Paper No. ___
`Date Filed: December 7, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`AMERIGEN PHARMACEUTICALS LIMITED
`and
`ARGENTUM PHARMACEUTICALS LLC
`Petitioners
`v.
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
`Case IPR2016-002861
`________________
`Patent No. 8,822,438 B2
`
`PETITIONERS’ UPDATED EXHIBIT LIST
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`1 Case IPR2016-01317 has been joined with this proceeding.
`
`
`Date Filed: December 7, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`AMERIGEN PHARMACEUTICALS LIMITED
`and
`ARGENTUM PHARMACEUTICALS LLC
`Petitioners
`v.
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
`Case IPR2016-002861
`________________
`Patent No. 8,822,438 B2
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`
`
`1 Case IPR2016-01317 has been joined with this proceeding.
`
`
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`LISTING OF EXHIBITS PURSUANT TO 37 C.F.R. § 42.63(e)
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`
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`Pursuant to 37 C.F.R. 42.63(e), Petitioner, Amerigen Pharmaceuticals, Ltd. hereby submits a
`current list of its exhibits:
`
`Exhibit
`
`AMG 1001
`
`Description
`
`U.S. Patent No. 8,822,438, Auerbach and Belldegrum, “Methods
`
`and Compositions for Treating Cancer” (“the ‘438 patent”)
`
`AMG 1002 Declaration of Dr. Scott Serels, MD (“Serels Decl.")
`O’Donnell, A. et al., “Hormonal impact of the 17α-hydroxylase/C17-
`20-lyase inhibitor abiraterone acetate (CB7630) in patients with
`
`AMG 1003
`
`prostate cancer,” British Journal of 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,” The Journal of Urology, 144(5):1177-9 (1990)
`
`AMG 1004
`
`(“Gerber”)
`
`AMG 1005
`
`U.S. Patent No. 5,604,213, Barrie S.E. et al., “17-Substituted
`
`Steroids Useful In Cancer Treatment” ("the '213 patent")
`
`AMG 1006
`
`AMG 1007
`
`AMG 1008
`
`Tannock et al., “Chemotherapy with mitoxantrone plus prednisone
`
`or prednisone alone for symptomatic hormone-resistant prostate
`
`cancer: a Canadian randomized trial with palliative end points,” The
`
`Journal of Clinical Oncology, 14:1756-1764 (1996) (“Tannock”)
`
`February 3, 2012 Office Action (excerpt from prosecution history of
`
`'438 patent)
`July 3, 2012 Response (excerpt from prosecution history of ’438
`
`patent)
`
`
`
`Ryan et al., “Abiraterone in metastatic prostate cancer without
`
`AMG 1009
`
`previous chemotherapy,” The New England Journal of Medicine,
`
`368:138-148 (2012).
`
`January 11, 2013 Response (excerpt from prosecution history of
`
`'438 patent)
`March 4, 2013 Office Action (excerpt from prosecution history of
`
`'438 patent)
`June 4, 2013 Response (excerpt from prosecution history of ’438
`
`patent)
`
`July 3, 2013 Notice of Allowance (excerpt from prosecution history
`
`of ’438 patent)
`October 25, 2013 Notice of Allowance (excerpt from prosecution
`
`history of ’438 patent)
`February 11, 2014 Notice of Allowance (excerpt from prosecution
`
`history of ’438 patent)
`June 2, 2014 Notice of Allowance (excerpt from prosecution history
`
`AMG 1010
`
`AMG 1011
`
`AMG 1012
`
`AMG 1013
`
`AMG 1014
`
`AMG 1015
`
`AMG 1016
`
`of ’438 patent)
`AMG 1017 Declaration of Dr. DeForest McDuff, PhD (“McDuff Declaration”)
`
`AMG 1018 2011 Zytiga® Approval Prescribing Information
`AMG 1019 2015 Zytiga® Prescribing Information, Co-administration Brochure
`Harris et al., “Low dose Ketoconazole with replacement doses of
`
`AMG 1020
`
`hydrocortisone in patients with progressive androgen independent
`
`prostate cancer,” The Journal of Urology, volume 168:542-545
`
`(August 2002)
`William Oh, “Secondary hormonal therapies in the treatment of
`
`AMG 1021
`
`prostate cancer,” Urology, volume 60:87-93 (Supplement 3A)
`
`(September 2002)
`
`
`
`Tannock, I. et al., “Docetaxel plus Prednisone or Mitoxantrone plus
`
`AMG 1022
`
`Prednisone for Advanced Prostate Cancer,” N. Eng. J. Med.,
`
`351:1502-12 (2004)
`
`Attard, G. et al., “Selective blockade of androgenic steroid synthesis
`
`AMG 1023
`
`by novel lyase inhibitors as a therapeutic strategy for treating
`
`metastatic prostate cancer,” Br. J. Urol. 96(9): 1241-1246 (2005)
`
`Hellerstedt et al., “The Current State of Hormonal Therapy for
`
`Prostate Cancer,” CA Cancer J. Clin., 52:154-179 (2002).
`
`AMG 1024
`
`AMG 1025
`
`Kasper, D.L. et al. (Eds.), Harrison's Principles of Internal
`Medicine, 16th Edition (2005), p. 549.
`
`Auchus, R.J. “The genetics, pathophysiology, and management of
`
`AMG 1026
`
`human deficiencies of P450c17,” Endocrinol. Metab. Clin. North
`
`Am. (30)1:101-119 (2001)
`
`Costa-Santos, M. et al., “Two Prevalent CYP17 Mutations and
`
`AMG 1027
`
`Genotype-Phenotype Correlations in 24 Brazilian Patients with 17-
`
`Hydroxylase Deficiency,” J. Clin. Endocrin. & Metabol. (89)1:49-
`
`Jubelirer, S.J., et al., “High dose ketoconazole for the treatment of
`
`AMG 1028
`
`hormone refractory metastatic prostate carcinoma,” J. Urol.,
`
`AMG 1029
`
`142(1):89-901 (1989)
`
`U.S. Patent 5,688,977, Sisti, N.J. et al., “Method for Docetaxel
`
`Synthesis”
`
`U.S. Food and Drug Administration ("FDA") FDA News Release
`
`AMG 1030
`
`dated May 19, 2004, “FDA Approves New Indication for Taxotere-
`
`Prostate Cancer”
`
`
`
`AMG 1031
`
`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,” Journal of Clin. Oncology, 7:590-7
`
`(1989)
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`AMG 1032 Taxotere® Prescribing Information (2004)
`
`Scher, H.I. et al., “Increased survival with Enzalutamide in Prostate
`
`AMG 1033
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`Cancer after Chemotherapy,” New Eng. J. Med., 367:1187-97
`
`(2012)
`
`de Bono, J.S. et al., “Abiraterone and Increased Survival in
`
`AMG 1034
`
`Metastatic Prostate Cancer,” New Engl. J. Med., 364:1995-2005
`
`(2011)
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`AMG 1035 Orange Book listing for Zytiga®
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`AMG 1036 Initial Application (excerpt from prosecution history of ’438 patent)
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`AMG 1037
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`AMG 1038
`
`AMG 1039
`
`November 25, 2011 Office Action (excerpt from prosecution history
`
`of ’438 patent)
`
`December 21, 2011 Response (excerpt from prosecution history of
`
`’438 patent)
`
`September 11, 2012 Office Action (excerpt from prosecution history
`
`of ’438 patent)
`Cancer.net (ASCO Patient Website), Treatment of Metastatic
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`Castration-Resistant Prostate Cancer,
`
`AMG 1040
`
`http://www.cancer.net/research-and-advocacy/asco-careand-
`
`treatment-recommendations-patients/treatment-metastatic-
`
`castrationresistant-prostate-cancer (accessed 7/24/2015).
`
`
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`Cancer.org (ACS), “What are the key statistics about prostate
`
`AMG 1041
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`cancer?” http://www.cancer.org/cancer/prostatecancer/detailed
`
`guide/prostatecancerkeystatistics (accessed 8/20/2015).
`
`AMG 1042 Cowen & Company, “Biotechnology Quarterly,” 7/2/2012.
`
`AMG 1043 Cowen & Company, “Quick Take – Johnson & Johnson,”
`12/11/2012.
`Credit Suisse, “Prostate Cancer – Implications of Zytiga’s Pre-
`
`AMG 1044
`
`AMG 1045
`
`Chemo Approval,” 12/11/2012.
`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.
`FDA Website, Drugs@FDA – Zytiga,
`
`AMG 1046
`
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fu
`
`AMG 1047
`
`AMG 1048
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`seaction=Search.DrugDetails (accessed 7/23/2015).
`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
`
`7/24/2015).
`Galderma Laboratories, L.P. et al. v. Tolmar, Inc., 737 F.3d 731,
`
`740–41 (Fed. Cir. 2013).
`Jevtana Website, Dosing and Administration,
`
`AMG 1049
`
`http://www.jevtana.com/hcp/dosing/default.aspx (accessed
`
`8/20/2015).
`Kirby, M., C. Hirst, and E.D. Crawford (2011), “Characterising the
`
`AMG 1050
`
`Castration-Resistant Prostate Cancer Population: A Systematic
`
`Review,” International Journal of Clinical Practice 65(11): 1180-
`
`1192.
`
`
`
`Mayo Clinic Website, Prostate cancer,
`
`AMG 1051
`
`http://www.mayoclinic.org/diseasesconditions/prostate-
`
`cancer/basics/definition/con-20029597?p=1 (accessed 7/24/2015).
`Medivation Press Release, “U.S. FDA Approves New Indication for
`
`the Use of XTANDI® (Enzalutamide) Capsules for Patients With
`
`AMG 1052
`
`Metastatic Castration-Resistant Prostate Cancer,” 9/10/2014,
`
`http://investors.medivation.com/releasedetail.cfm?ReleaseID=87026
`
`AMG 1053
`
`7.
`Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., 395 F.3d
`
`1364, 1376–77 (Fed. Cir. 2005).
`Murphy, William J., John L. Orcutt, and Paul C. Remus (2012),
`
`AMG 1054
`
`Patent Valuation: Improving Decision Making through Analysis,
`
`Hoboken, NJ: Wiley.
`PMLiVE Website, "Top 50 Pharmaceutical Products by Global
`
`AMG 1055
`
`AMG 1056
`
`AMG 1057
`
`AMG 1058
`
`AMG 1059
`
`Sales,"
`
`http://www.pmlive.com/top_pharma_list/Top_50_pharmaceutical_p
`
`roducts_by_global_sales (accessed 9/14/2015).
`RBC Capital Markets (via Barron’s Website), “Xtandi Beats
`
`Casodex, Set to Top Zytiga,” 4/3/2015,
`
`http://online.barrons.com/articles/xtandi-beats-casodexset-to-top-
`
`zytiga-1428075331 (accessed 7/24/2015).
`Syntex (U.S.A.) LLC and Allergan v. Apotex, Inc. et al., 407 F.3d
`
`1371, 1383 (Fed. Cir. 2005).
`
`UBS Investment Research, “Johnson & Johnson – Zytiga Label
`
`Extended,” 12/10/2012.
`UBS Research, “Medivation – A Look at the Growth and Share in
`
`Prostate Cancer,” 2/3/2014.
`
`
`
`Decline Accelerates From Last Quarter,” 7/14/2015.
`AMG 1061 Wells Fargo Securities, LLC., “Johnson & Johnson,” 6/29/2015.
`William Blair, “Biotechnology – Zytiga Fourth-Quarter Sales Imply
`
`Wedbush Securities, Inc., “Medivation: Zytiga Market Share
`
`Xtandi Strength,” 1/22/2013.
`William Blair, “Medivation, Inc. – Looking into Recent
`
`AMG 1060
`
`AMG 1062
`
`AMG 1063
`
`Weaknesses,” 7/15/2015.
`AMG 1064 Zytiga Brochure, Putting Prednisone in Perspective, 3/2015.
`
`AMG 1065 Zytiga Label, 5/20/2015.
`
`Zytiga Website, How Zytiga® (abiraterone acetate) Works,
`
`AMG 1066
`
`https://www.zytiga.com/print/about-zytiga/how-zytiga-works
`
`(accessed 7/23/2015).
`
`AMG 1067 IMS Health Data 2012-2015 for Zytiga®, Xtandi® and Jevtana®
`
`AMG 1068 Expunged
`
`AMG 1069 Expunged
`
`AMG 1070 Expunged
`
`AMG 1071 Expunged
`
`AMG 1072 Expunged
`
`AMG 1073 Petitioners' Notice of Deposition of Matthew Rettig, M.D.
`
`
`
`Udhane, S.S. et al., "Specificity of anti-prostate cancer CYP7A1
`
`AMG 1074
`
`inhibitors on androgen biosynthesis," Biochemical and Biophysical
`
`Research Communications, 477:1005-1010 (2016).
`
`Akakura, K. et al., "Possible Mechanism of Dexamethasone
`
`AMG 1075
`
`Therapy for Prostate Cancer: Suppression of Circulating Level of
`
`Interleukin-6," The Prostate, 56:106-109 (2003).
`
`AMG 1076 Petitioners' Notice of Deposition of Gerald Walter Chodak, M.D.
`
`Wilkinson, S. and Chodak, G., “An Evaluation of Intermediate-Dose
`
`AMG 1077
`
`Ketoconazole in Hormone Refractory Prostate Cancer,” European
`
`Urology, 45:581-585 (2004).
`
`AMG 1078 Email dated June 29, 2016.
`
`AMG 1079 Email string spanning September 8, 2016 and September 12, 2016.
`
`AMG 1080 Email string spanning September 8, 2016 and September 12, 2016.
`
`AMG 1081 Email dated October 7, 2016.
`
`Respectfully submitted,
`
`/william d. hare/
`William D. Hare
`Reg. No. 44,739
`Counsel for Petitioner
`
`
`
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`Date December 7, 2016
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Petitioners’
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`
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`Updated Exhibit List was served on counsel of record on December 7, 2016 by
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`filing this document through the End-to-End System, as well as delivering a copy
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`via electronic mail to counsel of record for the Patent Owner at the following
`
`addresses:
`
`Diane B. Elderkin
`Barbara L. Mullin
`Ruben Munoz
`JANS-ZYTIGA@akingump.com
`David T. Pritikin
`Bindu Donovan
`Isaac Olson
`Alyssa B. Monsen
`ZytigaIPRTeam@sidley.com
`Jennifer H. Roscetti
`jennifer.roscetti@finnegan.comn
`Anthony C. Tridico
`anthony.tridico@finnegan.com
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`
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`Date: December 7, 2016
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`Respectfully submitted,
`/William D. Hare/
`William D. Hare
`Reg. No. 44,739
`12 Roszel Road, Suite C104
`Princeton, NJ 08540
`(202) 640-1801
`bill@miplaw.com
`Counsel for Petitioner Amerigen
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