`Filed: May 10, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC., ACTAVIS
`LABORATORIES FL, INC., AMNEAL PHARMACEUTICALS LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, INC.,
`TEVA PHARMACEUTICALS USA, INC., WEST-WARD
`PHARMACEUTICAL CORP., and HIKMA PHARMACEUTICALS, LLC,
`
`Petitioners
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`
`Patent Owner
`
`Case IPR2016-013321
`Patent 8,822,438 B2
`
`
`
`
`
`FIFTH UPDATED LIST OF PETITIONER’S EXHIBITS
`
`
`
`
` Case IPR2017-00853 has been joined with this proceeding.
`
` 1
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits the following current
`
`exhibit list.
`
`Exhibit
`
`MYL 1001
`
`Description
`
`U.S. Patent No. 8,822,438, Auerbach and Belldegrun, “Methods
`and Compositions for Treating Cancer” (“the ’438 patent”)
`
`MYL 1002
`
`Declaration of Marc B. Garnick, MD (“Garnick Decl.”)
`
`MYL 1003
`
`MYL 1004
`
`O’Donnell, A. et al., “Hormonal impact of the 17α-
`hydroxylase/C17,20-lyase inhibitor abiraterone acetate (CB7630)
`in patients with prostate cancer,” Br. J. Cancer, (90):2317–2325
`(2004) (“O’Donnell”)
`
`Gerber, G.S. et al., “Prostate specific antigen for assessing
`response to ketoconazole and prednisone in patients with hormone
`refractory metastatic cancer,” J. Urology, 144(5):1177–9 (1990)
`(“Gerber”)
`
`MYL 1005
`
`U.S. Patent No. 5,604,213, Barrie S.E. et al., “17-Substituted
`Steroids Useful In Cancer Treatment” (“the ’213 patent”)
`
`MYL 1006
`
`Tannock, I. 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. Clinical Oncology, 14:1756–1764 (1996)
`(“Tannock”)
`
`MYL 1007
`
`February 3, 2012 Office Action (excerpt from prosecution history
`of ’438 patent)
`
`MYL 1008
`
`July 3, 2012 Response (excerpt from prosecution history of ’438
`patent)
`
`MYL 1009
`
`Ryan, C.J. et al., “Abiraterone in metastatic prostate cancer
`without previous chemotherapy,” New Eng. J. Med., 368:138–148
`(2013).
`
`MYL 1010
`
`January 11, 2013 Response (excerpt from prosecution history of
`’438 patent)
`
`MYL 1011
`
`March 4, 2013 Office Action (excerpt from prosecution history of
`’438 patent)
`
`
`
`2
`
`
`
`Exhibit
`
`MYL 1012
`
`Description
`
`June 4, 2013 Response (excerpt from prosecution history of ’438
`patent)
`
`MYL 1013
`
`July 3, 2013 Notice of Allowance (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1014
`
`October 25, 2013 Notice of Allowance (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1015
`
`February 11, 2014 Notice of Allowance (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1016
`
`June 2, 2014 Notice of Allowance (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1017
`
`Confidential Declaration of Ivan T. Hofmann (“Hofmann
`Declaration”)
`
`MYL 1018
`
`2011 Zytiga® Approval Prescribing Information
`
`MYL 1019
`
`2015 Zytiga® Prescribing Information, Co-administration
`Brochure
`
`MYL 1020
`
`Harris, K.A. et al., “Low dose ketoconazole with replacement
`doses of hydrocortisone in patients with progressive androgen
`independent prostate cancer,” J. Urology, 168:542–545 (August
`2002)
`
`MYL 1021
`
`Oh, W.K. “Secondary hormonal therapies in the treatment of
`prostate cancer,” Urology, 60(Supp. 3A):87–93 (2002)
`
`MYL 1022
`
`Tannock, I. et al., “Docetaxel plus prednisone or mitoxantrone
`plus prednisone for advanced prostate cancer,” N. Eng. J. Med.,
`351:1502–12 (2004)
`
`MYL 1023
`
`Attard, G. et al., “Selective blockade of androgenic steroid
`synthesis by novel lyase inhibitors as a therapeutic strategy for
`treating metastatic prostate cancer,” Br. J. Urol., 96(9): 1241–
`1246 (2005)
`
`MYL 1024
`
`Hellerstedt, B.A. et al., “The current state of hormonal therapy for
`prostate cancer,” CA Cancer J. Clin., 52:154–179 (2002).
`
`
`
`3
`
`
`
`Exhibit
`
`MYL 1025
`
`MYL 1026
`
`MYL 1027
`
`Description
`
`Kasper, D.L. et al. (Eds.), Harrison’s Principles of Internal
`Medicine, 16th Edition (2005), 549.
`
`Auchus, R.J. “The genetics, pathophysiology, and management of
`human deficiencies of P450c17,” Endocrinol. Metab. Clin. North
`Am. 30(1):101–119 (2001)
`
`Costa-Santos, M. et al., “Two prevalent CYP17 mutations and
`genotype-phenotype correlations in 24 Brazilian patients with 17-
`hydroxylase deficiency,” J. Clin. Endocrin. & Metabol., 89(1):49–
`60 (2004)
`
`MYL 1028
`
`Jubelirer, S.J., et al., “High dose ketoconazole for the treatment of
`hormone refractory metastatic prostate carcinoma,” J. Urol.,
`142(1):89–91 (1989)
`
`MYL 1029
`
`U.S. Patent 5,688,977, Sisti, N.J. et al., “Method for Docetaxel
`Synthesis”
`
`MYL 1030
`
`MYL 1031
`
`U.S. Food and Drug Administration (“FDA”) FDA News Release
`dated May 19, 2004, “FDA Approves New Indication for
`Taxotere-Prostate Cancer”
`
`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. Clin. Oncology, 7:590–7 (1989)
`
`MYL 1032
`
`Intentionally left blank
`
`MYL 1033
`
`MYL 1034
`
`Scher, H.I. et al., “Increased survival with enzalutamide in
`prostate cancer after chemotherapy,” New Eng. J. Med.,
`367:1187–97 (2012)
`
`de Bono, J.S. et al., “Abiraterone and increased survival in
`metastatic prostate cancer,” New Engl. J. Med., 364:1995–2005
`(2011)
`
`MYL 1035
`
`Orange Book listing for Zytiga®
`
`MYL 1036
`
`Initial Application (excerpt from prosecution history of ’438
`patent)
`
`MYL 1037
`
`Intentionally left blank
`
`
`
`4
`
`
`
`Exhibit
`
`Description
`
`MYL 1038
`
`Intentionally left blank
`
`MYL 1039
`
`September 11, 2012 Office Action (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1040
`
`MYL 1041
`
`Cancer.net (ASCO Patient Website), Treatment of Metastatic
`Castration-Resistant Prostate Cancer,
`http://www.cancer.net/research-and-advocacy/asco-care-and-
`treatment-recommendations-patients/treatment-metastatic-
`castration-resistant-prostate-cancer (accessed 6/28/2016).
`
`Cancer.org (ACS), “What are the key statistics about prostate
`cancer?”
`http://www.cancer.org/cancer/prostatecancer/detailedguide/prostat
`e-cancer-key-statistics (accessed 6/28/2016).
`
`MYL 1042
`
`Intentionally left blank
`
`MYL 1043
`
`Intentionally left blank
`
`MYL 1044
`
`Intentionally left blank
`
`MYL 1045
`
`FDA News Release, “FDA expands Zytiga’s use for late-stage
`prostate cancer,” 12/10/2012
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncement
`s/ucm331492.htm (access 6/30/2016).
`
`MYL 1046
`
`FDA Website, Drugs@FDA – Zytiga,
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
`fuseaction=Search.DrugDetails (accessed 6/28/2016).
`
`MYL 1047
`
`FDA Website, Orange Book, Zytiga (NDA 202379),
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cf
`m?Appl_No=202379&Product_No=001&table1=OB_Rx
`(accessed 6/30/2016).
`
`MYL 1048
`
`Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 740–41 (Fed.
`Cir. 2013).
`
`MYL 1049
`
`Jevtana Website, Dosing and Administration,
`http://www.jevtana.com/hcp/dosing/default.aspx (accessed
`6/28/2016).
`
`
`
`5
`
`
`
`Exhibit
`
`MYL 1050
`
`MYL 1051
`
`Description
`
`Kirby, M. et al., “Characterising the castration-resistant prostate
`cancer population: A systematic review,” Int’l J. Clinical Practice,
`65(11):1180–1192 (2011).
`
`Mayo Clinic Website, Prostate cancer,
`http://www.mayoclinic.org/diseasesconditions/prostate-
`cancer/basics/definition/con-20029597?p=1 (accessed 6/28/2016).
`
`MYL 1052
`
`Intentionally left blank
`
`MYL 1053
`
`Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364 (Fed. Cir.
`2005).
`
`MYL 1054
`
`Murphy, W.J., J.L. Orcutt & P.C. Remus (2012), Patent
`Valuation: Improving Decision Making through Analysis,
`Hoboken, NJ: Wiley.
`
`MYL 1055
`
`PMLiVe Website, “Top 50 Pharmaceutical Products by Global
`Sales,”
`http://www.pmlive.com/top_pharma_list/Top_50_pharmaceutical
`_products_by_global_sales (accessed 6/30/2016).
`
`MYL 1056
`
`Intentionally left blank
`
`MYL 1057
`
`MYL 1058-
`MYL 1063
`
`Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371 (Fed. Cir.
`2005).
`
`Intentionally left blank
`
`MYL 1064
`
`Zytiga Brochure, Putting Prednisone in Perspective, 3/2015.
`
`MYL 1065
`
`Zytiga Label, 5/20/2015.
`
`MYL 1066
`
`Zytiga Website, How Zytiga® (abiraterone acetate) Works,
`https://www.zytiga.com/print/about-zytiga/how-zytiga-works
`(accessed 6/28/2016).
`
`MYL 1067
`
`Intentionally left blank
`
`MYL 1068
`
`November 25, 2011 Office Action (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1069
`
`December 21, 2011 Response (excerpt from prosecution history
`of ’438 patent)
`
`
`
`6
`
`
`
`Exhibit
`
`MYL 1070
`
`Description
`
`September 11, 2012 Office Action (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1071
`
`October 3, 2013 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1072
`
`October 3, 2013 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1073
`
`January 10, 2014 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1074
`
`May 9, 2014 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1075
`
`May 9, 2014 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1076
`
`May 30, 2014 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1077
`
`May 30, 2014 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1078
`
`MYL 1079
`
`Barrie et al., “Pharmacology of novel steroidal inhibitors of
`Cytochrome P45017α (17α-hydroxylase/C17,20 lyase),”
`J. Steroid Biochem. Molec. Biol., 50:267-73 (1994)
`
`Fakih, M. et al., “Glucocorticoids and treatment of prostate
`cancer: A preclinical and clinical review,” Urology, 60:553-561
`(2002)
`
`MYL 1080
`
`Lam, J.S. et al., “Secondary hormonal therapy for advanced
`prostate cancer,” J. Urology, 175:28-34 (2006)
`
`MYL 1081
`
`Declaration of Bryan D. Beel in Support of Motion for Pro Hac
`Vice Admission
`
`MYL 1082
`
`Intentionally Left Blank
`
`MYL 1083
`
`Intentionally Left Blank
`
`MYL 1084
`
`Declaration of Shannon M. Bloodworth in Support of Motion for
`Pro Hac Vice Admission
`
`
`
`7
`
`
`
`Exhibit
`
`Description
`
`MYL 1085
`
`MYL 1086
`
`Potter, G.A. et al., “Novel steroidal inhibitors of human
`cytochrome P45017 (17-hydroxylase-C17,20-lyase): potential
`agents for the treatment of prostatic cancer,” J. Med. Chem.,
`38:2463-2471 (1995)
`
`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., 97:507-516 (2012)
`
`MYL 1087
`
`Declaration of Robert D. Swanson in Support of Motion for Pro
`Hac Vice Admission
`
`MYL 1088
`
`BTG Press Release, “BTG licenses new prostate cancer drug to
`Cougar Biotechnology,” 4/20/2004
`http://www.btgplc.com/media/press-releases/btg-licenses-new-
`prostate-cancer-drug-to-cougar-biotechnology (accessed
`4/3/2017)
`
`MYL 1089
`
`Zytiga Website, About Zytiga® (abiraterone acetate),
`https://www.zytiga.com/choosing-zytiga/results-of-zytiga
`(accessed 4/3/2017)
`
`MYL 1090
`
`Patent Owner’s Response, Paper No. 35 (Mar. 8, 2017)
`
`MYL 1091
`
`Reply Declaration of Ian McKeague, Ph.D.
`
`MYL 1092
`
`MYL 1093
`
`MYL 1094
`
`Cancer.org (ACS), “Hormone therapy for prostate cancer,”
`https://www.cancer.org/conten/cancer/en/cancer/prostate-
`cancer/treating/hormone-therapy.html (accessed 4/10/2017)
`
`Cancer.gov (NIH NCI), “Metastatic cancer,”
`https://www.cancer.gov/types/metastatic-cancer.html (accessed
`4/14/2017)
`
`Canger.gov (NIH NCI), “Prostate-specific antigen (PSA) test,”
`https://www.cancer.gov/types/prostate/psa-fact-sheet (accessed
`4/11/2017)
`
`MYL 1095
`
`Cougar Biotechnology, Inc., Clinical Study Report: COU-AA-001
`and COU-AA-001 EXT (Nov. 17, 2010)
`
`
`
`8
`
`
`
`Exhibit
`
`Description
`
`MYL 1096
`
`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. Onc., 28(9):1489-
`1495 (2010)
`
`MYL 1097
`
`Reply Declaration of John Bantle, M.D.
`
`MYL 1098
`
`Arlt, W. et al., “Adrenal insufficiency,” Lancet, 361:1881-93
`(2003)
`
`MYL 1099
`
`Oelkers, W., “Dose-response aspects in the clinical assessment of
`the hypothalamo-pituitary-adrenal axis, and the low-dose
`adrenocorticotropin test,” Eur. J. Endocrin., 135:27-33 (1996)
`
`MYL 1100
`
`MYL 1101
`
`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.
`Clin. Oncol., 19:62-71 (2001)
`
`Osoba, D. et al., “Health-related quality of life in men with
`metastatic prostate cancer treated with prednisone alone or
`mitoxantrone and prednisone,” J. Clin. Oncol., 17(6):1654-63
`(1999)
`
`MYL 1102
`
`Auchus, R.J. et al., “Use of prednisone with abiraterone acetate in
`metastatic castration-resistant prostate cancer,” Oncologist,
`19:1231-1240 (2014)
`
`MYL 1103
`
`Luthy, I.A. et al., “Androgenic activity of synthetic progestins and
`spironolactone in androgen-sensitive mouse mammary carcinoma
`(shionogi) cells in culture,” J. Steroid Biochem., 31(5):845-852
`(1988)
`
`MYL 1104
`
`Reply Declaration of Marc B. Garnick, M.D.
`
`MYL 1105
`
`Marc B. Garnick, Management of Metastatic Carcinoma of the
`Prostate – Treatment Options and Controversies, in PROSTATIC
`DISORDERS 354-67 (David F. Paulson et al. eds., 1989)
`
`
`
`9
`
`
`
`Exhibit
`
`Description
`
`MYL 1106
`
`De Coster, R. et al., “Effects of high-dose ketoconazole and
`dexamethasone on ACTH-stimulated adrenal steroidogenesis in
`orchiectomized prostatic cancer patients,” Acta Endocrinologica,
`115:265-271 (1987)
`
`MYL 1107
`
`Trump, D. L. et al., “High-dose ketoconazole in advanced
`hormone-refractory prostate cancer: endocrinologic and clinical
`effects,” J. Clin. Oncol., 7:1093-98 (1989)
`
`MYL 1108
`
`Figg, W.D. et al., “A randomized, phase II trial of ketoconazole
`plus alendronate versus ketoconazole alone in patients with
`androgen independent prostate cancer and bone metastases,” J.
`Urol., 173:790-96 (2005)
`
`MYL 1109
`
`Chang, A.Y.C. et al., “A study of aminoglutethemide and
`hydrocortisone in patients with advanced and refractory prostate
`carcinoma,” Am. J. Clin. Oncol., 12(4):358-360 (1989)
`
`MYL 1110
`
`MYL 1111
`
`MYL 1112
`
`MYL 1113
`
`MYL 1114
`
`Kruit, W.H. et al., “Effect of combination therapy with
`aminoglutethimide and hydrocortisone on prostate-specific
`antigen response in metastatic prostate cancer refractory to
`standard endocrine therapy,” Anit-Cancer Drugs, 15:843-47
`(2004)
`
`Bernard P. Schimmer and Keith L. Parker, Andrenocorticotropic
`Hormone: Adrenocortical Steroids and Their Synthetic Analogs;
`Inhibitors of the Synthesis and Actions of Adrenocortical
`Hormones, in GOODMAN & GILMAN’S THE PHARMACOLOGICAL
`BASIS OF THERAPEUTICS 1649-77 (10th ed. 2001)
`
`Small, E.J. et al., “Second-line hormonal therapy for advanced
`prostate cancer: A shifting paradigm,” J. Clin. Oncol., 15:382-88
`(1997)
`
`Small, E.J. et al., “Ketoconazole retains activity in advanced
`prostate cancer patients with progression despite flutamide
`withdrawal,” J. Urol., 157:1204-07 (1997)
`
`Ponder, B.A.J. et al., “Response to aminoglutethimide and
`cortisone acetate in advanced prostatic cancer,” Br. J. Cancer,
`50:757-63 (1984)
`
`
`
`10
`
`
`
`Exhibit
`
`Description
`
`MYL 1115
`
`MYL 1116
`
`Labrie, F. et al., “Anti-hormone treatment for prostate cancer
`relapsing after treatment with flutamide and castration addition
`of aminoglutethimide and low dose hydrocortisone to
`combination therapy,” Brit. J. Urol., 63:634-38 (1989)
`
`Berry, W. et al., “Phase III study of mitoxantrone and low dose
`prednisone versus low dose prednisone alone in patients with
`asymptomatic hormone refractory prostate cancer,” J. of Urology,
`168:2439-43 (2002)
`
`MYL 1117
`
`Abiraterone Acetate: Abbreviated Clinical Study Report Synopsis
`COU-AA-BE (Doc. EDMS-ERI-13494974:2.0) (“BE Synopsis”)
`
`MYL 1118
`
`Hugo Vanden Bossche et al., Effects of Inhibitors on the P450-
`Dependent Metabolism of Endogenous Compounds in Fungi,
`Protozoa, Plants and Vertebrates, in MOLECULAR ASPECTS OF
`MONOOXYGENASES AND BIOACTIVATION OF TOXIC COMPOUNDS
`345-63 (Emel Arinc et al. eds., 1991)
`
`MYL 1119
`
`Charles L. James et al., Antimicrobial Therapy, in TRAUMA
`CRITICAL CARE 927-60 (William C. Wilson et al. eds., 2007)
`
`MYL 1120
`
`Sartor, O. et al., “Effect of prednisone on prostate-specific
`antigen in patients with hormone-refractory prostate cancer,”
`Urology, 52:252-56 (1998)
`
`MYL 1121
`
`Collette, L. et al., “Is prostate-specific antigen a valid surrogate
`end point for survival in hormonally treated patients with
`metastatic prostate cancer? Joint research of the European
`Organisation for Research and Treatment of Cancer, the
`Limburgs Universitair Centrum, and AstraZeneca
`Pharmaceuticals,” J. Clin. Oncol., 23(25):6139-48 (2005)
`
`MYL 1122
`
`Collette, L. et al., “Prostate-specific antigen (PSA) alone is not
`an appropriate surrogate marker of long-term therapeutic benefit
`in prostate cancer trials,” Eur. J. Can., 42:1344-50 (2006)
`
`MYL 1123
`
`Halabi, S. et al., “Prostate-specific antigen changes as surrogate
`for overall survival in men with metastatic castration-resistant
`prostate cancer treated with second-line chemotherapy,” J. Clin.
`Oncol., 31(31):3944-50 (2013)
`
`
`
`11
`
`
`
`Exhibit
`
`Description
`
`MYL 1124
`
`Scher, H.I. et al., “Design and end points of clinical trials for
`patients with progressive prostate cancer and castrate levels of
`testosterone: recommendations of the Prostate Cancer Clinical
`Trials Working Group,” J. Clin. Oncol., 26(7):1148-59 (2008)
`
`MYL 1125
`
`FDA, Prostate Cancer End Points Workshop (2004)
`
`MYL 1126
`
`Intentionally left blank
`
`MYL 1127
`
`Intentionally left blank
`
`MYL 1128
`
`Intentionally left blank
`
`MYL 1129
`
`FDA letter approving Taxotere (May 19, 2004)
`
`MYL 1130
`
`U.S. Patent No. 7,709,517
`
`MYL 1131
`
`U.S. Patent No. 8,183,274
`
`MYL 1132
`
`U.S. Patent No. 9,126,941
`
`MYL 1133
`
`Orange Book, “Xtandi,”
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?
`Product_No=001&Appl_No=203415&Appl_type=N.html
`
`MYL 1134
`
`Confidential Reply Declaration of Ivan T. Hofmann
`
`MYL 1135
`
`Deposition of Matthew Rettig, M.D. (Mar. 31, 2017)
`
`MYL 1136
`
`Deposition of Christopher Vellturo, Ph.D. (Apr. 5, 2017)
`
`MYL 1137
`
`Deposition of Christopher Vellturo, Ph.D., Amerigen Pharms. Ltd.
`v. Janssen Oncology, Inc., IPR No. 2016-00286 (Dec. 20, 2016)
`
`MYL 1138
`
`Jevtana prescribing information (Sept. 2016)
`
`MYL 1139
`
`Taxotere prescribing information (Dec. 2015)
`
`MYL 1140
`
`Taxotere label (May 2004)
`
`MYL 1141
`
`Johnson & Johnson Press Release, “Zytiga® approved in the EU
`for use in the treatment of metastatic castration-resistant prostate
`cancer before chemotherapy,” 1/11/2013
`http://www.jnj.com/media-center/press-releases/zytiga-approved-
`in-the-eu-for-use-in-the-treatment-of-metastatic-castration-
`resistant-prostate-cancer-before-chemotherapy
`
`
`
`12
`
`
`
`Exhibit
`
`Description
`
`MYL 1142
`
`Deposition of Ian Judson (Apr. 7, 2017)
`
`MYL 1143
`
`Confidential Deposition of Richard Auchus (Apr. 10, 2017)
`
`MYL 1144
`
`Non-Confidential Deposition of Richard Auchus (Apr. 10, 2017)
`
`MYL 1145
`
`Non-Confidential Reply Declaration of Ivan T. Hofmann
`
`MYL 1146
`
`Reply Declaration of Ian McKeague, Ph.D.
`
`MYL 1147
`
`Reserved
`
`MYL 1148
`
`Email from R. Munoz regarding Deposition of Dr. Serels in
`IPR2016-00286 (Aug. 19, 2016)
`
`MYL 1149
`
`Email correspondence between B. White and B. Donovan
`regarding depositions in IPR2016-01332 (Mar. 9, 2017)
`
`MYL 1150
`
`Email from B. Donovan regarding IPR2016-01332 – Exhibit 2134
`(Apr. 4, 2017)
`
`MYL 1151
`
`Declaration of Ivan T. Hofmann, CPA/CFF, CLP
`
`MYL 1152
`
`Declaration of Bryan D. Beel
`
`MYL 1153
`
`Declaration of Marc B. Garnick, M.D.
`
`MYL 1154
`
`Declaration of Ivan T. Hofmann, CPA/CFF, CLP
`
`
`
`
`
`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
`
`PERKINS COIE LLP
`700 13th Street, NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6204
`Facsimile: (202) 654-6211
`Email: bmwhite@perkinscoie.com
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`
`
`Dated: May 10, 2017
`
`
`
`
`
`
`
`13
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing Fifth Updated List of
`
`Petitioner’s Exhibits was served electronically via email as follows:
`
`Patent Owners:
`
`Patent Owners:
`
`Dianne B. Elderkin
`Barbara L. Mullin
`Ruben H. Munoz
`Akin Gump Strauss Hauer & Feld LLP
`JANS-ZYTIGA@akingump.com
`
`Todd L. Krause
`David T. Pritikin
`Bindu Donovan
`Paul J. Zegger
`Sidley Austin LLP
`ZytigaIPRTeam@sidley.com
`
`
`
`Petitioners:
`
`Samuel S. Park
`Jovial Wong
`Ryan B. Hauer
`Winston & Strawn LLP
`spark@winston.com
`jwong@winston.com
`rhauer@winston.com
`
`
`
`
`
`
`Dated: May 10, 2017
`
`
`
`/Brandon M. White/
`Brandon M. White
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`
`
`
`
`
`
`
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