throbber
(12) 4 34tt RAIS AOL AEA S 1BR
`
`(19) HERSO AS AT HeA
`HRSA
`
`(43) BIRGRA
`2004 4F3 A4 A (04.03.2004)
`
` (10) BRAHMS Ss
`
`WO 2004/017973 Al
`
`(51) BRR st 3 HB’:
`AG61P 25/18 // COTD 417/12
`
`A61K 31/496,
`
`(21) BROS S:
`
`PCT/JP2003/010490
`
`(22) ERR RA:
`
`2003 4£8 A20 A (20.08.2003)
`
`(25) ERR WR Se:
`
`(26) BIRR ABA Bee:
`
`(30) BAET—4:
`60/404,927
`
`AA
`
`AA
`
`2002 4E8 A 22 A (22.08.2002)
`
`US
`
`(71) WRBA (KABER<K SCOREBIXDUT): ER
`sal SEE Ste tt (SUMITOMO PHARMACEUTICALS
`COMPANY,LIMITED)[JP/JP]; 541-8510 AMRAF XK
`Bari ph REE HT2T A 2285 Osaka(IP).
`
`(72) FHA; SKU
`(75) FFAS/MBA (KEI DU COA): PH =F (NAKA-
`MURA,Mitsutaka) [JP/JP]; 7541-0045 KBRAT KPA
`RBIS2T A238 ERMASLA Osaka
`(JP). 4 BR (OGASA,Masaaki) [JP/JP]; T 541-0045
`AR Ath $REGEN2T A2B85 ERM
`eat SFt A Osaka (IP). 20 4 St (SAMI,Shunsuke)
`[JP/JP]; 7541-0045 KiAF Aik PRR BBAT2T
`A288 (ESat St W Osaka(IP).
`
`(74) IBA: EO, 9}(CKXAWAMIYA,Osamuet al.); T
`540-0001 AAT Aikrh PRRRMA1T B3B7S1MP
`ko ob ET LU BSA Osaka (JP).
`
`(81) 485€H (BIA): AE, AG, AL, AM,AT, AU, AZ, BA, BB,
`BG,BR, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK,
`DM,DZ,EC,EE, ES, FI, GB, GD, GE, GH, GM, HR, HU,
`ID, IL, IN,IS, JP, KE, KG, KR, KZ, LC, LK, LR, LS, LT,
`LU,LV, MA, MD, MG, MK, MN, MW, MX, MZ,NI, NO,
`NZ, OM,PG, PH, PL, PT, RO, RU, SC, SD, SE, SG, SK,
`SL, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC,
`VN, YU, ZA, ZM, ZW.
`
`(84) #85e HB (ik): ARIPO #434 (GH, GM, KE, LS, MW, MZ,
`SD, SL, SZ, TZ, UG, ZM, ZW), 1-3 YF (AM,
`AZ, BY, KG, KZ, MD, RU, TJ, TM), 3—O wy s\ 4
`(AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB,
`GR, HU,IE, IT, LU, MC, NL, PT, RO,SE, SI, SK, TR),
`OAPI #43 (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW,
`ML,MR,NE, SN, TD, TG).
`
`RAS A:
`RRS RAaS
`
`2MFI—FRUMHOMBIANDUTCIA, EHRAENS
`SPCTH Hy FORBITEBMENTUS TI— FER
`OH4FVYA/—+b) eB.
`
`(54) Title: REMEDY FOR INTEGRATION DYSFUNCTION SYNDROME
`
`(54) HAOZM: Ra RAEARAl
`
`
`
`ACL|IAAYANIMUIOOTUTAAA
`
`(57) Abstract: It is intended to provide a novel methodoftreating integration dysfunction syndrome. Namely, 5 mg to 120 mg/day of
`7) an active compound (1R,2S,3R,4S)-N-[(1R,2R)-2-[4-(1 ,2-benzoisothiazol-3-yl)- 1-piperazinylmethyl]-1-cyclohexylmethyl]-2,3-bi-
`E~ cyclo[2.2.1]heptane dicarboxyimide or its pharmaceutically acceptablesalt (for example, hydrochloride) is orally administered to a
`patient with integration dysfunction syndrome once a day. According to this method, broad symptomsofintegration dysfunction
`syndrome, in particular, positive symptoms and negative symptoms, can be ameliorated without causing any extrapyramidal reac-
`eS tions.
`
`179
`2004/ (57) BH: MARAE OMMERRAKERHETSZAEDCHPrPC. BHEtKAWELT
`
`(1R,28,3R,4S)-N-[(1R,2R}2-[4-(1, 2-44 VFP VIL 8-4 WL) 1 -E RS VAIS FILE I1-
`VIONLYILAF ILE 2, 3-EVIO[2.2.1]NFTaV VARA FE FERMSZEORBRELHAB EN SHA
`©} if, BBE. 1BRBSBSme~120meiitibi, RABE BSICBORSTAZCEICEY,
`HANRARIVAORPBZEHE DICER“ PMARBEOMAUEK, RIKLBREKEBKEUEBEEKEKET S
`s CéEMCSSMARMEORRAK,. ZOUtHIACAYSARA,
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 001
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 001
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`EXONADBP
`
`ARSERAIL, BLMARAEOIRRTIEK LOVGRAITET 5, SOITHLS
`
`(kL, ASISEIEO EY ANTSAYVINK2 PPRAOMERS 1 A
`
`LMREORSTSU LICE, GEMSMAABER ORESED CLS. MAK
`
`PE COUCHES SHER KOCHITAW SIGRANTES.
`
`10
`
`PBT
`
`GERI (HRDSYR, schizophrenia) lt, ARMEBSHHAO 1 EC. ELL
`
`CHEMIL. BHORIEZ EEO, RBICAROMRBRe SUT. CO
`
`ERITH ILEOIRBCh O, HERE LCI, SEOMRICS< LONSSE
`
`15
`
`VBA EOGHEROIED, RITCCSERABRE LEBER, BHACSE
`
`(CES SRBAMERKREBHS, S OITTOUMUREKE UTI OIER, FRE
`
`TREbKHS,
`
`CL OKMGRAEOIPRITIL, boILSRMRED L OITWSR, RICHO
`
`CHEERS DECh 0, EKAIGMLKBACHRETILDOS LBET Siar
`
`20
`
`RE <. WCE CORMRE Si SVERBHS, CORD, RMREICL SOA
`
`(EOL 720, PPSERDPORMEHORV, RMRE b ARERRRE
`
`V4.
`
`BEIOIE L UCL, AARCDS SX OR, HIZIL, 7
`
`UMP AVLIY, AARVSAVVYYSOFT 2) FT VYGRE 7 I FTV
`
`20
`
`VCLIABER ET SUNT AFH AY, PVAYFEYNEOFAS
`
`PUP UB, AVEV RL AVETU REORY AT ® RIA, 2 OFT
`
`Bl. EFY FG AEOFLI VI ECUPBAREBSY, SHI, ABRU PR
`
`—y, KUNRY Poe POFF AI a) VBR, CPEV PEO IZ ecanT
`
`FVST 2 VBR, 2EBX OBMMBAV SINWS,
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 002
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 002
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`2
`
`LOELRB BS, PIRI, FeO FTUU, Fe IFT VVULE,
`
`SHaA7 x) VFBARE CS, BEREMER LC UC. RRA L. ICE
`
`BAH, BALIHAT ONE Y DIREREET 3 OES
`
`SME AREREREED, VI 2STFNS & VRPRIIRIRIEOIED, BEARS
`ATR EHO P CE BhS, EKO SRFOMMPRRIL, MaAMEICSIT
`SRPERETK, KEPERETK, BAVERO 5b, —RORERICILAWCHSBTRTTO
`
`HEIKO L COREIET S 6 OIL,
`
`LEO. UHL LCOMBARIEICH LCENEMREATS &
`
`FEC, SEASMER ATEIREEO 5 RRIF ORVREREWORBOBEVWS,
`
`10
`
`Hh, AIHADOMMES ITE D WM Stic FRORRCR SNS SRE
`
`(ADS. PUBAUSECRRETRE, PIRRED. & < Cera, BEATA
`
`BA, 77aeSOIRRAIL UCHR EBM SNWSCREE
`
`5,532,372),
`
`AP
`DV
`G-A
`Z—D-N
`\_/
`
`15
`
`su, Ztask:
`
`O
`
`(CHa),
`R!
`N—
`2
`
`R —B
`3
`R"
`R4
`
`Drs: —(CH,),-A-(CH,),—-. Glk%
`
`N—
`
`‘cu
` . ERIM & Arik
`
`FSR, FFERARE,
`
`20
`
`SE ORE
`
`ARSEIL, BMARHEOIRICENKMREA LL. Li biEKOBe
`
`DBS ICH IVS BEARS iEBRHE 78 UEORIVEFR AS 72 << REICHSD TYAB Ze
`
`of LVYARRAIS BLISS << , HOT 3 BRBREIRIZOVC, FOR, ARSE
`
`CREORE Boke, Pats:
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 003
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 003
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`(1)
`
`oy ‘s
`
`GRENS(1R,28,3R,4S)-N-[(1R, 2R)-2-[4-(1, 2-—“~v
`
`YA YVFI YN 8B -A NM) - 1TH ERG VENA FN) - 1-H
`
`AFVI—2,38-EVA7Al2. 2.1AARVVANHEVS & PEKO
`
`Wii 72 U OESLFA SN OHS, POGARTE LCHRIAY TERORBOIRS
`
`AL. £OMEEBS LALARARSTSI LICKED, SEAOMRARIE eS
`
`CER. HD CRAIC MAAME BIR LHS Ob eH LE.
`
`oie b, AHA Les (1) CRSMNS (LR, 28,3R,48S)-N-[(1
`
`R, 2R)—-2—-[4—-(1, 2-NvYV VY4 VF TYNn 8-40) -1- PRY
`
`10
`
`av RFU] -— LAH FanevrAFW)-—2,383-EYV7aAl2.2.1jIn7?
`
`VU AMRF 2 PERMEOBRLAA SN6HOMERt MARMESS
`
`ICL A LEER RSETSO ELD, GEARREIVFR ORES Cb e<,
`
`BEAARE LIBRSAIK, ROUICENMCHAVSIRRAIZERET Sb OTCHS,
`
`15
`
`Pai © fii BALAA
`
`BLSBSR LORRRRICKI 5. RRM OWE(LAWO(LR, 28,
`
`3R,4S)-N-[(1R, 2R)—2-[4—-(1, 2-"vYY4 VF TY—N- 8
`
`—4 IVY) 1H ERG VaAF) A- LAH aneYAFI] -2,38-EY
`
`JALZ.2.1IAPFVYVANHREYAT S PHBLUA AF EMRITE SHAK
`
`20
`
`AEST SORORECh SADRHERRMRE Brief Psychiatric
`
`Rating Scale: BPRS)OABST OREAILERLET IT CS,
`
`385A OFM72BAA
`
`ASEM SOI, (1R,25,3R,4S)-N-[(1R, 2R)—-2-[4-(1, 2
`
`29
`
`KAY YA YFP YN 38-4) - LK PERF Pan eAFr)]-1- yas
`
`HYMAFN]—-2, 8-72. 2.1LINARVY VANESD PE
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 004
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 004
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`4
`
`BAVC, BeeRMCRT ESIC, BUSES b> OMAAEBA ICT LT
`
`PERS 1 ALG WR ORS LEAL OA, RVVERICH CENARE
`
`BPA LI, BC AKI LI, BAOMMPEIC LENS E45 PRESSAB
`
`VER DIB LRD DIF, PRIC. BEEO APSR IT LID LISHED BNSFEAD
`
`Pps DEM DROSNT, kd TRAITPIAAREOITAFES &
`
`be Wi Le.
`
`ye b, AHABAK(1) CHRSNS (LR, 28, 3R,4S)-N-
`
`[(1R, 2R)—2—-[4—-(1, 2-AYV YA VFTYN38 -AN)-1-ES
`
`GVSMVAFNV]-1L-VI ANEYVRAFNV) -—2,3-EYV7ua[2.2.1]6
`
`10
`
`PRVVDNREVS F PERMLOBRLAA SNS, RICOPER
`
`BIAREO ESIC UCLA LER RSETSO LICE, GASB
`
`FROSPBEES CE 7e<. BBE, BUBIEKK, BAEK 72 CIRiEAa,
`
`& < CBHI£ UBEROU DK ET. OH LVBAKED IRATE
`
`REAKT 5 bO CHS,
`
`15
`
`ASEM, ET. DP SHAG OPMIPRA EET 5 OO CHS,
`
`ASAI LHIE, (1R, 2S, 3R,4S)—-N—-[(1R, 2R)-2-[4-(1,
`
`2Z—-RYSAV FF YN 8-4NM) - 1 HERI VENAFN)-1-V74
`
`NEYVAFINI-2,38 -EV7AL2.2. ASR YVANHEHUDPRK
`
`EOBRERR SNS (BIZIL, Ee, LARS ome~1 20m_~,
`
`20
`
`BRELSIUE1LOme~1OOmeg, SHIBELSIE2Omeg~8 Omg OHe
`
`IMCLALARARSTSI EICLY, MAAMEOMRAVERICH LCEvie
`
`eR SNS, Lab, RRHOMRATKIC LM, NF Y VIR
`
`KK. VARY T, TAY VYTSORMMMERAMEAS. DRPRES
`
`HEORMERDBERBO ONT, XDOCREC, RAVPRICOBLTWS,
`
`20
`
`7233, EHEHOMAAHEOREIOBAT SBAlcI, LINEPLAWORS
`
`BE CH SPUD RVECHERRIES 0, PPSBAITIL WF
`
`FEAwO1L ARSE ome~8 Omg, FEL<lt5meg~60mg, S5
`
`HEELS IEL Ome ~ 4 Ome OMMACI A LARORSTS,
`
`LACE OMAAE OIRTIEICAV ON SIARAlIL, BRL (1) CRS
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 005
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 005
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`5
`
`NS(LAWERIMIE ORBEA SNS, HIT(LR, 2S, 3R,4S)-N—
`
`[(1R, 2R)—-2-[4—-(1, 2-48vV YA YFP YN 8-47) -1-EN
`
`GVEMAFVI-A- VI anseyvrzAFNW)\—2,3-Ev7ul2.2,1]~s
`
`PEYVANMREYA > RRS, REMMSEY omg~1 20mg, ME
`
`L<tk1 Omg~1O00meg, SH5IMELSIE2 Omg~8 Omg, OHEBT
`
`SAT ARORA CHS, MORALE UCGEA, FRA, ARALAI, BORA
`
`ATEN, VAEvAASRBeTSnS, Midis 1 A LARSAA
`
`ETS,
`
`EAA, OSH DORRAIOMMICAV ONS RSLS SOE
`
`10
`
`tk, PIZIE, FL, BWR PROB FU UYRBAUA, WAVY,
`
`WV, eeVaA, ABR EOWA, 7K. BAIEDF YY, AW
`
`MIAEVAFIVEVA- A, EA VI, AFKFMENUA-A, TAFETAL, IW
`
`YR RU CHNVEAY PYREORRAL TUEORT hUUAL AYTY
`
`HK. PITIVR, RBKRITbUU AD. HU AHYEF LY YES VAR
`
`15
`
`DAFMVE FOU VHRRT bh UDA. APP U VERE TU EY PE CORE
`
`Al BRAND, ATTY VB. ROMER, RU TF UY TV ave LOR
`
`RANE LEAVY C RIBITHE o CHR SVS,
`
`FRB
`
`20
`
`DETR SEISCABOWES LOMRITOWT E SICAAMT
`
`BTS.
`
`7pis, SERGI CHV RIEHHLAWSM—-13496&Ik (1R,2S,3R,4
`
`S)-N-[(1R, 2R)—2—-[4-(1, 2-—"YY 4 VY FT Y—N- 3-7)
`
`— [HERS VaNVAFM LHI AREYAF) - 2, 3-EvV7 (2.
`
`25
`
`Q.1]IAAPRPVY VINEEFT SRSBRL, SRO POMELTHOR
`
`DSM-IV: Diagnostic and Statistical Manual of Mental Disorders,
`
`30
`
`CGI—S:
`
`4th ed.
`CAPR ODUR L Biay = = 7 VE 4 HD)
`Clinical Global Impressions scale-Severity of Illness
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 006
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 006
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`CGI-TI:
`
`AIMS:
`
`EPS:
`
`LOCF:
`
`10
`
`BAS:
`
`SAS:
`
`15
`
`PANSS:
`
`6
`
`(GPRARESBeeBAASBE)
`Clinical Global Impressions scale-Improvement
`(RRREAREDRBEE)
`Abnormal Involuntary Movement Scale
`(RRRNE)
`Extrapyramidal symptoms
`(SEARSMESTEA)
`Last Observation Carried Forward
`(LOC FART : FHIASA CEBAILENLARTORTH
`FAW SAN)
`
`Barnes Akathisia Scale
`(FOVSTPRE)
`
`Simpson-Angust Rating Scale
`(SEARSLES ABIEARPREE)
`Positive and Negative Syndrome Scale
`(BSRE + EMERREE)
`
`SERB 1
`
`BUTE1 LPR RRAAR
`
`(1) RRA
`
`20
`
`PRO 1 CARTAIT LD, ORE 1 SHRITKU S14 9 MOMBKMERE
`EMAL LC, EECTS 7 FERROBSRARESilk ST
`PRBRCEY Vava7 yb (washout)#%&, SM—-13496 40mg XMitl
`
`20mg, HL<SMUIURELA LAS BARA RS LARORMERVEE
`
`ze Rat Lc.
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 007
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 007
`
`

`

`RA
`en- 7) TAREE AHR Ee UCR CHIT LEB
`
`
`
`
`
`GFHEERO
`GEA BEE
`
`
`
`
`
`
`
`
`
`WO 2004/017973
`
`PCT/JP2003/010490
`
`#1
`
`
`
`ACESEMD, DSM-IVTERE EL ORAARERRICBC, SME
`13496 -#SE-BICL SO, (HER REA. BERSE, T7 EAR
`
`Re, UTR, GMOS, RSHERLOBATERR
`
`PESBH ORERIVER (DSM-IV) (Od SAERORSE
`
`HEICOVYC, PIERAMHRE KCBSRULE EO RN
`
`TS.
`
`BERIE
`
`
`1) DSM-IVTEIC LARAAEBCOEEHO bO
`
`
`
`
`2) Extracted-BPRSA=742UEAOCGI~SABTAUE
`3) Simpson-Angust’ = 7 2iOA IMS AAT 3 Rh
`4) FRIEDE
`
`
`5)
`1L18~64RO#Be
`
`
`BROKE
`
`
`
`
`1) JERrEORARHER
`2) FARAHARO RECLRAMAT & Be
`3) BRR ORBe
`
`
`4) NOE Y YU, FYDA IR, SE, ERR, TA
`PAUBE
`
`
`5) KebONESR LTV) S BIBBHEO SHO, FL PORS
`6) SAE ARTaT
`
`
`
`RTPY |S PAAR + ARPaie + SETI - ER
`
`
`
`Roe - RSF 4Ome/H, 120meg/HRAFFERE1 ALAC RIM OR
`iB
`5.
`
`
`LARGIR 3 HOFFTERREIZEV GFA Th,
`
`TAvay 7 beROBE 2LAB
`
`
`
`
`1) LOTHAR OGF Ti72V\, SUREARRANLo
`WSBRbR< &b 3 AGEDA)MILER(FRA OD st
`Ya7 7 PHIRET S.
`
`
`2) SEASUTEIRASEEL LIBR IIENOE VY PROPER Te
`
`
`®o
`3) 7FMRDHBLLEBAICIL FT BADER S,
`
`
`StHRE : 1 3 2Q2PI(VFER, 40mg, 120mg E584 46)
`
`
`PARRTRF: 14 OPI(SPA EARSEH 5 OB, 4 OmeSFE5 0
`
`
`fl, L20mg RSH 4 9 fi)
`
`
`
`AE : PANSS, Extracted-BPRS, CGI-S/I
`
`
`
`Feett : EPS Rating scale(Simpson-Angus, Barnes, AIMS), 7° 4 )V
`
`
`4Y(fh, LEE. HIE. 1 2 BER, BRRRE
`
`
`Cie, RAR, SOP FL, RR
`
`
`4) . WPAISER, IRE:TBR, ASR
`
`
`
`
`(2)ERA
`
`1) AE ORih
`
`(i FRRRATHIZB SBPRSBHEUPANS SK3F(LOCF)RBEUIZC
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 008
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 008
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`8
`
`GI-S#BILOCGI-IABRV(LOCE)®, 4Hen#2BLVUE Blo,
`
`RABLUEIMPSHMSHRLEIM, SM-13496 40mgRU1 20m
`
`g ReSRORRETH(RSE 6D)CHU SRSMDOOAATBYEBP
`
`RS, CGI-IRUCG1~—SHiRHiRBW CT, SRERREHO SHE heL
`
`CistatSAICAREO, ERPANS SAC, MRKTHICKU S SM—
`
`13496 120mgRS5ROAZAT RD BT 7 ERREHROCH Lim
`
`WIZARRESRSN, SM-1349 6 LSRHERKOKEDRY DN.
`
`#2
`
`Ree
`
`(PEREBO
`
`
`
`PIER
`
`SM-13496 40 mg
`
`SN-13496 120 mg
`
`(45)
`
`(47)
`
`(44)
`
`
`
` BPRS
`
`
`
`~4.0
`
`~10. 0
`
`
`“14.1
`~b. 8
`PANSS
`
`(23. 10)
`(14. 06)
`GHAaAy
`
`-11.3
`
`
`
`0. 063
`,
`
`#: Tiy{fll Dunnett’ s tHE (BABRL ST ERE LE OLnBR
`Hi, REBAR, RSCHBSL LEEORO
`
`)
`
`
`
`#3
`
`
`
`
`
`
`
`
`0. 002
`0. 004
`CGI-Ss
`
`
`
`
`amr|3% (sp)|328) (SD) 324 (SD)
`
`
`
`0.0 (0.77)|-0.7 (1. 12) -0.8 (1.03)
`
`(n=41)
`
`(n=41)
`
`(n=40)
`
`CGI-I
`
`(n=45)
`
`(n=47)
`
`4,0 (1.41)
`
`3.2 (1. 56)
`
`0. 013
`
`(n=42)
`
`
`
`3.0 (1. 29)
`
`0.005
`
`H: TVAAR yb tHE (REBE De BE & @EERE)
`eR, RSA, RSAETLRESL LEEDROW
`(i i)EK, BPRS##HAAT (LOCF) O#BETI 7icAT Lb, WHOM
`
`10
`
`LICRT LID CHS, M1lcRT ERY, SM-134968R5HicCBIS
`
`BPRSABRTORSGAMDOOBYDBIL, S72 RRS & RL QIN A Pb
`
`ealANCATE REAR BATE (p<0. 05),
`
`(ii i)S6iz, BRKTRCBUSBPR SODA 2 OYLEBL<S ICG
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 009
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 009
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`9
`
`I-11 RLL2ERLERE (VARY S—-) ORPSREAICRT, B45
`
`SDPREIIZ, SM-13496 40mgRU1 20meKhSHLIFERR
`
`GEE CiplaFANT ARREDBYD bIVIE,
`
`#4.
`
`REE
`
`PEERBO
`
`
`
`
`
`SPER
`
`(45)
`
`(47)
`
`(44)
`
`SM-13496 40 mg
`
`SM-13496 120 mg
`
`
`
`
`
`H: Higay 2as L7& Cochran-Mantel-Haenszel BARE (SAAB & PS NHL OLE)
`2) REVEORMM
`
`Ci) LOMUELOBEITHRY SNKASBRE PaOITAT,
`
`#5
`
`CC—C*dSe
`paar|co||
`
`ELE OAHRIEL OO)
`
`ABERD 1 RUBE HkLI)
`
`ABERIEBAR (%)
`
`HEAR
`
`ma
`
`&Hit
`
`PRYDSP
`
`PEPE RV (HUGE RC)
`
`St
`
`(GAR
`
`&
`Hoe
`
`6 (12)
`
`5 (10)
`
`5 (10)
`
`9 (18)
`
`3 @)
`
`6 (12)
`
`2 (A)
`
`es
`
`3 (6)
`
`7 (4)
`
`5 (10)
`
`7
`
`(14)
`
`5 (10)
`
`1 @)
`
`GROASBRIBY ONCEL VOY ELE,
`KSITRANSERY, 149AF11461(7 7%) CHBSRAaDBYOONE
`
`OD. HEA LBBRENIPSECHok, ASHRIZESAPILGIASM—1 34
`
`10
`
`9 6 REOMR CTI VERERLEYbEB< BOONE,
`
`ERABSHAL, GB WR, TRL TOUT, REDE (REE
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 010
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 010
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`10
`
`EIR<) Chok, BRIT 7ER. SM—-13496 40mg, 120mek
`
`GRECENEMN1 OR, 18%, LAWTBDO SN, MAITSM—-13496
`
`120mg 5-HChORICILRHEE Ch OEMS, WER EIST ST 2 RRS
`
`LU DRDO, HHOWRBISM—-13496 40mgRU120meg
`
`PeG-BE(4 YRU2%)CHP EHR(10%) LYUDRPOK, TAYYT IS
`
`SM—-1349 6RSHCOLBY ON, 40megkOl 20meR5H CoH
`
`ENSRRO1 AY CHOK, SM—-1349 6R5HOFSSRORRBIT
`
`PERE CIRCbok, PHI, BATHE, PERTH, PERRET.
`
`FREELY DILDO,
`
`10
`
`Ci i) _LACaS LIARREAR C88) ON KEBBRASHRTS Pal OORT,
`
`
`
`
`
`ES SARBRAAME ()
`
` SAREOS
`
`ithBor
`
`#HG6IRANSEBRY, PILAR, SM-13496 40mg, 120mg
`
`REHCENEHN API, 3H, 2A ERRABERONE, WPM
`
`TRERAK ¢ ORRERILBE SAE,
`
`15
`
`Ci
`
`i i) Ee, ARAMACHO OALCRIPEA& Pade 7 ICART.
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 011
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 011
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`11
`
`use
`
`HE
`
`q
`
`ee
`
`i)~~
`
`~—
`
`ry
`
`—_~doVs
`
`So
`
`e
`
`osOo=
`
`—i)~
`
`
`
`
`
`
`
`
`
`Pipes|fw50 fw7 [9“49 |
`
`
`
`
`
`eS
`—
`
`
`Wb DIRE
`]
`2—™~|oNEPo™ /o;o!]oSS|oja
`:>oa
`
`ePlo!lo}co
`mempfe1S|
`
`po[Re|p
`mm|aNoO|owa[mo
`o|o
`HERR
`mmloo:—
`ro}Oo[re
`
`ws|™/o|oNee
`oDLo|So—|e
`mmONnw;uwfNw
` ;o|o
`Re|e
`
`He7a
`
`
`
`
`
` in
`
`
`
` veOaHu
`
`
`
`
`|
`
`HFRS
`1 2)
`0 (0)
`Oe
`
`
`|PRGRS Ae
`
`
`
`
`
`
`
`
`
`
`
`
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 012
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 012
`
`

`

`Ba Dee
`
`BIE EV)
`(TlHERca @ BR < )
`
`ie
`
`etwas
`
`ERA
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 013
`
`WO 2004/017973
`
`PCT/JP2003/010490
`
`12
`
`iS
`
`1 F B
`
`K
`
`Be
`
`jee
`
`
`
`
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 013
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`
`
`
`
`MmpAIvyFYy + RA
`AREIM
`
`WS BM
`
`
`
`
`
`
`
`
`
`
`
`RTICRENSEBY, GEFROIL, SM—-13496R5LORREK
`
`SBECE RWER DO (BERD IL, FR, IER, TOYVT, SPEDE
`
`(EISMERCeR <). UR, BRR Choe, SM-1349685HCYA=X
`
`5
`
`— DFFLBSITED? 2 fe (4YAH),
`
`1 2 PRELUDE TIS C HRAICEEBEO SH
`
`PALITFIR7, RRARRB eR LEBSORAICSREC
`
`RERBLRDOK SM—-13496R5HCHSEROMPT AFI FU
`
`DEO OCA. Ni, MFR. AERAUSERATDAGGERCISPRERR
`
`ies & APTIOND,
`
`10
`
`(iv) SBI, HEASHRIERChAVAYRVT(AIMSIZES), FHIYYT
`
`(BASIZES), AH YY VEER(SA SILKS)OPPMOGRER 8 (TAT,
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 014
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 014
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`Fz 8
`
`14
`
`
`
`
`
`
`
`
`AVAWRBE mz (sp)|324) (SD) Ez) (SD)
`
`
`
`AIMS
`0.7 (2.63)
`0.7 (2. 88)
`0.2 (2.21)
`
`
`
`
`
`~0.1 (0.96)|0.1 (1.08)|0.588|0.1 (1.11)|0.808
`
`
`
`#: TERIAAy htRE (BAB LS eR L OLR)
`
`Wi, BORAT. RSA HEEL LEEDROT
`
`*: SEHAayiIZoxn=44~47
`ek: BAS Aa AVAIL
`
`XE SICHESNSRROSM SPRL, REMPOOAZIAYNAMA IT
`
`OPEBSA CoHSMICABREED bNRPok, ~vAbREY
`
`BYE L LEBAIXSM—13 49 ORE C2 4%, SAFURREHTI 8%
`
`Cho%K.
`
`pose LOAAATABLE
`
`ARIS OREAAVEDIPRAIEB LOSTAV SIARAIIL, HEPELAWO
`
`(1R,2S,3R,4S)—-N-[(1R,2R)—2-[4-(1, 2-"Y YA VFS
`
`10
`
`Yor 8-4) — LH ER FVENV AFNI - LAY BNIRAFI] —
`
`2,8-EY7 (2. 2. 1IAAPYVINREFD PERME ORSLAA
`
`SiS, PICOMERTMARHED BAIUCLA LERORSEST
`
`SrUICKO, AVHRR REA OPED CO ER<, BRR, MEEK,
`
`AMER: CIRieee, CS CGPI£ OREROCIEI
`
`15
`
`SRR L. ERICPDS DBM CIEE © SHER ZS LORD OIL
`
`72), HD CREIHAT SOLS CE, RRRORSGITDIBL, S 6 ICSat
`
`ILbRBICAVEBS ED, EDD CENKIRRATIES LOBRAl CHS.
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 015
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 015
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`1. BAREBSOWRDCho Tt, TEHEKAwEELTHK(1):
`aq
`OH
`
`
`ee
`Tits
`Ho
`
`(1)
`
`N ors
`.
`=
`SH A
`
`Ny
`N
`/
`N-Z S
`N
`'*“N
`
`CRAEMS(1R,25,38R,48S)—-N-[(1R, 2R)-—2-[4-(1, 2-~v
`
`SHA VFIF LN 8-4 NM) 1K ERG VENAFNV) - 1-7 ane
`
`RFMVI—2,3-EY7 a2. 2. 1]NFRPVVONHA TY2 PERHMtOR
`
`EAA SN OMe LARGER ome~1 20mg C1 AL MRARSSSCL
`
`(CLOT, PEASERIVER OPELAED MERC. PRRAELIBIG SK,
`
`10
`
`2. HtEbawA, (1R,2S,3R,4S)-N-[(1R, 2R)—2-[4—-(1,
`
`2—-RY YA VFI TYHN 8B -AN) HL HER FVaNAFN)-1-Yr7u
`
`AKUVAFN]—2,3 -EV7H[2.2.1INPRYVANWR2 EE
`
`taCd SFR 1 (CARO WARK,
`
`3. BEAARMED VEER EET 6 PR 1 EVIL 2 CHMOD,
`
`15
`
`4. ReAREOBMIEKS kOBRERE EET SFPRE 1 EK 2 ICRAMO
`
`RATE.
`
`5. WMMKGWO(1LR,2S,3R,4S)-N—-[(1R, 2R)—2-[4-(1, 2
`
`RAYS AVFFSV 38 -4A NM)-A KH ERP VENRAFI)-1-yg as
`
`HYMAFNVI]-2,38-ECv7al[2.2.1InARVYVAN4 S PR
`
`20
`
`eLARSB2 Omeg~8 Omg 1A 1 AROSST SIR 1 EK
`
`MOWAT
`
`6. PARTEORE EET 5 AR 5 IRROAK,
`
`7. BEARRHEO BPRS L UBER 2 CET SR 5 ITEROAY,
`
`8. EERIORAARIEOIGROTIECho TC. MEERWO(1R,2S8,3R,4
`S)-N—[(1R,2R)—2—[4—(1, 2-AYYR VFTY—N- 8-4 0)
`—LHERFVANVA FN) - 1 HONEA FN)—-2,39-EFe7e[e2.
`
`25
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 016
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 016
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`16
`
`2.1INTFYVYANHRAT4 > PRR LARSBS me~8 Ome C1A
`
`LARORSTSOLITL OT, GEASHRRBIER OPREEHS OLR. RE
`
`AME KEES SHAR L Eick 2 CAMO,
`
`9. RiaORE CET SAC 8 ITEROIE,
`
`10. MAAHEOBMERS LOBHHERE RET SRE 8 ICRROIRA
`
`1k,
`
`11. We(KeWO(1R,2S,3R,4S)—-N-[(1R, 2R)—-2-[4—-(1,
`
`2—-AYV SA VFTSN 8-H LOH ER PYaN AFN-1L-Y7u
`
`NEYAFW]—2,38-EVY AQ. 2.1InRAPRVVINX 2 SB
`
`10
`
`ie 1 ARSE 1 Omg~40meg C1 1 RORSTARS ICHROU
`
`ROT.
`
`12. BAARORMIER CUES SRA 1 1 CHROIRO,
`
`13. MeATEOBMHERS LOBHER SUGEEST SR 1 1 (CHRO
`
`Fiitk.
`
`15
`
`14. Ekewe UTH(1) :
`<c——=
`
`H
`
`.
`J Ny’
`
`Ho
`=
`Tlir
`

`\
`Ny
`=e—N N-" 'S
`H H
`\_/
`
`;
`
`(1)
`
`CRENS(1R,2S,3R,48S)-N-[(1R,2R)—2—-[4-(1, 2-~v
`
`SA VFIFT SN 8-4) - 1H ERG VEN AFIN) - 1-Hane
`
`AFMVI]—2,383-EVI7a[2. 2. UANAPRVYVANE 2 PERMEOER
`
`20
`
`REAASNSe LAL ERORSRE LCome~l 20mg SA ahis
`
`WE OVA,
`
`15. Weke@wA, (1R,2S,8R,48S)-N-[(1R, 2R)-2-[4-
`
`(1, 2-RYY 4 VF TYN38 - 4) - 1H URS VEaNAF) -1-Y
`
`DAUNEYMAFNV]—2,8-EV7EL2. 2. 1InRGRVVNREVI TE
`
`25
`
`HAMSCd SAAR 1 4 CHRROIARA
`
`16. WHILAwWOGAES 2 Ome~8 Omg CHSMREAIAERIZISK
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 017
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 017
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`17
`
`ECROIARA,
`
`17. (1):
`
`#49i Qn N.
`
`
`[ft
`Ho
`
`SiarNT?
`
`(1)
`
`CRENS(IR, 25,38R,4S)-N—-[(1R, 2R)—-2-[4—-(1, 2-“~v
`
`DAVFIF YN 8 -A NM) LH ERG VaR FN) - LHI BAN
`
`AFW)—2,38-Cv7a[2. 2.1 AASPVVANES YA PERIMCOR
`
`3KLEPA SPN ABOMARMEIARAL SMELT SOOKE,
`18. WMekewas, (1R,25S,3R,4S)-N-[(1R, 2R)—-2-[4-
`
`(1, 2-—RY SAV FTSN 38 -ANM) HLH ERG VENAFNI-1—-Y
`
`10
`
`DANEYUWVAFN)—-2, 8-EVAual2. 2.1]InAFFVYVANREP
`
`SMSC db SFR 1 7 CLOEAL
`
`
`19. BEAESRAIDISHMLAwe 1 LEA RSELt LUC omg~l1 2
`
`Omg StS, MORAL 7 ERIE 8 (CHRO,
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 018
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 018
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`1/1
`
`4 1
`
`
`
`
` —O— Foe (n=49)
`—m— SM-13496 40 mg“ (n=49)
`—O— SM-13496 120mg’ (n=47)
`
`
`
`4 4 8
`
`+10
`
`12
`
`
`
`ZAPORPHYEIL
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`Byles)
`
`(sled)
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 019
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 019
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/JP03/10490
`
`A. CLASSIFICATION OF SUBJECT MATTER
`Int.Cl’ A61K31/496, A61P25/18//C07D417/12
`
`According to International Patent Classification (IPC) or to both nationalclassification and IPC
`
`B. FIELDS SEARCHED
`Minimum documentation searched(classification system followed by classification symbols)
`Int.Cl’ A61K31/496, CO7D417/12
`
`Documentation searched other than minimum documentation to the extent that such documentsare included in the fields searched
`
`Electronic data base consulted during the international search (name ofdata base and, wherepracticable, search terms used)
`CAOLD (STN)
`REGISTRY (STN), CAPLUS (STN),
`
`C.fC.CONSIDEREDTOBERBLEVANTsssssisi‘“‘“(‘“(C;*™*rDOCUMENTS CONSIDERED TO BE RELEVANT
`
`
`
`"Relevant to claim No.
`Category*
`Citation of document, with indication, where appropriate, ofthe relevant passages
`08 January, 1992
`LID.),
`EP 464846 Al
`(SUMITOMO PHARMACEUTICALS CO.,
`(08.01.92),
`Full text; particularly,
`lines 29 to 34
`& JP 05-017440 A
`& CA 2046429 A
`
`(101); page 13,
`
`& US 5532372 A
`
`14-19
`
`(SUMITOMO PHARMACEUTICALS CO.
`
` compound
`
`WO 02/24166 Al
`LTD.),
`(28.03.02),
`28 March, 2002
`Full text; particularly,
`examples
`& AU 2001086237 A
`& BP 1327440 Al
`
`LC] See patent family annex.
`[_] Further documentsare listed in the continuation ofBox C.
`“T”—later documentpublished after the internationalfiling date or
`Special categories of cited documents:
`priority date and not in conflict with the application but cited to
`documentdefining the generalstate of the art which is not
`considered to be of particular relevance
`understand the principle or theory underlying the invention
`documentofparticular relevance; the claimed invention cannot be
`earlier documentbut published on orafter the internationalfiling
`date
`considered novel or cannot be considered to involve an inventive
`step when the documentis taken alone
`document which may throw doubts on priority claim(s) or which is
`documentofparticular relevance; the claimed invention cannot be
`cited to establish the publication date of anothercitation or other
`considered to involve an inventive step when the documentis
`special reason(as specified)
`combined with one or more other such documents, such
`documentreferring to an oral disclosure, use, exhibition or other
`means
`combination being obvious to a person skilled in the art
`document memberof the same patent family
`
`“ye
`
`“yr
`
`documentpublished priorto the internationalfiling date but later
`than thepriority date claimed
`Date of the actual completion ofthe international search
`25 November, 2003 (25.11.03)
`
`Date of mailing ofthe international search report
`16 December, 2003 (16.12.03)
`
`Name and mailing address of the ISA/
`Japanese Patent Office
`
`Facsimile No.
`
`Form PCT/ISA/210 (second sheet) (July 1998)
`
`Authorized officer
`
`Telephone No.
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 020
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 020
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/JP03/10490
`
`Box I Observations where certain claims were found unsearchable (Continuation of item 2 of first sheet)
`This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons:
`
`1.
`
`Claims Nos: 1 to 13
`
`2. [| Claims Nos.:
`becausetheyrelate to parts ofthe international application that do not comply with the prescribed requirements to such an
`extent that no meaningful international search can becarried out, specifically:
`
`3. [| Claims Nos.:
`because they are dependentclaimsandare not drafted in accordance with the second and third sentences of Rule 6.4(a).
`
`Box II Observations whereunity of invention is lacking (Continuation of item 3 of first sheet)
`
`,
`
`This International Searching Authority found multiple inventions in this international application, as follows:
`
`1, [| As all required additional search fees were timely paid by the applicant, this international search report covers all searchable
`claims.
`
`2. [| Asall searchable claims could be searched without effortjustifying an additional fee, this Authority did not invite payment
`of any additionalfee.
`
`3. [| As only someofthe required additional search fees were timely paid by the applicant, this international search report covers
`only those claims for which fees were paid, specifically claims Nos.:
`
`because theyrelate to subject matter not required to be searched bythis Authority, namely:
`Claims 1 to 13 pertain to methods for treatment of the human body by surgery
`or therapy andthus relate toa subject matter which this International Searching
`Authority is not required to search.
`
`[| No protest accompanied the paymentofadditionalsearch fees.
`
`4. [| No required additional search fees were timely paid by the applicant. Consequently, thisinternational search report is
`restricted to the inventionfirst mentioned in the claims; it is covered by claims Nos.:
`
`Remark on Protest [|
`
`Theadditional search fees were accompanied by the applicant’s protest.
`
`Form PCT/ISA/210 (continuation offirst sheet (1)) (July 1998)
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 021
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 021
`
`

`

`A. ®SHOBTS7HODR (BRO (1 PC) )
`
`ESieeetay
`
`PSHE PCT/IP03/10490
`
`Int. C17 A61K31/496, A61P25/18 // COTD417/12
`
`B. Wee ToORDe
`HaeTokeMRA RTO CI PC) )
`
`Int. Cl’ A61K31/496, CO7D417/12
`
`Re/MRASLDAORSCHE E172 KDHE ENS BO
`
`BURMACR LRPIAP AHA (FHAAOAA, REICH Lc
`
`REGISTRY (STN), CAPLUS (STN) , CAOLD (STN)
`
`aee te
`|
`
`Dray—x|
`
`X
`
`X
`
`BAH, ROCOMOMPREET SL x1, OMT SORE
`
`
`(SUMITOMO PHARMACEUTICALS COMPANY, LIMITED)
`
`EP 464846 Al
`1992. 01. 08
`BX. IEA (101) RO1 3R29~3 47S
`&JP 05-017440 A &US 5532372 A &CA 2046429 A
`
`(FEACERIRERELS4L) 2002. 03. 28
`WO 02/24166 Al
`BX, HICHPIBAR
`&EP 1327440 Al &AU 2001086237 A
`
`
`
`
`
`
`
`AROTOBE
`
`14-19
`
`14-19
`
`
`[J Cilogee cb RMA NTS.
`[L] AFv br SIMMSSREB.
`* BIRCRODFT TY
`OH OGIAH SNE
`(A) RICBREOSIMCHAS OT) BPR ISB RITARSNEMMTCHOT
`bO
`HLFETS bO CSE <. BAOREML
`TE) ESHER BIO HRS ceCSD, ERE
`DEROEOIZUATSbO
`DECAREHEDO
`IX) FCPOD SMKChHoC, SROCKOSCEH
`TL) GEFSHESSRITHERS EEETB OCHREALDMROAGT
`DSTFAPERITHEBED RAV LBA SNSSO
`Aa Le LORRIERT SE DISIETS
`TY) BOSS MRCHOT, SROCHL HOLY
`SRK GER eH)
`LOXREO, SHRI Lo CHAChH SMetI
`[O] ARRIC KSB, A, BRECERT SMM
`Loa CHEBEBRVEBZSNSLO
`IP) ERMA ATC, DORHOTFRORML SHR [&) AAT Yb 7 7 RY 3
`
`
`
`HPSe5eT LA
`PAA368 A
`25.11. 038 16.12.03
`
` [a7]p05
`KRTHE (HIRO SIR) zo
`
`
`EAR OLRRUS CH
`Ae}SAG
`A P=
`
`RABBIT (CISA/J P)
`
`
`TPES 100-8915
`Bee 03-3581-1101 Am 3492
`
`RRATRERBSHLTAAB3
`
`
`
`HERPCT/ISA/210 (B2x-Y)
`(1998474)
`
`
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 022
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 022
`
`

`

`ERAS
`
`BMWSS PCT/JPO03/10490
`
`Ligiro fe,
`
`PROM 1~1 BILENITRIC LEAKOMBAEROPTIECH, COE
`PISARRRBA 4m LEE LAVMBILRS EO CHS,
`
`tk, AEB RARMAETS LM Ck CREE CHEOBFEMKLTYY
`MRO
`7PV IREOMAITHRS BOCHS, DEY,
`
`2RORH
`Fito CHR S IVT),
`
`Ik, RBAPROGH CH oT PC THUG. 4(a) OH 2 LRU 3 KOMEI
`
`A OM—PEBARML CWS LEORE 1X VO 3 ORE
`
`RIAD LOCI OBB IULORBARHS L-OBBMMBARBTROL.
`
`SS Hl FROG O—-MOMEA CARY LEORE GB1X- VO 2 OE)
`BH SARI (PCT 17RDG)) CREED. <ORMEARORAEY REROROBICOCH
`1. k] HRoOgEH
`1-13
`ik, — ORRARMBMAETS IL EBLRVWRILRS OCHS,
`DED,
`
`[] sSOUBAAS=ERCSNet & RIC BLAa © ARERR ECARDTe
`
`AaERSTSCAH LOC, CORDA, TC ORBITER
`OPI OVYC HERR Lice
`. () RNAAEEBLEBERTSE CHES. FAC OMAROMITOVCHET S IER TEROT, JB
`ANFAZSEPBBOAH BRD PBA Te
`
`BAReeePESeROA LORAIN LADOKOTC, CORDHEREIL SEO
`MO t aICROPBROHA OAC OV THER Leo
`
`EJ HRADABEEACESIAC LADO LOC, CORPREIL, APROMGAORMICA
`SIVTW A ASAITAR RORO HA ICOVV CHER LZ.
`
`INEFREORRO Hicict SER
`(] JE01RSBORLOMACEIDb RMAC Rb ore,
`
`MSRP CT/ISA/210 (81%-VOwBE (1) )
`
`(1998478)
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 023
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 023
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket