`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`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
`_____________________
`
`WOCKHARDT BIO AG'S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`
`
`Description
`
`Auerbauch, A. H. & Belldegrum, A. S., U.S. Patent No. 8,822,438
`(filed Feb. 24, 2011; issued Sep. 2, 2014) ("the '438 patent")
`Declaration of Paul A. Godley, M.D., Ph.D., MPP
`
`Dr. Paul A. Godley's Curriculum Vitae
`Gerber, G. S. & Chodak, G. W., "Prostate specific antigen for
`assessing response to ketoconazole and prednisone in patients with
`hormone refractory metastatic prostate cancer," J. of Urology,
`144(5): 1177-9 (1990) ("Gerber")
`O'Donnell, A. et al., "Hormonal impact of the
`17α-hydroxylase/C17,20-lyase inhibitor abiraterone acetate (CB7630)
`in patients with prostate cancer," British J. of Cancer, 90: 2317-2325
`(2004) ("O'Donnell)
`Sartor, O. et al., "Effect of prednisone on prostate-specific antigen in
`patients with hormone-refractory prostate cancer," Urology, 52:
`252-6 (1998) ("Sartor")
`Tannock, I. F. et al., "Docetaxel plus prednisone or mitoxantrone plus
`prednisone for advanced prostate cancer," New Engl. J. Med., 351:
`1502-1512 (2004)
`Attard, G. et al., "Selective blockade of androgenic steroid synthesis
`by novel lyase inhibitors as a therapeutic strategy for treating
`metastatic prostate cancer," BJU Inter., 96:1241-1246 (2005)
`Kasper, D. L. et al. (Eds.). (2005). Harrison's Principles of Internal
`Medicine , Vol. 1, 16th ed. New York City, NY: The McGraw-Hill
`Companies, Inc.
`
`
`
`Wockhardt
`Exhibit #
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`
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`- 1 -
`
`
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`Tannock, I.F. et al., "Chemotherapy with mitoxantrone plus
`prednisone or prednisone alone for symptomatic hormone-resistant
`prostate cancer: a Canadian randomized trial with palliative end
`points," J. Clin. Oncol., 14: 1756-1764 (1996).
`Harris, K.A. et al., "Low dose ketoconazole with replacement doses
`of hydrocortisone in patients with progressive androgen independent
`prostate cancer," J. of Urology, 168: 542-545 (2002)
`Hellerstedt, B. A. and Pienta, K. J., "The current state of hormonal
`therapy for prostate cancer," CA Cancer J. Clin., 52:154-179 (2002)
`Trump, D. L. et al., "High-dose ketoconazole in advanced
`hormone-refractory prostate cancer: endocrinologic and clinical
`effects," J. Clin. Oncol., 7:1093-1098 (1989)
`Costa-Santos, M. et al., "Two prevalent CYP17 mutations and
`geno-type-phenotype correlations in 24 Brazilian patients with
`17-hydroxylyase deficiency," J. of Clin. Endocrin. & Metab., 89(1):
`49-60 (2004)
`Oh, W.K., "Secondary hormonal therapies in the treatment of
`prostate cancer," Urology, 60 (Suppl 3A): 87-93 (2002)
`Scholz, M. et al., "Long-term outcome for men with androgen
`independent prostate cancer treated with ketoconazole and
`hydrocortisone," J. of Urology, 173: 1947-1952 (2005)
`Fosså, S. D., et al., "Flutamide versus prednisone in patients with
`prostate cancer symptomatically progressing after androgen-ablative
`therapy: a phase III study of the European Organization for Research
`and Treatment of Cancer Genitourinary Group," J. of Clin. Oncol.,
`19(1): 62-71 (2001)
`Brassel, S. A. et al., "Prostate-specific antigen versus
`prostate-specific antigen density as predictor of tumor volume,
`margin status, pathologic stage, and biochemical recurrence of
`prostate cancer," Urology, 66:1229-1233 (2005)
`- 2 -
`
`Wockhardt
`Exhibit #
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`
`
`
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`Berry, W. et al., "Phase III study of mitoxantrone plus low dose
`prednisone versus low dose prednisone alone in patients with
`asymptomatic hormone refractory prostate cancer," J. of Urology,
`168: 2439-2443 (2002)
`U.S. Food and Drug Administration ("FDA") News Release dated
`May 19, 2004, "FDA Approves New Indication for
`Taxotere—Prostate Cancer,"
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2
`004/ucm108301.htm (last accessed 8/8/2016)
`Ryan, C. J. et al., "Phase II study of abiraterone acetate in
`chemotherapy-naïve metastatic castration-resistant prostate cancer
`displaying bone flare discordant with serologic response," Clin.
`Cancer Res., 17:4854-4861 (2011) ("Ryan 2011")
`Attard, F. et al., "Selective inhibition of CYP17 with abiraterone
`acetate is highly active in the treatment of castration-resistant
`prostate cancer," J. of Clin. Oncol., 27:3742-3748 (2009) ("Attard
`2009")
`Ryan, C. J. et al, "Abiraterone in metastatic prostate cancer without
`previous chemotherapy," N Engl J Med, 368:138-148 (2013) ("Ryan
`2013")
`Danila, D. C. et al., "Phase II multicenter study of abiraterone acetate
`plus prednisone therapy in patients with docetaxel-treated
`castration-resistant prostate cancer," J. of Clin. Oncol., 28:1496-1501
`(2010) ("Danila")
`Kelly, W. K. et al., "Prostate-specific antigen as a measure of disease
`outcome in metastatic hormone-refractory prostate cancer," J. of
`Clin. Oncol., 11:607-615 (1993)
`
`Wockhardt
`Exhibit #
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`
`
`- 3 -
`
`
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`Small, E. J. et al., "Serum prostate-specific antigen decline as a
`marker of clinical outcome in hormone-refractory prostate cancer
`patients: association with progression-free survival, pain end points,
`and survival," J. of Clin. Oncol., 19:1304-1311 (2001)
`Miller, G. M. & Hinman, Jr., F., "Cortisone treatment in advanced
`carcinoma of the prostate," J. of Urology, 72(3): 485-496 (1954)
`Tannock, I. et al., "Treatment of metastatic prostatic cancer with
`low-dose prednisone: evaluation of pain and quality of life as
`pragmatic indices of response," J. of Clin. Oncol., 7(5): 590-597
`(1989)
`Scher, H. I. & Sawyers, C. L., "Biology of progressive,
`castration-resistant prostate cancer: directed therapies targeting the
`androgen-receptor signaling axis," J Clin Oncol, 23:8253-8261
`(2005)
`Barrie, S. E. et al, U.S. Patent No. 5,604,213 (filed Sep. 30, 1994;
`issued Feb. 18, 1997)
`File History for U.S. Patent No. 8,822,438
`Gilman, A. et al. (Eds.). (1990). The Pharmacological Basis of
`Therapeutics, 8th ed. Elmsford, NY: Pergamon Press, Inc., 62-83,
`1431-1462
`Ganong, W. F. (1979). Review of Medical Physiology. Los Altos,
`CA: Lange Medical Publications, 277-300
`Taxotere Prescribing Information (2004),
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s
`028lbl.pdf (last accessed 8/8/2016)
`Potter, G. A. et al, "Novel steroidal inhibitors of human cytochrome
`P45017α (17α-hydroxylase-C17,20-lyase): potential agents for the
`treatment of prostate cancer," J. Med. Chem., 38:2463-2471 (1995)
`("Potter")
`
`Wockhardt
`Exhibit #
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`
`
`- 4 -
`
`
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`Fakih, M. et al., "Glucocorticoids and Treatment of Prostate Cancer:
`A Preclinical and Clinical Reivew," Urology, 60:553-561 (2002)
`("Fakih")
`MacAdams, M. R. et al, "Reduction of serum testosterone levels
`during chronic glucocorticoid therapy," Ann Int Med, 104:648-651
`(1986)
`Rajfer, J. et al, "Mechanism of inhibition of human testicular
`steroidogenesis by oral ketoconazole," J Clin Endocrinol Metab,
`63:1193-1198 (1986)
`Santen, R. J. et al, "Site of action of low dose ketoconazole on
`androgen biosynthesis in men," J Clin Endocrinol Metab, 57:732
`(1983)
`Sonino, N., "The use of ketoconazole as an inhibitor of steroid
`production," N Engl J of Med, 317:812-817 (1987)
`Osol, A. (Ed.). (1980). Remington's Pharmaceutical Sciences, 16th
`ed. Easton, PA: Mack Publishing Company, Ch. 89: 1553-1584 and
`Ch. 99: 1703-1714
`Sartor, O., "Abiraterone prolongs survival in metastatic prostate
`cancer," Nat Rev Clin Oncol, 8:515-516 (2011)
`Fisher, R. I. et al, "Comparison of a standard regimen (CHOP) with
`three intensive chemotherapy regimens for advanced non-Hodgkin's
`lymphoma," N Engl J Med, 328:1002-1006 (1993)
`Bearden, J. D. et al, "Combination chemotherapy using
`cyclophosphamide, vincristine, methotrexate, 5-fluoruracil, and
`prednisone in solid tumors," Cancer, 39:21-26 (1977)
`Mauro, F. R. et al, "Fludarabine + prednisone ± α-interferon followed
`or not by α-interferon maintenance therapy for previously untreated
`patients with chronic lympocytic leukemia: long term results of a
`randomized study," Haematologica, 88:1348-1357 (2003)
`
`Wockhardt
`Exhibit #
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`
`
`- 5 -
`
`
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`Scher, H. I. et al, "Targeting the androgen receptor: improving
`outcomes for castration resistant prostate cancer," Endocrine-Related
`Cancer, 11:459-476 (2004)
`Yamamoto, M. et al, "Role of prostate-specific antigen and digital
`rectal examination in the detection of prostate cancer," Int J Urol,
`1:74-77 (1994)
`Mayo Clinic Website, Prostate cancer,
`http://www.mayoclinic.org/diseasesconditions/prostate-
`cancer/basics/definition/con-20029597?p=1 (accessed Aug. 8, 2016)
`Cancer.org (ACS), "What are the key statistics about prostate
`cancer?"
`http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-
`cancer-key-statistics (accessed Aug. 8, 2016)
`Cancer.net (ASCO Patient Website), Treatment of Metastatic
`Castration-Resistant Prostate Cancer,
`http://www.cancer.net/research-and-advocacy/asco-care-and-treatm
`ent-recommendations-patients/treatment-metastatic-castration-resist
`ant-prostate-cancer (accessed Aug. 9, 2016)
`Kirby, M., C. Hirst, and E.D. Crawford (2011), "Characterising the
`Castration-Resistant Prostate Cancer Population: A Systematic
`Review," International Journal of Clinical Practice 65(11):
`1180-1192
`Zytiga Label (Mar. 20, 2015),
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s
`018lbl.pdf (accessed Aug. 9, 2016)
`Zytiga Website, How Zytiga® (abiraterone acetate) Works,
`https://www.zytiga.com/print/about-zytiga/how-zytiga-works
`(accessed Aug. 8, 2016)
`
`Wockhardt
`Exhibit #
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`
`
`- 6 -
`
`
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`Mayo Clinic Website, Hormone Therapy for Prostate Cancer,
`http://www.mayoclinic.org/tests-procedures/hormone-therapy-for-pr
`ostate-cancer/home/ovc-20201738 (accessed Aug. 8, 2016).
`FDA Website, Drugs@FDA – Zytiga,
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fu
`seaction=Search.DrugDetails (accessed Aug. 8, 2016)
`FDA News Release, "FDA expands Zytiga's use for late-stage
`prostate cancer," 12/10/2012,
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u
`cm331492.htm (accessed Aug. 8, 2016)
`Wells Fargo Securities, LLC., "Johnson & Johnson," 6/29/2015.
`FDA Website, Orange Book, Zytiga (NDA 202379),
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm
`?Appl_No=202379&Product_No=001&table1=OB_Rx (accessed
`Aug. 8, 2016)
`Murphy, William J., John L. Orcutt, and Paul C. Remus (2012),
`Patent Valuation: Improving Decision Making through Analysis,
`Hoboken, NJ: Wiley
`Cowen & Company, "Quick Take – Johnson & Johnson,"
`William Blair, "Biotechnology – Zytiga Fourth-Quarter Sales Imply
`Xtandi Strength," 1/22/2013
`Zytiga Brochure, Putting Prednisone in Perspective, 3/2015
`Jevtana Website, Dosing and Administration,
`http://www.jevtana.com/hcp/dosing/default.aspx (accessed Aug. 8,
`2016)
`FDA News Release, "FDA Approves New Treatment for Advanced
`Prostate Cancer," 06/17/2010,
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u
`cm216143.htm (accessed Aug. 8, 2016)
`
`Wockhardt
`Exhibit #
`
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`1063
`
`1064
`
`
`
`- 7 -
`
`
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`Nasdaq.com, "One Drug To Rule Them All: Medivation's Xtandi To
`Dominate Prostate Cancer Market," available at
`http://www.nasdaq.com/article/one-drug-to-rule-them-all-medicatio
`ns-xtandi-to-dominate-prostate-cancer-market-cm376782 (accessed
`Aug. 8, 2016)
`Medivation Press Release, "U.S. FDA Approves New Indication for
`the Use of XTANDI® (Enzalutamide) Capsules for Patients With
`Metastatic Castration-Resistant Prostate Cancer," 9/10/2014,
`http://investors.medivation.com/releasedetail.cfm?ReleaseID=87026
`7 (accessed Aug. 8, 2016)
`UBS Research, "Medivation – A Look at the Growth and Share in
`Prostate Cancer," 2/3/2014
`Wedbush Securities, Inc., "Medivation: Zytiga Market Share Decline
`Accelerates From Last Quarter," 7/14/2015
`RBC Capital Markets (via Barron's Website), "Xtandi Beats
`Casodex, Set to Top Zytiga," 4/3/2015,
`http://www.barrons.com/articles/xtandi-beats-casodex-set-to-top-zyt
`iga-1428075331 (accessed Aug. 8, 2016)
`Cowen & Company, "Biotechnology Quarterly," 7/2/2012.
`Credit Suisse, "Prostate Cancer – Implications of Zytiga's Pre-Chemo
`Approval," 12/11/2012
`UBS Investment Research, "Johnson & Johnson – Zytiga Label
`Extended," 12/10/2012
`William Blair, "Medivation, Inc. – Looking into Recent
`Weaknesses," 7/15/2015
`Bloomberg.com, "Tesaro Rises on $85 Million J&J Cancer Drug
`Licensing Deal," available at
`www.bloomberg.com/news/articles/2016-04-06/j-j-to-pay-85-millio
`n-to-license-tesaro-cancer-drug-rights (accessed Aug. 9, 2016)
`
`Wockhardt
`Exhibit #
`
`1065
`
`1066
`
`1067
`
`1068
`
`1069
`
`1070
`
`1071
`
`1072
`
`1073
`
`1074
`
`
`
`- 8 -
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`
`
`Wockhardt
`Exhibit #
`
`1075
`
`1076
`
`1077
`1078
`
`1079
`
`1080
`
`1081
`1082
`
`1083
`
`1084
`
`1085
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`Scherer, F.M., et al., (Eds.). (1990). Industrial Market Structure and
`Economic Performance, Third Ed. Boston, MA: Houghton Mifflin
`Company.
`Investor Words, "hurdle rate," accessed at
`http://www.investorwords.com/2362/hurdle_rate.html (accessed
`Aug. 8, 2016)
`Declaration of Robert D. Stoner, Ph.D.
`Dr. Robert D. Stoner's Curriculum Vitae
`Attard,, G. et al, "Phase I clinical trial of a selective inhibitor of
`CYP17, abiraterone acetate, confirms that castration-resistant
`prostate cancer commonly remains hormone driven," J Clin Oncol,
`26(28):4563-4571 (2008)
`IMS Health Data, 2012–2015 (submitted in Amerigen Pharms. Ltd. v.
`Janssen Oncology, Inc., IPR2016-00286, Ex. 1067)
`Declaration of Gopal Venkatesan
`Montgomery, B., et al., "Androgen Receptor Modulation
`Optimization for Response (ARMOR) Phase I and II Studies:
`Galeterone for the Treatment of Castration-Resistant Prostate
`Cancer," Cancer Therapy:Clinical 22(6)1356-1363 (2016)
`Nishimura, K., et al., "Low Doses of Oral Dexamethasone for
`Hormone-Refractory Prostate Carcinoma," Cancer 89:2570-2576
`(2000)
`Declaration of Matthew B. Rettig, M.D., in Support of Janssen
`Oncology, Inc.'s Patent Owner Response (submitted in Amerigen
`Pharms. Ltd. and Argentum Pharms LLC v. Janssen Oncology, Inc.,
`IPR2016-00286, Ex. 2119)
`Declaration of Matthew B. Rettig, M.D., in Support of Janssen
`Oncology, Inc.'s Patent Owner Response (submitted in Mylan
`Pharms Inc. v. Janssen Oncology, Inc., IPR2016-01332, Ex. 2038)
`
`
`
`- 9 -
`
`
`
`Wockhardt
`Exhibit #
`1086
`
`1087
`
`1088
`1089
`
`1090
`
`1091
`
`1092
`
`1093
`
`1094
`
`1095
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`Declaration of Marc B. Garnick, M.D. (submitted in Mylan Pharms
`Inc. v. Janssen Oncology, Inc., IPR2016-01332, Ex. 1002)
`"BTG Licenses New Prostate Cancer Drug to Cougar
`Biotechnology," April 20, 2004, 2 pages (last accessed on April 3,
`2017)
`Deposition Transcript of Ian Judson, M.D., Friday, April 7, 2017
`Deposition Transcript of Richard J. Auchus, M.D., Ph.D., Monday,
`April 10, 2017
`Auchus, R.J., "The Genetics, Pathophysiology, and Management of
`Human Deficiencies of P450c17," Endocrinol. Metab. Clin. North
`Am. 30(1):101-119 (2001)
`Auchus, R.J. et al., "Use of Prednisone with Abiraterone Acetate in
`Metastatic Castration-Resistant Prostate Cancer," Oncologist
`19:1231-1240 (2014)
`Attard, G. et al., "Clinical and Biochemical Consequences of
`CYP17A1 Inhibition with Abiraterone Given with and without
`Exogenous Glucocorticoids in Castrate Men with Advanced Prostate
`Cancer," J. Clin. Endocrinol. Metab. 97(2):507-516 (2012)
`Akakura, K. et al., "Possible Mechanism of Dexamethasone Therapy
`for Prostate Cancer: Suppression of Circulating Level of
`Interleukin-6," Prostate 56:106-109 (2003)
`Attard, G., et al. "A randomized trial of abiraterone acetate (AA)
`administered with 1 of 4 glucocorticoid (GC) regimens in metastatic
`castration-resistant prostate cancer (mCRPC) patients (pts)," J. Clin.
`Oncol. 34:Suppl 2, Abstract number 261 (2016)
`Ryan, C.J. 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. Clin. Oncol. 28:1481-1488 (2010)
`
`
`
`- 10 -
`
`
`
`Wockhardt
`Exhibit #
`1096
`
`1097
`
`1098
`1099
`
`1100
`
`1101
`
`1102
`
`1103
`1104
`1105
`1106
`1107
`
`1108
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`Reid, A.H.M. et al., "Significant and Sustained Antitumor Activity in
`Post-Docetaxel, Castration-Resistant Prostate Cancer With the
`CYP17 Inhibitor Abiraterone Acetate," J. Clin. Oncol. 28:1489-1495
`(2010)
`Deposition Transcript of Matthew B. Rettig, M.D., Friday, March 31,
`2017
`Updated Curriculum Vitae for Dr. Robert D. Stoner
`Deposition Transcript of Christopher A. Vellturo, Ph.D., Wednesday,
`April 5, 2017
`Cancer Research UK, "Our milestones: the birth of a new prostate
`cancer drug," September 21, 2015 (last accessed April 17, 2017)
`Mohler, J.L., et al., "The Androgen Axis in Recurrent Prostate
`Cancer," Clin Can Res 10:440-447 (2004)
`The Institute of Cancer Research, "Abiraterone: a story of scientific
`innovation and commercial partnership," May 11, 2014 (last accessed
`April 19, 2017)
`Second Declaration of Robert D. Stoner, Ph.D.
`Second Declaration of Paul A. Godley, M.D., Ph.D., MPP
`Updated Curriculum Vitae for Paul A. Godley, M.D., Ph.D., MPP
`Declaration of Ian McKeague, Ph.D.
`Mestre-Ferrandiz, J., et al., “The R&D Cost of a New Medicine,”
`Office of Health Economics, London UK, 1–86 (2012)
`DiMasi, J.A., et al., "Innovation in the pharmaceutical industry: New
`estimates of R&D costs," Journal of Health Economics 47: 20–33
`(2016)
`
`
`
`- 11 -
`
`
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`NCT0205010, Phase II Clinical Trial of Abiraterone Acetate Without
`Exogenous Glucocorticords in Men with Castration-resistant Prostate
`Cancer with Correlative Assessment of Hormone Intermediates,
`Clinicaltrials.gov
`Zytiga® Approved in the EU for Use in the Treatment of Metastatic
`Castration-Resistant Prostate Cancer Before Chemotherapy,
`https://www.jnj.com/media-center/press-releases/zytiga-approved-in
`-the-eu-for-use-in-the-treatment-of-metastatic-castration-resistant-pr
`ostate-cancer-before-chemotherapy (last accessed 4/18/17)
`Dizdar, O., “Is Dexamethasone a Better Partner for Abiraterone than
`Prednisolone?,” The Oncologist 20: e13 (2015)
`EMA – Zytiga Product Information,
`http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Pr
`oduct_Information/human/002321/WC500112858.pdf (last accessed
`4/18/17)
`Storlie, J.A,. et al., “Prostate Specific Antigen Levels and Clinical
`Response to Low Dose Dexamethasone for Hormone=Refractory
`Metastatic Prostate Carcinoma,” Cancer 76:96–100 (1995)
`David, Jesse and Stewart (2005), “Commercial Success: Economic
`Principles Applied to Patent Litigation,” in Gregory K. Leonard and
`Lauren J. Stiroh, ed., Economic Approaches to Intellectual Property
`Policy, Litigation, and Management, White Plains, NY: National
`Economic Research Associates, Inc., at 196
`Deposition Transcript of Richard Auchus, M.D., Ph.D., Thursday,
`December 15, 2016 (IPR2016-00286)
`Cancer.org (ACS), “Hormone therapy for prostate cancer,”
`https://www.cancer.org/conten/cancer/en/cancer/prostatecancer/
`treating/hormone-therapy.html (accessed 4/10/2017)
`Auerbauch, A. H. & Belldegrum, A. S., U.S. Pat. Appl. Publ. No.
`2015/0005268 (filed September 12,2014; issued January 1, 2015)
`
`Wockhardt
`Exhibit #
`1109
`
`1110
`
`1111
`
`1112
`
`1113
`
`1114
`
`1115
`
`1116
`
`1117
`
`
`
`- 12 -
`
`
`
`Wockhardt
`Exhibit #
`1118
`
`1119
`
`1120
`
`1121
`
`1122
`1123
`
`1124
`1125
`1126
`
`1127
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`Canger.gov (NIH NCI), “Prostate-specific antigen (PSA) test,”
`https://www.cancer.gov/types/prostate/psa-fact-sheet (accessed
`4/11/2017)
`Cougar Biotechnology, Inc., Clinical Study Report: COU-AA-001
`and COU-AA-001 EXT (Nov. 17, 2010)
`Deposition Transcript of Christopher A. Vellturo, Ph.D., Tuesday,
`December 20, 2016 (IPR2016-00286)
`Deposition Transcript of Richard J. Auchus, M.D., Ph.D., Monday,
`April 10, 2017 (Redacted)
`Second Declaration of Robert D. Stoner, Ph.D. (Redacted)
`Supplemental Declaration of Declaration of Paul A. Godley, M.D.,
`Ph.D., MPP
`Second Supplemental Declaration of Robert D. Stoner, Ph.D.
`Declaration of Lestin L. Kenton Jr.
`Replacement of Auchus, R.J., "The Genetics, Pathophysiology, and
`Management of Human Deficiencies of P450c17," Endocrinol.
`Metab. Clin. North Am. 30(1):101-119 (2001) (previously filed as
`exhibit 1090, also served on Patent Owner on May 10, 2017)
`Replacement of EMA – Zytiga Product Information,
`http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Pr
`oduct_Information/human/002321/WC500112858.pdf (last accessed
`4/18/17) (previously filed as exhibit 1112, also served on Patent
`Owner on May 10, 2017)
`
`
`
`- 13 -
`
`
`
`Wockhardt Bio AG's Updated Exhibit List
`IPR of USPN 8,822,438
`
`
`Description
`
`Replacement of David, Jesse and Stewart (2005), “Commercial
`Success: Economic Principles Applied to Patent Litigation,” in
`Gregory K. Leonard and Lauren J. Stiroh, ed., Economic Approaches
`to Intellectual Property Policy, Litigation, and Management, White
`Plains, NY: National Economic Research Associates, Inc., at 196
`(previously filed as exhibit 1114, also served on Patent Owner on
`May 10, 2017)
`Supplemental Declaration of Paul A. Godley, M.D., Ph.D., MPP
`(served on Patent Owner on February 16, 2017)
`Supplemental Declaration of Robert D. Stoner, Ph.D. (served on
`Patent Owner on February 16, 2017)
`Supplemental for Cowen & Company, "Biotechnology Quarterly,"
`7/2/2012 (previously filed as exhibit 1070 and served on Patent
`Owner on February 16, 2017)
`
`Respectfully submitted,
`
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Wockhardt
`Exhibit #
`1128
`
`1129
`
`1130
`
`1131
`
`
`
`
`
`
`
`
`
`
` Dennies Varughese
`Date: May 12, 2017
` Registration No. 61,868
`
`
`
`
`
`1100 New York Avenue, N.W. Attorney for Petitioner
`Washington, D.C.20005-3934
`
`(202) 371-2600
`
`5294669_1
`
`
`
`- 14 -
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`
`
`The undersigned hereby certifies that the above-captioned "Wockhardt Bio
`
`AG's Updated Exhibit List", along with Exhibits 1123 – 1131, were served in their
`
`entirety on May 12, 2017, upon the following parties via email:
`
`Dianne B. Elderkin: delderkin@akingump.com
`Barbara L. Mullin: bmullin@akingump.com
`Ruben H. Munoz: rmunoz@akingump.com
`JANS-ZYTIGA@akingump.com
`
`David. T. Pritikin: dpritikin@sidley.com
`Bindu Donovan: bdonovan@sidley.com
`Paul J. Zegger: pzegger@sidley.com
`Todd L. Krause: tkrause@sidley.com
`Alyssa Monsen: amonsen@sidley.com
`ZytigaIPRTeam@sidley.com
`
`Anthony C. Tridico: anthony.tridico@finnegan.com
`Jennifer H. Roscetti: jennifer.roscetti@finnegan.com
`
`
`
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`
` Dennies Varughese
`Date: May 12, 2017
` Registration No. 61,868
`
`
`
`
`
`1100 New York Avenue, N.W. Attorney for Petitioner
`Washington, D.C.20005-3934
`
`(202) 371-2600
`
`
`
`
`
`
`
`
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