 

(II)

(Yield 0.7 g-30-%). Caculted 'Cor loN20sP C: 16.63 H 2.33 N: 6.47.

Found a 16.60 a 2,64 N: 6.80, '

GEN STUCT CONFORMTION

(soluliD in HI0) Th maonate group is shown to be 'cordiated to 30

the platium by the obsed cha in the elonic

spe on going from the aquo to the maonate spees. MeI 1m Thus, strtu such as (P(N3)2(H20)z2(H2C304)) ':': (I ar rued out conf the anytca da Simly, (SohniOD in HI0)

ze-tie conductivity meaents support a neutr 3S

compound. The Lr. spectra show the prece of coordiat caxyl grups (1601650 em and 140

cm-l) with no C02H grups (whih would show at

17001750 em). Finy the carboxyl grup vibrations

ar copab"ble wi a che1te strctu as compar to 

oxaate complexes of kno stes. O:':"Pla tium The compounds of the mv tion wer te for 

antituor actvity, i., for setivi to a pla ds plaum(I conitiou compound or an octaedra

d2s platium(I codition co und usg our stda scrg tuor, soli sa 180 tuor in maonl,2 feme Swi white mice, foUowig stdad protocols prpylea

for th teg as set by the Natona Cace Intute plum (D

(Cancer Chemthy Rep.. 2S (1962)). ,

For these te an S ISO tuor taen from a sariced SO :: min

mouse was dite free of supuous tiue and cut pla (D

under sterie COdion intO approxitey 10 mI- gr si piec Thes tie pice wer th im- melYIm

plated by tr il the lef ax leon, sutae- ';;1:; )um

ousy, in new mi The mice were, on the averge S5

approxitey four wee old an weied 18-20

gr Takg day 0' as th day of implat. th 

sace on y 10. The ors wee exciBld _1I weghed and the rati of the Weights of the tuors m (soloton in HI0)

mice in the trea to the cool set of an 

wa obtaed Th ratio, multilic; by 100, is given as

the TIC ratio in Table i. maonatoylene- For the fi set of tets the codition compound dialati (l

'wa freshly diolved in st ditied wate and in- (sotolion in HI0) jec intrperitoeay on day 1 iltO eah of the te 6S

mice Tbe volume of the iJection was usuay i ml. In

some ca in order to get an active dose into the anma wher the chem was not soluble in th amount

Daiy for

days 1-

10 

IS mglg

20 mgg

2S mgg 30 mgg

40 mgl

SO mslg

60 mg 

mgl 6 mgg 7 mglg 30 mglg 

40 mg 

SO mgg 

60 mgl 70 mgg 124

80 mglg

100

120

100

110

120

3D 

40 

SO mgg

60 

70 mglg

90 

3D mgl

40 

SO 

60 mgl

70 mgg

80 mgl

10 mglg

20 mgg

40 mglg

4S mglg

SO mglg

S5 

60 mgg

80 mslg

maoDBIoeylene.

dilalium (U

No. or

TIC 76 38 64 31 

1/6

616

5/6

6/6

3/6

616

3/6

3/6

138

, 3S
Samples of the maonato rli"mmine an maon

20 ethylene die complexes of plaum(I were sub- mi to the Drug Resh an Development Brach

In addition to th day 1 injections des"bed above, in of the Natonal Cacer Intute for sc for antia number of cae injections were delyed unti day 8 of mor actvity aga the L1210 tuor in mice. The retuor. grwt. In these ca the tuor was usualy at suits obtaed on th tumor syste are shown in Table

leat lager tha ! gm, as estite by palpation. The 2S IV. They conf the acvity of the compounds of the

an were then injecte and observed for a perod of invention.

. approxiately 60 days. Activi was meur by the, ' 

number of anal whose tuors ha regresed to the

vang point, whie sti alowig the II to survive for th tie perod Such te results ar desn'bed 30

in TABLE n below.

, TABLE n

Tcs of Lae Sama ISO Reesas by MaoD8o Coinon

Complexes or Pltium.

Tuor-Sarma 180. Anal-Fee Swi while Coorn Sinlde iniecons on Day Ii intrpelonealy in H20 solutions

Tota Numbe Complex Do of Reons maDBdi- 14 mgg 

ameplatum (n) 16 mgl 18 mg/g 

20 mg maonbylene- 40 mg/g 

dilatium (I 45 mgl 

SO mg/g Ii mgl 

TABLE l-cntiue

Tes of AD Ac: (for setivity 10 a I!Ia ds plawn

(I cordtion cound or an oc dZsp3 plaum 

cordintion c:poun of Mao and SubslDled Maonalo Conln CompJces or Platium Tuor-Sma 180 Anl-Feme Sw while mice

SinRi injecns on dayS nole. intrlOeaY Cordon Day or Coplex ilection

I-clobutca- I

boxyla plti (U)

manalob

(metylae) platium

Dos 

20 mgl

40 

60 mg/g

SO mi/

100 

120 mgl

160 mg/g

80 mglg

100 ms/

120 mglg

140 mglg

160 mglg

ISO mgl

No. of

TIC 71 60 38 42 69 18 62 58 53 28 15 17 19 

Deth

657,927

TABLE m-cntiued

Conlirmlory Tes of Antior Acy (for sevity 10 a pla

ds2 platinm (11) cordtion compo or aD oced d2s Do Dlatimn aV) coon cound) ., Inbon 

Sirde iniecn Dav Iin 0i Inpeeay 40 20 100 15 

SO 

160 

Tum ADIPC6 - An - Mous

Slnlde inie Day 15 in ou Intreay 20 100 100 94 

500 

TABLE IV

Coumory Tes of AntilDor Acvity (for sevity 10 a JlIa

ds2 platinm (I cordion compom or aD oced d2s

platium (I eonln compoun

al th Nation Cace lnlDe.

Tuor: LI210 AD - Mi

Daiy iniecons Days 1-9. IntrlOealv Coon

3S 

Coplcx

Malonaloi-

, ameplllum CD

Maonaylen

diaeplanum (U)

Dos

50 mgl

15 mgl

12.5 mgl

SO mgl

15 

12.5 mgg

37.5 mglg

15 mgl

16. mgl

11 mgl

% Incr in Lies

163

133

115

101

160

151

121

196

IQJ

145

Maonloylele- dieplaum (I (re te)

The maonatolaum cordition compoun of

The rets decn"bed in Tables I and n indicate tht the invention ar preferly dilved or sused 

the compounds of the invention are ver Potet antito- 'Y r or other phanuti y acptale 

mor agents agait the S 180 tuor in Sw wbite mice. 6qmds The par adble copotion

Cotory tets of antior activity agt the SO should preferaly 

(:nta from abut 0.5 mg to abut 10

Waler 256 Ca in rats and the ADJIP- mg per mi, it beg under th the amout may

C6A tuor in mice were conducte. The inti tes va gry depg upn the pacu copound

results are shown in Table II and CO the potent employed and the an to be 

action of the copounds of the invention agt these The platum cordon compounds of the invenother tuor sys 55 tion are preferbly aded paenteray to an anTABLE II ma afecte with a magnt tur seve to a plna ds pltium(D cordtion compound or an

Tes or An or Acvity (for setivity 10 a 1;la octaed d2sp pJtium(I cordition com und.

"" plunum (U eonlon COd or an oced d's 

Dlatinnm (I co comll) e oron 0 trtment and the do level, of cour Dos % ln"bti Dea 60 wi dep in eah ca upon the si of the hos anOIlommlno:lalium (I ma, nat and si of the tuor, et. Geeray, howTuor: Wal 156 Caos An - Ra ever, a dose level of fr about 20 to abut 200 mglg

Sinlde iniecon Day I in 0i, Intr!llOeay . of boy weight, per day wi be sucient. It is to be

10 mg 100 undertood, however, tht the platium cordion 20 mg/g 100 65 copowlIls compouned with a suitale pbauti-

: :

100 ca caer in the sae proportons as recte abve may

Malonlhyleaediaep1aum (I alo be admed oray at the sae dosage level.

Tmnor: Walke 256 Caosma - Anal - Ral We cla:
metod Cor treatig magnant tuors senstive

to a pla ds p1aum(l cordion copound or

an octaed d2s platium(I coordition com.

poun in ao which CQmpries pantey adiserg to- an an afecte with sa magnt tuor 5

a solution cotag in an amount sufcient to cause

regron of the tumor a platium cordition compound of the formul:

(P(IOOcn!J

, 4,657,927

grup contig of H, lower alyl, arl, ar1,

hydrxy lower all, hydroxyl- and aloxyl;

ames and aloxyl all am;

when z= 1, L is a bidenta anoDic li and

when z=2, L is a monodentate anonc ligad.

3. A compoon suble for patera adtion to an an afec with a maigt tuor sentive to a pla dsp platium(l cordition compound ,or an oced d2 plaum(l cord- -

10 tion coound comprig a phacay actable caer and a platium coordon cound of

the formul

ci or tr (P(IA"((OOI),L wher: (P"(OOJI x=1 or 2; 

z=O, 1 or 2, provide y= I or 2; th when y=2, z=O, and CI or I1 (P(JV)"((ood"L

whe y= I, Z is greater th 0: h ' Rand RI are seeced from the group constig ofH. 20 w erem.

lower all, lil. arl, aJenyl, cycloal. cy- x= 1 or 2:

cloaJyl, aloxy, OH and cOmbine with the ca- y=l or 2: 

bon atom to form a cycloayl or cycloalenyl grUp' z=O, I or 2, p oV1ded tht when y=2, z=O, and

when y= I, Z IS greate th 

when ': 1, A is HR2N-CHR3-CII-NRsH and 2S Rand RI ar selected fr the grUP constig oCH,

when x=2, A is H2NR or an amino acd; wherin lower alyl. arl, arl, eny cyc oalkyl, cyR:z R. R4 and Rs ar the sae or dierent and are cloal.Yl, aIoxy, QH an cobme With the caseecte from the gronp Consg oC H, CH3, bon ato to form a cycloall or eyeloayl

C2Hs-. bycloxand lower aloxy, provided tht group:

R2 and Rs may al be arl or aryl and each R6 30 when x= I, A IS :z-CHR3- NRsH IId

is the sae or diferent and is selec frm the when x=2, A IS H2NR or an amo aCd; where

group consistig oC H, lower alyl, arl. aryl. R:z R3, R4 an Rs ar the e f:r erent and 

hydroxy lower all, hydroxy- and aloxyl-ames seleced from the group cOnsg of H, CH.

. and aloxyl all ames C2Hs, hydroxy and lower aloxy, provided tht

when z= I, L is a bidentBte anonic ligad, and 35 2 and Rs may be arl or aryl an each R6

when z=2, L is a monodentae anoDic ligand. IS the sae. o! dierent and 18 selecte from the

2. A method for treatig magnant tuors sentive group CODStig oC H, lower all. arl. arl,

to a pla dsplatium(l cordon compound or xy lower all, hY'!xyl- an alkoxylan octedr d2s platium(I cotion com- ames an aloxyl all ames;

pound in,ao which compri ory adteg 40 when z= 1, L is a bidente anoDic ligad, 

to an an afec with sad malignant tuor a solu- when z=2, L is monod anonic lid, sad

tion contag' in an amount sucient to ca reg- compound be prest in an amount sucient to

sion of the tUor a plaum cordation compound oC caus regron of sad tuor. the formu1 4. A compoon sutable for or adtrtion 

4S an an afec with a magnt tuor setie to a

plan ds platium(l cordtion copoun or an

octaed d2s3 platium(I cotion compound

comprig a pbauticaY actale caer and a

p1aum cordtion compound of the formul

(POOh-RRJI 

(PIA.OO-c!J

ci or tr (P(OOC)2-CRI),

wherei:

x=1 or 2;

y=1 or 2;

z=O, I or 2, provided tht when y=2, z=O, and 

when y= I, z is grte th 

Rand Rl arc seec from the grup consg ofH,

lower 8l1, arl. aryl, a1yl, eycloal, oycloalenyl, al, OH and cobine with the cabon atom to form a cyeloa11 or eycloaenyl 60

grup;

when x= 1, A is HR2N-CHR3-C-NRsH and

when x=2, A is H2NR or an amo acid; wherin

R2. R3, R4 and Rs are the sae or dierent and 

seecte from the group consg of H, CH3, 65

C2Hs, hydroxy an lower aloxy, provided that

R2 and Rs may al be arl or arl an eah R6

is the sae or dierent aud is selec from the

, or tr (P(I(00-cJ)"L

wherei:

x=l or 2:

y=l or 

z=O, I or 2, provided tht when y=2, z=O, and

whe y= I, z is grte th 

Rand Rl ar seleced from the grup consg oCH,

lower alyl, arl. aryl, a1yl, cyeloal. eyeloayl, aloxy, OH and combine with the cabon atom to form a cycloa11 or cycloalenyl

group:

when x= 1, A is HR2N-CH3-CH-NRsH and

when x=2, A is H2NR6 or an amo acd: wherein
657,927

R20 11, R4 and Rs ar the sam or dierent and are

selecte frm th grup consg of H, CH3,

C2Hs, hydrxy and lower aloxy, provided 

R2 an Rs may alo be arl or arkyl an eah Re 

is the sae or dieret and is seec from th

grup consstg of H, lower all, arl, aryl,

hydroxy lower alyl, hydroxyl- and aloxylames and aloxyl all amesj

when z= I, L is a bideta anonic ligad, and

. when z=2, L is a monodenta anonc liga sa

compound beg pret in an amount sucient to

caus reeson of sad tuor.
fV 

.. .

UNITED STATES PATENT AND TRADEMARK OFFICE

CERTIFICATE OF CORRECTION

PATENT NO. 

DATED

INVENTOA(S) :

657, 927

April 14, 1987

Michael J. Cleare et al.

It is certified that error appears in the above-identified patent and that said Letters Patent is hereby

corrected as,shown below:

On the title - page, bracket 62: "Division of Ser.

No. 902, 706, May 4, 1978, abandoned. should read as

--Division of Ser. No. 902, 706" May 4, 1978, abandoned

which is a divisional of U. N. 778, 955 filed March 18,

1977 now Patent No. 4, 140, 707 which is a Continuation of

N. 260, 989 filed June 8, 1972 now abandoned.

Signed and Sealed thi

Seventh Day of March, 1989

Attest:

DONALD J. QUIGG

Alestig Offcer Commissioner of PatenlS and Traemarks
"'''1 IVI c."''''''T I I. ...J rnA Io! Io! c: I tI q::::l I-lTPATRICK N, V. It 005/011

.I,

,

1 .

.. : :.

UN' STATES DISCT COURT

ORIGINAL 

JUL 2 9 

. FORTBDISCtOFNEWJEY

T. Wf\H. 

BRISTOL-MY SQUIB COMPAN )

an REEACH CORPORATION )

TEOLOGIB, iNC.. 

) 

Plaitis, CIV AciQN No. 01-3751 (MC)

PHACHE B.

))efdat.

ENRED

'JUl 2" lOO

MEMQRAUM OPINON .A ORDER

WU T. WAL. \L. 

(i)

. 

tn co bcfhre the Cour punuat to Deendat Pbaceme ;I.

'Phaacheme ) motion for paal sumuy judgen and Pllli,, Brstol:.Myem Sqob

Compy's BMS") an Rese Cmption Technologies, 1Dc. s ("'RCT') crss.moton for p8 su judent on 't Bpcail of3S U. c. i 121.1 Th Counba re an

consder th me1xa of law and supportng docents submtt by RCT U1 BM ao

Phcheme. and on Mach 4. 200 th Cour hea ma aren on the abve isss. At 

conclusion ofth ri"g. th Courntedin favoofBCT an BMS. 1h mem1:

OPWOJ se fort th reevt fa1B an concluons unciedyig the Co's decisin.

Phcleme a1o moved for sun og1eQt on ar and ofs1 in

1he ar RCT ard BMS apposed Pbatcbes motioD for pa swnarJudgmcm in this

rcga buf did not cross.moe fo SPmP"'judgttb Th Co wiR,dckreutOl

of thes issues unti a Ma,./r" he. is coed in or to beUerundcd, 

!h patnt-insui\ tbe retevam ar an,tbe level of skill in th an Pbache' $ m tifor 

par suuy judent on iss of th :rle ar is t1OIe aeed with'U pre.
W"'r I OJ, c....... I 1. ..0 r fiA I': I': L. ItS FITPATRICK N. V. ft 008/011

, ., . :,.

BACKGROUN

Plaitiff RCT and BM fied a complaitln th Co on Au 8

,. 

201 al inemt by Phad1 ofU s. Patet 1-o. 4.651,927 C'te '97 . RCT

. is th assgn md BM is th exclusve licc oftbe 1927 pa Th .claims of th '97

pat ar to meOds of1teatg tuor with ce pla!,nm:oon colexes en pJica ce1Diqon 

;,,

sueb plti-con coex. 'I ' 927 pa is in 1987 an 2S sceded to exir in Apr 2004; itha not be the sujec of anY

pror litgaon or ohcn uner the Ha-Waxan Act.

. ,

pharrru1cbcm.f an Abbed New Drg ApPn ANA" wi 11 U.S. .

Foo 8n Drg ,itlnfm tm1iQD ("FDA " seg aproval to ra a powd for injection 

prdua nt c:DPJa w1 is a platium-cordti coex before the '927

patnt exir. Tha fi oftb ANA foam th bass fo ths lawsui pur to 35. U. C. 

271(e)(2)(A).

Among oth deeue, Phheue b,as aserd tht th 1927 pat is fxrvald for

obviouSlestype double pati ov u.s. Patet No. 4 130,,707 ("th 707 pat'j. Th 1701 patcisueonz;ebr' , 1979 anexixd on Aug 24" 1998. The 707p1htc from

The sae origiaplieati ficd. 0. June 8. 1972 1h laC ri to th ' 927 p"en

Phheme moved for suar judgm th th ba to obvusnes-te doube pa c;nta.j, 3S u.s.c. A 121 does notsply in ths ca. In r RCI" an 9MS ergud th 35 V. C. f .121 do aply an prccludes. I'" eme frm us the 701 paen as a refeen agns th pant. Neith pa:other .uove o and ths Cour ha not der and does not addr, meritS ofPharacheme's as obviUs-we double paentig deen. Beuse th COur agees with RCT an BMB t 35 U.8.C. ti 121 

Ph&nachemc fr usin th 707 pat as a. rqerce ag1he ''/7 pat, Pba

obviousess-ty doube patg defe is precuded in th cae, Phache,u' s moton is

deni an RCTs and BMSls mouan is gted. 3 

Phuachemie suequcy:fed a second ANAfor an iDecle fo of carbo and

RCT Bn BMS fied a sepate acon aga Phaxhemie in ths dict (Ca'No. OI-CV..

1270) wi re tQ th.AA. Tht acton ha sie bee consoda wi th cas an

tbs ni is aplile to 'both acons. 

, .

Th jces enteed into a 10int Stpuon and Orer" efve as o Ap2 2002 th ha elimed ce clai fi def fr th litigan. Du to th aged to by

the 

de&e, only 

es an 

the 

beau 

ise of 

n 121 bar Phhes obvonss-tye doUble pag .igemen remains in ths cae. 
, ....( .

, r;....., I I . ..\3 r n/\ ILIL Llti 'f:J:J t-lII"AIRlCK N. IgOO7l011

. .

1 "

PROSECUON HISTORY

!he fats gc to the applcabilit of 3S 1I. C. 121 at pripa coiltaied in the

prseonL1ry of the 9T an 1707 

paen . and 1h fact ar unc1sput (thou the

pares disput 1ega siguica of cer fa eni"ed in 1f pron lU). 

thorough reew of th prseCUon bi is WBan and necat dete the

applicaty of3S U . i 121 in 'tis ca 

. .

Th invenrs of th 1927 pa-in-sut fied OJgi pat appltin on June 8.

1972 (seal nube 260 989. "t ar'989.aplicaton' '1 con.Wag clai to 

counds method of Dt an phaceca COmpitOl. In its fi Offce Action"

to!? U.S. Pat an Tratl-JlY'\: Ofce (ItPTO") issued a rescton requi beee novel

co\Dda on 1h on h8n and of1rc:t an phacal:poti on the:

oter. ("Resct is reui 

... 

bet 1he followi inventil1: 1. Cls 1-8 whch 

dmwn 1: co'Uds whCh is clasfied in Class 260. ll. la 9-13 whch &t drwn to

composition an meod of tr cacer wbk is clasied in Clas 424." Jan: 11, ' 1913 Of Ac; Ex A to avan Decl. at 2).

Th appli att '\essfly to trver$e the ori rectin'1equient 

 

SI ti (8u e.g., FeD. 12; 191) Amndent Ex. r 10 CaVa Del.; July 13, 1973 Ame. Sx. H to Cavan Dec) in ord to obt all ofthei cla in a smo pateL 

th pro made "Fin" th restction Rquienent arng copounds ft metods of

traten am phcs oosition (Aprll!8. 197 Off Aet Ex 010 caV De.

at 2):,;te appficats ntinu to cbenge the: reon xeuicnt. (luJy 13. 1913 . 

Amenen Ex H to Cavan:De.). Ber""ge of the reson :r l1 th pplicts

prvisonay e1e ted to pms ineJy th compoun clai. The apnc.tsproSe1id 

coPOQDi! clai with the PTO bot did not jrodiatly obt a1 fo aDY ofthci clai.

Wbe an apeal of the rejecon of applicants compund cla wa pe with Bo oCPatcn the applicats chose to fie a coua a1 numbe 778 955. l

'9SS contion ; Ex Q 10 Cava Decl.

). 

Af fig the tipl1:1tion th apcats

abadone th orgi '989 applicaton thus moog th pen apea Beca the

apca fied the contion Wo abaDi the 989 apcati "t "955 

, contnuaon ba the sae ef as thugh fi on the Jun 8. ,19 ppodty dae oftbe origi 

989 apllciatan an ha 

e dIec in hr of ntiDn; the praseon:oftht 

apcaon 

Sst! 35 U. c. i 120 an Dote 4 infa.

On Augu 1977 th PT maed its fh Ofce Action OD th '955 conttiOD.

Among oth tb(,, th Offce Action se fort a fur r=strcto: reemt. a fOur-Way

recton amon grs of compun. (E R to Cava De!. at 2). ExR1er Helen Sne

wa 1ht PT :pminer of the '9.55 cotiuaon. Af reeivi tb! Offee AcOD 

aplicants sutt an amendmen on Septebe 7, 1977, in whch th prvia1Y'clco

ComPun ft tw of th foar, grups. (Ex. S to Cavan De at 3-4) Af.

proseGUon, the applieats therreivcd a nonce of alowance ofthej compoun cls 

. Apr 28 1978 (E Vto CavanDel.). 

, 
- -- r 

... 

"""""""T I I. U rnl\ 1l:1l: l:/t! q:J:J FIT PATRICK N. /tOOS/Oll

., . . .., ,. 

applictiQJl to 

Befor 

thir 

compoun 

nOn ted 

cl cla. issue in th '707 patt. applicants :f ' di 

'Tis di siGna appllcato

706 dii se n1l 902, 706 the lo"'

)..

wa filed,on Ma14, 1978.. In th ti Offce Actan in the 706 divi I'n ne Sn= 

betee (who ba eX the 9SS rtpnAti) st th II(r)estc: been plum COlnples EU method ofus an pbautca comptions. (Augu 17, 1978 Ofe Acon; Ex. Z to Cav Deal at 2). The UDy to 'be th rcStcton aplica ag at.

1978 teuient in JD Amendment 4a Se.pte (E. AA to Ca.va Dec.). so as to obta cla in cagores th weno yet aIow

wmber 497

.A 

10 ("t ' fu precon. the apRcats ffed an dioDa apli 806 divisiona"). The '806 divion 'W tU on Ma 1D Ca Dcc.)1 M(I preim amenem 2S. 1983 (E BB wa Bl 0i1u 21. 1983. De. (E. CC to Cava ). In a fi Ofce.AcoD date Aug 3.: 1984,. thPTO re that "Rescton. . . is 

" JDtbods 

r.ed nnder 

ofus 8n 

Secon 

pharace 121" bet cl draw to a pla comlex an clai drwn to '

prec cosiODS. (E DD to Ca De). at 2). Af th ajUC8 r a IJtice of allo me in e.,Jun 21. 1985 Off Acton of 1: and phacutca copositlol1 cla. pat isued on Apdl 14, 198'. (E. EB to Cav Dee!.). Th 1927

, . 

STANAR FOR. S:uY.1GMB

llm jwlgJcnt is 

met an the movi par apprprat where the is an ab of a geui ise 

Cfl

is cntitle( to judgment as a matt of la. FedCi... S6(c); reA Corp. 

judgmentw the coUr mus 

V. GaITen 477 U.S. 317, 327 (1986). Wh bothpaerMOv." for Sni1 eva ea motion QU, its OWD mer reolvi alheaJile infece agaitb pa whose moon is 1Ddf dc Kiv. u.s. '199 P. :131 1380 (Fed. Cir. 

of law for the 

199). Th Dn of v.het Sec 121 apJfes in th cais a matt

nccar ,

Cour Althug macd facts ar not in disp, tho CoUl deon prmid. on the fat-intene file hitory afth '97 patc

.. .

ANALYSIS OF 35 US.C. , 121

, . 

Cour grts RCTs and BMS's crssmotion fO 121 judgment 1h 3S ,V.s.C. i apes on the facts of1b cae to ,bar Phaeme.1rom 

patem as a rocruc agans 

ing the 707 th tg27 pat-in-sut. 1b decn 1s' 0:i8, .-tb reew the pate aplicaon 

hioty in light of the relevt ca Jaw. 

Secton 121 srei in pereni pm

If tw or more .icpent an dict ineDtcs at claied in one appfcatioD; th (PTO) ma reir th applicaon to 'b rescted to on of"t inventions. If th o1her invetion is mae

th subjcctof a dhision application whtch complis wiCh the ' rcuicat of sectin 120 of ths 1i it sb be entied to ,th 
I U / '- 

\,\, 

11. ;,0 r 1'/\ ,-' I" "I tI q::::Z HTPATRICK N. V, 008/0 

... 

befit of th fi date of th origi aplicaon. is on an app1icllon wi tesct- to whch a requien for .

'lctn UD th se ba be m8 or 01 an aptin fi as a resu ofsu a n: sh no be us as II 

:rerence eith in t1e))at.au Tmd OBorm. th

cour aga divioul apJiat or ag the aplica or aay pa issud 01 d r o:t iftbe ' divona apca is fied before th is of th pa 

th oth 8.pp on.

35 U. C. f 121.

. .

' Cones ened Secon 121 as a n: st in orto pm ap1i and patetees 

Material.

ftm the un conSeueces ofPTO restcton See. e.g. gutZy :.pplied v. Advanced Ser.lC0dutr MaerIo .4m., Inc; 98 P3d 1563, IS68-69 (Fed Ci. 1996). Pror to th enent of SectiDn 121, a Cl wh ha beC3 suect to a I'Gton reen CGlJld have its latq pa.ivac= on th bas oCme fi issu patt even thugh the pa had intiy sougtto prsee al ofib clai toge. Su, e.g., RBingttmRcm Bu. Sen. v. .AcmsCiJ(/ S)s. .Co. 11 F.2d 628 (4th,Cir

). 

i:er' dDed 293. U.S. '

, 

62 (1934). .SecoD,121 wa eu to elmin th '1D ,tnes an ODe oftb pr PUIse -oScc1ion 121 is I&to sagu vadity WID tbe vapdos ofthcrccton pr 

. .. 

Seon 121 a ove .8 th the te1mcaties of rection prce ar not elevte from thei 

P1nos of CXRq; OD. conveence to a pote ta,OD th ty of eng. patents" Applied M6riQU at 15689; see alo S..Rep. No 82-197 (June 27 1952):0

re171ledin 

19S2U. c.C.AN.2394 2A13. 

..

In th cas the fi pat (th '707 pa) "issu( ed) on an apcati01 wi xe whch a requie:t for resbcton (wa) mae.,14 Fmm a reew ofthpts hito as a

who it 19 evdentb me , recli:OIl reuic:D1 A;ae in eoauleui

the applca to pure tbcimethod of1Jtmem an pba compon cl in divcm applic.oD. Ib tescton requi JU cacee&1 reoke orwi Phachee 1: not offer an peve auoli in suppor of it coteon th th 197

retrcton requiemen was cl1er excitl or implicitly withdmwn by th PTOs:fer

Th is tr for at lea the xen. th the '955 contuaon togeVtth th o rd '989

aplicaon COtc none contiou applicaton wi tb mcag of th law. Goe: 

Btes. 68 U.s. 317) 325-26 (1863); 8f a1$O 7ramo Prods. 1n v. Perj" OmtTm:ti fl7 38 F.3d 551. SS6wS7 (Fed Cir. 1994) (citi1D Godf) ("Bef$eon 121 enct th SU Comnote th a co on BD tb apJUOI1 01 whchit is 

am conered pa of the sae 1ra OD cons one COui ap . Th legie hiStry of QD 120 d.oe 1iot inca an congrsson int,tO alte-th 

CourS intee1OD of co aplicaon ctc?' "

), 

cer tlene 513 U.S. : 151- U99.S\

... 
. "'VI I ul ,"",V"t I I - r"'l\ 1.0 1.0 "ItS q

FIT PAT R I.C K N. V, fg01o/o11

.

rectnr uieD\en in the '955 contato an Phanacemies arguent is beled by the

whole oftl pruton hiry. Examr's Sne' mmen m. the fi Oft Acton on 

106 divion COborate t' th rection bc copoim an metoa of11en an pNnoa coposion teJliue in eft thug the " 55 canuaon ("estion. . 

has bctequ. be tw clai drwn to cooum an glai "dr 

compon(s) andmes)lI :e z to Cava Dec. at 2,. On at leutfb ot occons, 'te pr reiteat tbJlppUam coound cls need to be sep fr th me of 1T_en and phcal copoon 1a. s 1k Cour cou& th th diviom

applicaon pu me1h of tratt and phaacutica coposition clms was $ed as a re of the restrction requen en wa not a ''voltItaD ac over th ye 1h aplica , 11repd atts to trVCt the PTO' restetn reui but wer nOt pC1 

bi copound clas 'Wth "metod oftrJment phaceutca composition claims.

Fu. the '927 paent is fn conson with tbe J973 restcti lC

upn by app1 ....nR fl the c)ai of e "97 p nt do not crss ba ov th lie of den to clai subjectma c in the eali ?07 pat. 'I= 707 pat contae4 cJa drwn exclu.vdy to compounds. and the rr7 paeuiu.S\ co cla dr exJ:.Jly to method oftrateD.t &c phaeu eomposition. Thus. 

consoomce reqre'as set fort m Ger.her Garent Tech.. Inc. \I. Lectra l11C., 916 F.2 683 (Fed Ci. 1990). is met he.

Finy. th caes upon whh Phachem ba relied do not milta in -favot of a cont deoiOD by th Cour The Court of Custobl an Pate Appal' detionS in 1" 

Zfegler. #3 P.2d 12U (C.C;P.A 9'1) (iotvigthe offcial wifhdialofarescton

requient-n a parentapplicaon). ln re Wl'!ght. 393 F 2d 1001 (C P.A 1968) (no P1:P -

imosed retrction requiment) an In re Scheler 397 F.2d 350 (C.C.P.A. ,1968) (sach do

not ch the Coar' s concluson that Secon 121 aplies in "t casc.

Her

, ,

the Pr unqUvocy impo a rcstiction separ tb.acats'

coua claims fim metod of tratmen and pharceca composition cbm,

ne rescded tb rcuh and two pate then issued (oue wi otai dr 

exlusively tQ compoUD and one with clai dmwn exclusvely to ma1hod df1ttmen and pbsacca compositions). Sccon 121 aplies in th ca to ba th us of.tbe eBerised 707 paen as .a refence agst the later-isue '92 paeo-m-suit 

. ..

See, e. 11. 1973 Of. Action (E. E to Cavan Pee.); Aprl 18. 1913- OBi Acton

(E. G to Cava Deet); Mah 22. 1974 Offce Action (E I to C&V8 DeCL) an- ugll 3 1984 Ofce Action (Ex. DD to Cava Del.). 

.
., .... ( . 

( 

,"VV"T I I . .. I r nl\ I.! I.! ltI q:l:ll FITPATRICK N. V. 0l1/011

.. \,

1, .

IUER

2.8 U C. S 1292(b) CereatioD

pJAnnacio h :ruest cecaon so th it may-appe th deonon an

iDlo0u.basls. RCT BD BMS do not join In Phls tB bu th ha 

not ta oPse ths Cour ceQ!oD, of an inteocury aP. I bate r..it Pbitil

to apea ibs ruli on an inocn s, fig th Ib cae "ilv cotrllg

quan oflaw as to which the is su poun for ofr.pion and t1 an

iat ap:fom an oncr .t umtey ad 1h ultifPA I1 ofth

. lition." 21 U.S.C. f 12.92(b). 1 herby cafy fl follwin queson fo mmrlocQ reew

by the United St Cour of Appe fo the; Fedet Ci 

CET1/E QUEION

Whre (i) th PTO found tht tw 01 more independet and diltict inenons wee

claied iD one applicaon orl aplicaon"). and th PTO requ tb orgil aplicaoD.

. to be IC teci to 011 ofth invenoDS \ftreOE n.; Cu) ea1ipat issued fr co1111nafi: of the ori applicaon (tii) befo isSUce of th eaer-

_cd pa 1hc other vc:on wa JD th subjec of a clvicm appltion which

ultite mat in the lat-is pa ("dJvion application": (iv) fu rccton ieui 'W h c:ceed reoke or withwn am (v) a retion reen 

imO$ by the no dung prsecuton oftbe diviional apli ("J. rection

reuieDt'

).

Did the Disct Comt er in holding tht 35 U. C. i 121 8PPUes in th to bar the

use of tM eaer-is ' 707 pat asa refece ag the: issued "927 p in-sui

ba upn the followig 1eg rus: 

, (1) The diviiona aplication W8 fied 'Cas a ret of the fi IectOIl ment, .

with th meing of S on 121; 

, .

(2) Th no did not 1icit1 or implicitly withdr 1he fist rectin requiemen by.

imo th la restrcln rent, an1he t'e ih 1'cton ent .

contiue to apply to the divion etplicaon far pUtge ofinwki Secon 121; and

(1) The clas or1h eatlier-isueci patet. and 11 clai' oftb laie..jssu patnt er

fay couat with th fi m;Cton reuien ,

. ; . . .  _.  .

SO OBEIJi:

MA Y

t. o2lJ .I 
;.' Vul I 01 UULf

. ..,

I I.

:::: 

r 0'/\ HI FITPATRICK N, V. 002/0"

STERNS &: WEO'

A Prafesiopal Corporation

so Wei Sta Stm

Suite 140 Tt Nl 08607 

(609 392-2100 

KC-848

fo Defedat

Phaceme B.

qRIGtNALriLE

. 

00'(2 

. 0

tn;T r '1\ "7'Ct-t "":0 --

. 

..:.1 .I 

\:. ,

ClvIL crONNo.Ol-37

(Civil Action No. 021270 .", I CQnsJ1da herth) on 

. .. .

-I ' \'l1. J\ I , 

':1.

. 1JIT1 STAms DlSnucr cOI

FOR THE DISTRICT OF NEW .1Y

BR,TOL-MY SQUI

COMPAN -.d

. .

RBCH CORPORATION

. 

TBOLOIB, INC..

:PJaiff

,...

pHACHB.V..

Deenda.

FIAL JUGME

WHRES.. on July 29t 2002 th Co issued a Memcm Opn and

gr S\1 judgment for plaintiff on the mvaJd4.defeue af atmQUSasty doubl :.

em the gr1U thaI 35 U-S.C. g 121 baa 1r of U.s. Pa No. 140 701 (th 10 

, i pat.') as a refi agait U.S. Paten No. 41)57.921 (tho en 921 pate

WHB, on Ocber 2 200 the 'Uuite Staea Ca DC Appaa for th F

Cit deed deCen&!t Pbannacheme B. s' ( ach tiOD 1C " fie

, i

appeal &om 't Cour saar jud8DC1t otder.

WHE, the onty issue Temnilt in ths case is th -ie ofiI

, 

. t

. . , , , ;. .. .. :..! \!.

r '
" ..v, I U, I I , r fill I': I': 11: 

FITPATRICK N. V, Ig 003/011

.. . .,,, 

W1. PDArnohemc. in OIer to ee1i its ri tQ IpJlea1h i 121 ba iss

ha. With the wrtt conse DfpIaia filed an .Aende Auer am C011talaJ

. ..

th Pbhenc s fiUng of the AN.As refci in tho CODSUda cols is an se 0 

inmngemenf dr.at ODe 1a of the " 27 patt md 'twi its afrmve deeJ 0

Wl. DOW th tha Amcad-= Aner an CoMcJs hi filc DO i es .

reain to be tr.

WHOn. fi judgment be and heryis cnten as fo1iows:

Judent is i tavorDf platis Resh Cortion ogica mc. 8I

. 

BMI- Squibb Compy on th Conolida en Complai aa 

defeadat Pharhe V. on its Countelai in tht U.s. Pat No. 65./21 is DO I

. .. ).. 

ii d, DO un as U1:u1, p fi of1h

Now Drg Applic:an for pla proct ig an t4t of emt of at J.t OD clam of I.

tht pateAt put to 35 U. C. 271( e)(2), and that the mata 'Ue. sa 01: off fo sae i

wi the Un St or hapomt1on into the UDtec St, of the cabolat prots 

refe to in the Abbr&k New Dru Applications wod in at ' anc clai of tht 

pat

, It is fwea ordet that the cfecvo date of of Phmemc

Abbratd New nm AppIicaOl Nos. 15-162. and 76-292 is detcd to be the e on

whlcl Nly Foo "a Dt Adm&1n exclusvity th may be J1 to ptsti put 

. . ..

to 21 U. C- Section 3SSa "Kpy sad exclusivity comiJ into efec up GXirat of the .

927 paten and" if no such exclusivity is . a. dat pot eaer du th Ap t4, 200

expimon of the pa1
--I . 'O 

I I, -'-' 1- nl\ 1-"

10 ":J:J I-llt'AIK1CI\ N, Ig 004/011

...

enjoied fi tImriay matin& usin& sdHn J:r oftg for-sde witb th U .

Ste.. or iDto th thtec Sta. dls caJan tefe to In 'tsc

, Abbmiated 'New Drug 1icati9na oth th US reDa rd 

I . .

n is tU 0l Ih pd to th tI dalo of o' I

Ahbr New 'Dmg Application Nos 76-162 md 76.292, dc Plthem. 

, 0

,; 

th deyelopeat and of intou un Fect la whch te th 

uinf. or sae of dngs as set fort in 3S U. c. Secn 271(e)(1). .

Ma L 

, 

le si8 -ct Jud

Dat! Octber 200

  .   _... . . .  ... . ., ,.. , .. .. . 
to. "

United States Court of Appeals for the Federal Circuit

03-1077

BRISTOL-MYERS SQUIBB COMPANY

Plaintiff-Appellee,

and

RESEARCH CORPORATION TECHNOLOGIES, INC.,

Plaintiff-Appellee,

. v.

PHARMACHEMIE B.V.,

Defendant-Appellant.

David T. Pritikin, Sidley Austin Brown & Wood, of Chicago, Ilinois , argued for

both plaintiffs-appellees. With him on the brief were Constantine L. Trela. Jr. Lisa A.

Schneider, and Marc A. Cavan ; and EUQenia S. Hansen , Sidley Austin Brown & Wood,

of Dallas, Texas. On the brief for plaintiff-appellee Bristol-Myers Squibb Company, was

Robert L. Baechtold, Fitzpatrick, Cella, Harper & Scinto, of New York, New York.

Francis C. Lvnch, Palmer & Dodge, LLP of Boston, Massachusetts, argued for

defendant-appellant. With him on the brief was Laurie S. Gill.

Appealed from: United States District Court for the District of New Jersey

Judge Mary L. Cooper
, i

. 

United States Court of Appeals for the Federal Circuit

03-1077

BRISTOL-MYERS SQUIBB COMPANY

Plaintiff-Appellee,

and

RESEARCH CORPORATION TECHNOLOGIES, INC.

. Plaintiff-Appellee,

PHARMACHEMIE B.

Defendant-Appellant.

DECIDED: March 17, 2004

Before NEWMAN, MICHEL , and BRYSON, Circuit Judaes

Opinion for the court filed by BRYSON, Circuit Judae Dissenting opinion filed by

NEWMAN, Circuit Judae

BRYSON, Circuit Judae

The question in this patent case is whether the patent in suit is invalid for double

patenting. The district court held on summary judgment that an earlier patent, which

stemmed from the same application as the patent in suit, could not be used as a

reference against the patent in suit for double patenting purposes. Bristol-Mvers

Squibb Co. v. Pharmachemie. BV., No. 01-3751 (MlC) (D. J. July 29, 2002).
Because we disagree with a key conclusion on which the district court's summary

judgment was based, we vacate the district court's judgment and remand the case to

the district court for further proceedings.

Research Corporation Technologies, Inc., is the owner of U.S. Patent No.

657,927 ("the '927 patent"), and Bristol-Myers Squibb Co. is the exclusive licensee

under that patent. The patent claims (1) methods for treating malignant tumors with

certain platinum coordination compounds and (2) compositions containing those

compounds in amounts sufficient to cause regression of those tumors. Appellant

Pharmachemie, B. , filed an Abbreviated New Drug Application ("ANDA") with the

Food and Drug Administration, seeking FDA approval to market a cancer-treating drug

covered by the '927 patent. Research Corporation Technologies, Inc., and BristolMyers Squibb Co. (collectively "Bristol-Myers ) brought suit charging Pharmachemie

with patent infringement under 35 U. C. 271 (e)(2). As a defense, Pharmachemie

asserted that the '927 patent was invalid for obviousness-type double patenting over

S. Patent No. 4 140 707 ("the '707 patent"), which was issued in 1979 and expired in

1998.

The double patenting issue in this case turns on whether Bristol-Myers is entitled

to invoke section 121 of the Patent Act, 35 U. C. 121, as a defense against the

claim of double patenting. That issue in turn depends on an interpretation of the

prosecution history of the '707 and ' 927 patents.
The '927 patent can be traced to an application filed with the Patent and

Trademark Offce in 1972. That application, Serial No. 260 989 ("the '989 application

disclosed and claimed compounds corresponding generally to the compounds that were

ultimately claimed in the '707 patent. In addition, the '989 application claimed methods

of treatment and compositions corresponding to the claims that were ultimately included

in the '927 patent.

In the course of the prosecution of the '989 application, the examiners imposed

two restriction requirements. The first, imposed in 1973, required that the applicants

elect either the compound claims; classified in art class 260, or the method of treatment

and composltjon ' claims, classified in.,art class 424. In addition , the ' 1973 restriction

requirement directed the applicants to elect "a single disclosed species for examination

on the merits." As a result of the 1973 restriction requirement, the applicants elected

the compound claims and withdrew the non-elected method of use and composition

claims from further consideration at that time. The examiner then rejected the elected

compound claims on the basis of lack of utilty.

In 1974, adifferent examiner issued a second restriction requirement on the '989

application. That restriction requirement identified four different compound groups

within the compounds claimed in the application as constituting independent and

distinct inventions. The four ' groups were: (1) "Organometallc platinum compound(s)

classified in class 260, subclass 429"; (2) "Platinum compounds containing 'heterocyclic

amines' or ('heterocyclic substituents ' classified in class 260, subclass 270R and many

various subclasses ; (3) "Compounds of the above type with 2-valent platinum and no L

moiety ; and (4) "Compounds with 4-valent platinum containing various 'anionic
ligands." In addition , the examiner expressly stated that the 1973 restriction

requirement segregating the compound claims from the method of use and composition

claims was maintained. The applicants did not file a divisional application in response

to either of the restriction requirements, but instead appealed the final rejection of the

claims to the PTO Board of Appeals.

In 1977, while that appeal was pending, the applicants filed a continuation

application, Serial No. 778,955 ("the '955 application ), and abandoned the '989

application. The '955 application presented all of the original claims of the '989

application for examination. A new examiner examined the '955 application "for

restriction only" and imposed a new restriction requirement. The 1977 restriction.

requirement differed from the 1973 and 1974 requirements that had been imposed in

connection with the '989 application. The 1977 restriction requirement mandated that

the claims be separated into four groups, but unlike the 1973 restriction requirement, it

did not segregate the compound claims from the method of use and composition

claims. Instead , the first two of the four groups set forth in the restriction requirement

referred to art groups that included methods of use and compositions as well as

compounds. The first group consisted of U(o)rganometallc platinum compound(s)

classified in class 260, subclass 429 (compounds) and class 424, subclass 287

(methods of use and compositions)." The second group consisted of U(p)latinum

compounds containing 'heterocyclic amines' or ('heterocyclic substituents ' classified in

Class 260, subclasses 270R and many various subclasses (compounds), and Class

424 subclass 245 (compositions and methods of use)." The third group set forth in the

1977 estriction requirement consisted of "(c)ompounds of the above type with 2-valent
platinum and no L moiety." The fourth group consisted of "(c)ompounds with 4-valent

platinum containing various 'anionic' ligands.

The applicants responded to the 1977 restriction requirement by electing four

claims, which corresponded to the claims that were ultimately included in the '707

patent that issued two years later. Before that patent issued, however, the applicants

filed a divisional application, Serial No. 902,706 ("the '706 divisional application ). After

preliminary amendment, the '706 divisional application 'ncluded 16 claims,

denominated claims 5-20. Claims 5-13 were cancelled shortly thereafter. The

remaining claims, in slightly rewritten form, claimed the non-elected compound groups

and' the' methods of use and compositions originally claimed in both' the '989 and the

955 applications. Following the filng of the '706 divisional application, the '707 patent

issued, containing the four compound claims that had been elected from the '955

application.

The examiner issued a restriction requirement with respect to the '706 divisional

application. The office action began with the statement "Restriction has been

required. . . between the following inventions," after which the examiner divided the

claims into three groups: claim 14

, 

which is drawn to Platinum (II) complexes classified

in Class 260, subcla$s 270R"; claim 15

, 

which is directed to platinum (IV) complexes

classified in Class 260, subclass 429R"; and claims 16-20, ''which are drafted to

composition and method (sic) classified in Class 424, subclass 245, 287." In the same

office action , the examiner then set forth a second, four-way restriction requirement

which replicated the four-way restriction requirement that had earlier been imposed on

the claims of the '955 application. The applicants responded to that office action by
, .

asserting that the two restriction requirements seemed to be "somewhat in conflict" in

that "any invention elected in a cordance with the requirements (of the first) would

necessarily involve election of one or more of the groups set forth (in the second)." In

an effort to comply with the requirements, however, the applicants elected claim 14 of

the '706 divisional application.

In 1983, after further unsuccessful appellate proceedings, the applicants filed

another divisional application, which again consisted of the original 1972 application. In

preliminary amendments, the applicants canceled the 13 original claims and added, as

claims 14- 19, the claims that had been claims 15-20 of the '706 divisional application.

Another examiner was assigned to the application and another' restriction . requirement'

was issued. This time, the examiner divided the claims into two groups, one consisting

of claim 14

, 

drawn to platinum IV complexes, classified in Class 260, subclass 239E

and the other consisting of claims 15-

, 

drawn to methods of use and compositions,

classified in Class 424 subclass 245." In 1987, that application matured into the '927

patent. The four claims of the '927 patent corresponded generally to four of the method

of use and composition claims of the 1983 divisional application.

The district court noted that the question whether section 121 of the Patent Act is

available to Bristol-Myers . depends on whether the applicants were required by a

restriction requirement to prosecute the claims that ultimately became part of the '927

patent separately from the claims that became part of the '707 patent. The court

concluded that the statutory requirement was satisfied because "it is evident that the

original 1973 restriction requirement remained in effect and required the applicants to
pursue their method of treatment and pharmaceutical composition claims in a divisional

application. This restriction requirement was never cancelled, revoked. or withdrawn.

Accordingly, the court concluded,

the divisional application pursuing method of treatment and

pharmaceutical composition claims was filed as a result of the restriction

requirement and was not a ''voluntary '' act; over the years, the applicants

made repeated attempts to traverse the PTO's restriction requirement but

were not permitted to combine compound claims with method of treatment

and composition claims.

Because the court concluded that section 121 barred the assertion of double

patenting as a basis for Pharmachemie to assert the invalidity of the '927 patent, and

because Pharmachemie abandoned any other, defense against Bristol-Myers' claim of

infringement, the court entered final judgment of infringement. Pharmachemie

appealed.

Section 121 of the Patent Act provides, in pertinent part, as follows:

If two or !'ore independent and distinct inventions are claimed in

one application, the Director may require the application to be restricted to

one of the inventions. If the other invention is made the subject of 

divisional application which complies with the requirements of section 120

(of the Patent Act) it shall be entitled to the benefi of the filng date of the

original application. A patent issuing on an application with respect to

which a requirement for restriction under this section has been made, or

an application filed as a result of such a requirement, shall not be used as

a reference either in the Patent and Trademark Office or in the courts

against a divisional application or against the original application or any

patent issued on either of them, if the divisional application is filed before

the issuance of the patent on the other application.

35 U. C. 121.
. , , ..

As section 121 has been interpreted by this court, Bristol-Myers is entitled to

invoke the statutory prohibition against the use of the '707 patent "as a reference

against the divisional application that resulted in the '927 patent only if the divisional

application was filed as a result of a restriction requirement and is consonant with that

restriction requirement. See Geneva Pharms.. Inc. v. Glaxosmithkline PLC, 349 F.

1373, 1378, 1381 (Fed. Gir. 2003); Gerber Garment Tech.. Inc. v. Lectra Svs.. Inc. 916

2d 683, 687 (Fed. Cir. 1990). The district court held that the divisional application

that led to the '927 patent was filed as a result of, and was consistent with, the

restriction requirement issued in 1973. According to the court, that 1973 restriction

. requirement resulted in the 1978 divisional application that ,ultimately, resulted in the

.

927 patent, because the 1973 restriction requirement "remained in effect and required

the applicants to pursue their method of treatment and pharmaceutical composition

claims in a divisional application. Although the 1973 restriction requirement was

issued against the '989 application, and not against the '955 application, from which the

1978 divisional was filed, the court ruled that the 1973 restriction requirement applied to

the later application because it "was never cancelled, revoked, or withdrawn.

Our review of the district court's summary judgment order in this factually

complex case presents a relatively straightforward question: whether the district court

was correct to conclude, as a matter of law, that the 1973 restriction requirement was

applicable to the 1977 application and therefore resulted in the 1978 divisional

application.1 The district court held that it was and that the patent therefore cannol' 

The dissent appears to take the position that by issuing the '927 patent the PTO

in effect found that the applicant complied with all applicable restriction requirements,

and that we should not disturb that determination. In fact, however, the question
cited as a reference against the '927 patent for double patenting purposes.

Pharmachemie, on the other hand, argues that the 1973 restriction requirement was not

in effect at the time of the filng of the divisional application that matured into the '927

patent, and that the '927 patent therefore cannot be said to have been filed as a result

of that restriction requirement.

We agree with Pharmachemie. The '955 continuation application, which was

filed in 1977, began a new proceeding in which all of the original claims of the '989

application were once again presented for examination? In 1977, when the examiner

for the '955 application issued the restriction requirement for that application, she did

I"ot reinstate ,or even' advert to the -1973 restriction requkement. I n fact, the 1977

restriction requirement that she issued at the outset of the prosecution of the '955

whether the requirements of section 121 have been satisfied is a question of law that

we have addressed de novo after reviewing the relevant materials. See Geneva, 349

3d at 1377; In re BerQ, 140 F.3d 1428, 1432 (Fed. Gir. 1988). The approach

suggested by the dissent would be inconsistent with the approach we have employed in

similar cases in the past. In Geneva , and Gerber, for example, we held that applicants

had failed to satisfy the requirements of section 121 based on our analysis of the

prosecution history. Even in cases in which we have held that the requirements of

section 121 were satisfied, we did so not as a result of deference to the PTO but as a

result of our own analysis of the prosecution history. See Symbol Techs.. Inc. v.

Opticon, Inc. , 935 F.2d 1569 (Fed. Gir. 1991); Tex. Instruments Inc. v. U.S. Int' Trade

Comm , 988 F.2d 1165 (Fed. Cir. 1993).

2 Bristol-Myers has not cited any statutory or regulatory basis for concluding that

the 1973 restriction requirement was automatically applicable to the '955 continuation.

Bristol-Myers cites several cases and a provision (section 201.07) of the 1972 version

of the Manual of Patent Examining Procedure ("MPEP") for the proposition that 

continuation application and its parent are "one continuous application, withih the

meaning of the law. Godfrey v. Eames, 68 U.S. 317 , 326 (1864); accord Transco

Prods. Inc. v. Performance GontractinQ, Inc. , 38 F.3d 551 , 556-57 (Fed. Gir. 1994).

Those authorities, however, do not support the proposition for which Bristol-Myers cites

them. The cases deal only with the issue of priority, and not with PTO procedure for

examining a continuation application in light of its parent. Likewise, the cited MPEP
. .

, application was different from, and inconsistent with, the 1973 restriction requirement.

The 1977 restriction requirement, unlike the 1973 restriction requirement, grouped

compounds together with methods of use and compositions in at least two of the four

invention groups, while the 1973 restriction requirement directed that compounds be

segregated from methods of use and compositions. Moreover, the examiner examined

the method of use and composition claims "for subject matter of (the elected groups)

readable on the elected species" as reflected in the subsequent office action. This

suggests that the applicant could have complied with the 1977 restriction requirement in

a way that would have been contrary to the categories set forth in the 1973 restriction

requirement:' By imposition of a new and' different restriction requirement and failng to 

make any reference to the restriction requirements imposed in connection with the

parent application, the examiner made clear that the previous restriction requirements

did not carry over to the '955 application.

Bristol-Myers argues that the examiner in effect adopted the 1973 restriction

requirement ,in the course of the prosecution of the '955 application. Bristol-Myers

suggests that the four-way restriction requirement of 1977 incorporated the two-way

restriction requirement of 1973 and thus resulted in a six- or eight-way restriction

requirement, part explicit and part implicit. There is no indication in the record,

however, that the PTO intended one of the two restriction requirements imposed on the

989 application to carry forward to the '955 application, but not the other. Moreover

the record does not indicate that the applicant proceeded under the assumption that the

1973 restriction requirement continued in effect. During prosecution of the '706

section does not address PTO procedure for examining a continuation , but merely sets
divisional application, when a restriction requirement similar to the 1973 requirement

appeared in conjunction with a restriction requirement similar to the 1977 r striction

requirement, the applicant noted that the two requirements were "somewhat in conflict"

and that "any invention elected in accordance with the requirements (of the first) would

necessarily involve election of one or more of the groups set forth (in the second).

There was, to say the least, some confusion at various points as to how the

various claims should be sorted out for purposes of restriction. But even though at

some points restriction requirements were imposed that were similar to, or even

identical to, earlier restriction requirements, each requirement was nevertheless

. separately imposed with respect to each separate application.. The record thus does

not support the inference that any of the various restriction requirements automatically

carried forward, in part or in whole, from one application to the next. For that reason

we cannot sustain the district court's summary judgment order, which was based on the

court' s conclusion that the 1973 restriction requirement continued in effect with respect

to the continuation application that was filed in 1977. Accordingly, we reverse the

district court' s judgment and remand for further proceedings.

forth the requirements of a continuation application.

inting to the examiner s statement, in an office action on the '706 divisional

application, that restriction "has been required" between three categories of inventions,

Bristol-Myers argues that the statement indicates the examiner considered that at least

some of the restriction requirements from previous applications continued to apply to

the later applications. We do not agree with Bristol-Myers' conclusion in that regard.

The examiner s isolated use of the present perfect tense,in the 1978 .office action is not

a sufficient basis from which to infer that the examiner understood , or intended to

convey, that a restriction requirement imposed five years earlier, in connection with a

grandparent application , continued to be in effect for all applications related to the

original '989 application because it was never formally withdrawn.
In light of the complexity of the factual record in this case, we go no further than

to address the ground on which the district court ruled. Whether further analysis of the

sequence of applications, restriction requirements, and responses by the applicants

may reveal other grounds for concluding that the protection of section 121 should be

extended to some or all of the claims of the '927 patent is a matter for the district court

to address in the first instance.

VACATED and REMANDED.
United States Court of Appeals for the Federal Circuit

03-1077

BRISTOL-MYERS SQUIBB COMPANY

Plaintiff-Appellee,

and

RESEARCH CORPORATION TECHNOLOGIES, INC.,

Plaintiff-Appellee,

PHARMACHEMIE: B.

Defendant-Appellant.

NEWMAN, Circuit JudQe, dissenting.

My colleagues have peered deep. into the recesses of patent examination

plucked out a routine and unreviewable administrative procedure -- the "restriction

requirement" for faciltating examination of , complex cases -- and created a new

standard of administrative review and a new ground of patent invalidity. I must

respectfully, dissent.

Whether or not the patent applicant here in suit was given proper or consistent

restriction requirements by the various examiners, the issuance of these actions was

entirely discretionary with the Commissioner. When the examiners accepted the

03-1077
applicantls elections and the divisional applications filed in compliance therewith, these

actions are not rulings of law; they are discretionary actions reviewable, if at all, under

the strictures of the Administrative Procedure Act. It is not disputed that the applicant

made the required election for each restriction requirement, and that the divisional and

continuing applications at issue were accepted by the examiner as properly filed. The

district court reviewed these procedures and found that 35 U. C. 121 protected the

patentee from citation of the earlier patent against the later one:

35 U. C. 121. . . A patent issuing on an application with

respect to which a requirement for restriction under this section has been

made, or on an application filed as a result of such a requirement, shall

not be used as a reference either in the Patent and Trademark Office or 

tht3 courts against a, divisionai application or against . the original

application or any patent issued on either of them. 

. . .

Thus the district court held that under 35 U. C. 121 the patent at issue was not an

available reference.

If my colleagues on this panel now intend to require that the minutiae of the

various discretionary restriction requirements and the acceptance by the examiners of

the applicant's compliances with those requirements are subject to appellate review, the

standard of review is that of the Administrative Procedure Act, not the de novo

untangling of internal procedures for which my colleagues remand to the district court.

See Dickinson v. Zurko, 527 U.S. 150 (1999).

The majority opinion, in its footnote 1, misperceives my concern. The

issue is not the standard of review of the agency s findings of substantive fact 

determining patentabilty. In holding that lithe PTO is an lagency' subject to the APA'

constraints, Zurko, 527 U.S. at 1819, the Court required that matters of agency

procedure (such as whether a restriction requirement must be repeated) are delegated

to the agency. The APA assigns such procedures, which have no substantive impact,

to internal agency management; the panel majority distorts the administrative process

03-1077
Restriction Requirements are not Appealable within the PTO

The PTO has myriad procedures to guide and faciltate the conduct of patent

examination. Rules of operation are essential to the effective performance of a

complex agency with many employees and an enormous volume of work. The PTOl

patent examination procedures fill a three-inch thick Manual of fine print. In addition

PTO regulations fill Volume 37 of the Code of Federal Regulations. Over 3500

scientists and engineers apply these procedures to the most advanced science and

technology of the age.

Early in the evolution of patent examination the Patent Office adopted the

discretionarY restricti6i1" practice, to , simplify the' search , and examination of complex

inventions. In electing to require "restriction" the patent examiner requires the applicant

to select a specified aspect of the claimed subject matter, the examiner having first

divided the subject matter into groups of cJaims based on classification for search

purposes. The applicant then selects the aspect to be examined, and usually also

traverses the requirement, a formality grounded in administrative protocols.

Examination then proceeds as to the selected subject matter. The non-selected

aspects are then removed from consideration in that case; they may be rejoined or they

may be moved into one or more divisional applications for examination. Lest the first

patent be citable as prior art against a divisional application -- an ilogical event that

in holding that the agency s examining practices in complex cases receive plenary . judicial review and management. 

In 2002 the PTO received 333 688 new patent applications and granted

162 221 patents. See 2002 United States Patent & Trademark Offce Performance &

Accountabiliy Rep. at 15. The average pendency was twenty-four months id. , and

hundreds of thousands of applications are under examination at any given time.

03-1077
apparently had occurred -- the 1952 Patent Act precluded this event by enacting 121.

Thus the patentee was shielded from this unintended substantive consequence of an

examination procedural convenience. In Applied Materials. Inc. v. Advanced

Semiconductor Materials America. Inc. , 98 F,3d 1563 (Fed. Cir. 1996) this court

explained:

The purpose of 121 is to accommodate administrative

convenience and to protect the patentee from technical flaws based on

this unappealable examination practice. . .. Section 121, viewed overall,

assures that the technicalities of restriction practice are not elevated from

their purpose of examination convenience to a potential taint on the

validity of the ensuing patents.

kl at 1568.

In the present case, four different examiners imposed somewhat variant

restriction requirements, reflecting their divergent views of how the subject matter

should be divided ,for search and examination. Some examiners grouped all of the

platinum compounds together and all of the cancer-treatment uses together; another

put the compositions with the compounds, another with the uses; another separated the

different kinds of platinum compounds; another included the corresponding composition

and use claims with each type of platinum compound. Some required an election of

species; some did not.

To each examiner restriction requirement, the applicant made the requisite

election from among the examiner s categories, while duly "traversing" the requirement.

None of the examiners objected to the applicant's compliance with any of the restriction

requirements. None rejected a later filed application on an earlier on.e. None of these

actions is appealable to the Board of Appeals or the courts. The Court of Customs and

Patent Appeals explained that a restriction decision is not an actual rejection on

03-1077
. . 

grounds of patentabilty, but simply a procedural requirement. The court explained in 

re Henaehold , 440 F.2d 1395, 1399 (CCPA 1971):

On considering 99121 , 132 and 134 and the intent unmistakably evinced

by the clear language therein, it is evident to us that Congress. . . decided

not to regard the procedure involved in matters of "division" or "restriction

as a "rejection. Instead, section 121 denominates restriction procedure

as a "requirement." . It is apparent, then, that Congress intended to

differentiate between whatever requirements and objections an examiner

might make on the one hand , and matters involving actual rejections of

claims on the other, at least insofar as its provision of statutory rights of

appeal to the board accruing from such actions in and of themselves.

440 F.2d at 1402-03 (citations omitted). Restriction requirements are like other PTO

requirements" that are "matters of a discretionary, procedural or nonsubstantive

nature. ld. at 1403. See also Inre Harnisch, 631 F.2d 716 (CCPA1980):

In the PTO, patent applications are examined for compliance with the

statutory provisions of Title 35, United States Code, as set forth in

sections 100, 101 , 102, 103, and 112. These are considered to be

examinations "on the merits." There are also procedural questions arising

under section 121 and related PTO rules concerned with "restriction

practice. "

!! at 721.

The only remedy available to an applicant who is dissatisfied with the restriction

requirement is a petition to the Director for review:

37 C. R. 91. 144. After a final requirement for restriction, the applicant

in addition to making any reply due on the remainder of the action, may

petition the Director to review the requirement. Petition may be deferred

until after final action- on or allowance of claims to the invention elected

but must be filed not later than appeal. ,A petition wil not be considered if

reconsideration of the requirement was not requested (see 91. 181).

Such a procedure implements standard administrative practice relative to agency

actions. See generallv .Mn v. Occupa etv & Health Review Comm , 499

S. 144, 151 (1991) ("Because applying an agency regulation to complex or

03-1077
changing circumstances, calls upon the agency s unique expertise and policymaking

prerogatives, we presume that the power authoritatively to interpret its own regulations

is a component of the agency s delegated lawmaking powers. "

,. Indeed, should there be any imperfections in the agency s interpretations or

applications of the regulations with respect to the examiner's theory of restriction or

compliance by the applicant, they are not grounds of invalidity. See Maanivision. Inc. v.

Bonneau Co. , 115 F.3d 956 (Fed. Cir. 1997):

Procedural lapses during examination, should they occur, do not provide

grounds of invalidity. Absent proof of inequitable conduct, the examiner

or the applicantls absolute compliance with the internal rules of patent

examination becomes irrelevant after the patent has issued.

k! at 960. Such internal agency procedures are not judicially reviewable. See Hvatt v.

Boone , 146 F.3d 1348 (Fed. Cir. 1998):

Regularity of routine administrative procedures is presumed , and

departure therefrom, should such have occurred, is not grounds of

collateral attack. Courts should not readily intervene in the day-to-day

operations of an administrative agency, especially when the agency

practice is in straightforward implementation of the statute.

Id. at 1355-56.

The presumption of validity would collapse if the PTOls administration of the

restriction protocols could be turned into satellte litigation of patent-destroying

consequence. In American Hoist & Derrick Co. V. Sowa & Sons. Inc. , 725 F.2d 1350

(Fed. Cir. 1984) the court referred to

the deference that is due to a qualified government agency presumed to

have properly done its job, which includes one or more (patent) examiners

who are assumed to have some expertise in interpreting the references

and to be familiar from their work with the level of skil in the art and

whose duty it is to issue only valid patents.

k! at 1359.

03-1077
Restriction is a Discretionary Requirement

No statute defines the parameters of the examiner discretion beyond the

authorization of 35 U. C. 9121, for the subject and scope of this discretion is unrelated

to patentabilty. In In re Henaehold the court explained:

There are a host of various kinds of decisions an examiner makes in the

examination proceeding -- mostly matters of a discretionary, procedural or

nonsubstantive nature -- which have not been and are not now appealable

to the board or to this court. . . (A) requirement for restriction under

9121 is now one of those discretionary matters no longer tantamount to a

rejection of the claims, . . .

440 F.2d at 1339.

The entrusting of discretionarx agency pr cedures , o agency management is a

classical administrative practice, requiring judicial restraint. See Vermont Yankee

Nuclear Power Corp. v. Natural Res. Def. Council, Inc., 435 U.S. 519 (1978):

(T)his Court has for more than four decades emphasized that the

formulation o(procedures was basically to be left within the discretion of

the agencies to which Congress had confided the responsibilty for

substantive judgments.

Id. at 524. In Citizens to Preserve Overton Park. Inc. v. Volpe, 401 U.S. 402, 410

(1971) the Court, interpreting the Administrative Procedure Act, stated that internal

agency actions are not reviewable if either (1) Congress expressed an intent to prohibit

judicial review, or (2) the decision is "committed to agency discretion.'1

Undoubtedly' the procedures surrounding restriction requirements can be

complex. An entire Chapter of the Manual of Patenting Examining Procedure , is

devoted to it. 3 By statute it is discretionary, for its purpose is administrative

A commentator experienced in the field states: "Many patent examiners

and patent practitioners are confused by restriction practice and unity of invention

practice in the (USPTO)." Jon W. Henry, Some Comments on "Independent and

03-1077
. .

convenience , not pitfalls in substantive validity. The fact that four examiners made

somewhat inconsistent requirements for restriction does not change the controllng

weight of the examiners' steady determination of the applicant's compliance with their

requirements. A discretionary action having no substantive consequence and that is

unreviewable is not a ground of patent invalidity, and is not subject to collateral attack.

Remand is Inappropriate

The panel majority orders the district court to repeat its review of the restriction

process, to search for flaws in the procedure, for my colleagues find it too complex for

their appellate decipherment. A complex agency record is not sound reason to discard

the required agency deference, or to ask the district court to repeat what the court has

already done and ruled upon. Whatever the continuing force of the pre-Zurko

consonance" cases, on which the majority relies, in this case the patents at issue were

the product of restriction requirements in which the examiners accepted the applicant'

elections and the ensuing divisional applications. The courts lack authority to invalidate

Distinct" Inventions of 35 U. C. '121 and Unity of Invention (pt. 1), 84 J. Pat. 

Trademark Off. Soc y 745, 748 (2002). 

The majority states by footnote that precedent requires de novo review of

not only the lineage of continuating and divisional applications, but also of the

correctness of the examiner s issuance of restriction requirements and the examiner

acceptance of the applicantls response to restriction requirements. That is an inapt

enlargement of precedent, indeed the case on which the majority relies Geneva

Pharmaceuticals, Inc. v. GlaxoSmithKline. PLC, 349 F.3d 1373 (Fed. Cir. 2003), states

that "requirements for restriction under 35 U. C. 121 are discretionary with the

Commissioner." 19 at 1378 quoting MPEP '803.01. The Manual of Patent Examining

Procedure abjures the examiners to exercise care in making restriction requirements,

id" but neither the MPEP nor any judicial decision removes the discretion of the

Director, formerly termed the Commissioner, nor carves out an exception for restriction

requirements into APA review of discretionary actions.

03-1077
. .

the patent on the basis of an asserted flaw in a discretionary procedure, here proposed

after sixteen years. That these restriction requirements were varied ahd somewhat

inconsistent cannot now penalize the patentee, who complied with them and whose

compliance was accepted by all of the examiners involved in the examination. See

Northern Telecom. Inc. v. Datapoint CorP., 908 F.2d 931, 938 (Fed. Cir. 1990) ("rA)ny

doubt as to whether the examiner lapsed in his duty (under 121) does not increase the

burden on the applicant. "

The sequence of restriction requirements was presented to the district court, who

decided the question. It cannot be correct that when the examiner found no flaw in this

non-substantive non-appealable procedure, the courts can later conduct a de novo

search for some tenuous lapse, and invalidate any patent for which we disagree with

the agency s discretionary decision. In Securities & ExchanQe Commission v. Chenerv

Corp. , 318 U.S. 80 (1943), the Court discussed such discretionary administrative

authority:

If the action rests upon an administrative determination -- an exercise of

judgment in an area which Congress has entrusted to the agency -- of

course it must not be set aside because the reviewing court might have

made a different determination were it empowered to do so. But if the

action is based upon a determination of law as to which the reviewing

authority of the courts does come into play, an order may not stand if the

agency has misconceived the law.

1! at 94.

Compliance with a restriction requirement is an "exercise of judgment, id. , and is

entrusted to the Director. Each examiner in the case before us determined that the

applicant had complied with the requirement that was imposed. The question of

03-1077
. 

restriction, its correctness and its compliance, cannot now be collaterally attacked as

grounds of patent invalidity. The district court's decision should be affrmed.

03-1077
Attachment Number 5

REDACTED
FITZPATRICK. CELLA. HAER & VED

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April 8, 2004

VI BA DELIVRY

The Honorable Jan Horably

Clerk of the Cour

u.s. Cour of Appea for the Federa Circuit

717 Madson Pl., N. W.

Room 401

Washington, D.C. 20439

Re: Bristol-Myers Sqwob Company, et a1.

v. Phaachemie B.

Appea No. 03-1077

Dea Mr. Hambly:

Because there is a pending Motion For Reheag En Ban in the above

appeal I am Wrtig on behaf of all paries to inform the Cour tht the pares have an

agreement in priciple for reolving the litigation. The pares will submit a Stipulon diming the case ealy next week for the Cour' s approval.

Resectfly submitted ,

;tr

Rober L. Baechtold 

cc: David T. Pritik, Esq.

Fracis C. Lynch, Esq.

AMagm

DC3.tIN 162717,,1