Paper No. ______
`Filed: March 15, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.
`
`Patent Owner
`____________________________
`
`Case No. IPR2016-01332
`U.S. Patent No. 8,822,438
`____________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EXHIBITS
`
`
`
`
`
`
`
`
`Filed: March 15, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.
`
`Patent Owner
`____________________________
`
`Case No. IPR2016-01332
`U.S. Patent No. 8,822,438
`____________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EXHIBITS
`
`
`
`
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Mylan Pharmaceuticals Inc.
`
`(“Petitioner”) objects to the admissibility of the following exhibits filed by Patent
`
`Owner Janssen Oncology, Inc. (“Janssen”) in the Patent Owner’s Response in the
`
`above-captioned inter partes review.
`
`Petitioner’s objections are timely under 37 C.F.R. § 42.64(b)(1) because
`
`they are being filed and served within five (5) business days of the filing of Patent
`
`Owner’s Response on March 8, 2017, Paper No. 35. Petitioner’s objections
`
`provide notice to Janssen that Petitioner may move to exclude these exhibits under
`
`37 C.F.R. § 42.64(c).
`
`In this paper, a reference to “FRE” means the Federal Rules of Evidence, a
`
`reference to “CFR” means the Code of Federal Regulations, and “’438 patent”
`
`means U.S. Patent No. 8,822,438. All objections under FRE 801-803 (hearsay)
`
`apply to the extent Patent Owner relies on the exhibits identified in connection
`
`with that objection for the truth of the matter asserted therein.
`
`Exhibit descriptions provided in this table are from Patent Owner’s exhibit
`
`list and are used for identification purposes only. The use of the description does
`
`not indicate that Petitioner agrees with the descriptions or characterizations of the
`
`documents.
`
`Exhibit
`JSN 2004
`
`Description
`2016/11/10 (DI 239)-Opinion on Markman
`Patent Claim Construction (DNJ)
`
`Objection
`A, I, N, O, U,
`V
`
`- 1 -
`
`
`
`
`
`Exhibit
`JSN 2005
`
`JSN 2006
`
`JSN 2007
`
`JSN 2008
`
`JSN 2009
`
`JSN 2010
`
`JSN 2011
`
`JSN 2012
`
`Description
`2016-14-10 (DI 240)-Order on Markman Patent
`Claim Construction (DNJ)
`Hoffman Deposition Ex. 1 - J&J 2015 4th Q
`results
`Hoffman Deposition Ex. 2 - J&J 2016 4th Q
`results
`Hoffman Deposition Ex. 3 - Concordia v.
`Method
`Garnick Deposition Ex. 1 – 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)
`Garnick Deposition Ex. 2 - 2015-12-04 Serels
`Declaration, Amerigen Pharmaceuticals Ltd. v.
`Janssen Oncology, Inc., IPR2016-00286.
`Garnick Deposition Ex. 3 – Blackhard, Letter to
`Editor, J. Urology, 146(6):1621-1622 (1991)
`Duc et al., “In vitro and in vivo models for the
`evaluation of potent inhibitors of male rat 17α-
`hydroxylase/C17,20-lyase,” Journal of Steroid
`Biochemistry & Molecular Biology, 84:537-542
`(2003)
`
`Objection
`A, I, N, O, U,
`V
`A, B, D, F, L,
`T
`
`A, B, D, F, L,
`T
`A, B, I, K, L,
`N, O1
`A, J, K, M
`
`A, C, D, E, F,
`G, H, I, M, N,
`O, W, X, Y
`A, B, K, L,
`M2
`A, M, N, O
`
`
`1 Petitioner objects to JSN 2008 because it is not an accurate representation of
`
`Hofmann Deposition Ex. 3, as demonstrated by the Hofmann deposition transcript.
`
`JSN 2128 at 3, 103–04.
`
`2 Petitioner objects to JSN 2011 because it is not an accurate representation of
`
`Garnick Deposition Ex. 3, as demonstrated by the Garnick deposition transcript.
`
`JSN 2126 at 4, 184–88.
`
`- 2 -
`
`
`
`
`
`Exhibit
`JSN 2013
`
`JSN 2014
`
`JSN 2015
`
`JSN 2016
`
`JSN 2017
`
`JSN 2018
`
`JSN 2019
`
`Description
`Boehringer-Ingelheim-BTG Press Release –
`“NEW TREATMENT FOR PROSTATE
`CANCER UNDER DEVELOPMENT,” dated
`May 22, 1996
`Attard et al., “Phase I Clinical Trial of a
`Selective Inhibitor of CYP17, Abiraterone
`Acetate, Confirms That Castration-Resistant
`Prostate Cancer Commonly Remains Hormone
`Driven,” Journal of Clinical Oncology,
`26(28):4563-4571 (2008)
`Attard et al., “Selective Inhibition of CYP17
`With Abiraterone Acetate Is Highly Active in
`the Treatment of Castration-Resistant Prostate
`Cancer,” Journal of Clinical Oncology,
`27(23):3742-3748 (2009)
`Danila et al., “Phase II Multicenter Study of
`Abiraterone Acetate Plus Prednisone Therapy in
`Patients With Docetaxel-Treated Castration-
`Resistant Prostate Cancer,” Journal of Clinical
`Oncology, 28(9):1496-1501 (2010)
`Ryan et al., “Phase II Study of Abiraterone in
`Chemotherapy-Naïve Flare Discordant with
`Serologic Response Metastatic Castration-
`Resistant Prostate Cancer Displaying Bone,”
`Clinical Cancer Research, 17:4854-4861
`(2011)
`Jubelirer and Hogan, “High Dose Ketoconazole
`For The Treatment Of Hormone Refractory
`Metastatic Prostate Carcinoma: 16 Cases And
`Review Of The Literature,” The Journal of
`Urology, 142:89- 91 (1989)
`Public Citizen Press Room Release – “Antifunal
`Treatment Should Be Taken Off the Market,
`Public Citizen Tells FDAD,” dated February 24,
`2015
`
`Objection
`A, B, C, D, E,
`F, K, N, O
`
`A, C, D, E, F
`
`A, C, D, E, F
`
`A, C, D, E, F
`
`A, C, D, E, F
`
`A
`
`A, B, C, E, K,
`N, O
`
`- 3 -
`
`
`
`
`
`Exhibit
`JSN 2020
`
`JSN 2021
`
`JSN 2022
`
`JSN 2023
`
`JSN 2024
`
`JSN 2025
`
`JSN 2026
`
`JSN 2027
`
`JSN 2028
`
`JSN 2029
`JSN 2030
`
`Description
`Williams et al., “Objective Responses to
`Ketoconazole Therapy in Patients with
`Relapsed Progressive Prostatic Cancer,” British
`Journal of Urology, 58:45-51 (1986)
`Boumpas et al., “Glucocorticoid Therapy for
`Immune-mediated Diseases: Basic and Clinical
`Correlates,” Ann. Internal Medicine, 119:1198-
`1208 (1993)
`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)
`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)
`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)
`Conde and Aronson, “Risk factors for male
`osteoporosis,” Urologic Oncology, 21:380-383
`(2003)
`Remington – The Science and Practice of
`Pharmacy, 20th ed., pp. 1363-1370 (2000)
`Rumohr and Chang, “Current chemotherapeutic
`approaches for androgen-independent prostate
`cancer,” Current Opinion in Investigational
`Drugs, 7(6):529-533 (2006)
`Declaration of Professor Ian Judson, M.D.
`
`Judson CV
`Clinical Cancer Research Peer Review letter to
`Judson, dated May 12, 2003
`
`Objection
`A, N, O
`
`A, N, O
`
`A, I, N, O
`
`A, N, O
`
`A, N, O
`
`A, N, O
`
`A, I, K, M, N,
`O
`A, C, E, K,
`M, N, O
`
`A, D, F, G, H,
`I, J, N, O, Q,
`S, T, U
`A, L, I, N, O
`A, B, C, D, E,
`F, N, O
`
`- 4 -
`
`
`
`
`
`Exhibit
`JSN 2031
`
`JSN 2032
`
`JSN 2033
`JSN 2034
`JSN 2035
`JSN 2036
`
`JSN 2037
`
`JSN 2038
`
`Description
`Burgess and Roth, “Changing Perspectives of
`the Role of Chemotherapy in Advanced
`Prostate Cancer,” Urol. Clin. N. Am., 33:227-
`236 (2006)
`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)
`Press Release 1/26/2016
`Press Release 1/21/2014
`Press Release 1/20/2015
`Hadaschik et al., “Novel targets and approaches
`in advanced prostate cancer,” Current Opinions
`Urology, 17:182-187 (2007)
`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.
`Declaration of Matthew Rettig, M.D.
`
`JSN 2039
`JSN 2040
`
`Rettig CV
`Declaration of Richard Auchus, M.D., Ph.D.
`
`JSN 2041
`JSN 2042
`
`JSN 2043
`
`JSN 2044
`
`Auchus CV
`Papatsoris et al., “Novel Biological Agents for
`the Treatment of Hormone-Refractory Prostate
`Cancer (HRPC),” Current Medicinal
`Chemistry, 12:277-296 (2005)
`Armstrong and Carducci, “New drugs in
`prostate cancer,” Current Opinions Urology,
`16:138-145 (2006)
`Declaration of Christopher A. Vellturo, Ph.D.
`
`JSN 2045
`
`Vellturo CV
`
`Objection
`A, C, E, M,
`N, O
`
`A, M, N, O
`
`A, B, D, F
`A, B, D, F
`A, B, D, F
`A, C, E, M,
`N, O
`
`A, C, E, D, E,
`F, G, H, I, M,
`N, O, W
`
`D, F, G, H, I,
`J, N, O, Q, S,
`T, U
`A, L, I, N, O
`D, F, G, H, I,
`J, N, O, Q, S,
`T, U
`A, L, I, N, O
`A, M, N, O
`
`A, C, E, M,
`N, O
`
`B, D, F, G, H,
`I, J, N, O, Q,
`S, T, U
`A, L, I, N, O
`
`- 5 -
`
`
`
`
`
`Exhibit
`JSN 2046
`
`JSN 2047
`
`JSN 2048
`
`JSN 2049
`
`JSN 2050
`
`JSN 2051
`
`JSN 2052
`
`JSN 2053
`
`JSN 2054
`
`JSN 2055
`
`JSN 2056
`
`Description
`Therasse et al., “New Guidelines to Evaluate the
`Response to Treatment in Solid Tumors,” J.
`Natl Cancer Inst., 92:205-216 (2000)
`Stamey et al., “Prostate-Specific Antigen As A
`Serum Marker For Adenocarcinoma Of The
`Prostate,” NEJM, 317(15):909-916 (1987)
`Altman et al., “The Revised CONSORT
`Statement for Reporting Randomized Trials:
`Explanation and Elaboration,” Ann. Intern.
`Med., 134:663-694 (2001)
`Blackard, “Letters to the Editor,” Journal of
`Urology, 146(6):1621- 1622 (1991)
`MedlinePlus, “ACTH stimulation test,”
`available at
`https://medlineplus.gov/ency/article/003696.htm,
`last visited Sept. 30, 2016
`Dorin et al., “Diagnosis of Adrenal
`Insufficiency,” Ann. Inern. Med., 139:194-204
`(2003)
`Grinspoon and Biller, “Clinical Review 62
`Laboratory Assessment of Adrenal
`Insufficiency,” J. Clin. Endocrinol. And
`Metabolism, 79(4):923-931 (1994)
`Lara and Meyers, “Treatment Options in
`Androgen-Independent Prostate Cancer,”
`Cancer Investigation, 17(2):137-144 (1999)
`Kuzel et al., “A Phase II Study of Continuous
`Infusion 5- Fluorouracil in Advanced Hormone
`Refractory Prostate Cancer,” Cancer,
`72(6):1965-1968 (1993)
`Scher et al., “Bicalutamide for Advanced
`Prostate Cancer: The Natural Versus Treated
`History of Disease,” J. Clin. Oncology,
`15:2928-2838 (1997)
`Sternberg, “Hormone refractory metastatic
`prostate cancer,” Annals of Oncology, 3:331-
`335 (1992)
`
`Objection
`A, N, O
`
`A, M, N, O
`
`A, N, O
`
`A, M, N, O
`
`A, B, C, E, I
`
`A, M, N, O
`
`A, M, N, O
`
`A, M, N, O
`
`A, M, N, O
`
`A, M, N, O
`
`A, M, N, O
`
`- 6 -
`
`
`
`
`
`Exhibit
`JSN 2057
`
`JSN 2058
`
`JSN 2059
`
`JSN 2060
`
`JSN 2061
`
`JSN 2062
`
`JSN 2063
`
`JSN 2064
`
`Description
`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)
`Excerpts from Seifter, Concepts in Medical
`Physiology, Chapter 34, pp. 540-553, Chapter
`37, pp. 606-620 (2005)
`Petrylak et al., “Docetaxel and Estramustine
`Compared with Mitoxantrone and Prednisone
`for Advanced Refractory Prostate Cancer,”
`NEJM, 351:1513-1520 (2004)
`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)
`Body, “Low-dose prednisone and increased risk
`of development of bone metastases,” Annals of
`Oncology, 7:643-645 (1996)
`Craft, “Eplerenone (Inspra), a new aldosterone
`antagonist for the treatment of systemic
`hypertension and heart failure,” BUMC
`Proceedings, 17:217-220 (2004)
`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)
`Millikan, et al., “Randomized phase 2 trial of
`ketoconazole and ketoconazole/doxorubicin in
`androgen independent prostate cancer,”
`Urologic Oncology, 6:111-115 (2001)
`
`Objection
`A, M
`
`A, C, E, I, M,
`N, O
`
`A, M, N, O
`
`A, K, M, N,
`O
`
`A, M, N, O
`
`A, M, N, O
`
`A, M, N, O
`
`A, M, N, O
`
`- 7 -
`
`
`
`
`
`Exhibit
`JSN 2065
`
`JSN 2066
`
`JSN 2067
`
`JSN 2068
`
`JSN 2069
`
`JSN 2070
`
`JSN 2071
`
`JSN 2072
`
`JSN 2073
`
`Description
`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)
`Mantero et al., “Long-term treatment of
`mineralocorticoid excess syndromes,” Steroids,
`60:81-86 (1995)
`Palmer, “Managing Hyperkalemia Caused by
`Inhibitors
`of
`the
`Renin–Angiotensin–
`Aldosterone System,” NEJ, 351:585-592 (2004)
`Swartz and Dluhy, “Corticosteroids: Clinical
`Pharmacology and Therapeutic Use,” Drugs,
`16:238-255 (1978)
`Seale and Compton, “Side-effects of
`corticosteroid agents,”, Med. J. of Australia,
`144(3):139-142 (1986)
`FDA Press Release (2011)
`
`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)
`Booth et al., “Oncology’s trials,” Nature
`Reviews, 2:609-610 (2003)
`Tokai July 26, 2016 Press Release
`
`JSN 2074
`
`Active/Ipsen April 16, 2015 Press Release
`
`JSN 2075
`
`Takeda June 19, 2014 Press Release
`
`Objection
`A, M, N, O
`
`A, M, N, O
`
`A, N, O
`
`A, M, N, O
`
`A, M, N, O
`
`A, B, C, D, E,
`F, I, K, M, N,
`O
`A, C, D, E, F
`
`A, N, O
`
`A, B, C, D, E,
`F, I, K, N, O
`A, B, C, D, E,
`F, I, K, N, O
`A, B, C, D, E,
`F, I, K, N, O
`
`- 8 -
`
`
`
`
`
`Exhibit
`JSN 2076
`
`JSN 2077
`
`Description
`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)
`OncoGenex (April 28, 2014) Press Release
`
`JSN 2078
`
`BMS Sept. 12, 2013 Press Release
`
`JSN 2079
`
`JSN 2080
`
`JSN 2081
`
`JSN 2082
`
`JSN 2083
`
`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)
`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)
`Genentech March 12, 2010 Press Release
`
`Mulcahy, Medscape October 17, 2008 Press
`Release
`Novacea Form 8-K at 1.02
`
`JSN 2084
`
`ImmunoGen, Inc. Form 8-K, Item 8.01
`
`JSN 2085
`
`Sephton, et al., “Diurnal Cortisol Rhythm as a
`Predictor of Breast Cancer Survival,” Journal
`of National Cancer Institute, 92(12):994-1000
`(2000)
`
`Objection
`A, C, D, E, F,
`N, O
`
`A, B, C, D, E,
`F, I, K, N, O
`A, B, C, D, E,
`F, I, K, N, O
`A, C, D, E, F,
`M, N, O
`
`A, C, D, E, F,
`M, N, O
`
`A, B, C, D, E,
`F, I, K, N, O
`A, B, C, D, E,
`F, I, K, N, O
`A, B, C, D, E,
`F, I, K, M, N,
`O
`A, B, C, D, E,
`F, I, K, M, N,
`O
`A, M, N, O
`
`- 9 -
`
`
`
`
`
`Exhibit
`JSN 2086
`
`JSN 2087
`
`JSN 2088
`
`JSN 2089
`
`JSN 2090
`
`JSN 2091
`
`JSN 2092
`
`JSN 2093
`
`Description
`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
`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
`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
`NCI - SEER Stat Fact Sheets: Prostate Cancer
`
`Tucker et al., “Reversible Adrenal Insufficiency
`Induced by Ketoconazole,” JAMA,
`253(16):2413-2414 (1985)
`What You Need to Know About Prostate
`Cancer, NIH Publication No. 12-1576 (2012)
`Understanding Zytiga Users “Urologist
`Success” Qualitative Research, January 2014
`Patient Affordability, 2013-11-06
`
`JSN 2094
`JSN 2095
`
`Reserved
`Zytiga Usage – prednisone information
`
`JSN 2096
`
`Zytiga Usage – total promotional spend
`
`JSN 2097
`JSN 2098
`
`Reserved
`ACS – “What is Prostate Cancer? Topics”
`
`JSN 2099
`
`Cancer.Net - September 8, 2014 “Treatment of
`Metastatic Castration Resistant Prostate Cancer”
`
`- 10 -
`
`Objection
`A, I, M, N, O
`
`A, I, M, N, O
`
`A, I, M, N, O
`
`A, B, C, E, I,
`K, N, O
`A, M, N, O
`
`A, C, E, N, O
`
`A, B, C, D, E,
`F, I, K, N, O
`A, B, C, D, E,
`F, I, K, N, O
`P
`A, B, C, D, E,
`F, G, I, N, O,
`T, U
`A, B, C, D, E,
`F, G, I, T, U
`P
`A, B, C, E, I,
`N, O
`A, B, C, E, I,
`N, O
`
`
`
`
`
`Exhibit
`JSN 2100
`
`Description
`CDC – “Prostate Cancer”
`
`JSN 2101
`JSN 2102
`
`JSN 2103
`
`J&J May 21, 2009 Press Release
`Mayo Clinic – Prednisone and other
`corticosteroids
`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
`
`JSN 2110
`
`JSN 2111
`JSN 2112
`JSN 2113
`JSN 2114
`JSN 2115
`
`JSN 2116
`
`JSN 2117
`
`Hotte and Saad, “Current management of
`castrate-resistant prostate cancer,” Current
`Oncology, 17(2):S72-S79 (2010)
`J&J January 22, 2013 Press Release – Johnson
`& Johnson Reports 2012 Fourth-Quarter and
`Full-Year Results
`Reserved
`Reserved
`Standing Protective Order
`Redline of Standing Protective Order
`Redacted Expert Report of Christopher Vellturo
`
`Williams, “Discontinued Drugs in 2007:
`oncology drugs,” Expert Opinion on
`Investigational Drugs, 17(12):1791-1816 (2008)
`Williams, “Discontinued Drugs in 2008:
`oncology drugs,” Expert Opinion on
`Investigational Drugs, 18(11):1581-1594 (2009)
`
`Objection
`A, B, C, E, I ,
`N, O
`A, C, E, N, O
`A, B, C, E, I,
`N, O
`A, B, C, E, I,
`N, O
`A, B, C, D, E,
`F, I, N, O
`A, B, C, E, I,
`N, O
`A, B, C, D, E,
`F, I, K
`A, B, C, D, E,
`F, I, K
`A, B, C, D, E,
`F, I, K
`A, C, E, N, O
`
`A, B, C, D, E,
`F, J, L, N, O,
`
`P
`P
`
`
`B, D, F, G, Q,
`S, T, U
`A, C, D, E, F,
`M, N, O
`
`A, C, D, E, F,
`M, N, O
`
`- 11 -
`
`
`
`
`
`Exhibit
`JSN 2118
`
`Description
`Declaration of Johann S. De Bono
`
`JSN 2119
`JSN 2120
`
`JSN 2121
`JSN 2122
`
`JSN 2123
`JSN 2124
`
`JSN 2125
`
`JSN 2126
`
`JSN 2127
`
`JSN 2128
`
`JSN 2129
`
`JSN 2130
`
`Reserved
`Declaration of Scott Serels, MD, filed on Dec.
`4, 2015 in Amerigen Pharmaceuticals Ltd. v.
`Janssen Oncology, Inc., IPR2016-00286.
`
`Reserved
`Declaration of Scott Serels, MD, filed on Jan.
`16, 2017 in Amerigen Pharmaceuticals Ltd. v.
`Janssen Oncology, Inc., IPR2016-00286.
`
`Reserved
`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.
`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.
`Deposition Transcript of Marc b. Garnick, M.D.,
`taken by Patent Owner on February 16, 2017
`Deposition Transcript of Scott R. Serels, taken
`by Patent Owner on January 21, 2017 in
`Amerigen Pharmaceuticals Ltd. v. Janssen
`Oncology, Inc., IPR2016-00286.
`Deposition Transcript of Ivan T. Hofmann,
`taken by Patent Owner on February 7, 2017
`Eplerenone Label
`
`Academy of Managed Care Pharmacy (AMCP)
`Nexus 2016 Poster
`
`Objection
`A, B, C, E, D,
`E, F, G, H, I,
`M, N, O, S,
`T, U, W, Y
`P
`A, B, C, D, E,
`F, G, H, I, M,
`N, O, W. X,
`Y
`P
`A, B, C, D, E,
`F, G, H, I, M,
`N, O, W, X,
`Y
`P
`A, B, C, D, E,
`F, G, H, I, M,
`N, O, W, X,
`Y, Z
`A, B, C, D, E,
`F, G, H, I, M,
`N, O, W, X,
`Y, Z
`Z
`
`A, B, C, D, E,
`F, G, H, I, M,
`N, O, W, X,
`Y, Z
`Z
`
`A, C, E, M,
`N, O
`A, B, D, F, N,
`O
`
`- 12 -
`
`
`
`
`
`Exhibit
`JSN 2131
`
`JSN 2132
`
`JSN 2133
`
`JSN 2134
`
`Description
`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)
`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.).
`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)
`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
`
`Objection
`A, N, O
`
`A, M, N, O,
`W
`
`A, C, D, E, F,
`M, N, O
`
`A, B, D, F, G,
`I, L, T, U
`A, B, D, F, G,
`I, L, T, U
`A, B, D, F, I,
`K, N, O
`A, B, D, F,
`M, N, O
`A, B, D, F,
`M, N, O
`A, B, D, F, J,
`K, M, N, O
`A, B, D, F, J,
`K, M, N, O
`A, B, D, F, J,
`K, M, N, O
`A, B, D, F, J,
`K, M, N, O
`
`- 13 -
`
`
`
`
`
`Exhibit
`JSN 2143
`
`Description
`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
`
`JSN 2146
`
`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
`
`IMS Health Data
`
`JSN 2151
`
`JSN 2152
`
`2016-10-04 (Paper 33) Patent Owner Response
`in IPR2016-00286
`Declaration of Bindu Donovan
`
`Objection
`A, B, D, F, J,
`K, M, N, O
`A, B, D, F, J,
`K, M, N, O
`A, B, D, F, J,
`K, M, N, O
`A, B, D, F, J,
`K, M, N, O
`A, B, D, F, J,
`K, M, N, O
`A, B, D, F, J,
`K, M, N, O
`A, B, D, F, J,
`K, M, N, O
`A, B, D, F, G,
`I, K, L, Q, T,
`U
`A, I, M, N, O,
`W, AA
`
`
`Petitioner objects to paragraphs in the Patent Owner’s Response and
`
`Declarations in Support of Patent Owner’s Response (JSN 2028, JSN 2038, JSN
`
`2040, and JSN 2044) that rely on exhibits objected to in this Petitioner’s Objection
`
`to Evidence.
`
`
`
`- 14 -
`
`
`
`
`
`Objection Key:
`
`A:
`B:
`
`C:
`
`D:
`
`E:
`
`F:
`
`G:
`
`H:
`
`I:
`
`J:
`
`K:
`L:
`
`M:
`N:
`
`O:
`
`P:
`Q:
`
`FRE 801/802/803 (hearsay)
`FRE 901/902 (lacking authentication)
`
`FRE 402 (relevance) the document is not relevant to any issue in this IPR
`proceeding because the purported date of the document is after the filing
`date of the ’438 patent or the prior art status is not clear
`FRE 402 (relevance) to the extent the document is relied upon for secondary
`considerations of nonobviousness, there is no nexus to the claimed
`compositions and methods
`
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in this IPR proceeding because the purported date of the document is
`after the filing date of the ’438 patent or the prior art status is not clear
`FRE 403 (confusing, waste of time) to the extent the document is relied
`upon for secondary considerations of nonobviousness, there is no nexus to
`the claimed compositions and methods
`FRE 702 (improper expert testimony) expert testimony that relies on the
`document is not based on sufficient facts or data and/or is not the product of
`reliable principles and methods
`FRE 703 (bases of expert opinion) expert testimony that relies on the
`document is unreliable because the document is not of a type reasonably
`relied upon by experts in the field
`FRE 106 (completeness) the document is incomplete and includes only a
`select portion of a larger document that in fairness should be considered
`along with this document
`FRE 701, 702 (improper expert testimony) improper expert testimony by a
`lay witness
`FRE 1001-1003 (best evidence)
`FRE 403, 901 (improper compilation)
`
`FRE 403 (cumulative)
`FRE 402 (relevance) the document is not relevant to any issue in the IPR
`proceeding
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in the IPR proceeding
`No exhibit filed.
`Expert testimony fails to identify with particularity the underlying facts or
`data on which the opinion is based, violating 37 C.F.R. § 42.65(a)
`
`- 15 -
`
`
`
`
`
`R:
`S:
`
`FRE 602 (lack of personal knowledge)
`FRE 702/703 to the extent that the expert declarant relies on an exhibit
`objected to under grounds G and H, the testimony is (i) not based on
`sufficient facts or data and/or is not the product of reliable principles and
`methods and/or is (ii) is unreliable because the exhibit is not of a type
`reasonably relied upon by experts in the field
`FRE 1006 (improper summary)
`37 C.F.R. § 42.65 (fails to provide underlying facts or data on which opinion
`is based)
`V: FRE 403 (confusing, waste of time, unfair prejudice) the opinion is in a
`different forum with a different claim construction standard and its use
`would unfairly prejudice Petitioner, waste time and confuse the issues
`W: FRE 403 (confusing, waste of time, unfair prejudice) the paper, declaration,
`or opinion has been filed in a proceeding to which Petitioner is not a party
`and/or had no opportunity to cross-examine the witness in this proceeding
`and/or assess the basis or correctness of the opinions offered
`Petitioner was excluded from participation in proceeding, deposition or cross
`examination of the declarant or witness.
`Patent Owner has refused to provide declarant or witness for deposition.
`Y:
`Transcript does not include errata.
`Z:
`AA: Filing of Patent Owner Response in separate proceedings violates page
`limits of 37 C.F.R. § 42.24(b)
`
`T:
`U:
`
`X:
`
`March 15, 2017
`
`
`
`
`
`Respectfully submitted,
`
`/Brandon M. White/
`Brandon M. White, Esq.
`Reg. No. 52,354
`Perkins Coie LLP
`700 Thirteenth Street, N.W.
`Suite 600
`Washington, DC 20005-3960
`bmwhite@perkinscoie.com
`Tel: 202-654-6206
`Fax: 202-654-9681
`
`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
`
`- 16 -
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
`
`correct copy of the foregoing: PETITIONER’S OBJECTIONS TO PATENT
`
`OWNER’S EXHIBITS by email to the electronic service addresses for Patent
`
`Owner:
`
`Dianne B. Elderkin
`Barbara L. Mullin
`Ruben H. Munoz
`Akin Gump Strauss Hauer & Feld LLP
`JANS-ZYTIGA@akingump.com
`
`David T. Pritikin
`Bindu Donovan
`Sidley Austin LLP
`ZytigaIPRTeam@sidley.com
`
`
`Dated: March 15, 2017
`
`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
`
`
`
`
`
`Counsel for Petitioner Mylan Pharmaceuticals Inc.
`
`
`
`
`
`
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