PTCHSBJS1 (D1-09)
`Approved for use through 1113042011. OMB 0551-0035
`US. Patent and Trademark Oifice: U_S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act at 1995, no persons are required to respond to a coilection oi information unless it displays a valid OMB oontrol number.
`
`POWER OF A.|.I.oRNEY
`OR
`REVOCATION or POWER or ATTORNEY
`WITH A NEW POWER or ATTORNEY
`AND
`CHANGE or CORRESPONDENCE ADDRESS
`
`Application Number
`Filing Date
`___
`“"‘ '’‘‘*'“°‘' ''‘‘'‘"‘°'
`
`11.’Brl4,44tIl
`August 24, 2007
`
`was mm“ cam
`9
`
`_"°
`1623_— Confinnabon tl_~l_cI. 6850
`
`Number
`
`I hereby revoke all previous powers of attomey given in the above-identified application.
`
`D A Power of Attomey is submitted herewith.
`OR
`
`I hereby appoint Praclttionerls) associated with the following Customer
`Number as mylour atlomeyls) or agent(s) to prosecute the application
`identified above. and to transact all business in the United States Patent
`and Trademark Office connected therewith:
`OR
`
`|
`
`I hereby appoint Practltlone-r(s] named below as mylour attomeyls) or agent(s) to prosecute the application identified above, and
`to transact all business in the United States Patent and Trademark Office connected therewith:
`
`Praotitionafls} Name
`
`Registration Number
`
`Please recognize or change the correspondence address for the above-identified application to:
`
`The address associated with the above-mentioned Customer Number.
`OR
`
`|:|
`
`The address associated with Customer Number:
`OR
`
`firm or
`Individual Name.
`Address
`
`City
`tjountry
`Telephone
`I am the:
`
`I
`
`| Applicantllnventcn-_
`' on
`
`Assignee of record of the entire interest. See 37 CFR 3.T1.
`Statement under 3? CFR 3. 73fbJ (Form PTCl.-’SBr'96J submitted herewith or fired on
`
`fl Slt3MA‘l'lJFtE of Applicant or Aasignaa of lktacord
`Date
`Signature
`Telephone
`Andrea Karnage. E§q__
`Name
`Asst. Secretary, Cougar Biotechnology, lncJJohnson 8. Johnson
`‘fitle and Company
`NOTE‘. Signatures of all the inventors or asslgneas oi record 01 the entire interest or their representatjvexisl are required. Submit multiple forms if more than one
`signature is required. see below‘.
`
`H“ _
`_Q\,').';‘i_1\
`(732) 524i-_§.’_-£_a]57
`
`forms are submitted.
`
`This collection at intormation Is required by 3? CFR 1.31. 1.32 and 1.33. The information is required to obtain or retain a benefit by the public which is to file (and by the
`USPTD to process) an application. Confidentiality is governed by 35 L|_S_C_ 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take El minutes to complete,
`including gathering. preparing. and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on
`the amount of time you require to complete this form andior suggestions for reducing this burden, should be mm to the Chief Intorlttatiort Cltficur. U.S. Patient and
`Trademark Ofiioe, U.S. Department of Commerce. PO. Box 1-450. Alexandria. VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS
`ADDRESS, SEND TO: Commissioner for Patents, P.O. Box ‘I450, Alexandria. VA 22313-1450.
`
`ltyou need assistance in completing the form. call‘ f—8D(J—PTO—9‘t99 and select option 2.
`
`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 1
`
`

`
`PTOISBIQG (D7-09)
`Approved for use through 07.i31i'2D12. OMB 0651-0031
`US. Patent and Trademark Office: U. 3. DEPARTMENT OF COMMERCE
`Under the Pa - = rwcrlt Reduction Act of 1995. no persons are required to respond to a collection of Information uniess it rtispl =
`a valid OMB control number.
`
`
`
`STATEMENT UNDER 37 CFR 3.73jb[
`
`Appiicanupatent Owner. Cougar Biotechnology. Inc.
`Application No.lPatent No.2 113344.440
`Titled:
`
`METHODS AND COMOSITIONS FOR TREATING CANCER
`
`__
`
`Filedllssue Date: AUQU5t 24. 2007
`
`Cougar Biotechnology, Inc.
`(Name of Assigr-ea)
`
`states that it is:
`
`_
`
`Corporation
`{Type of Assignee, e.g.. corporation. partnership. university. government agencv. etc.
`
`1.
`
`the assignee of the entire right. title, and interest in;
`
`D an assignee of less than the entire right, title, and interest in
`(The extent (by percentage) of its Ownership interest is
`
`°/o}; or
`
`3, D the assignee of an undivided interest in the entirety of (a complete assignment from one of the joint inventors was made)
`
`the patent eppllcationipatent identified above, by virtue of either:
`
`A. E]
`
`OR
`
`B.
`
`An assignment from the inventorts) of the patent applicationfpatent identified above. The assignment was recorded in
`the United States Patent and Trademark Clffice at Reel
`, Frame
`. or for which a
`copy therefore is attached.
`
`A chain of title from the inventoI’(s}. of the patent applicationipatent identified above. to the current assignee as follows:
`
`1_ From; Alan H. Auerbach and Arie S. Belldegmn
`
`1-0; Cougar Biotechnology, Inc-
`
`The document was recorded in the United States Patent and Trademark Office at
`
`Reel 013339
`
`,
`
`Frame0027
`
`,
`
`or for which a copy thereof is attached.
`
`2. From: Alan H. Auerbach
`
`To: Cougar Biotechnology. Inc.
`
`The document was recorded in the United States Patent and Trademark Office at
`
`Reel 020040
`
`.
`
`FrarneD635
`
`.
`
`or for which a copy thereof is attached.
`
`3_ From; Arie S. Belldegrun
`
`To: Cougar Biotechnology, Inc.
`
`The document was recorded in the United States Patent and Trademark Office at
`
`:.
`
`Reel 020040
`
`,
`
`FrameD690_
`
`,
`
`or for which a copy thereof is attached.
`
`Additional documents in the chain of title are listed on a supplemental sheet(s).
`
`[E As required by 37 CFR 3.73(b){1)(i), the documentary evidence of the chain of title from the original owner to the assignee was,
`or concurrently is being. submitted for recordation pursuant to 37 CFR 3.11.
`
`[NOTE A separate copy (i'.e.. a true copy of the original assignment document{s)} must be submitted to Assignment Division in
`accordance with 37 CFR Part 3, to record the assignment in the records of the USPTO. E MPEP 302.08]
`
`The u
`
`rsigncd (whose title is supplied below) is authorized to act on behalf of the eeeignee.
`
`Lv\A:i/but
`
`Signature
`
`Andrea Kamage. Esq.
`
`elaa[ii__
`
`Date
`
`Assistant Secretary
`
`Tide
`_
`Printed or Typed Name
`This collection of information is required by 37 CFR 3.7309). The information is required to obtain or retain a benefit by the public which ‘is to file [end by the USPTO to
`process) an eppticeticn. Confidentiality is governed by 35 U_S_C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 12 minutes to complete. including
`gatheriig. preparing, and submittirig the completed application forri1 to the USPTO. Time will vary depending upon the individual case. Any rxinimcnts on the amount of time
`you require to complete this form anclicr suggestions for reducing this burden. should be sent to the I:hlel Information Orfioer, U.S. Parent and Trademark Office. US.
`Depamnenl DI Corrimercle, P.O. Box 1455, Alexandria, VA 2231&145€I. DO NOT SEND FEES CIR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner
`for Patents. P.O. Box 1450. Alexandria. VA 22313-1450.
`
`ffycu need’ assistance in completing the form. call 1-300-PTO-9199 andselect option 2.
`
`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 2
`
`

`
`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`Title of Invention:
`
`Methods and Compositions forTreating Cancer
`
`First Named lnventormpplicant Name:
`
`Alan H. Auerbach
`
`Attorney Docket Number:
`
`CGFI5001USCNT1
`
`Filed as Large Entity
`
`Utility under 35 USC 1 1 1 (a) Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Su b-Tota I in
`Usmsi
`
`Basic Filing:
`
`Utility Search Fee
`
`Utility Examination Fee
`
`Claims in excess of20
`
`Independent claims in excess of3
`
`1202
`
`1201
`
`Miscellaneous-Filing:
`
`1
`
`1
`
`1
`
`540
`
`|
`
`540
`
`52
`
`220
`
`220
`
`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 3
`
`

`
`Petition:
`
`Patent-Appeals-a nd-Interference:
`
`Po st-Allowa nce-and-Po st-lss uance:
`
`Description
`
`Su b-Total Il"|
`
`Extension-of-Time:
`
`Miscellaneous:
`
`Total in USD (5)
`
`2142
`
`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 4
`
`

`
`Electronic Acknowledgement Receipt
`
`Application Number:
`
`13034340
`
`International Application Number:
`
`Confirmation N um ber:
`
`Title of Invention:
`
`Methods and Compositions forTreating Cancer
`
`First Named |n\rentorIApp|icant Name:
`
`Alan H. Auerbach
`
`Customer N umber:
`
`27777
`
`Filer:
`
`Andrea J. Kamage/Laurie Phillips
`
`Filer Authorized By:
`
`Andrea J. Kamage
`
`Attorney Docket Number:
`
`CGFi5001USCNT1
`
`Receipt Date:
`
`24—FEB—201 1
`
`Filing Date:
`
`Time Stamp:
`
`16:49:59
`
`Application Type:
`
`Utility under 35 USC 111ia]
`
`Payment information:
`
`Submitted with Payment
`
`yes
`
`Payment Type
`
`Deposit Accou nt
`
`3721 De posit Accou nt
`
`Payment was successfully received in RAM
`
`$2142
`
`RAM confirmation Number
`
`100750
`
`Authorized User
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Charge any Additional Fees required under 37 CFR. Section 1.16 (National application filing. search, and examination fees]
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.1 7 (Patent application and reexamination processing fees)
`
`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 5
`
`

`
`Charge any Additional Fees required under 3? C.F.R. Section 1.19 (Document supply fees)
`
`Charge any Additional Fees required under 37 CFR. Section 1.20 [Post Issuance fees]
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.21 [Miscellaneous fees and charges]
`
`File Listing:
`
`Document
`Number
`
`.
`.
`Document Descnptmn
`
`.
`me Name
`
`CGRSOMUSCNTAPPLICATIOND
`
`File Size(Bytesli'
`Message Digest
`1031200
`
`Pages
`Multi
`Part Lzip (ifappl.}
`
`Application Data Sheet
`
`ATA SH EET.pC.lf
`
`uuvm-1hu.uwe1a9su<Jrl:I-Iurasowucul
`i'lai"h
`
`Warnings:
`
`Info rrnation:
`
`Warnings:
`
`Info rmation:
`
`Warnings:
`
`Info rmation:
`
`Warnings:
`
`Info rmation:
`
`Warnings:
`
`Info rmation:
`
`Warnings:
`
`CGR5001 USNPAPPLNASORIGIN
`
`I
`1649829
`ALLYFlLED.pdf fl yes
`
`‘)I.il.ll‘Ll!.? flt.6lJUJ J 1 5 'Ji:HiL(E|4d 1 B‘JLK.K3 9'92
`rlrfifil
`
`Multipart Descriptiom'PDF files in .zip description
`
`Specification
`
`Claims
`
`‘I
`
`24
`
`30
`
`23
`
`29
`
`30
`
`Oath or Declaration filed
`
`CGR5001DECLARAT|ON.pdf
`
`1292?'8
`
`cL1v1tll6“)l'lh-Illb-ll I lllle-I¢lJ9aa(d«l0dflL1SS9|
`11.\:I
`
`Change ofAddress
`
`118444-40POA.pdf
`
`511 aa33fa(c8h?lvl)(.lJ(.fr41l1d[| l09dl5llHJ( I5
`IIH'1
`
`Assignee showing of ownership per 37
`(FR 3-73
`
`1 1844-440STATEMENT373B.pdf |3il'h[rIrIbcJh¥rIl:l3a4hl'|I193‘1eel‘311n\1e(lc[il) I
`1l.'I3[I.l'
`
`Fee Worksheet [PTO-875]
`
`fee-info.pdf
`
`ha 3o=n?e§ lamb 1 3.19r:[hl7Iwe Nlmofil-Ill?
`389::
`
`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 6
`
`

`
`Info rrnation:
`
`2936584
`
`Total Files Size (in bytes]
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`Ifa new application is being filed and the application includes the necessary components for a filing date {see 37 CFR
`1.53{b)-(d) and MPEP 506], a Filing Receipt (37 CFR 1 .54} will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date ofthe application.
`
`National Stage ofan International Application under 35 U.S.C. 371
`Ifa timely submission to enter the national stage ofan international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCTIDO.-"EO!903 indicating acceptance ofthe application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Application Filed with the USPTO asa Receiving Office
`Ifa new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP1810}, a Notification of the International Application Number
`and ofthe International Filing Date (Form PCTfRO!105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 7
`
`

`
`Electronic Acknowledgement Receipt
`
`Application Number:
`
`13034340
`
`International Application Number:
`
`Confirmation N um ber:
`
`Title of Invention:
`
`Methods and Compositions forTreating Cancer
`
`First Named |n\rentorIApp|icant Name:
`
`Alan H. Auerbach
`
`Customer N umber:
`
`27777
`
`Filer:
`
`Andrea J. Kamage/Laurie Phillips
`
`Filer Authorized By:
`
`Andrea J. Kamage
`
`Attorney Docket Number:
`
`CGFi5001USCNT1
`
`Receipt Date:
`
`24—FEB—201 1
`
`Filing Date:
`
`Time Stamp:
`
`16:49:59
`
`Application Type:
`
`Utility under 35 USC 111ia]
`
`Payment information:
`
`Submitted with Payment
`
`yes
`
`Payment Type
`
`Deposit Accou nt
`
`3721 De posit Accou nt
`
`Payment was successfully received in RAM
`
`$2142
`
`RAM confirmation Number
`
`100750
`
`Authorized User
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Charge any Additional Fees required under 37 CFR. Section 1.16 (National application filing. search, and examination fees]
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.1 7 (Patent application and reexamination processing fees)
`
`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 8
`
`

`
`Charge any Additional Fees required under 3? C.F.R. Section 1.19 (Document supply fees)
`
`Charge any Additional Fees required under 37 CFR. Section 1.20 [Post Issuance fees]
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.21 [Miscellaneous fees and charges]
`
`File Listing:
`
`Document
`Number
`
`.
`.
`Document Descnptmn
`
`.
`me Name
`
`CGRSOMUSCNTAPPLICATIOND
`
`File Size(Bytesli'
`Message Digest
`1031200
`
`Pages
`Multi
`Part Lzip (ifappl.}
`
`Application Data Sheet
`
`ATA SH EET.pC.lf
`
`uuvm-1hu.uwe1a9su<Jrl:I-Iurasowucul
`i'lai"h
`
`Warnings:
`
`Info rrnation:
`
`Warnings:
`
`Info rmation:
`
`Warnings:
`
`Info rmation:
`
`Warnings:
`
`Info rmation:
`
`Warnings:
`
`Info rmation:
`
`Warnings:
`
`CGR5001 USNPAPPLNASORIGIN
`
`I
`1649829
`ALLYFlLED.pdf fl yes
`
`‘)I.il.ll‘Ll!.? flt.6lJUJ J 1 5 'Ji:HiL(E|4d 1 B‘JLK.K3 9'92
`rlrfifil
`
`Multipart Descriptiom'PDF files in .zip description
`
`Specification
`
`Claims
`
`‘I
`
`24
`
`30
`
`23
`
`29
`
`30
`
`Oath or Declaration filed
`
`CGR5001DECLARAT|ON.pdf
`
`1292?'8
`
`cL1v1tll6“)l'lh-Illb-ll I lllle-I¢lJ9aa(d«l0dflL1SS9|
`11.\:I
`
`Change ofAddress
`
`118444-40POA.pdf
`
`511 aa33fa(c8h?lvl)(.lJ(.fr41l1d[| l09dl5llHJ( I5
`IIH'1
`
`Assignee showing of ownership per 37
`(FR 3-73
`
`1 1844-440STATEMENT373B.pdf |3il'h[rIrIbcJh¥rIl:l3a4hl'|I193‘1eel‘311n\1e(lc[il) I
`1l.'I3[I.l'
`
`Fee Worksheet [PTO-875]
`
`fee-info.pdf
`
`ha 3o=n?e§ lamb 1 3.19r:[hl7Iwe Nlmofil-Ill?
`389::
`
`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 9
`
`

`
`Info rrnation:
`
`2936584
`
`Total Files Size (in bytes]
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`Ifa new application is being filed and the application includes the necessary components for a filing date {see 37 CFR
`1.53{b)-(d) and MPEP 506], a Filing Receipt (37 CFR 1 .54} will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date ofthe application.
`
`National Stage ofan International Application under 35 U.S.C. 371
`Ifa timely submission to enter the national stage ofan international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCTIDO.-"EO!903 indicating acceptance ofthe application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Application Filed with the USPTO asa Receiving Office
`Ifa new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP1810}, a Notification of the International Application Number
`and ofthe International Filing Date (Form PCTfRO!105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 10
`
`

`
`PTOISBI14 (11-08)
`Approved for use through 0973072010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`_
`_
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`CGR5001USCNT1
`
`Application Number
`
`document may be printed and included in a paper filed application.
`
`Title of Invention
`
`Methods and Compositions for Treating Cancer
`
`The application data sheet is part of the provisional or nonprovlsional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`
`Secrecy Order 37 CFR 5.2
`
`
`|:| Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`
`A - licant Information:
`
`A - licant 1
`
`Applicant Authority @|nventor OLegal Representative under 35 U.S.C. 117
`Prefix Given Name
`Middle Name
`
`C)Party of Interest under 35 U.S.C. 118
`Family Name
`Suffix
`
`2 R
`
`esidence Information (Select One)
`City
`Hermosa Beach
`
`(9 US Residency 0 Non US Residency 0 Active US Military Service
`StateIProvince
`Country of Residencei
`
`Mailing Address of Applicant:
`Address 1
`One Johnson & Johnson Plaza
`
`Addressz
`New Brunswick
`State! Province
`NJ
`
`Postal Code
`
`A - licant 2
`
`
`
`Applicant Authority @|nventor OLegal Representative under 35 U_S_C_ 117
`Prefix Given Name
`Middle Name
`
`OParty of Interest under 35 U_S_C_ 118
`Family Name
`Suffix
`
`Arie
`
`S.
`
`Belldegrum
`
`Residence Information (Select One) @ US Residency 0 Non US Residency 0 Active US Military Service
`
`Los Angeles
`
`StateIProvince
`
`Country of Residence i
`
`Citizenship under 37 CFR 1.41(b) i
`
`Mailing Address of Applicant:
`Address 1
`One Johnson & Johnson Plaza
`
`Address 2
`
`New Brunswick
`
`State! Province
`
`Postal Code
`
`Inventor Information blocks may be
`Inventors Must Be Listed - Additional
`All
`generated within this form by selecting the Add button.
`
`Add
`
`Correspondence Information:
`
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`|:| An Address is being provided for the correspondence Information of this application.
`
`EFS Web 2.2.2
`
`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 11
`
`

`
`PTOISBI14 (11-08)
`Approved for use through 0913072010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`_
`
`CGR5001USCNT1
`
`_T
`
`Title of Invention
`
`Methods and Compositions for Treating Cancer
`
`Customer Number
`27777
` Email Address
`jnjuspatent@corus.jnj.com
`
`Application Information:
`
`Title of the Invention
`
`Methods and Compositions for Treating Cancer
`
`Attorney Docket Number CGR5001USCNT1
`APP'l=a*l°" Tvve
`Subject Matter
`
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`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 12
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`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 13
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`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 15
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`

`
`
`
`METHODS AND COMPOSITIONS FOR TREATING CANCER
`
`Attorney Docket No. ll5l5—004-999
`
`FIELD OF THE INVENTION
`
`[0001]
`
`Methods and compositions for treating cancer are described herein. More
`
`particularly, the methods for treating cancer comprise administering a l7o.-hydroxylascfC;-,».
`
`3;;-lyase inhibitor, such as abiraterone acetate (:'.c.. 3]i~acetoxy~l 7—(3~pyridyl) androsta-5,
`
`I6-diene). in combination with at least one additional therapeutic agent, such as an anti-
`
`cancer agent or a steroid. Furthermore. disclosed are compositions comprising a 17(1-
`
`hydroxylase/C.730-lyase inhibitor. and at least one additional therapeutic agent such as an
`
`anti—cancer agent or a steroid. e.g._. a corticosteroid or, more specifically, a glucoeorticoid.
`
`BACKGROUNI)
`
`[0002]
`
`The number of people diagnosed with cancer has significantly increased. Of‘
`
`special interest are individuals diagnosed with androgemdependent disorders, such as
`
`prostate cancer, and estrogen-dependent disorders, such as breast cancer since such
`
`diagnoses are increasing in number at an alarming rate.
`
`[0003]
`
`Prostate cancer is currently the most common non-skin cancer and the
`
`second leading cause ofcancenrelated death in men after lung cancer. The primary course
`
`of treatment for patients diagnosed with organ-confined prostate cancer is usually
`
`prostatectomy or radiotherapy. Not only are these treatments highly invasive and have
`
`undesirable side effects, such localized treatments are not effective on prostate cancer after
`
`it has inetastasized. Moreover, a large percent ofindividuals who receive localized
`
`treatments will suffer from recurring cancer.
`
`[0004]
`
`Additionally, breast cancer incidence in women has increased from one out
`
`of every 20 women in 1960 to one out of every eight women in 2005. Moreover, it is the
`
`most common cancer among white and African—American women. Similar to treating
`
`prostate cancer. most options For women diagnosed with breast cancer are highly invasive
`
`and have significant sidc—el'fects_ Such treatments include surgery. radiation and
`
`chemotherapy.
`
`[0005]
`
`Hormone therapy is another treatment option for individuals diagnosed with
`
`prostate or breast cancer. Hormone therapy is a form of systemic treatment for prostate or
`
`breast cancer wherein hormone ablation agents are used to suppress the production or block
`
`-1-
`
`MYLAN PHARMS. INC. EXHIBIT 1036 PAGE 16
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`

`
`
`
`the effects of hormones. such as estrogen and progesterone in the body, which are believed
`
`to promote the growth of breast cancer. as well as testosterone and dihydrotestosterone.
`
`which are believed to promote the growth of prostate cancer. Moreover, hormone therapy is
`
`less invasive than surgery and does not have many of the side effects associated with
`
`chemotherapy or radiation. Hormone therapy can also be used by itself or in addition to
`
`localized therapy and has shown to be effective in i.ndividuals whose cancer has
`
`metastasized.
`
`[0006]
`
`Even though hormone therapy is less invasive and can be used on more
`
`advanced stages of cancer, some individuals administered current hormone therapy
`
`treatments may not show a significant response or may not show any response at all to such
`
`treatments. Additionally, some patients treated with current hormone therapy treatments
`
`may also suffer from relapsing or recurring cancer. Currently. such refractory cancer
`
`patients are left with very few treatment options.
`
`[0007]
`
`Despite the progress made in the treatment of cancer. there remains a need
`
`for more effective ways to treat cancer such as, but not limited to. prostate cancer and breast
`
`cancer. Additionally, there is a need for effective anti-can