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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`COALITION FOR AFFORDABLE DRUGS IV LLC
`Petitioner
`v.
`PHARMACYCLICS, INC.
`Patent Owner
`_____________________
`
`Case No. IPR2015-01076
`Patent No. 8,754,090
`_____________________
`
`
`PETITIONER’S UPDATED APPENDIX OF EXHIBITS
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`Description
`Exhibit
`Ex. 1001 U.S. Patent No. 8,754,090
`Ex. 1002 ClinicalTrials.gov Archive, Study of the Safety and
`Tolerability of PIC-32765 in Patients with Recurrent B Cell
`Lymphoma (February 23, 2009),
`https://clinicaltrials.gov/archive/NCT00849654/2009_02_23
`Ex. 1003 U.S. Patent App. Pub. No. 2008/0139582
`Ex. 1004 Press Release, Pharamacyclics, Pharmacyclics Initiates
`Phase I Clinical Trial of Novel Oral Btk Inhibitor for
`Refractory B-Cell Non-Hodgkin’s Lymphoma (April 13,
`2009)
`Ex. 1005 Zhengying Pan, et al., Discovery of Selective Irreversible
`Inhibitors for Bruton’s Tyrosine Kinase, 2 ChemMedChem
`58 (2007)
`Ex. 1006 Lee Honigberg et al., Targeting Btk in Lymphoma: PCI-
`32765 Inhibits Tumor Growth in Mouse Lymphoma Models
`and a Fluorescent Analog of PCI-32675 Is an Active-Site
`Probe That Enables Assessment of Btk Inhibition In Vivo,
`Blood (ASH Annual Meeting Abstracts) at 1592 (November
`2007)
`Ex. 1007 Christophe Le Tourneau et al., Dose Escalation Methods in
`Phase I Cancer Clinical Trials, 101 J. Nat’L Cancer Inst.
`708 (2009)
`Ex. 1008 Jonathan McConathy, Ph.D., & Michael J. Owens, Ph.D.,
`Stereochemistry in Drug Action, 5 Primary Care Companion
`J Clinical Psychiatry 70 (2003)
`Ex. 1009 Stefano A. Pileri & Brunangelo Falini, Mantle Cell
`Lymphoma, 94 Haematologica 1488 (2009)
`Ex. 1010 Agency For Toxic Substances and Disease Registry, Public
`Health Assessment Guidance Manual, (2005)
`Ex. 1011 MacPartlin et al., Bruton’s tyrosine kinase is not essential
`for Bcr-Abl-mediated transformation of lymphoid or
`myeloid cells, 22 Lekemia 1354 (2008)
`Ex. 1012 National Center for Biotechnology Information, PubChem
`Compound Database, CID=16126651, available at
`http://pubchem.ncbi.nlm.nih.gov/compound/16126651
`Ex. 1013 Elaine S. Jaffe, The 2008 WHO classification of
`lymphomas: implications for clinical practice and
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`Filed
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`translational research, Hematology (2009)
`Ex. 1014 Original Claims, December 29, 2011, U.S. Patent App. No.
`13/340,522
`Ex. 1015 Examiner Initiated Interview Summary, December 23,
`2012, U.S. Patent App. No. 13/340,522
`Ex. 1016 Requirement for Restriction/Election, January 3, 2013, U.S.
`Patent App. No. 13/340,522
`Ex. 1017 Preliminary Amendment and Response to Restriction
`Requirement, February 4, 2013, U.S. Patent App. No.
`13/340,522
`Ex. 1018 Final Office Action, November 1, 2013, U.S. Patent App.
`No. 13/340,522
`Ex. 1019 Response to Final Office Action, December. 17, 2013, U.S.
`Patent App. No. 13/340,522
`Ex. 1020 Notice of Allowance, January 27, 2014, U.S. Patent App.
`No. 13/340,522
`Ex. 1021 Declaration by Djordje Atanackovic, M.D., Regarding U.S.
`Patent No. 8,754,090 Under 37 C.F.R. § 42.63(a)
`Ex. 1022 Curriculum Vitae of Djordje Atanackovic, M.D.
`Ex. 1023 R. Eric Davis, et al., Chronic Active B-Cell-Receptor
`Signalling in Diffuse Large B-Cell Lymphoma, Nature, Vol.
`463, Letters, pp. 88-92 (January 7, 2010)
`Ex. 1024 Declaration of Brent Routman in Support of Petitioner’s
`Motion for Admission Pro Hac Vice
`Ex. 1025 Declaration of Shane A. Brunner in Support of Petitioner’s
`Motion for Admission Pro Hac Vice
`Ex. 1026 Declaration of Juan (Julie) Wu, PH.D, M.S.
`Ex. 1027 Joint letter from AARP, AHIP, BCBSA and PCMA to
`Chairmen Grassley and Goodlatte and Ranking Members
`Leahy and Conyers ( July 9, 2015)
`Ex. 1028 Center for Economic and Policy Research paper titled “The
`Impact of Exempting the Pharmaceutical Industry from
`Patent Reviews” by Dean Baker (July, 2015)
`Ex. 1029 Orange Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations (August 11, 2015)
`Ex. 1030 FiercePharma.com article titled “J&J, Pharmacyclics slap
`$130,000 price on Imbruvica for rare lymphoma” by Tracy
`Staton (November 14, 2013)
`Ex. 1031 Curriculum Vitae of Juan (Julie) Wu
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`Ex. 1032 Karl B. Diether, Kuan-Hui Lee and Ingrid M. Werner, It’s
`SHO Time! Short-Sale Price Tests and Market Quality, The
`Journal of Finance, Vol LXIV, No. 1 37 (February, 2009)
`Ex. 1033 Political /Regulatory Timeline
`Ex. 1034 Excerpts, with Executive Summary of SEC 2010
`Amendments to Regulation SHO final rule 34-61595
`Ex. 1035 Jonathan M. Karpoff and Xiaoxia Lou, Short Sellers and
`Financial Misconduct, The Journal of Finance, Vol LXV,
`No. 5 1879 (October, 2010)
`Ex. 1036 Vivian W. Fang, Allen H. Huang and Jonathan Karpoff,
`Short Selling and Earnings Management: A Controlled
`Experiment (November 16, 2014)
`Ex. 1037 Ekkehart Boehmer and Juan (Julie) Wu, Short Selling and
`the Price Discovery Process (2012)
`Ex. 1038 Ekkehart Boehmer, Charles M. Jones and Xiaoyan Zhang,
`Shackling Short Sellers: The 2008 Shorting Ban (2013)
`Ex. 1039 Massimo Massa, Bohui Zhang and Hong Zhang, The
`Invisible Hand of Short Selling: Does Short Selling
`Discipline Earnings Management? (October, 2014)
`Ex. 1040 Massimo Massa, Bohui Zhang and Hong Zhang,
`Governance Through Threat: Does Short Selling Improve
`Internal Governance? Faculty and Research Working Paper
`(2013)
`Ex. 1041 Jie (Jack) He and Xuan Tian, Short sellers and innovation:
`Evidence from a quasi-natural experiment (March, 2014)
`Ex. 1042 Patricia M. Dechow, Amy P. Hutton, Lisa Meulbroek and
`Richard G. Sloan, Short-sellers, fundamental analysis, and
`stock returns, Journal of Financial Economics 61 (2001)
`Ex. 1043 Ferhat Akbas, Ekkehart Boehmer and Egemen Genc, Peer
`stock short interest and future returns (February, 2015)
`Ex. 1044 Karl B. Diether, Kuan-Hui Lee and Ingrid M. Werner,
`Short-Sale Strategies and Return Predictability (2008)
`Ex. 1045 Testimony of Professor Owen A. Lamont (June 28, 2006)
`Ex. 1046 Joseph E. Engelberg, Adam V. Reed and Matthew C.
`Ringgenberg, How are shorts informed? Short sellers, news,
`and information processing, Journal of Financial Economics
`105 (2012)
`Ex. 1047 Press Release, Pharmacyclics, Pharmacyclics Initiates Phase
`I Clinical Trial of Novel Oral Btk Inhibitor for Refractory
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`B-Cell Non-Hodgkin’s Lymphoma (April 13, 2009)
`Ex. 1048 Declaration of Jeffrey D. Blake
`Ex. 1049 Declaration of Tchao J. Thao
`Ex. 1050 Declaration of Kristin Drieman
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`5
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