`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`SANDOZ INC.,
`Petitioner,
`
`v.
`
`PHARMACYCLICS LLC,
`Patent Owner.
`
`__________________
`
`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`__________________
`
`PATENT OWNER’S EXHIBIT LIST
`
`
`

`

`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner Pharmacyclics LLC hereby
`
`submits a current listing of exhibits.
`
`2002
`
`2003
`
`2004
`
`2005
`
`EXHIBIT DESCRIPTION
`Dignan FL, et al., Diagnosis and management of chronic graft-
`2001
`versus-host disease. BRIT J HAEMATOL, 158:46–61 (2012).
`Choi SW, Levine JE & Ferrara JL, Pathogenesis and management
`of graft‐versus‐host disease. IMMUNOL ALLERGY CLIN N AM, 30:75–
`101 (2010).
`Min CK, The pathophysiology of chronic graft-versus-host disease:
`the unveiling of an enigma. KOREAN J HEMATOL, 46(2):80–87
`(2011).
`Pavletic SZ & Fowler DH, Are we making progress in GVHD
`prophylaxis and treatment? HEMATOLOGY AM SOC HEMATOL EDUC
`PROGRAM, 2012(1):251–64 (2012).
`Ferrara JLM & Reddy P, Cellular Therapy for Hematology
`Malignancies: Allogeneic Hematopoietic Stem Transplantation,
`Graft-Versus-Host Disease, and Graft Versus Leukemia Effects, in
`ADVANCES IN STEM CELL RESEARCH. STEM CELL BIOLOGY AND
`REGENERATIVE MEDICINE, 303–66 (Baharvand H & Aghdami N
`eds, 2012).
`2006 Martin PJ, et al., Treatment of chronic graft-versus-host disease:
`past, present and future. KOREAN J HEMATOL, 46(3):153–63 (2011).
`Ferrara JL, et al., Graft-versus-host disease. LANCET, 373:1550–61
`(2009).
`Yoon HK, et al., Effects of Pravastatin on Murine Chronic Graft-
`Versus-Host Disease. TRANSPLANTATION, 90(8):853–60 (2010).
`Reserved.
`Lee SJ, New approaches for preventing and treating chronic graft-
`versus-host disease. BLOOD, 105(11):4200–06 (2005).
`Kobbe G, et al., Treatment of severe steroid refractory acute graft-
`versus-host disease with infliximab, a chimeric human/mouse anti
`TNFα antibody. BONE MARROW TRANSPLANT, 28:47–49 (2001).
`Levine JE, et al., Etanercept plus methylprednisolone as initial
`therapy for acute graft-versus-host disease. BLOOD, 111(4):2470–
`75 (2008).
`
`2007
`
`2008
`2009
`2010
`
`2011
`
`2012
`
`1
`
`

`

`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`EXHIBIT DESCRIPTION
`Shimabukuro-Vornhagen A & von Bergwelt-Baildon MS.
`Response: Friend or foe in GVHD: a matter of targeting the right B-
`cell subset. BLOOD, 115(12):2559–60 (2010).
`McIver Z, et al., Rituximab administration within 6 months of T cell-
`depleted allogeneic SCT is associated with prolonged life-
`threatening cytopenias. BIOL BLOOD MARROW TRANSPLANT,
`16:1549–56 (2010).
`MacMillan ML, et al., A phase 2/3 multicenter randomized clinical
`trial of ABX-CBL versus ATG as secondary therapy for steroid-
`resistant acute graft-versus-host disease. BLOOD, 109(6):2657–62
`(2007).
`Kitko CL, et al., Combination therapy for graft-versus-host disease
`prophylaxis with etanercept an extracorporeal photopheresis:
`Results of a Phase II clinical trial. BIOL BLOOD MARROW
`TRANSPLANT, 22:862–68 (2016).
`Betts BC, et al. Anti-IL-6 receptor alpha (tocilizumab) does not
`inhibit human monocyte-derived dendritic cell maturation or
`alloreactive T-cell responses. BLOOD, 118(19):5340–43 (2011).
`Henden AS & Hill GR, Cytokines in graft-versus-host disease. J
`IMMUNOL, 194:4604–12 (2015).
`Martin PJ, et al., Evaluation of mycophenolate mofetil for initial
`treatment of chronic graft-versus-host disease. BLOOD,
`113(21):5074–82 (2009).
`Reserved.
`Kitko CL, et al., Plasma CXCL9 elevations correlate with chronic
`GVHD diagnosis. BLOOD, 123(5):786–93 (2014).
`FDA expands ibrutinib indications to chronic GVHD, U.S. Food &
`Drug Administration, https://www.fda.gov/drugs/resources-
`information-approved-drugs/fda-expands-ibrutinib-indications-
`chronic-gvhd, (last visited May 24, 2019).
`2023 Miklos D, et al., Ibrutinib for chronic graft-versus-host disease after
`failure of prior therapy. BLOOD, 130(21):2243–50 (2017).
`Dubovsky JA, et al., Ibrutinib is an irreversible molecular inhibitor
`of ITK driving a Th1-selective pressure in T lymphocytes. BLOOD,
`122(15):2539–49 (2013).
`Buggy JJ & Elias L, Bruton Tyrosine Kinase (BTK) and Its Role in
`B-cell Malignancy. INT REV IMMUNOL, 31:119–32 (2012).
`
`2020
`2021
`
`2022
`
`2024
`
`2025
`
`2
`
`

`

`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`
`2026
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`EXHIBIT DESCRIPTION
`FDA Approves Ibrutinib to Treat Chronic Graft Versus Host
`Disease, Lymphoma Research Foundation, Aug. 3, 2017,
`https://www.lymphoma.org/newsarchive/fda-approves-ibrtutinib-
`cgvhd/ (last visited June 24, 2019).
`U.S. Patent Application Publication No. 2015/0086507 to Izumi et
`2027
`al.
`2028 Magenau J, et al., Advances in understanding the pathogenesis of
`graft-versus-host disease. BR J HAEMATOL, 173:190–205 (2016).
`Notice of Allowance in U.S. Patent Application No. 14/523,650
`(Aug. 16, 2017).
`Final Office Action in U.S. Patent Application No. 14/523,650
`(Nov. 3, 2016).
`Reddy P & Ferrara JLM, Graft-Versus-Host Disease and Graft-
`Versus-Leukemia Responses in HEMATOLOGY, 1650–68 (Hoffman R
`et al. eds, 2018).
`Aalipour A & Advani RH, Bruton tyrosine kinase inhibitors: a
`promising novel targeted treatment for B cell lymphomas. BR J
`HAEMATOL, 163:436–43 (2013).
`van den Akker E, et al., The BTK inhibitor LFM-A13 is a potent
`inhibitor of Jak2 kinase activity. BIOL CHEM, 385:409–13 (2004).
`Zorn CN, et al., Bruton’s tyrosine kinase is dispensable for the Toll-
`like receptor-mediated activation of mast cells. CELL SIGNAL,
`21:79–86 (2008).
`Reserved.
`Prescribing Information for Imbruvica® dated January 2019.
`Stewart J, Health Canada OKs Imbruvica for Treating Chronic
`Graft-Versus-Host Disease, Lymphoma News Today, Oct. 31, 2017,
`https://lymphomanewstoday.com/2017/10/31/janssen-inc-
`announces-imbruvica-ibrutinib-as-the-first-approved-treatment-for-
`chronic-graft-versus-host-disease-cgvhd-granted-by-health-canada-
`priority-review/ (last visited May 24, 2019).
`NCI Staff, Ibrutinib Relieves Chronic Graft-Versus-Host Disease
`Symptoms, NIH National Cancer Institute, Jan. 11, 2017,
`https://www.cancer.gov/news-events/cancer-currents-
`blog/2017/ibrutinib-stem-cell-transplant-gvhd (last visited June 24,
`2019).
`Reserved.
`
`2035
`2036
`
`2037
`
`2038
`
`2039
`
`3
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`

`

`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`
`2041
`
`EXHIBIT DESCRIPTION
`Pharmacyclics LLC v. Fresenius Kabi USA, LLC, Docket Sheet,
`2040
`Case 1:18-cv-00192-CFC Consolidated (accessed Jun. 26, 2019).
`Pharmacyclics LLC v. Fresenius Kabi USA, LLC, Notice of Service,
`Case 1:18-cv-00192-CFC Consolidated, D.I. 130 (Mar. 15, 2019).
`Pharmacyclics LLC v. Fresenius Kabi USA, LLC, Excerpts from
`Plaintiffs’ First Supplemental Responses to Defendants’ First Set of
`Joint Interrogatories (Nos. 1–4), Case 1:18-cv-00192-CFC
`Consolidated (Mar. 15, 2019).
`
`2042
`
`
`
`Date: June 28, 2019
`
`
`
`Respectfully submitted,
`
`
`
`By: / William B. Raich /
`William B. Raich, Reg. No. 54,386
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`
`Counsel for Patent Owner
`Pharmacyclics LLC
`
`
`
`4
`
`

`

`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Patent Owner’s
`
`Exhibit List and Exhibits 2001–2008, 2010–2019, 2021–2034, 2036–2038, 2040–
`
`2042 were served electronically via email on June 28, 2019, in their entirety on the
`
`following:
`
`Kirk T. Bradley
`Alston & Bird LLP
`101 South Tryon Street, Suite 4000
`Charlotte, NC 28280
`kirk.bradley@alston.com
`
`Siraj M. Abhyankar
`Alston & Bird LLP
`1201 W. Peachtree Street NE #4900
`Atlanta, GA 30309
`shri.abhyankar@alston.com
`
`Christopher L. McArdle
`Alston & Bird LLP
`90 Park Avenue, Suite 1200
`New York, NY 10016
`chris.mcardle@alston.com
`
`
`Petitioner has consented to service by email.
`
`
`Date: June 28, 2019
`
`
`
`By: / William Esper /
`William Esper
`Litigation Legal Assistant
`
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`
`
`
`
`
`
`
`