`Date Filed: November 14, 2016
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`
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`Filed On Behalf Of:
`Novartis AG
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`ROXANE LABORATORIES, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`
`
`Case IPR2016-01461
`
`Patent No. 9,006,224
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`PATENT OWNER’S EXHIBIT LIST 1
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`
`
`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)
`
`Seeley
`
`2004
`
`Moertel, C.G., et al., “Streptozocin-
`Doxorubicin, Streptozocin-Fluorouracil,
`Or Chlorozotocin In The Treatment Of
`Advanced Islet-Cell Carcinoma,” New
`Engl. J. Med. 326(8):519-523 (1992)
`
`Moertel
`
`2005
`
`Laughlin, E.H., Coming To Terms With
`Cancer: A Glossary Of Cancer-Related
`Terms, page 4 (2002)
`
`Laughlin
`Cancer Glossary
`
`2006
`
`Hewitt, M.R. & Yu, K., “Treatment
`Update For Metastatic Pancreatic
`Cancer,” Community Oncol. 3(7):428-430
`(July 2006)
`
`Hewitt and Yu
`
`
`
`1
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2007
`
`Yu, K.H. & Ahman, N.A., Chapter 25,
`“Diagnosis And Evaluation Of Pancreatic
`Ductal Adenocarcinoma,” Endoscopic
`Oncology: Gastrointestinal Endoscopy
`And Cancer Management (Faigel, D.O. &
`Kochman, M.L., eds. 2006)
`
`2008
`
`Motzer, R.J. & Russo, P., “Systemic
`Therapy For Renal Cell Carcinoma,” J.
`Urology 163:408-417 (2000)
`
`2009
`
`2010
`
`2011
`
`“Wyeth Pharmaceuticals Announces
`Termination Of Phase 3 Clinical Program
`With Oral Temsirolimus In Women With
`Metastatic Breast Cancer,” PR Newswire,
`AP Alert (March 16, 2006)
`
`Pazdur, R., et al. (eds.), Chapters 11, 14,
`16, & 19, 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)
`
`Yu
`
`Motzer
`
`Wyeth
`Press Release
`
`Pazdur
`
`Kouvaraki
`
`
`
`2
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2012
`
`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)
`
`Delaunoit
`
`
`
`3
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`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Exhibit List 1 was
`
`served on November 14, 2016 by causing it to be sent by email to counsel for
`
`Petitioner at the following email addresses:
`
`
`Keith A. Zullow (kzullow@goodwinprocter.com)
`
`Marta E. Delsignore (mdelsignore@goodwinprocter.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 14, 2016
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