Paper No. ___
`Date Filed: Aug. 19, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`
`________________
`
`Case IPR2016-00286
`Patent 8,822,438 B2
`
`________________
`
`
`JANSSEN ONCOLOGY, INC.’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`Date Filed: Aug. 19, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`
`________________
`
`Case IPR2016-00286
`Patent 8,822,438 B2
`
`________________
`
`
`JANSSEN ONCOLOGY, INC.’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`IPR2016-00286
`Patent 8,822,438
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioner, Janssen Oncology, Inc. hereby
`submits a current list of its exhibits.
`
`Exhibit
`
`JSN 2001
`
`Description
`
`Declaration of David T. Pritikin in Support of Motion to Appear
`
`Pro Hac Vice
`
`JSN 2002
`
`Declaration of Bindu Donovan in Support of Motion to Appear Pro
`
`Hac Vice
`
`JSN 2003
`
`Remington – The Science and Practice of Pharmacy, 20th ed., pp.
`
`1363-1370 (2000)
`
`JSN 2004
`
`Rumohr and Chang, “Current chemotheratpeutic approaches for
`
`androgen-independent prostate cancer,” Current Opinion in
`
`Investigational Drugs, 7(6):529-533 (2006)
`
`JSN 2005
`
`Declaration of Professor Ian Judson, dated June 29, 2015, cited in
`
`the Opposition of European Patent 2 061 561
`
`JSN 2006
`
`Clinical Cancer Research Peer Review letter to Judson, dated May
`
`12, 2003
`
`JSN 2007
`
`Burgess and Roth, “Changing Perspectives of the Role of
`
`Chemotherapy in Advanced Prostate Cancer,” Urol. Clin. N. Am.,
`
`33:227-236 (2006)
`
`
`
`IPR2016-00286
`Patent 8,822,438
`
`Exhibit
`
`JSN 2008
`
`Description
`
`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 2009
`
`Hadaschik et al., “Novel targets and approaches in advanced
`
`prostate cancer,” Current Opinions Urology, 17:182-187 (2007)
`
`JSN 2010
`
`Papatsoris et al., Novel Biological Agents for the Treatment of
`
`Hormone-Refractory Prostate Cancer (HRPC), Current Medicinal
`
`Chemistry, 12:277-296 (2005)
`
`JSN 2011
`
`Armstrong and Carducci, “New drugs in prostate cancer,” Current
`
`Opinions Urology, 16:138-145 (2006)
`
`JSN 2012
`
`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)
`
`JSN 2013
`
`Boehringer-Ingelheim-BTG Press Release – “NEW TREATMENT
`
`FOR PROSTATE CANCER UNDER DEVELOPMENT,” dated
`
`May 22, 1996
`
`
`
`IPR2016-00286
`Patent 8,822,438
`
`Exhibit
`
`JSN 2014
`
`Description
`
`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)
`
`JSN 2015
`
`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)
`
`JSN 2016
`
`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)
`
`JSN 2017
`
`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)
`
`
`
`IPR2016-00286
`Patent 8,822,438
`
`Exhibit
`
`JSN 2018
`
`Description
`
`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)
`
`JSN 2019
`
`Public Citizen Press Room Release – “Antifunal Treatment Should
`
`Be Taken Off the Market, Public Citizen Tells FDAD,” dated
`
`February 24, 2015
`
`JSN 2020
`
`Williams et al., “Objective Responses to Ketoconazole Therapy in
`
`Patients with Relapsed Progressive Prostatic Cancer,” British
`
`Journal of Urology, 58:45-51 (1986)
`
`JSN 2021
`
`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)
`
`
`
`IPR2016-00286
`Patent 8,822,438
`
`Exhibit
`
`JSN 2024
`
`Description
`
`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
`
`Notice of Termination of Preprocessing of Ex Parte Reexamination
`
`Request
`
`JSN 2027
`
`Declaration of S. Isaac Olson in Support of Motion to Appear Pro
`
`Hac Vice
`
`
`
`
`
`Respectfully submitted,
`
`
`
`/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`Date: Aug. 19, 2016
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`IPR2016-00286
`Patent 8,822,438
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`
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`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 August
`
`19, 2016 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 at the
`
`William Hare
`Gabriela Materassi
`McNeeley Hare & War LLP
`bill@miplaw.com
`materassi@miplaw.com
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`Respectfully submitted,
`
`By: /Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`following addresses:
`
`
`
`Date: Aug. 19, 2016
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