Paper No. ____
`Date Filed: March 19, 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.,
`
`
`
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`
`
`
`Case IPR2017-01592
`
`Patent No. 8,410,131
`
`
`
`
`
`
`
`
`PATENT OWNER’S EXHIBIT LIST 3
`
`
`
`Date Filed: March 19, 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.,
`
`
`
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`
`
`
`Case IPR2017-01592
`
`Patent No. 8,410,131
`
`
`
`
`
`
`
`
`PATENT OWNER’S EXHIBIT LIST 3
`
`
`
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2001
`
`Expert Declaration Of Howard A. Burris,
`III, M.D.
`
`Burris Decl.
`
`2002
`
`Curriculum Vitae Of Howard A. Burris,
`III, M.D.
`
`Burris C.V.
`
`2003
`
`Laughlin, E.H., Coming To Terms With
`Cancer: A Glossary Of Cancer-Related
`Terms, pages 4, 126, 140, 173-174, 188-
`190 (2002)
`
`Laughlin
`
`2004
`
`Altman, R. & Sarg, M.J., The Cancer
`Dictionary, pages 51-52, 278 (1992)
`
`Altman
`
`2005
`
`2006
`
`Sutcliffe, S.B. & Gospodarowicz, M.K.,
`Chapter 25, “Primary Extranodal
`Lymphomas,” The Lymphomas
`(Canellos, G.P. et al. eds. 1998)
`
`Molina, A. & Pezner, R.D., Chapter 30,
`“Non-Hodgkin’s Lymphoma,” Cancer
`Management: A Multidisciplinary
`Approach: Medical, Surgical, &
`Radiation Oncology, 4th Edition (Pazdur,
`R., et al. eds. 2000)
`
`Sutcliffe 1998
`
`Pazdur
`
`
`
`1
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2007
`
`Sutcliffe, S.B. & Gospodarowicz, M.K.,
`“Clinical Features And Management Of
`Localized Extranodal Lymphomas,”
`Haematological Oncology, Volume 2
`pages 189-222 (Keating, A., et al. eds.
`1992)
`
`Sutcliffe 1992
`
`2008
`
`Lynch, C.F. & Cohen, M.B., “Urinary
`System,” Cancer 75(1 Suppl.): 316-329
`(1995)
`
`Lynch & Cohen
`
`2009
`
`2010
`
`2011
`
`Ligato, S. et al., “Benign Tumors And
`Tumor-Like Lesions Of The Adult
`Kidney Part I: Benign Renal Epithelial
`Neoplasms,” Adv. Anat. Pathol. 6(1): 1-
`11 (1999)
`
`Glenn, G.M. et al., Chapter 75, “The
`Molecular Genetics Of Renal Cell
`Carcinoma,” Principles And Practice Of
`Genitourinary Oncology (Raghavan, D.,
`et al. eds. 1997)
`
`Hyland, S. & Wilkinson, D., Chapter 14,
`“The Nurse Practitioner And The
`Organization Of Support Services For
`The Patient With Genitourinary Cancer,”
`Principles And Practice Of Genitourinary
`Oncology (Raghavan, D., et al. eds. 1997)
`
`Ligato
`
`Raghavan-Glenn
`
`Raghavan-Hyland
`
`
`
`2
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`Vasey, P.A., “Immunotherapy For Renal
`Carcinoma: Theoretical Basis And
`Current Standard Of Care,” Br. J. Clin.
`Pharmacol. 50: 521-529 (2000)
`
`Kawai, K., et al., “Ex Vivo Gene Therapy
`Using Granulocyte-Macrophage Colony-
`Stimulating Factor-Transduced Tumor
`Vaccines,” Mol. Urol. 4(2): 43-46 (2000)
`
`Adjei, A.A., “Signal Transduction
`Pathway Targets For Anticancer Drug
`Discovery,” Cur. Pharm. Design 6: 361-
`378 (2000)
`
`Gordon, M.S. et al., “Phase I Safety And
`Pharmacokinetic Study Of Recombinant
`Human Anti-Vascular Endothelial
`Growth Factor In Patients With
`Advanced Cancer,” J. Clin. Oncol. 19(3):
`843-850 (2001)
`
`Vasey
`
`Kawai
`
`Adjei
`
`Gordon
`
`Penn, I. & Starzl, T.E.,
`“Immunosuppression And Cancer,”
`Transplant Proc. 5(1): 943-947 (1973)
`
`Penn & Starzl
`
`January 19, 2016 Office Action,
`Prosecution File History Of U.S. Patent
`Application No. 13/893,537
`
`
`
`
`
`3
`
`
`
`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
`
`Kozlowski, J.M. et al., Chapter 78,
`“Renal Cell Carcinoma, Tumor Markers,”
`Principles And Practice Of Genitourinary
`Oncology (Raghavan, D., et al. eds. 1997)
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`
`
`4
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2024
`
`2025
`
`Motzer, R.J. & Russo, P., “Systemic
`Therapy For Renal Cell Carcinoma,” J.
`Urology 163:408-417 (2000)
`
`Physicians’ Desk Reference, 55th Edition
`(2001), pages 3443-3448 (Entry for
`Rapamune® Oral Solution (Sirolimus))
`
`2026
`
`Document Stamped At The March 13,
`2018 Deposition Of Dr. Allan J. Pantuck
`
`
`
`
`
`
`
`
`
`
`
`
`
`5
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Exhibit List 3 was
`
`served on March 19, 2018 by causing it to be sent by email to counsel for
`
`Petitioner at the following email addresses:
`
`
`Daniel R. Evans (devans@merchantgould.com)
`
`Jeffrey D. Blake (jblake@merchantgould.com)
`
`Melissa M. Hayworth (mhayworth@merchantgould.com)
`
`
`
`Dated: March 19, 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
`
`
`
`
`
`6
`
`
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