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`Par Pharm., Inc.
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`Par Pharm., Inc.
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`Page 001
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`Par Pharm., Inc.
`Exhibit 1019
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`Par Pharm., Inc.
`Exhibit 1019
`Page 002
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`WO 2004/017973
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`Par Pharm., Inc.
`Exhibit 1019
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`Par Pharm., Inc.
`Exhibit 1019
`Page 003
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`

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`WO 2004/017973
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`Par Pharm., Inc.
`Exhibit 1019
`Pae 004
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`Par Pharm., Inc.
`Exhibit 1019
`Page 004
`
`

`

`WO 2004/017973
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`Par Pharm., Inc.
`Exhibit 1019
`Pae 005
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`Par Pharm., Inc.
`Exhibit 1019
`Page 005
`
`

`

`WO 2004/017973
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`PCT/JP2003/010490
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`Par Pharm., Inc.
`Exhibit 1019
`Pae 006
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`Par Pharm., Inc.
`Exhibit 1019
`Page 006
`
`

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`Par Pharm., Inc.
`Exhibit 1019
`Pae 007
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`Par Pharm., Inc.
`Exhibit 1019
`Page 007
`
`

`

`WO 2004/017973
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`PCT/JPZOO3/010490
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`
`(UfififiTfimfifiéBpRS$iprNs82:7uxxmwtawmc
`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 008
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 008
`
`

`

`WO 2004/017973
`
`PCT/JPZOO3/010490
`
`8
`
`GI—Sfii3CGI—IXZTUAMHU%\%fl%flfi2%i@§3flfif0
`
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`
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`
`13496 120mgEfifiwx:7mwim7fikfi&fifiw%mkfifii
`
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`
`$2
`
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`
`75-1271?
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`
`13496 40 mg
`
`SM-13496 120 mg
`
`(Wfi%fi)
`
`(%)
`
`(47)
`
`(44)
`
`éWfiRE
`
`(SD) W? (SD)
`
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`
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`
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`(SD)
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`SM-13496 40 mg
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`SM—13496 120 mg
`(s9)
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`CG I -—8
`
`(11:41)
`
`(11:41)
`
`0.004
`
`(n=40)
`
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`
`—0. 8 (1.03)
`
`0.002
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`
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`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 009
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 009
`
`

`

`WO 2004/017973
`
`PCT/JPZOOS/010490
`
`9
`
`1—Ifl1Xd2€fibt$fi0amfidflfiwflé&§4mfifioi4mbw
`
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`
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`
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`
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`
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`
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`
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`
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`
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`38 (78)
`
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`6 (12)
`
`2 (4)
`
`11 (22)
`
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`
`7
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`
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`
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`sum
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`
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`
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`
`fifiwfi%$%fl%bamk%fiumwaw¢ybLko
`
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`
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`
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`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 010
`
`
`
`Tfiffi‘?
`
`Wfifififit
`
`50
`
`fig$23§fififl§t (%)
`
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`
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`
`Par Pharm., Inc.
`Exhibit 1019
`Page 010
`
`

`

`WO 2004/017973
`
`PCT/JPZOOS/010490
`
`10
`
`H%OT%Okofi%fi75?fi\SM~1349640mg~120mgfl
`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 011
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 011
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`11
`
`E 7
`
`mm
`
`
`
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`
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`
`
`
`
`
`
`
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`
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`
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`
`
`
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`
`
`
`
`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 012
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 012
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
`
`
`ifii-E‘I‘fiig
`
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`
`W
`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 013
`
`
`
`
`
`
`
`.
`
`Eib’ribb i 1/ \
`
`_ I
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 013
`
`

`

`WO 2004/017973
`
`PCT/JPZOO3/010490
`
`
`
`
`
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`
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`
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`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 014
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 014
`
`

`

`WO 2004/017973
`
`PCT/JPZOO3/010490
`
`is
`
`-EMERE
`may (SD)
`821-0 (SD)
`1129 (SD)
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`0.7 (2.63)
`0.7 (2.88)
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`
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`
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`
`0.588
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`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 015
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 015
`
`

`

`WO 2004/017973
`
`PCT/JPZOO3/010490
`
`
`
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`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 016
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 016
`
`

`

`WO 2004/017973
`
`PCT/JPZOO3/010490
`
`m
`
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`
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`
`15.Efiké%fix(H&ZS,3RMHD~N—H1R,Zm-2—14—
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`
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`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 017
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 017
`
`

`

`WO 2004/017973
`
`PCT/JP2003/010490
`
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`
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`
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`
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`
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`
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`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 018
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 018
`
`

`

`
`
`WO 2004/017973
`
`PCT/JPZOO3/010490
`
`
`
`+ 751271? (11:49)
`
`-I— SM—13496 40 mg/ El
`
`(n=49)
`
`—o— SM-13496 120 mg/E (11:47)
`
`3
`
`HFFHE]
`
`(SE)
`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 019
`
`£ R
`
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`
`- S [
`
`kn K
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 019
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/JPO3/10490
`
`A. CLASSIFICATION OF SUBJECT MATTER
`
`Int.c17 A61K31/496, A61P25/18//CO7D4l7/12
`
`According to International Patent Classification (IPC) or to both national classification and IPC
`
`B. FIELDS SEARCHED
`
`Minimum documentation searched (classification system followed by classification symbols)
`Int.c17 A61K3l/496, CO7D4l7/12
`
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`
`Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)
`REGISTRY (STN) , CAPLUS (STN) , CAOLD (STN)
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Citation ofdocument, with ndication, where appropriate, ofthe relevant passages
`
`1
`
`‘ Relevant to claim No.
`
`EP 464846 A1
`(SUMITOMO PHARMACEUTICALS CO., LTD.) ,
`08 January, 1992 (08.01.92),
`Full text; particularly, compound (101); page 13,
`lines 29 to 34
`& JP 05—017440 A
`& CA 2046429 A
`
`& US 5532372 A
`
`(SUMITOMO PHARMACEUTICALS CO.,
`
`WO 02/24166 A1
`LTD.) ,
`28 March, 2002 (28.03.02),
`Full text; particularly, examples
`& EP 1327440 A1
`& AU 2001086237 A
`
`Further documents are listed in the continuation ofBox C. D See patent family annex.
`
`
`
`Special categories of cited documents:
`document defining the general state of the art which is not
`‘
`considered to be of particular relevance
`'
`.
`earlier document but published on or alter the international filing
`date
`document which may throw doubts on priority claim(s) or which is
`cited to establish the publication date of another citation or other
`special reason (as specified)
`document referring to an oral disclosure, use, exhibition or other
`means
`document published prior to the international filing date but later
`than the priority date claimed
`
`X
`
`X
`
`*
`“A”
`u "
`E
`
`“L”
`
`“0”
`
`“P”
`
`later document published afier the international filing date or
`priority date and not in conflict with the application but cited to
`understand the principle or theory underlying the invention
`document of particular relevance; the claimed invention cannot be
`considered novel or cannot be considered to involve an inventive
`step when the document is taken alone
`document of particular relevance; the claimed invention cannot be
`considered to involve an inventive step when the document is
`combined with one or more other such documents, Such
`combination being obvious to a person skilled in the art
`document member of the same patent family
`
`Date of the actual completion of the 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/ZIO (second sheet) (July 1998)
`
`Authorized officer
`
`Telephone No.
`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 020
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 020
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/JPO3/1049O
`
`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.
`
`2. I: Claims N05,:
`because they relate to parts of the international application that do not comply with the prescribed requirements to such an
`extent that no meaninng international search can be carried out, specifically:
`
`3. [:1 ClaimsNos.:
`because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).
`
`Box 11 Observations where unity of invention is lacking (Continuation of item 3 of first sheet)
`
`'
`
`This International Searching Authority found multiple inventions in this international application, as follows:
`
`ClaimsNos.: l to 13
`because they relate to subject matter not required to be searched by this Authority, namely:
`Claims 1 to 13 pertain to methods for treatment of the human body by surgery
`or therapy and thusrelate to a subject matter which this International Searching
`Authority is not required to search.
`
`
`
`1. D As all required additional search fees were timely paid by the applicant, this international search report covers all searchable
`claims.
`
`2. El As all searchable claims could be searched without effort justifying an additional fee, this Authority did not invite payment
`of any additional fee.
`
`3. D As only some of the 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:
`
`4. [:1 No required additional search fees were timely paid by the applicant. Consequently, thislinternational search report is
`restricted to the invention first mentioned in the claims; it is covered by claims Nos:
`
`Remark on Protest
`
`[:1
`
`The additional search fees were accompanied by the applicant’s protest.
`
`[:1 No protest accompanied the payment of additional search fees.
`
`Form PCT/ISA/210 (continuation of first sheet (1)) (July 1998)
`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 021
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 021
`
`

`

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`fifiPCT/ISA/210(%2&~V)(1998fi7fi)
`
`Par Pharm., Inc.
`Exhibit 1019
`Pae 022
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 022
`
`

`

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`Par Pharm., Inc.
`Exhibit 1019
`Pae 023
`
`Par Pharm., Inc.
`Exhibit 1019
`Page 023
`
`