`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SANDOZ INC.,
`Petitioner,
`
`v.
`
`PHARMACYCLICS LLC,
`Patent Owner.
`____________
`
`Case No. IPR2019-00865
`Patent 9,795,604
`
`
`
`
`
`MOTION FOR ADMISSION PRO HAC VICE
`OF CHRISTOPHER L. MCARDLE
`
`
`
`
`
`
`
`

`

`IPR2019-00865
`Patent 9,795,604
`
`
`1004
`
`1005
`
`AMENDED EXHIBIT LIST
`Exhibit
`Ex #
`1001 U.S. Patent No. 9,795,604 B2 (“the ’604 Patent”)
`1002 U.S. Patent Pub. No. 2015/0140085 A1 (“the ’085 Publication ”)
`1003
`Shimabukuro-Vornhagen et al., “The role of B cells in the pathogenesis
`of graft-versus-host disease,” BLOOD, Volume 114, No. 24, pp. 4919–
`4927, December 3, 2009 (“Shimabukuro-Vornhagen”)
`Herman et al., “Bruton tyrosine kinase represents a promising therapeutic
`target for treatment of chronic lymphocytic leukemia and is effectively
`targeted by PCI-32765,” BLOOD, Volume 117, No. 23, pp. 6287–6296,
`June 9, 2011 (“Herman”)
`Uckun et al., “Bruton’s tyrosine kinase as a molecular target in treatment
`of leukemias and lymphomas as well as inflammatory disorders and
`autoimmunity,” EXPERT OPINION ON THERAPEUTIC PATENTS, Volume 20,
`No. 11, pp. 1457–1470, November 2010 (“Uckun”)
`1006 Declaration of James L. M. Ferrara M.D., D.Sc.
`Goldstein et al., “Induction of Costimulatory Molecules B7-1 and B7-2 in
`Murine B Cells: the CBA/N Mouse Reveals a Role for Bruton’s Tyrosine
`Kinase in CD4- Mediated B7 Induction,” MOLECULAR IMMUNOLOGY,
`Volume 33, No. 6, pp. 541–551, 1996 (“Goldstein”)
`1008 Declaration of Sylvia D. Hall-Ellis, Ph.D.
`1009
`July 22, 2016 Amendment and Response in Appl. No. 14/523,650
`Barak et al., “Cytokine Dysregulation in Chronic Graft Versus Host
`Disease,” LEUKEMIA AND LYMPHOMA, Volume 17, pp. 169–173, 1995
`(“Barak”)
`PCT No. PCT/US2013/047958
`Cetkovic-Cvrlje, “Dual targeting of Bruton’s tyrosine kinase and Janus
`kinase 3 with rationally designed inhibitors prevents graft-versus-host
`disease (GVHD) in a murine allogeneic bone marrow transplantation
`model,” BRITISH JOURNAL OF HAEMATOLOGY, Volume 126, pp. 821–827,
`2004
`1013 U.S. Patent No. 7,514,444 B2
`1014
`Provisional Patent Application No. 61/666,562 and filing receipt
`Honigberg et al., “The Bruton tyrosine kinase inhibitor PCI-32765 blocks
`B-cell activation and is efficacious in models of autoimmune disease and
`B-cell malignancy,” PROCEEDINGS OF THE NATIONAL ACADEMY OF
`SCIENCES OF THE USA, Volume 107, No. 29, pp. 13075–13080, July 20,
`2010
`
`1007
`
`1010
`
`1011
`
`1012
`
`1015
`
`- 1 -
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`

`

`Advani et al., “Bruton Tyrosine Kinase Inhibitor Ibrutinib (PCI-32765)
`Has Significant Activity in Patients With Relapsed/Refractory B-Cell
`Malignancies,” JOURNAL OF CLINICAL ONCOLOGY, Volume 31, No. 1, pp.
`88–94, January 1, 2013
`1017 Dolgin, “Precision therapies take aim at non-Hodgkin’s lymphoma”
`NATURE, Volume 563, S46–S47, November 14, 2018
`1018 U.S. Patent No. 8,476,284 B2
`1019 U.S. Patent No. 8,497,277 B2
`1020 Orange Book Listing for Ibrutinib 420 mg Capsules
`1021 April 22, 2016 Office Action in Appl. No. 14/523,650
`Auphan et al., “Immunosuppression by Glucocorticoids: Inhibition of NF-
`κB Activity Through Induction of IκB Synthesis,” SCIENCE, Volume 270,
`pp. 286–290, October 13, 1995
`1023 Curriculum Vitae of Dr. James L. M. Ferrara M.D., D.Sc.
`Koreth et al., “Current and Future Approaches for Control of Graft-
`Versus-Host Disease,” EXPERT REVIEWS IN HEMATOLOGY, Volume 1, No.
`1, pp. 111–128, 2008
`Sarantopoulous et al., “Altered B-cell Homeostasis and Excess BAFF in
`Human Chronic Graft-Versus-Host Disease,” BLOOD, Volume 113, No.
`16, pp. 3865–3874, April 16, 2009
`Cutler et al., “Rituximab Prophylaxis Prevents Corticosteroid-Requiring
`Chronic GVHD After Allogeneic Peripheral Blood Stem Cell
`Transplantation: Results of a Phase 2 Trial,” BLOOD, Volume 122, No. 8,
`pp. 1510–1517, August 22, 2013
`NCCN Clinical Practice Guidelines in Oncology, Hematopoietic Cell
`Transplantation (HCT): Pre-Transplant Recipient Evaluation and
`Management of Graft Versus Host Disease, Version 1.2020, October 30,
`2019
`1028 April 27, 2017 Response and Amendment in Appl. No. 14/523,650
`1029 October 14, 2014 Specification Filed in Appl. No. 14/523,650
`1030 March 13, 2020 Deposition Transcript of John Koreth M.B.B.S., D. Phil.
`1031 Declaration of Christopher L. McArdle in Support of Motion pro hac vice
`
`1022
`
`1024
`
`1025
`
`1026
`
`1027
`
`IPR2019-00865
`Patent 9,795,604
`
`
`1016
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`IPR2019-00865
`Patent 9,795,604
`
`
`Pursuant to 37 C.F.R. §§ 42.10(b) and (c), Petitioner, Sandoz Inc., hereby
`
`moves for the admission of Christopher L. McArdle, a member of the Bar of the
`
`State of New York, as co-counsel for Petitioner in this inter partes review (“IPR”)
`
`proceeding. An appropriate power of attorney from Petitioner so appointing Mr.
`
`McArdle was filed with the Petition. See Paper 1.
`
`
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`Mr. McArdle holds a B.A. degree in Chemistry from Washington University
`
`in St. Louis and a J.D. degree from Tulane University. Exhibit 1023 ¶ 1. Mr.
`
`McArdle is a member in good standing with the Bar of the State of New York.
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`Exhibit 1023 ¶ 2. He has never been suspended, disbarred, sanctioned, denied
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`admission to practice, or cited for contempt by any court or administrative body. Id.
`
`at ¶¶ 3–5.
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`
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`Mr. McArdle has become intimately familiar with the patent at issue in this
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`proceeding and the prior art, including Petitioner’s arguments as to why the claims
`
`at issue are invalid in view of Petitioner’s prior art. Mr. McArdle’s technical
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`experience will aid Petitioner in this proceeding. He also satisfies the remaining
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`conditions for admissibility identified by the Board. Exhibit 1023 ¶¶ 6–9.
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`
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`Petitioner moves for the admission of Mr. McArdle to designate him as back-
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`up counsel in this IPR, in view of his knowledge, familiarity, and experience with
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`the subject matter of this IPR. Although Mr. McArdle is not a registered USPTO
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`IPR2019-00865
`Patent 9,795,604
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`practitioner, Petitioner’s undersigned lead counsel is registered and remains on this
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`case.
`
`Dated: May 29, 2020
`
`Respectfully submitted,
`
`/ Kirk T. Bradley /
`Kirk. T. Bradley
`Reg. No. 46,571
`
`
`Counsel for Petitioner Sandoz Inc.
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`IPR2019-00865
`Patent 9,795,604
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §42.6(e), the undersigned hereby certifies that, on the
`
`29th day of May, 2020 a complete copy of the foregoing “MOTION FOR
`
`ADMISSION PRO HAC VICE OF CHRISTOPHER L. MCARDLE” was served
`
`via electronic mail to the Patent Owner by serving their attorneys of record:
`
`William B. Raich
`Erin M. Sommers
`Cora R. Holt
`Stefan O. Ochiana
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Telephone: (202) 408-4210
`Facsimile: (202) 408-4400
`Email: william.raich@finnegan.com
`erin.sommers@finnegan.com
`cora.holt@finnegan.com
`stefan.ochiana@finnegan.com
`
`
`Dated: May 29, 2020
`
`/ Kirk T. Bradley /
`Kirk T. Bradley
`Reg. No. 46,571
`
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