" . .~
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`
`PTO/SB/01 (10-01)
`Approved for use through 10/31/2002. OMB 0651-0032
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under I/le Paperwor1< Reduction Act of 1995, no persons are required to respond to a collection ol information unless it contains a valid OMB control number.
`Att rnev D ck t Numb r PC-1834033
`MICHAEL SPINO
`COMPLETE IF KNOWN
`/
`
`•
`
`•••
`
`DECLARATION FOR UTILITY OR
`DESIGN
`PATENT APPLICATION
`(37 CFR 1.63)
`0 Declaration
`D Declaration
`
`OR
`
`Submitted
`with Initial
`Filing
`
`Submitted after initial
`Filing (surcharge
`(37 CFR 1.16 (e))
`required)
`
`"'
`
`First Named Inv ntor
`
`Application Number
`
`Filing Date
`
`Art Unit
`
`Examiner Name
`
`~
`
`As the below named inventor, I hereby declare that:
`
`My residence. mailing address, and citizenship are as stated below next to my name.
`
`I believe I am the original and first inventor of the subject matter which is claimed and for which a patent is sought on the Invention entiUed:
`
`A NEW USE FOR DEFERIPRONE
`
`(Title of the Invention)
`.. .
`
`OR
`
`..
`the specification of which
`IT] is attached hereto
`I as United States Application Number or PCT International
`D was filed on (MM/DDIYYYY) I 06/28/2001
`Application Number jPCT{CAOl/00956 I and was amended on {MMJDD/YYYY) I
`
`"
`
`l{lf applicable).
`
`I hereby state that I have reviewed and understand the contents of the above identified specification, including the claims, as amended by
`any amendment specifically referred to above.
`
`I acknowledge the duty to disclose Information which is material to patentability as defined in 37 CFR 1.56, including for continuation-in-part
`material information which became available between the filing date of the prior application and the national or PCT
`applications
`1
`intemationa filing date of the continuation-in-part application.
`I hereby claim foreign priori~ benefits under 35 U.S.C. 119(a)-(d) or (2, or 365(b) of any foreign apfilication(s) for patent, inventor's or plant
`
`breeder's rights certificate(s , or 365(a) of any PCT international app icalion which designated at east one country other than the United
`States of America, listed be ow and have also identified below, by checking the box, any foreign application for patent, inventor's or plant
`breeder's rights certificate(s), or any PCT International application having a filing date before that of the application on which prionty is
`claimed.
`Prior Foreign Application
`Number{s)
`
`Country
`
`Foreign Filing Date
`CMMIDD/YYYYl
`
`Priority
`NotClalmed
`
`D
`D
`D
`D
`I Additional foreian application numbers are listed on a supplemental prioritv data sheet PTO/SB/028 attached hereto:
`(Page 1of2]
`
`Certified Copy Attached?
`YES
`NO
`
`D D
`D D
`D D
`D D
`
`I
`
`Burden Hour Statement: This form is estimated to take 21 minutes to complete. nme will vary depending upon the needs of I/le individual case. Any comments on
`lhe amount of time you are required to complete thls lorm should be sent to the Chief Information Officer. U.S. Patent and Trademark Office. Washington. DC
`20231 . DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Assistant Commissioner for Patents. Washington. DC 20231 .
`
`
`1 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`•
`
`PTO/SB/01 (10-01)
`Approved for use through 10/31/2002. OMS 0651-0032
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the PaDarwork Reduction Act of 1995, no Dersons aro re<1ulrod to resDOnd to a collecUon oflnformaUon unless II contains a valid OMS control number.
`
`DECLARATION - Utility or Design Patent Application
`Customer Number I
`
`Direct all correspondence to: [!!
`
`or Bar Code Label
`
`23607
`
`loq D Correspondence address below
`
`Name
`
`Address
`
`Cltv
`
`Country
`
`State
`
`I Telephone
`
`ZIP
`
`Fax
`
`I hereby dedare that all statements made herein of my own knowledge are true and that all statements made on information and belief
`are believed to be true; and further that these statements were made with the knowledge that willful false statements and the like so
`made are punishable by fine or imprisonment, or both, under 18 U.S.C. 1001 and that such willful false statements may jeopardize the
`validity of the application or any patent issued thereon.
`
`NAME OF SOLE OR FIRST INVENTO~ : I D A petition has been filed for this unsigned inventor
`
`Given Name
`(first and middle [If any])
`
`M[CHAEL
`
`FamllyName
`or Surname ~ .
`
`SPINO
`
`:
`
`i
`
`Date
`
`Inventor's
`Sia nature
`
`Residence: Cltv
`
`Malling Address
`
`PICKERING
`
`ONTARIO
`State
`
`CANADA
`Country
`
`CA
`
`Citizenship
`
`980 DUNCANNON DRIVE
`
`City
`
`PICKERING
`
`NAME OF SECOND INVENTOR:
`
`ANTONI@,
`Given Name
`(first and middle rit any])
`
`Country GAN ADA
`State ONTARIO
`ZIP LlX 2P3
`I D A petition has been filed for this unsigned inventor
`PIGA
`
`Family Name
`or Surname
`
`Inventor's
`Signature
`
`Date
`
`Residence: City
`
`MONCALIERI
`
`State
`
`ITALY
`Country
`
`IT
`Citizenship
`
`Mailing Address
`
`STRADA TORINO 15B
`
`City
`
`MONCALIERI
`ITALY
`ZIP I-10024
`0 Additional inventors are being named on the __ supplemental Additional lnventor(s) sheet(s) PTO/SBI02A attached hereto.
`
`State
`
`Country
`
`(Page 2 of 2)
`
`
`2 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`PATENT APPLICATION FEE DETERMINATION RECO~D
`Effective October 1, 2001
`ClAIMS AS .FILED --PART I
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`
`3 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`' !
`
`PATENT APPLICATION SERIAL NO . - - - - - - - --
`
`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`FEE RECORD SHEET
`
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`
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`01731/2003 GFREYl
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`
`..
`
`
`4 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`.-~
`
`MULTlPLE DEPENDENT CLAIM
`FEE CALCULATION SHEET
`(FOR USE WJTH FORM PT().876)
`
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`
`5 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`1"1-\ICNI \AIUt't:HAllUN IHCATY
`
`From the
`INTERNATIONAL PAELIMINAA
`
`MINING AUTHOR
`
`To:
`
`Hughes, Ivor M.
`BARRISTER & SOLICITOR
`Patent & Trade Mark Agents
`175 Commerce Valley Drive West
`Suite ~oo n~"':,, !' ~~Yf~fl\
`Thom~lll. on~· ~i:·'tw"Sl"ll u~
`CANADA
`
`IVOR M. HUGHES
`
`T
`
`NOTIFICATION OF TRANSMITTAL OF ·
`THE INTERNATIONAL PRELIMINARY
`EXAMINATION REPORT
`(PCT Rule 71.1)
`
`Date of malling
`(day/monlh/y9ar)
`
`13.09.2002
`
`\ ~ ~ L/ oo D
`
`AppUcanrs or agent's file reference
`J. ~( -
`lntematlonal appRc8tlon No.
`PdtiCA01/00956
`·~
`
`AppRcant
`APOTEX INC. et $1.
`
`lnte!1'8tlona!,flllng date (daylrnonthlyear)
`28/06/2001
`
`IMPORTANT NOllRCATION
`Pt1or1ty date {daytr@nth/y9ar)
`30(06/2000
`;
`
`1. The applicant Is hereby notified that this International Preliminary Examining Authority transmits herewith the
`international preliminary examination report and its annexes, if any, established on the international application.
`
`2. A copy of the report and its annexes, if any, is being transmitted to the International Bureau for communication
`... :\·.·'··~~
`to all the elected Offices.
`...
`'
`w ~·.:.-. . :·.-.-.~ .. \ :·
`
`3. Where required by any of the elected Offices, the International Bureau will prepare an English translation of the
`report (but not of any annexes) and will transmit such translation to those Offices.
`
`4. REMINDER
`
`The applicant must enter the national phase before each elected Office by performing certain acts (filing
`translations and paying national fees) within 30 months from the priority date (or later in some Offices) (Article
`39(1)) (see also the reminder sent by the International Bureau with Fonn PCT/18/301).
`
`Where a translation of the international application must be furnished to an elected Office, that translation must
`contain a translation of any annexes to the international preliminary examination report. It Is the applicant's
`responsibility to prepare and furnish such translation directly to each elected Office concerned.
`
`For further details on the applicable time limits and requirements of the elected Offices, see Volume II of the
`PCT Applicant's Guide.
`
`For the purpose of deciding whether the claimed invention is patentable or not, the elected Offices may apply
`criteria additional to or different from the criteria on which the international preliminary examination report is
`based (see Articles 27(5), 33(5)). Additional criteria may Include e.g. exemptions from patentability and the
`requirements of enabling disclosure and of clarity and support of claims.
`
`Name and mallfng address of the IPEAI
`
`----,.... Europ&an Patent Office
`A~ o..so29a Munich
`Jll Tel. +49 89 2399 - o Tx: 523656 epmu d
`
`Fax: +49 89 2399 • 4465
`
`Form PCT/IPEA/416 (July 1992)
`
`Authot1zed officer
`
`Senkel, H
`
`Tel.+49 89 2399-8071
`
`
`6 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`// .. ;-
`
`PATENT COOPERATION TREATY
`PCT
`INTERNATIONAL PRELIMINARY EXAMINATION REPORT
`
`(PCT Article 36 and Rule 70)
`
`Applicant's or agent's file reference
`J.
`lntematlonal fifing date (day/month/year)
`lntematlonal application No.
`28/06/2001
`PCT/CA01/00956
`ln1emallonal Patent Classification (IPC) or national cfasslflcatfon and IPC
`A61K31/44
`
`FOR FURTHER ACTION
`
`See Notification of Transmittal of lntematlonal
`Prellmlnary Examination Report (Fonn PCT/IPEA/416)
`
`Pr1ortty dale (day/month/year}
`30/06/2000
`
`..
`
`Applicant
`APOTEX INC. et al.
`
`1. This International preliminary examination report has been prepared by this International Preliminary Examining Authority
`and Is transmitted to the applicant according to Article 36.
`
`2. This REPORT consists of a total of 5 sheets, Including this cover sheet.
`
`0 This report is also accompanl.ed by ANNEXES, I.e. sheets of the description, claims and/or drawings which have
`been amended and are the basis for this report and/or sheets containing rectifications made before this Authority
`(see Rule 70.16 and Section 607 of the Administrative Instructions under the PCT).
`
`These annexes consist of a total of sheets.
`
`3. This report contains indications re'latlng to the following Items:
`
`I
`II
`Ill
`IV
`V
`
`l8I Basis of the report
`0 Priority
`l8I Non-establishment of opinion with regard to novelty, inventive step and Industrial appllcabllity
`0 Lack of unity of invention
`l8I Reasoned statement under Article 35(2) with regard to novelty, Inventive step or Industrial applicability;
`citations and explanations suporting such statement
`0 Certain documents cited
`VI
`0 Certain defects In the International application
`VII
`VIII D Certain observations on the lntematlonal application
`
`Date of submission of the demand
`
`Date of completion of thts·report
`
`17/01/2002
`
`Name and malling address of the International
`prellmlnary xamlnlng author1ty:
`European Pat nt Office
`D-80298 Munich
`Tel. +49 89 2399 - o Tx: 523656 epmu d
`Fax: +49 89 2399 - 4465
`
`~
`
`Fo~ P~'.l.'.P~~9 (cover sheet) (January 1994)
`
`13.09.2002
`
`Authortzed officer
`
`Beeck, M
`
`Telephone No. +49 89 2399 8473
`
`( ·:I J
`~]
`~ .. _.~
`
`
`7 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`INTERNATIONAL PRE .... ARY
`EXAMINATION REPOR'fll9'
`..
`
`lntemation.licati~n No. PCT/CA01/00956
`
`I. · Basis of the report
`
`1. With regard to the el m nts of the international application (Replacement sheets which have been furnished to
`the receiving Office In response to an invitation under Article 14 are referred to In this report as "originally filed"
`and are not annexed to this report since they do not contain amendments (Rules 70.16 and 70.17))'.
`Description, pages:
`
`1-43
`
`as originally filed
`
`Claims, No.:
`
`1--50
`
`as originally filed
`
`.... .
`
`Drawings,, sheets:
`
`1/1
`
`as originally filed
`
`2. With regard to the language, all the elements marked above were available or furnished to this Authority in the
`language In which the international ~plication was filed, unless otherwise indicated under this ite""!.
`
`These elements were available or furnished to this Authority in the following language:
`
`, which is:
`
`0
`0
`0
`
`the language of a translation furnished for the purposes of the international search (under Rule 23.1 (b)).
`the language of publication of the international application (under Rule 48.3(b)).
`the language of a translation furnished for the purposes of International preliminary examination (under Rule
`55.2 and/or 55.3).
`
`3. With regard to any nucleotide and/or amino acid sequence disclosed in the international application, the
`International preliminary examination was carried out on the basis of the sequence listing:
`
`contained In the international application in written form.
`0
`0
`filed together with the International application in computer: readable form.
`furnished subsequently to this Authority in written form.
`0
`0
`furnished subsequently to this Authority in computer readable form.
`0 The statement that the subsequently furnished written sequence listing does not go beyond the disclosure in
`the international application as filed has been furnished.
`0 The statement that the information recorded in computer readable form is identical to the written sequence
`listing has been furnished.
`
`4. The amendments have resulted In the cancellation of:
`
`0
`0
`
`the description,
`the claims,
`
`pages:
`Nos.:
`
`F:Q.nn .PCTIJfEA/409 (Boxes l·Vlll, Sheet 1) (July 1998)
`
`
`8 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`INTERNATIONAL PRei.taARv
`EXAMINATION REPOR'f9'
`
`lntemation.llcatio~· No. PCT/CA01/00956
`
`0
`
`the drawings,
`
`sheets:
`
`5. O This report has been established as if (some of) the amendments had not been made, since they have been
`considered to go beyond the disclosure as filed (Rule 702(c)):
`(Any replacement sheet containing such amendments must be referred to under item 1 and annexed to this
`report.)
`
`6. Additional observations, if necessary:
`
`Ill. Non-establlshment of opinion with regard to novelty, Inventive step and Industrial appllcablllty
`1. The questions whether the claimed invention appears to be novel, to involve an inventive step (to be non(cid:173)
`obvious), or to be Industrially applicable have not been examined In respect of:
`0
`the entire international application.
`
`~ claims Nos. 1-7, 11-13, 17,20-50.
`
`because:
`
`~ the said intemationaJ application, or the said claims Nos. 1-7, 11-13, 17,20-50 relate to the following subject
`matter which does not require an international preliminary examination (specify):
`see separate sheet
`
`0
`
`0
`
`0
`
`the description, claims or drawings (indicate particular elements belovlj or said claims Nos. are so unclear
`that no meaningful opinion could be formed (specity):
`
`the claims, or said claims Nos. are so inadequately supported by the description that no meaningful opinion
`could be fotmed.
`
`no International search report has been established for the said claims Nos ..
`
`2. A meanlngf ul lntemattonal preliminary examination cannot be carried out due to the failure of the nucleotide
`and/or amino acid sequence listing to comply with the standard provided for In Annex C of the Administrative
`Instructions:
`
`0
`0
`
`the written form has not been furnished or does not comply with the standard.
`the computer readable form has not been furnished or does not comply with the standard.
`
`V. Reasoned statement under Article 35(2) with regard to novelty, Inventive step or industrial appllcablllty;
`citations and explanations supporting such statement
`1. Statement
`
`Novelty (N)
`
`Yes: Claims
`
`. Fom:i PCT/IPEN409 (Boxes I-VIII, Sheet 2) (July 1998)
`
`
`9 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`•
`
`. INTERN.ATIONAL l'RELliaARY
`EXAMINATION REPORT'm'
`
`lntem~tion.lication No: PCT/CA01/00956
`
`Inventive step (IS)
`
`No:
`
`Claims
`
`1-50
`
`Yes: Claims
`No:
`Claims
`
`1-50
`
`industrial applicability (IA)
`
`Yes: Claims
`Claims
`No:
`
`8-10, 14-16, 18, 19
`
`2. Citations and explanations
`see separate sheet
`
`.Fonn PCT/IPEA/409 (Boxes I-VIII, Sheet 3) (J,\Jly 1991:!)
`
`. ..
`
`
`10 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`..
`
`•
`
`INTERNATIONAL- PR.INARY
`·
`International appll
`EXAMINATION REPO~ SEPARATE SHEET
`
`No. PCT/CA01/00956
`
`SECTION Ill:
`
`Claims 1 to 7, 11 to 13, 17 and 20 to 50 relate to subject-matter considered by this
`Authority to be covered by the provisions of Rule 67.1 (iv} PCT. Consequently, no
`opinion will be formulated with respect to the Industrial applicability of the
`subject-matter of these claims (Article 34{4}(a}(i} PCT}.
`
`SECTION V:
`
`1)
`
`The documents are numbered according to their sequence in the search report.
`
`2) Pharmaceutical compositions comprising deferiprone are already known from
`documents 04 and 01 O (see 04, page 2, formula II, in conjunction with line 7,
`when Rand R1 are methyl; see 010, page 236, figure 2).
`
`Therefore the subject-matter of claims 8 to 1 O and 18 is not novel (Article 33 (2)
`PCT}.
`
`3) The use of deferiprone for treating iron induced cardiac disease in a patient with
`iron overload; is already known from document 01 O (see page 239, last
`paragraph, 0 lmprovement in Organ Function").
`
`Therefore the subject-matter of claims 1 to 7, 11 to 17 and 19 to 50 is not novel
`either.
`
`4)
`
`For the assessment of the present claims 1 to 7, 11 to 13, 17 and 20 to 50 on the
`question whether they are industrially applicable, no unified criteria exist in the
`PCT Contracting States. The patentability can also be dependent upori the
`formulation of the claims. The EPO, for example, does not recognize as
`industrially applicable the subject-matter of claims to the use of a compound in
`medical treatment, but may allow, however, claims to a known compound for first
`use in medical treatment and the use of such a compound for the manufacture of
`a medicament for a new medical treatment.
`
`Fonn PCT/Separate SheeV409(Sheet1)..(EPQ·Aprtl 19~7)
`
`
`11 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`PATENT c)ooPERATION TREATY
`•
`.
`."
`•
`
`1t
`
`. ,
`From the INJ"iRNA TIQNAL S~A
`
`GAUTHORITY
`
`To:
`BAR RI STER & SOL IC I~OR
`Pat ent & Tr .ade Mark Agents
`ug e~s.JiJJ.._;vorf .•. · :: : · : © 1 ~·":
`Att H h ,;-.1"'" I i . M
`..
`n .
`7~1.'~
`175 Conmer ce'·va H ey Ori ve· We st .. :
`.... bl; "' V._,
`Suite 200
`Thornhi 11 , Ontari o L 3T 7P6
`CANADA
`
`PCT
`
`NOTIFICATION OF TRANSMITTAL OF
`THE INTERNATIONAL SEARCH REPORT
`OR THE DECLARATION
`
`j)\.UZ
`
`(PCT Rule 44. 1)
`
`. De.c. dd. /O(
`
`Applfcanrs or agenrs file rererence
`PC-1834000
`International applicallon No.
`PCT/ CA 01/ 00956
`Applicant
`
`Date of malling
`(day/month/y88.r)
`
`22/10/2001
`
`FOR FURTHER ACTION
`
`See paragraphs 1 and 4 below .
`
`International fillng date
`{day/month/yBat)
`
`28/06/2001
`
`APOTEX INC.
`1. IlJ The applicant is hereby notified that the lntematlona1 Search Report has been established and Is transmitted herewith.
`Fifing o f amendments and statement under Article 19:
`The applicant Is entltled, If he so wishes, to amend the claims of the lntematlonal Application (see Rule 46):
`
`When? The time limit for filing such amendments Is normally 2 months from the date of transmittal of the
`International Search Report; however, for more details, see the notes on the accompanying sheet.
`
`Where? Directly to the
`
`International Bureau of WIPO
`.34, chemin des Col<>GJbettes
`121 1 Geneva20, Switzerland
`Fasclmlle No.: (41-22) 740.14 .35
`
`For more detailed Instructions, see the notes on the accompanying sheet.
`2. D The applicant is hereby notified that no International Search Report will be established and that the declaration under
`Article 17(2)(a) to that effect Is transmitted herewith.
`
`3 . D With regard to the protest against payment of (an) additional fee(s) under Rule 40.2, the applicant Is notlfled that
`0 the protest together with the decision thereon has been transmitted to the lntemalional Bureau together with the
`applicanrs request to forward the texts of both the protest and the decision thereon to the designated Offices.
`
`0 no decision has been made yet on the protest; the applicant will be notified as soon as a decision is made.
`
`4. Further actlon(g): The applicant Is reminded of the following:
`
`Shortly after 18 months from the priority date, the International application will be published by the International Bureau.
`II the applicant wishes to avoid or postpOne publication. a notice of withdrawal of the International application, or of the
`priority claim, must reach the International Bureau as provided in Rules 90b/s. 1 and 90bls.3 . respectively, before the
`completion of the technical preparations for International publ!cation.
`
`Within 19 months from the priority date, a demand for International preliminary examination must be filed If the applicant
`wishes to postpone the entry ~nto the national phase until 30 months from the priority date (in some Offices even later).
`
`Within 20 months from the priority date, the applicant must perform the prescribed acts for entry·into the national phase
`before all designated Offices which have not been elected in the demand or in a later election within 19 months from the
`priority date or could not be elected because they are not bound by Chapter II.
`
`Name and mailing address of the lnternatlonar Searching Authority
`
`Authorized ottlCer
`
`J) European Patent Office, P.B. 5818 Patentlaan 2
`
`NL-2280 HV Aljswljk
`Tel. (+31-70) 340-2040, Tx. 31 651 epo nl,
`----"=-- Fax: (+31-70) 340-3016
`.
`
`Form PCT/ ISA/220 (J uly 1998)
`
`Joannes Vergoosen
`
`
`12 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`NOTES TO FORM PCTnSA/220
`
`&lticle 19. Th
`These Notes are intended to give
`lo lnstructiona oonoemlng th fifing hmendme
`• • •
`P.tent Cooperation Treaty, hi Regulatio"' end ttl
`Not88 .,.. baaed «t the requireft14111ts
`dminlslrative lnatrvdiol18
`ufldef that Trellly. In oaae ot diacnipancy between theN Notee end thoae requirements, the latter ere applicable. F r mont
`f WIPO.
`detailed Information, eee atso lhe PCT Appioant'e GYide, a publioati n
`
`•
`
`In theae Notes, •Artic1e·, "Rule", and "Seotion" refer to th•proviaiona of the PCT, the PCT Regulations and the PCT
`Adminiatrative lnatrudlons respectively.
`
`INSTRUCTIONS CONCERNING AMENDMENTS UNDER ARTICLE 19
`
`The applioant has, after having r-nted Iha intemational search report, one opportunity to amend the claima of the
`intemational application. ft should h<1Mlver be emphasind Iha!, aince all parta of the intemational application (claims,
`deacription and drawings) may be amended during the intemaiional prellminary exam!nalion prooedura, there ia usually
`no need to file amendment. of Iha clalma under Article 19 except where, e .g. the applicant wants the latter to be published
`for the purpoees of provisional protection or has another raaaon for amending the claims before intemational pbulication.
`Furthermore, it •hould be emphasized that provisional protecition is available in aome stetea only.
`
`What p.U of the International -s>PllClltlon may lie amended?
`Under Article 19, only the claima may be amended.
`
`During the International ptiaae, the dl.ima may also be amended (or further amended) under Article 34 before
`lhe International Preliminary Ex.mining Authority. The description and drawings may only be amended tmder
`.Article 34 before the International Examining Authority.
`
`Upon entry into the national P,ase, all parts of the intemational appr1eation may be amended under Miele 28
`or, where llpf>licable, Article 41 .
`
`When?
`
`Wdhin 2 months from the dale of transmittal of the international search report or 16 months from the priority
`date, whichever lime limit expirea later. It should be noted, howevac, that the amendment9 will be oonaidered
`as having been received on time if they llAI received by the lntemafional Bureau after the expiration of the
`applicable time limit but before the completion of the technical pre~arationa for international publication
`(liWle 46.1 ).
`
`Where not to 111e th• emendmenta?
`
`The amendment• may only be filed with the International But-eau and not with the receiving Offioe or the
`lr:ilemational Searching Authority (Rule 46.2).
`
`Where a demand for intemational preliminary examination haa been Ila filed,•- below.
`
`How?
`
`Either by oanoelling one or more entire daim•, by adding one or rnorw n- claim• or by arnencing the text of
`one or more of the daima a filed.
`
`A replacement aheet must be submitted for eaoh ah-t of the d.ttn. which, on account of an amendment or
`amendment•, diff8"8 from the sheet originally filed.
`
`All the claim• appearing on a replacement sheet must be numbered in Arabio numerals. Wfaere a olaim ia
`cano8'1ed, no ren1.1mbering of the oltlac claims ia required. In all caaea where claims are renumbered, they muat
`be renumbered consecutively (Admini.tratiYe Instructions, Section 205(b)).
`
`The emendment• must be made In the l;inguage In which thelntem.Uonal appflcatlon b to be publlahed.
`
`Whal documents muattmay accompany the amendment•?
`
`Letter (Section 205(b)):
`
`Til8 amendments must be submitted with a letter.
`
`Tll9 letter will not be published with the intemalionlll application and the amended claims. It ahould not be
`confua.ed with the "Statement under Article 19(1 }" (aee below, under "Statement under Article 19(1 )j.
`
`The letter must be In Engllatt or Frencti, llt the c:ftoke Of th 11ppllC11nt. Ho-var, If lhe languag of the
`lntematlonal appllcatlon la English, the letter must be In English; tf th blnguage of the tntemlltlonal appllcatlon
`la French, th letter must be In Frenc:ft.
`
`Notes lo Form PCTllSA/220 (firBt •heat) (January 1994)
`
`
`13 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`NOTES TO FORM PCT/ISA/220 (continued)
`
`The letter muet indicate the diff-noes between th clelma as filed and th olaima as amended. I must, In
`particular, indcat • in.connection with each claim appearing in the international ilpPlication (it being understood
`that identical indioationa conoeming several claims may be grouped), whether
`(i)
`th claim ia unchanged;
`the olaim Ill cancelled;
`
`(ii)
`
`(Iii)
`
`(iv)
`
`(v)
`
`the claim ia new;
`the claim replaces one or more olaima aa filed;
`the claim ia the 1981.111 of the division of a claim aa filed.
`
`TIMt followfng example• lluatrate the manner In whlcfl amendments must be explained In the
`8Cel0fllpanylng letter:
`
`1. (Where originany there -re 48 claims and after amendment of aome claims there are 51 }:
`"Oaima 1 to 29, 31, 32, 34, 35, 37 to 48 replaced by amended claims bearing the aame numbers;
`claims 30, ~ and 36 unchanged; new claims 49 to 51 added.•
`
`2.
`
`(Where originany there were 15 claims and after amendment of all claims there -
`"Claima 1 to 15 replaced by amended olaima 1 to 11. •
`3. (Where originally there were 14 claims and the amendments conaiat in canoelting aome claim• and in adcing
`new olaima):
`"Claims 1to6 and 14 unchanged; claims 7 to 13canceDed; new claima 15, 16 and 17 added." or
`"Claims 7 to 13 cancelled; new claims 15, 16 and 17 added; all other claims unchanged.•
`4 . ('Mlere various kinds of amendmenta are made):
`"Claima 1-10unchanged; clama11to13, 18and19 cancel ed; olaima 14, 15and16repl~by amended
`claim 14; claim 17 aubdividedlnto amended claims 15, 16and17; new claims 20 and21 added."
`
`11 ):
`
`"Sbltement under mtlcle 19(1,. (Rule 46.4)
`The amendments may be aooompanied by a statement ellplaining the amendments and indicating any impact
`that such amendmentlt might ha\19 on the description and the drawings (which cannot be amended under
`Article 19(1))".
`
`The .aatement will be published with the international applic«tion and the amended claims.
`a must be In the langu-se In which the lntematlon .. appplellllon la to be publlahed.
`It muat be brief, not exceeding 500 words if in English or if tr-lated into Eng fl ah.
`It should not be confused with and doea not replace the letter in<fteating the cifferencea between the clalma
`filed and aa amended. It must be filed on a separate sheet and must be identified as auch by a heading,
`•
`prvfwably by using th• words •statement under Miele 19(1 }. •
`It may not contain any c:fisparaging oommenla on the intematlonal seamh report or the relevance of citations
`contained in that report. Refwence to citations, relevant lo a given claim, oontained in the intemational search
`report may be made only in connection with an amendmM of th.a claim.
`
`Consequence If• demand for International prellmlnary examination has already been flied
`If, at the time of filing any amendments und.,. Miele 19, a demand for international preliminary examination
`haa already been submitted, the ..,Picant must preferably, Ill the same time of filing the amendments with the
`International Bureau, also file a oopy of audl amendments with the International Preliminary Examining
`Authority (see Rule 62.2(a), finst sentence).
`
`Consequence with regard to tranalatlon of the tntematlonal application for entry Into the natlonal phase
`1he appicant'a attention ia dr-n to the fact that, where upon entry into the national phaae, a translation of the
`claims aa amended under Article 19 may have to be fumiahed to tile deaignatedlefected Olfacea, instead of, or
`in addition to, the translation of the claims aa filed.
`For futiher details on the requirements ol each deaignaled/elected Office, -
`Guide.
`
`Volume II of the PCT Applicant's
`
`Nol•• to Fonn PCTnSA/220 {MQOrld thfft) (January 1994)
`
`t!NSOOCIO: <XSISA220NOENP-4_1_>
`
`
`14 of 435
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1004
`
`

`

`PATENT COOPERATION TREATY
`PCT
`
`INTERNATIONAL SEARCH REPORT
`
`(PCT Article 18 and Rules 43 and 44)
`FOR FURTHER see Notification of Transmittal of lntemattonal Search Report
`(Fonn PCT/lSAf220) as w ell as, where applicable, Item 5 below.
`ACTION
`International filing date (day/month/year)
`
`(Eartlest) Priority Date (day/month/year)
`
`28/06/2001
`
`30/06/2000
`
`Appllcanrs Of' agenrs file reference
`PC-1834000
`International appUcation No.
`PCT I CA O 1/ 00956
`Applicant
`
`APOTEX INC.
`
`This International Search Report has been prepared by this International Searching Authority and Is transmitted to the applicant
`according to Articte 18. A copy Is being transmitted to the International Bureau.
`
`This International Search Report consists of a total oi
`5
`sheets.
`I!J
`It Is also accompanied by a copy of each prior art docYment cited in this report.
`
`1 . Basis of the report
`a . With regard to the language, the International search was carried out on the basis of the International application fn the
`language In whieh It was filed, unless otherwise Indicated under this Item.
`
`the International search was carried out on the basis of a translation of the International ap