throbber
Paper No. ____
`Date Original Version Filed: April 4, 2018
`Date Corrected Version Filed: April 24, 2018
`
`
`Filed On Behalf Of:
`Novartis Pharmaceuticals Corporation
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com; ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`BRECKENRIDGE PHARMACEUTICAL, INC., AND
`WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED.
`
`
`
`Petitioners,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`
`
`
`
`Case IPR2017-015921
`
`Patent No. 8,410,131
`
`
`
`
`CORRECTED PATENT OWNER’S EXHIBIT LIST 4
`
`
`
`1 IPR2018-00507 has been joined to this proceeding (Paper 29, Apr. 03, 2018)
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`Expert Declaration Of Howard A. Burris, III,
`M.D.
`
`Burris Decl.
`
`Curriculum Vitae Of Howard A. Burris, III,
`M.D.
`
`Burris C.V.
`
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`Localized Extranodal Lymphomas,”
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`
`
`
`1
`
`

`

`Exhibit
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`
`Abbreviation
`
`2010
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`2012
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`2017
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`January 19, 2016 Office Action, Prosecution
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`13/893,537
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`
`Vasey
`
`Kawai
`
`Adjei
`
`Gordon
`
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`
`
`
`
`
`2
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`2018
`
`January 27, 2016 Office Action, Prosecution
`File History Of U.S. Patent Application No.
`13/893,589
`
`October 17, 2006 Official Communication and
`February 26, 2007 Applicant Response
`(received February 27, 2007), Prosecution File
`History Of European Patent Application No. 01
`903 095.6-2112 (International Application No.
`PCT/US01/01537)
`
`Declaration In Support Of Patent Owner
`Novartis’s Motion For Pro Hac Vice
`Admission Of Christina Schwarz Under 37
`C.F.R. § 42.10
`
`Declaration In Support Of Patent Owner
`Novartis’s Motion For Pro Hac Vice
`Admission Of Charlotte Jacobsen Under 37
`C.F.R. § 42.10
`
`Declaration In Support Of Patent Owner
`Novartis’s Motion For Pro Hac Vice
`Admission Of Susanne L. Flanders Under 37
`C.F.R. § 42.10
`
`
`
`
`
`
`
`
`
`
`
`2019
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`Rapamune® Oral Solution (Sirolimus))
`
`Rapamune®
`PDR
`
`
`
`3
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`2026
`
`2027
`
`2028
`
`Document Stamped At The March 13, 2018
`Deposition Of Dr. Allan J. Pantuck
`
`
`
`March 13, 2018 Deposition Testimony of Dr.
`Allan J. Pantuck
`
`Pantuck
`
`Truong, L. et al., “The Diagnostic and
`Therapeutic Roles of Fine-Needle Aspiration,”
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`
`Hanahan, D. & R.A. Weinberg, “The
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`
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`(2000)
`
`Braybrooke
`
`2033
`
`“Proleukin®,” Physicians’ Desk Reference®,
`874-78 (47th ed. 1993)
`
`Proleukin®
`PDR
`
`2034
`
`Yagoda, A. et al., “Chemotherapy for
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`Seminars Oncol. 22(1):42-60 (1995)
`
`Yagoda
`
`
`
`4
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`2035
`
`2036
`
`Figlin, R.A. et al., “Multicenter, Randomized,
`Phase III Trial of CD8+ Tumor-Infiltrating
`Lymphocytes in Combination With
`Recombinant Interleukin-2 in Metastatic Renal
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`29 (1999)
`
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`18(16):2972-80 (2000)
`
`Figlin
`
`Motzer 2000
`
`2037
`
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`Cell Carcinoma,” Cancer 89(3):615-18 (2000)
`
`Pagliaro
`
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`Weekly Intravenous Interleukin 12 in Patients
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`γ Induction Is Associated with Clinical
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`(2000)
`
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`
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`Downward
`
`2038
`
`2039
`
`2040
`
`2041
`
`
`
`5
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`2042
`
`Sekulić, A. et al., “A Direct Linkage between
`the Phosphoinositide 3-Kinase-AKT Signaling
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`
`2043
`
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`
`Alexandre
`1999
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
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`
`NCI
`
`Douros II
`
`Marsoni
`
`Goldin
`
`
`
`6
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`2049
`
`2050
`
`2051
`
`2052
`
`2053
`
`2054
`
`2055
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`
`Tabernero
`
`O’Donnell
`
`
`
`Furie
`
`
`
`7
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`2056
`
`2057
`
`2058
`
`2059
`
`Creaven, P.J. & D. Raghavan, “Principles of
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`
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`
`Sakurada
`
`Cairns
`
`
`
`8
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`2070
`
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`2016)
`
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`
`Pantuck 2000
`
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`
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`
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`
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`
`Hojo
`
`
`
`9
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`2071
`
`2072
`
`2073
`
`2074
`
`2075
`
`2076
`
`2077
`
`Fosså, S.D. et al., “Vinblastine in Metastatic
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`
`Fosså
`
`Morita
`
`Stadler 1999
`
`Brunda
`
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`
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`Vivo Targeting of Immunoliposomal
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`Lopes de
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`
`
`
`10
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`2078
`
`Altman, R. & Sarg, M.J., The Cancer
`Dictionary pages 28, 269, 285 (1992)
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`Pazdur, R., et al. (eds.), Chapters 6-16, Cancer
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`Altman
`
`Pazdur
`
`2079
`
`2080
`
`2081
`
`2082
`
`2083
`
`2084
`
`2085
`
`2086
`
`Expert Declaration of Krishna V. Komanduri,
`M.D.
`
`Komanduri
`
`Curriculum vitae of Krishna V. Komanduri,
`M.D.
`
`Komanduri
`CV
`
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`Sokoloff 1996
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`ACHN (ATCC® CRL-1611™), AMERICAN
`TYPE CULTURE COLLECTION (ATCC), available
`at https://www.atcc.org/Products/All/CRL-
`1611.aspx#characteristics (accessed March 29,
`2018)
`
`ACHN
`
`
`
`11
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`A-498 (ATCC® HTB-44™), AMERICAN TYPE
`CULTURE COLLECTION (ATCC), available at
`https://www.atcc.org/Products/All/HTB-
`44.aspx#generalinformation (accessed March
`29, 2018)
`
`ATCC A-498
`
`A-498, HYPERCLDB, available at
`http://bioinformatics.hsanmartino.it/cldb/cl164.
`html (accessed March 29, 2018)
`
`HYPERCLDB
`A-498
`
`2087
`
`2088
`
`2089
`
`2090
`
`2091
`
`Nobuhara
`
`De Mulder
`
`Skillings
`
`Burris
`
`Cho
`
`Nobuhara, M. et al., “The Inhibition of
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`
`2092
`
`Second Expert Declaration of Howard A.
`Burris, III M.D.
`
`2093
`
`Excerpts of September 14, 2017 Trial
`Testimony of Dr. Daniel Chang Cho, in
`Novartis Pharms. Corp. v. West-Ward Pharms.
`Int’l Ltd., No. 15-cv-474-RGA, 2017 U.S. Dist.
`LEXIS 205600 (D. Del. Dec. 14, 2017)
`
`
`
`12
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`2094
`
`2095
`
`2096
`
`2097
`
`2098
`
`2099
`
`Excerpts of March 3, 2017 Deposition
`Testimony of Dr. Daniel Chang Cho, in
`Novartis Pharms. Corp. v. West-Ward Pharms.
`Int’l Ltd., No. 15-cv-474-RGA, 2017 U.S. Dist.
`LEXIS 205600 (D. Del. Dec. 14, 2017)
`
`Robbins, S.L. et al., Chapter 15, “Diseases Of
`White Cells, Lymph Nodes, And Spleen,”
`Pathologic Basis Of Disease, 653-705 (3rd ed.
`1984)
`
`Buzaid, A.C. & E. Cadman, Chapter 52:
`“Pharmacology Of Antineoplastic Agents And
`Mechanisms Of Multidrug Resistance,”
`Hematology Basic Principles And Practice
`(Hoffman, R. et al. eds., 1991)
`
`Zisman, A., A.J. Pantuck, & A.S. Belldegrun,
`“Molecular-based Therapies for Renal Cell
`Carcinoma,” Curr. Urol. Reports 2:55-61
`(2001)
`
`Molldrem, J.J. et al., “Overexpressed
`Differentiation Antigens As Targets Of Graft-
`Versus-Leukemia Reactions,” Curr. Opin.
`Hematol. 9:503-08 (2002)
`
`Zisman, A., A.J. Pantuck, & A. Belldegrun,
`“Gene and Immune-based Therapies for
`Genitourinary Malignancies: Current Status
`and Future Prospects,” Israel Med. Assoc. J.
`2:33-42 (2000)
`
`Cho
`
`Robbins
`
`Buzaid
`
`Zisman 2001
`
`Molldrem
`
`Zisman 2000
`
`2100
`
`Motzer, R.J. & P. Russo, “Systemic Therapy
`For Renal Cell Carcinoma,” J. Urology
`163:408-417 (2000)
`
`Russo
`
`
`
`13
`
`

`

`Exhibit
`
`Description
`
`Abbreviation
`
`2101
`
`Pantuck, A.J., A. Zisman, & A. Belldegrun,
`“Gene and immune therapy for renal cell
`carcinoma,” Int’l J. Urology 8:S1-S4 (2001)
`
`Pantuck 2001
`
`
`
`
`
`
`
`
`
`
`
`14
`
`

`

`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Exhibit List 4 was
`
`served on April 4, 2018 by causing it to be sent by email to counsel for Petitioners
`
`
`
`
`at the following email addresses:
`
`
`Daniel R. Evans (devans@merchantgould.com)
`
`Jeffrey D. Blake (jblake@merchantgould.com)
`
`Melissa M. Hayworth (mhayworth@merchantgould.com)
`
`Keith A. Zullow (kzullow@goodwinprocter.com)
`
`Marta E. Delsignore (mdelsignore@goodwinprocter.com)
`
`
`
`Dated: April 4, 2018
`
`
`
`
`
`
`
`
`
`
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`

`

`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Corrected Patent Owner’s Exhibit List
`
`4 was served on April 24, 2018 by causing it to be sent by email to counsel for
`
`
`
`
`Petitioners at the following email addresses:
`
`
`Daniel R. Evans (devans@merchantgould.com)
`
`Jeffrey D. Blake (jblake@merchantgould.com)
`
`Melissa M. Hayworth (mhayworth@merchantgould.com)
`
`Keith A. Zullow (kzullow@goodwinprocter.com)
`
`Marta E. Delsignore (mdelsignore@goodwinprocter.com)
`
`
`
`Dated: April 24, 2018
`
`
`
`
`
`
`
`
`
`
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`

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