Paper No. ____
`Date Filed: November 18, 2016
`
`
`
`
`Filed On Behalf Of:
`Novartis AG
`
`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
`
`
`
`
`
`PAR PHARMACEUTICAL, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`
`
`Case IPR2016-01479
`
`Patent No. 9,006,224
`
`
`
`
`
`
`
`
`PATENT OWNER’S EXHIBIT LIST 1
`
`
`
`Date Filed: November 18, 2016
`
`
`
`
`Filed On Behalf Of:
`Novartis AG
`
`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
`
`
`
`
`
`PAR PHARMACEUTICAL, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`
`
`Case IPR2016-01479
`
`Patent No. 9,006,224
`
`
`
`
`
`
`
`
`PATENT OWNER’S EXHIBIT LIST 1
`
`
`
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2001
`
`Expert Declaration Of Matthew H. Kulke,
`M.D., M.M.Sc.
`
`Kulke Decl.
`
`2002
`
`Curriculum Vitae of Matthew H. Kulke,
`M.D., M.M.Sc.
`
`Kulke C.V.
`
`2003
`
`Seeley, R. R., Stephens, T.D., & Tate, P.,
`Anatomy & Physiology, 3rd Edition,
`pages 585 – 586 (1995)
`
`2004
`
`Reserved
`
`Seeley
`
`
`
`2005
`
`Laughlin, E.H., Coming To Terms With
`Cancer: A Glossary Of Cancer-Related
`Terms, page 4 (2002)
`
`Laughlin
`Cancer Glossary
`
`2006
`
` Reserved
`
`2007
`
` Reserved
`
`2008
`
`Motzer, R.J. & Russo, P., “Systemic
`Therapy For Renal Cell Carcinoma,” J.
`Urology 163:408-417 (2000)
`
`2009
`
` Reserved
`
`
`
`
`
`Motzer
`
`
`
`
`
`1
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`Pazdur, R., et al. (eds.), Chapters 6, 11,
`14-16, 19, 25, Cancer Management: A
`Multidisciplinary Approach: Medical,
`Surgical, & Radiation Oncology, 9th
`Edition (2005)
`
`Kouvaraki, M.A. et al., “Fluorouracil,
`Doxorubicin, And Streptozocin In The
`Treatment Of Patients With Locally
`Advanced And Metastatic Pancreatic
`Endocrine Carcinomas,” J. Clin. Oncol.
`22(23):4762-4771 (2004)
`
`Delaunoit, Th., et al., “The Doxorubicin-
`Streptozotocin Combination For The
`Treatment Of Advanced Well-
`Differentiated Pancreatic Endocrine
`Carcinoma: A Judicious Option?,” Eur. J.
`Cancer 40:515-520 (2004)
`
`Kulke, M.H., Chapter 110,
`“Neuroendocrine Cancer,” Clinical
`Hematology and Oncology: Presentation,
`Diagnosis and Treatment (Furie, B., et al.
`eds. 2003)
`
`Kulke, M.H. et al., “A Phase II Trial Of
`Gemcitabine For Metastatic
`Neuroendocrine Tumors,” Cancer
`101(5): 934-939 (2004)
`
`Pazdur
`
`Kouvaraki
`
`Delaunoit
`
`Kulke 2003
`
`Kulke 2004
`
`
`
`2
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2015
`
`Margolin, K. et al., “CCI-779 In
`Metastatic Melanoma: A Phase II Trial
`Of The California Cancer Consortium,”
`Cancer 104(5): 1045-1048 (2005)
`
`Margolin
`
`2016
`
`“Novartis Drug Afinitor Is First
`Treatment For Advanced Pancreatic NET
`To Provide Overall Survival Of More
`Than 3.5 Years In Phase III Trial,”
`Novartis Institutes For Biomedical
`Research (September 27, 2014)
`
`Novartis Press
`Release
`
`2017
`
`Ritschel, W.A., Handbook of Basic
`Pharmacokinetics, 4th Edition, pages 6-7,
`264-267 (1992)
`
`Ritschel
`
`Heitz, Ph.U., et al., Chapter 4, “Tumours
`Of The Endocrine Pancreas,” World
`Health Organization Classification of
`Tumours, Pathology and Genetics,
`Tumours of Endocrine Organs, pages
`177-182 (DeLellis, R.A. et al., eds. 2004)
`
`WHO
`
`Physicians’ Desk Reference, 59th Edition
`(2005), pages 1844-1849 (Entry for
`Gemzar®(Gemcitabine HCl))
`
`Gemzar®
`Prescribing
`Information 2005
`
`Kulke, M.H. & Mayer, R.J., “Carcinoid
`Tumors,” N. Eng. J. Med. 340(11): 858-
`868 (1999)
`
`Kulke 1999
`
`2018
`
`2019
`
`2020
`
`
`
`3
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2021
`
`Gennaro, A.R. (Ed.), Remington’s, 18th
`Edition, pages 726-730 (1990)
`
`Remington’s
`
`2022
`
`2023
`
`2024
`
`2025
`
`Yao, J.C. et al., “Everolimus For
`Advanced Pancreatic Neuroendocrine
`Tumors,” N. Eng. J. Med. 364(6): 514-
`523 (2011)
`
`Yao
`
`Kola, I. & Landis, J., “Can The
`Pharmaceutical Industry Reduce Attrition
`Rates?,” Nat. Rev. Drug Discov., 3:711-
`715 (2004)
`
`Excerpts of Transcript of Trial Testimony
`of M. Ratain, Pfizer Inc. et al. v. Mylan
`Pharms. Inc., (C.A. No. 10-528-GMS),
`(D. Del. November 29, 2012), Pages 778-
`79, 950, 995
`
`Excerpts of Transcript of Trial Testimony
`of M. Ratain, Novartis v. Breckenridge,
`Roxane and Par (C.A. Nos. 14-1043-
`RGA, 14-1196-RGA and 14-1289-RGA)
`(D. Del. August 31, 2016), Pages 769-
`772, 957, 993-94, 1003, 1010, 1012, 1014
`
`Kola & Landis
`
`Ratain Trial Tr. I
`
`Ratain Trial Tr. II
`
`
`
`4
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2026
`
`2027
`
`2028
`
`Excerpts of Transcript of Deposition of
`M. Ratain, Novartis v. Breckenridge,
`Roxane and Par (C.A. Nos. 14-1043-
`RGA, 14-1196-RGA and 14-1289-RGA)
`(D. Del. Apr. 11, 2016), Pages 1-5, 34,
`156, 340
`
`Dancey, J.E., “Inhibitors Of The
`Mammalian Target Of Rapamycin,”
`Expert Opin. Investig. Drugs 14(3): 313-
`328 (2005)
`
`Duran, I, et al., “A Phase II Clinical And
`Pharmacodynamic Study Of
`Temsirolimus In Advanced
`Neuroendocrine Carcinomas,” British J.
`of Cancer 95(9): 1148-1154 (2006)
`
`
`
`Ratain Dep. Tr.
`
`Dancey 2005
`
`Duran 2006
`
`5
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Exhibit List 1 was
`
`served on November 18, 2016 by causing it to be sent by email to counsel for
`
`Petitioner at the following email addresses:
`
`
`Daniel G. Brown (daniel.brown@lw.com)
`
`Jonathan M. Strang (jonathan.strang@lw.com)
`
`
`
`/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
`
`
`
`Dated: November 18, 2016
`
`
`
`
`
`
`
`
`
`6
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