Paper No. ___
`Date Filed: Mar. 17, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`________________
`
`WOCKHARDT BIO AG,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`
`________________
`
`Case IPR2016-01582
`Patent 8,822,438
`
`________________
`
`JANSSEN ONCOLOGY, INC.’S UPDATED EXHIBIT LIST
`
`
`Date Filed: Mar. 17, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`________________
`
`WOCKHARDT BIO AG,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`
`________________
`
`Case IPR2016-01582
`Patent 8,822,438
`
`________________
`
`JANSSEN ONCOLOGY, INC.’S UPDATED EXHIBIT LIST
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner, Janssen Oncology, Inc.
`
`hereby submits a current list of its exhibits.
`
`Exhibit
`
`JSN 2001
`
`Description
`
`Notice of Termination of Preprocessing of Ex Parte Reexamination
`
`Request
`
`JSN 2002
`
`SEALED Reda Dhanorkar Email Chain – Protective Order Material
`
`JSN 2003
`
`SEALED Reda Declaration – Protective Order Material
`
`JSN 2004
`
`Reda Declaration – Redacted
`
`JSN 2005
`
`Reda Dhanokar Email Chain - Redacted
`
`JSN 2006
`
`Standing Protective Order IPR2016-01582
`
`JSN 2007
`
`Redline of Standing Protective Order IPR2016-01582
`
`JSN 2008
`
`Declaration of David T. Pritikin in Support of Motion to Appear
`
`Pro Hac Vice
`
`JSN 2009
`
`Declaration of Bindu Donovan in Support of Motion to Appear Pro
`
`Hac Vice
`
`JSN 2010
`
`2016/11/10 (DI 239) – Opinion on Markman Patent Claim
`
`Construction (DNJ)
`
`JSN 2011
`
`2016/14/10 (DI 240) – Order on Markman Patent Claim
`
`Construction
`
`
`
`1
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2012
`
`Description
`
`PM Live Top 50 Pharmaceuticals
`
`JSN 2013
`
`Johnson & Johnson Press Release 1/26/2016
`
`JSN 2014
`
`Johnson & Johnson Press Release 1/24/2017
`
`JSN 2015
`
`Declaration of Dr. Marc Garnick
`
`JSN 2016
`
`Deposition Transcript of Marc B. Garnick, M.D., taken by Patent
`
`Owner on February 16, 2017
`
`JSN 2017
`
`Declaration of Scott Serels, MD, filed on Dec. 4, 2015 in Amerigen
`
`Pharmaceuticals Ltd. v. Janssen Oncology, Inc., IPR2016-00286.
`
`JSN 2018
`
`Deposition Transcript of Scott R. Serels, taken by Patent Owner on
`
`January 21, 2017 in Amerigen Pharmaceuticals Ltd. v. Janssen
`
`Oncology, Inc., IPR2016-00286.
`
`JSN 2019
`
`Declaration of Scott Serels, MD, filed on Jan. 16, 2017 in Amerigen
`
`Pharmaceuticals Ltd. v. Janssen Oncology, Inc., IPR2016-00286.
`
`JSN 2020
`
`Deposition Transcript of Scott Serels, M.D., taken by Patent Owner
`
`on August 22, 2016 in Amerigen Pharmaceuticals Ltd. v. Janssen
`
`Oncology, Inc., IPR2016-00286.
`
`
`
`2
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2021
`
`Description
`
`Boumpas et al., “Glucocorticoid Therapy for Immune-mediated
`
`Diseases: Basic and Clinical Correlates,” Ann. Internal Medicine,
`
`119:1198-1208 (1993)
`
`JSN 2022
`
`Debruyne and Witjes, “Ketoconazole High Dose (H.D.) In The
`
`Management Of Metastatic Prostatic Carcinoma,” The Journal of
`
`Urology, 135(4, pt.2):203A, Abstract 397 (1986)
`
`JSN 2023
`
`Herr and Pfitzenmaier, “Glucocorticoid use in prostate cancer and
`
`other solid tumours: implications for effectiveness of cytotoxic
`
`treatment and metastases,” The Lancet, 7:425-430 (2006)
`
`JSN 2024
`
`Krishnan et al., “A Glucocorticoid-Responsive Mutant Androgen
`
`Receptor Exhibits Unique Ligand Specificity: Therapeutic
`
`Implications for Androgen-Independent Prostate Cancer,”
`
`Endocrinology, 145:1889-1900 (2002)
`
`JSN 2025
`
`Conde and Aronson, “Risk factors for male osteoporosis,” Urologic
`
`Oncology, 21:380-383 (2003)
`
`JSN 2026
`
`Remington – The Science and Practice of Pharmacy, 20th ed., pp.
`
`1363-1370 (2000)
`
`
`
`3
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2027
`
`Description
`
`Rumohr and Chang, “Current chemotherapeutic approaches for
`
`androgen-independent prostate cancer,” Current Opinion in
`
`Investigational Drugs, 7(6):529-533 (2006)
`
`JSN 2028
`
`Declaration of Professor Ian Judson, M.D.
`
`JSN 2029
`
`Judson CV
`
`JSN 2030
`
`Clinical Cancer Research Peer Review letter to Judson, dated May
`
`12, 2003
`
`JSN 2031
`
`Burgess and Roth, “Changing Perspectives of the Role of
`
`Chemotherapy in Advanced Prostate Cancer,” Urol. Clin. N. Am.,
`
`33:227-236 (2006)
`
`JSN 2032
`
`Strother et al., “Novel cytotoxic and biological agents for prostate
`
`cancer: Where will the money be in 2005?,” European Journal of
`
`Cancer, 41:954-964 (2005)
`
`JSN 2033
`
`Reserved
`
`JSN 2034
`
`Press Release 1/21/2014
`
`JSN 2035
`
`Press Release 1/20/2015
`
`JSN 2036
`
`Hadaschik et al., “Novel targets and approaches in advanced
`
`prostate cancer,” Current Opinions Urology, 17:182-187 (2007)
`
`
`
`4
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2037
`
`Reserved
`
`Description
`
`
`JSN 2038
`
`Declaration of Matthew Rettig, M.D.
`
`JSN 2039
`
`Rettig CV
`
`JSN 2040
`
`Declaration of Richard Auchus, M.D., Ph.D.
`
`JSN 2041
`
`Auchus CV
`
`JSN 2042
`
`Papatsoris et al., “Novel Biological Agents for the Treatment of
`
`Hormone-Refractory Prostate Cancer (HRPC),” Current Medicinal
`
`Chemistry, 12:277-296 (2005)
`
`JSN 2043
`
`Armstrong and Carducci, “New drugs in prostate cancer,” Current
`
`Opinions Urology, 16:138-145 (2006)
`
`JSN 2044
`
`Declaration of Christopher A. Vellturo, Ph.D.
`
`JSN 2045
`
`Vellturo CV
`
`JSN 2046
`
`Therasse et al., “New Guidelines to Evaluate the Response to
`
`Treatment in Solid Tumors,” J. Natl Cancer Inst., 92:205-216
`
`(2000)
`
`
`
`5
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2047
`
`Description
`
`Stamey et al., “Prostate-Specific Antigen As A Serum Marker For
`
`Adenocarcinoma Of The Prostate,” NEJM, 317(15):909-916 (1987)
`
`JSN 2048
`
`Altman et al., “The Revised CONSORT Statement for Reporting
`
`Randomized Trials: Explanation and Elaboration,” Ann. Intern.
`
`Med., 134:663-694 (2001)
`
`JSN 2049
`
`Blackard, “Letters to the Editor,” Journal of Urology, 146(6):1621-
`
`1622 (1991)
`
`JSN 2050
`
`MedlinePlus, “ACTH stimulation test,” available at
`
`https://medlineplus.gov/ency/article/003696.htm, last visited Sept.
`
`30, 2016
`
`JSN 2051
`
`Dorin et al., “Diagnosis of Adrenal Insufficiency,” Ann. Inern.
`
`Med., 139:194-204 (2003)
`
`JSN 2052
`
`Grinspoon and Biller, “Clinical Review 62 Laboratory Assessment
`
`of Adrenal Insufficiency,” J. Clin. Endocrinol. And Metabolism,
`
`79(4):923-931 (1994)
`
`
`
`6
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2053
`
`Description
`
`Lara and Meyers, “Treatment Options in Androgen-Independent
`
`Prostate Cancer,” Cancer Investigation, 17(2):137-144 (1999)
`
`JSN 2054
`
`Kuzel et al., “A Phase II Study of Continuous Infusion 5-
`
`Fluorouracil in Advanced Hormone Refractory Prostate Cancer,”
`
`Cancer, 72(6):1965-1968 (1993)
`
`JSN 2055
`
`Scher et al., “Bicalutamide for Advanced Prostate Cancer: The
`
`Natural Versus Treated History of Disease,” J. Clin. Oncology,
`
`15:2928-2838 (1997)
`
`JSN 2056
`
`Sternberg, “Hormone refractory metastatic prostate cancer,” Annals
`
`of Oncology, 3:331-335 (1992)
`
`JSN 2057
`
`Bubley et al., “Eligibility and Response Guidelines for Phase II
`
`Clinical Trials in Androgen-Independent Prostate Cancer:
`
`Recommendations From the Prostate-Specific Antigen Working
`
`Group,” J. Clin. Oncology, 17:3461-3467 (1999)
`
`JSN 2058
`
`Excerpts from Seifter, Concepts in Medical Physiology, Chapter
`
`34, pp. 540-553, Chapter 37, pp. 606-620 (2005)
`
`
`
`7
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2059
`
`Description
`
`Petrylak et al., “Docetaxel and Estramustine Compared with
`
`Mitoxantrone and Prednisone for Advanced Refractory Prostate
`
`Cancer,” NEJM, 351:1513-1520 (2004)
`
`JSN 2060
`
`Marini et al., “The effect of adjuvant prednisone combined with
`
`CMF on patterns of relapse and occurrence of second malignancies
`
`in patients with breast cancer,” Annals of Oncology, 7:245-250
`
`(1996)
`
`JSN 2061
`
`Body, “Low-dose prednisone and increased risk of development of
`
`bone metastases,” Annals of Oncology, 7:643-645 (1996)
`
`JSN 2062
`
`Craft, “Eplerenone (Inspra), a new aldosterone antagonist for the
`
`treatment of systemic hypertension and heart failure,” BUMC
`
`Proceedings, 17:217-220 (2004)
`
`JSN 2063
`
`Small et al., “Antiandrogen Withdrawal Alone or in Combination
`
`With Ketoconazole in Androgen-Independent Prostate Cancer
`
`Patients: A Phase III Trial (CALGB 9583),” J. Clin. Oncology,
`
`22(6):1025-1033 (2004)
`
`
`
`8
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2064
`
`Description
`
`Millikan, et al., “Randomized phase 2 trial of ketoconazole and
`
`ketoconazole/doxorubicin in androgen independent prostate
`
`cancer,” Urologic Oncology, 6:111-115 (2001)
`
`JSN 2065
`
`Farwell, et al., “Total Suppression of Cortisol Excretion by
`
`Ketoconazole in the Therapy of the Ectopic Adrenocorticotropic
`
`Hormone Syndrome,” American Journal of Medicine, 84:1063-
`
`1066 (1988)
`
`JSN 2066
`
`Mantero et al., “Long-term treatment of mineralocorticoid excess
`
`syndromes,” Steroids, 60:81-86 (1995)-
`
`JSN 2067
`
`Palmer, “Managing Hyperkalemia Caused by Inhibitors of the
`
`Renin–Angiotensin–Aldosterone System,” NEJ, 351:585-592
`
`(2004)
`
`JSN 2068
`
`Swartz and Dluhy, “Corticosteroids: Clinical Pharmacology and
`
`Therapeutic Use,” Drugs, 16:238-255 (1978)
`
`JSN 2069
`
`Seale and Compton, “Side-effects of corticosteroid agents,”, Med.
`
`J. of Australia, 144(3):139-142 (1986)
`
`
`
`9
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2070
`
`FDA Press Release (2011)
`
`Description
`
`
`JSN 2071
`
`Ryan et al., “Abiraterone acetate plus prednisone versus placebo
`
`plus prednisone in chemotherapy-naive men with metastatic
`
`castration-resistant prostate cancer (COU-AA-302): final overall
`
`survival analysis of a randomised, double-blind, placebo-controlled
`
`phase 3 study,” Lancet Oncology, 16:152-160 (2015)
`
`JSN 2072
`
`Booth et al., “Oncology’s trials,” Nature Reviews, 2:609-610 (2003)
`
`JSN 2073
`
`Tokai July 26, 2016 Press Release
`
`JSN 2074
`
`Active/Ipsen April 16, 2015 Press Release
`
`JSN 2075
`
`Takeda June 19, 2014 Press Release
`
`JSN 2076
`
`Michaelson et al., “Randomized, Placebo-Controlled, Phase III
`
`Trial of Sunitinib Plus Prednisone Versus Prednisone Alone in
`
`Progressive, Metastatic, Castration-Resistant Prostate Cancer,” J.
`
`Clin. Oncology, 31:1-8 (2013)
`
`JSN 2077
`
`OncoGenex (April 28, 2014) Press Release
`
`
`
`10
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2078
`
`Description
`
`BMS Sept. 12, 2013 Press Release
`
`JSN 2079
`
`Carducci et al., “A Phase 3 Randomized Controlled Trial of the
`
`Efficacy and Safety of Atrasentan in Men With Metastatic
`
`Hormone-refractory Prostate Cancer,” Cancer, 110(9):1959-1966
`
`(2007)
`
`JSN 2080
`
`Antonarakis and Eisenberger, “Phase III Trials With Docetaxel-
`
`Based Combinations for Metastatic Castration-Resistant Prostate
`
`Cancer: Time to Learn From Past Experiences,” J. Clin. Oncology,
`
`31(14):1709-1712 (2013)
`
`JSN 2081
`
`Genentech March 12, 2010 Press Release
`
`JSN 2082
`
`Mulcahy, Medscape October 17, 2008 Press Release
`
`JSN 2083
`
`Novacea Form 8-K at 1.02
`
`JSN 2084
`
`ImmunoGen, Inc. Form 8-K, Item 8.01
`
`
`
`11
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2085
`
`Description
`
`Sephton, et al., “Diurnal Cortisol Rhythm as a Predictor of Breast
`
`Cancer Survival,” Journal of National Cancer Institute,
`
`92(12):994-1000 (2000)
`
`JSN 2086
`
`White, P.C., “Synthesis and Metabolism of Corticosteroids,”
`
`Principles and Practice of Endocrinology and Metabolism, Ed.
`
`Kenneth L. Becker, Philadelphia: Lippincott Williams & Wilkins,
`
`2001, Chapter 72, 704-714
`
`JSN 2087
`
`White, P.C., “Synthesis and Metabolism of Corticosteroids,”
`
`Principles and Practice of Endocrinology and Metabolism, Ed.
`
`Kenneth L. Becker, Philadelphia: Lippincott Williams & Wilkins,
`
`2001, Chapter 73, 714-719
`
`JSN 2088
`
`White, P.C., “Synthesis and Metabolism of Corticosteroids,”
`
`Principles and Practice of Endocrinology and Metabolism, Ed.
`
`Kenneth L. Becker, Philadelphia: Lippincott Williams & Wilkins,
`
`2001, Chapter 78, 751-764
`
`JSN 2089
`
`NCI - SEER Stat Fact Sheets: Prostate Cancer
`
`
`
`12
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2090
`
`Description
`
`Tucker et al., “Reversible Adrenal Insufficiency Induced by
`
`Ketoconazole,” JAMA, 253(16):2413-2414 (1985)
`
`JSN 2091
`
`What You Need to Know About Prostate Cancer, NIH Publication
`
`No. 12-1576 (2012)
`
`JSN 2092
`
`Understanding Zytiga Users “Urologist Success” Qualitative
`
`Research, January 2014
`
`JSN 2093
`
`Patient Affordability, 2013-11-06
`
`JSN 2094
`
`Reserved
`
`JSN 2095
`
`Zytiga Usage – prednisone information
`
`JSN 2096
`
`Zytiga Usage – total promotional spend
`
`JSN 2097
`
`Reserved
`
`JSN 2098
`
`ACS – “What is Prostate Cancer? Topics”
`
`JSN 2099
`
`Cancer.Net - September 8, 2014 “Treatment of Metastatic
`
`Castration Resistant Prostate Cancer”
`
`
`
`13
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`Description
`
`
`JSN 2100
`
`CDC – “Prostate Cancer”
`
`JSN 2101
`
`J&J May 21, 2009 Press Release
`
`JSN 2102
`
`Mayo Clinic – Prednisone and other corticosteroids
`
`JSN 2103
`
`Medical Dictionary – refractory cancer
`
`JSN 2104
`
`NCI – Docetaxel
`
`JSN 2105
`
`NCI – Metastatic Cancer
`
`JSN 2106
`
`Orange Book – Xofigo
`
`JSN 2107
`
`Orange Book – Xtandi
`
`JSN 2108
`
`Orange Book – Jevtana
`
`JSN 2109
`
`Hotte and Saad, “Current management of castrate-resistant prostate
`
`cancer,” Current Oncology, 17(2):S72-S79 (2010)
`
`JSN 2110
`
`J&J January 22, 2013 Press Release – Johnson & Johnson Reports
`
`2012 Fourth-Quarter and Full-Year Results
`
`
`
`14
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2111
`
`Description
`
`Duc et al., “In vitro and in vivo models for the evaluation of potent
`
`inhibitors of male rat for the 17α-hydroxylase/C17,20-lyase,” Journal
`
`of Steroid Biochemistry & Molecular Biology, 84:537-542 (2003).
`
`JSN 2112
`
`Boehringer-Ingelheim-BTG Press Release – “NEW TREATMENT
`
`FOR PROSTATE CANCER UNDER DEVELOPMENT,” dated
`
`May 22, 1996
`
`JSN 2113
`
`Public Citizen Press Room Release – “Antifungal Treatment
`
`Should Be Taken Off the Market, Public Citizen Tells FDA,” dated
`
`February 24, 2015.
`
`JSN 2114
`
`Williams et al., “Objective Responses to Ketoconazole Therapy in
`
`Patients with Relapsed Progressive Prostatic Cancer,” British
`
`Journal of Urology, 58:45-51 (1986).
`
`JSN 2115
`
`Redacted Expert Report of Christopher Vellturo
`
`JSN 2116
`
`Williams, “Discontinued Drugs in 2007: oncology drugs,” Expert
`
`Opinion on Investigational Drugs, 17(12):1791-1816 (2008)
`
`
`
`15
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2117
`
`Description
`
`Williams, “Discontinued Drugs in 2008: oncology drugs,” Expert
`
`Opinion on Investigational Drugs, 18(11):1581-1594 (2009)
`
`JSN 2118
`
`Declaration of Johann S. De Bono
`
`JSN 2119
`
`Reserved
`
`JSN 2120
`
`Reserved
`
`JSN 2121
`
`Reserved
`
`JSN 2122
`
`Reserved
`
`JSN 2123
`
`Reserved
`
`JSN 2124
`
`Deposition Transcript of Mark J. Ratain, M.D., taken by Patent
`
`Owner on January 23, 2017 in Amerigen Pharmaceuticals Ltd. v.
`
`Janssen Oncology, Inc., IPR2016-00286.
`
`JSN 2125
`
`Deposition Transcript of Richard Dorin, M.D., taken by Patent
`
`Owner on January 19, 2017 in Amerigen Pharmaceuticals Ltd. v.
`
`Janssen Oncology, Inc., IPR2016-00286.
`
`JSN 2126
`
`Reserved
`
`
`
`16
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2127
`
`Reserved
`
`Description
`
`
`JSN 2128
`
`Deposition Transcript of Ivan T. Hofmann, taken by Patent Owner
`
`on February 7, 2017
`
`JSN 2129
`
`Eplerenone Label
`
`JSN 2130
`
`Academy of Managed Care Pharmacy (AMCP) Nexus 2016 Poster
`
`JSN 2131
`
`Van den Akker et al., “Differential Inhibition of 17a-Hydroxylase
`
`and 17,20-Lyase Activities by Three Novel Missense CYP17
`
`Mutations Identified in Patients with P450c17 Deficiency,” J. Clin.
`
`Endocrinol. & Metabolism, 87(12):5714-5721 (2002)
`
`JSN 2132
`
`Order Granting Janssen’s Motion to Set a Hearing and Correct
`
`Inventorship of the ‘438 Patent Pursuant to 35 U.S.C. § 256 and
`
`Authoring the Filing of a Second Amended Complaint, BTG
`
`International Ltd., et al. v. Actavis Laboratories FL, Inc., et al., No.
`
`2:15-cv-05909-KM-JBC, D.I. 270 (Jan. 24, 2017 D.N.J.).
`
`
`
`17
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2133
`
`Description
`
`Ryan, et al., “Phase I Clinical Trial of the CYP17 Inhibitor
`
`Abiraterone Acetate Demonstrating Clinical Activity in Patients
`
`With Castration-Resistant Prostate Cancer Who Received Prior
`
`Ketoconazole Therapy,” J Cancer Oncology 28(9):1481-1488
`
`(2010)
`
`JSN 2134
`
`ZYTIGA Market Share data
`
`JSN 2135
`
`Truven Commercial and Medicare Data
`
`JSN 2136
`
`BTG Webpage from WayBack Machine
`
`JSN 2137
`
`BTG Annual Report, 2003
`
`JSN 2138
`
`BTG Annual Report, 2004
`
`JSN 2139
`
`J&J Q1 2013 Earnings Call Transcript
`
`JSN 2140
`
`J&J Q2 2013 Earnings Call Transcript
`
`JSN 2141
`
`J&J Q3 2013 Earnings Call Transcript
`
`JSN 2142
`
`J&J Q4 2013 Earnings Call Transcript
`
`JSN 2143
`
`J&J Q1 2014 Earnings Call Transcript
`
`JSN 2144
`
`J&J Q2 2014 Earnings Call Transcript
`
`JSN 2145
`
`J&J Q3 2014 Earnings Call Transcript
`
`
`
`18
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2146
`
`Description
`
`J&J Q4 2014 Earnings Call Transcript
`
`JSN 2147
`
`J&J Q1 2015 Earnings Call Transcript
`
`JSN 2148
`
`J&J Q2 2015 Earnings Call Transcript
`
`JSN 2149
`
`J&J Q3 2015 Earnings Call Transcript
`
`JSN 2150
`
`Reserved
`
`JSN 2151
`
`Patent Owner Response in IPR2016-00286
`
`JSN 2152
`
`Declaration of Bindu Donovan
`
`JSN 2153
`
`Declaration of Ivan Hofmann, filed on June 30, 2016 in Mylan
`
`Pharmaceuticals Inc. v. Janssen Oncology, Inc., IPR2016-01332
`
`JSN 2154
`
`Patent Owner Response in IPR2016-01332
`
`JSN 2155
`
`Butler affidavit and archive notarization
`
`JSN 2156
`
`Sartor, “The Continuing Challenge of Hormone-Refractory Prostate
`
`Cancer,” Clinical Genitourinary Cancer, pp. 238-239 (2006)
`
`JSN 2157
`
`Sweeney, “ECOG 3805: CHAARTED – ChemoHormonal Therapy
`
`versus Androgen Ablation Randomized Trial for Extensive Disease
`
`in Prostate Cancer,” Clinical Advances in Hematology & Oncology,
`
`4(8):588-590 (2006).
`
`
`
`19
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2158
`
`Description
`
`“ECOG Performance Status,” available at http://ecog-
`
`acrin.org/resources/ecog-performance-status, last visited march 14,
`
`2017
`
`JSN 2159
`
`de Bono, J.S. et al., “Abiraterone and increased survival in
`
`metastatic prostate cancer,” New Engl. J. Med., 364:1995–2005
`
`(2011)
`
`JSN 2160
`
`Deposition Transcript of Robert D. Stoner, taken by Patent Owner
`
`on February 10, 2017
`
`JSN 2161
`
`Deposition Transcript of Paul A. Godley, taken by Patent Owner on
`
`March 7, 2017
`
`JSN 2162
`
`Redacted deposition transcript of Paul A. Godley, taken by Patent
`
`Owner on March 7, 2017
`
`JSN 2163
`
`Sweeney, et al., “Chemohormonal Therapy in Metastatic Hormone-
`
`Sensitive Prostate Cancer,” NEJM, 373:737-746 (2015)
`
`JSN 2164
`
`July 3, 2013 Notice of Allowance from prosecution history of
`
`’438 patent
`
`
`
`20
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`Exhibit
`
`JSN 2165
`
`Description
`
`February 11, 2014 Notice of Allowance (from prosecution history
`
`of ’438 patent)
`
`JSN 2166
`
`June 2, 2014 Notice of Allowance (from prosecution history of
`
`’438 patent)
`
`JSN 2167
`
`June 4, 2013 Response to Office Action (from prosecution history
`
`of ’438 patent)
`
`JSN 2168
`
`Zytiga Label (2011)
`
`
`
`
`
`
`
`
`
`21
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`
`
`Dated: March 17, 2017
`
`Respectfully Submitted,
`
`By: /Dianne B. Elderkin/
`Dianne B. Elderkin (Reg. No. 28,598)
`delderkin@akingump.com
`Barbara L. Mullin (Reg. No. 38,250)
`bmullin@akingump.com
`Ruben H. Munoz (Reg. No. 66,998)
`rmunoz@akingump.com
`AKIN GUMP STRAUSS HAUER &
`FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel: (215) 965-1200
`Fax: (215) 965-1210
`
`David T. Pritikin (pro hac vice)
`dpritikin@sidley.com
`Bindu Donovan (pro hac vice)
`bdonovan@sidley.com
`Paul Zegger (Reg. No. 33,821)
`pzegger@sidley.com
`Todd Krause (Reg. No. 48,860)
`tkrause@sidley.com
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`ZytigaIPRTeam@sidley.com
`Counsel for Patent Owner
`
`
`
`
`
`
`
`22
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
`
`CERTIFICATE OF SERVICE
`
`
`
`The undersigned hereby certifies that a copy of the foregoing Janssen
`
`Oncology, Inc.’s Updated Exhibit List was served on counsel of record on March
`
`17, 2017 by filing this document through the End-to-End System, as well as
`
`delivering a copy via electronic mail to counsel of record for the Petitioner and
`
`Patent Co-Owner at the following addresses:
`
`Dennies Varughese - dvarughe-PTAB@skgf.com
`Deborah A. Sterling - dsterlin-PTAB@skgf.com
`Christopher M. Gallo - cgallo-PTAB@skgf.com
`Ralph W. Powers III – tpowers-PTAB@skgf.com
`
`Anthony C. Tridico - anthony.tridico@finnegan.com
`Jennifer H. Roscetti - jennifer.roscetti@finnegan.com
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`By: /Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`
`23
`
`
`
`Date: Mar. 17, 2017
`
`
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