`
`
`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 UPDATED EXHIBIT LIST AS OF JANUARY 6, 2020
`
`
`

`

`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`
`Further to 37 C.F.R. § 42.63(e), Patent Owner Pharmacyclics LLC hereby
`
`submits a current listing of Pharmacyclics 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).
`Ferrara JL & Yanik G, Acute graft versus host disease:
`Pathophysiology, risk factors, and prevention strategies. CLIN ADV
`HEMATOL ONCOL, 3(5):415-19 (2005).
`Rota M et al., Impact of Recipient Statin Treatment on Graft-
`Versus-Host disease after Allogenetic Hematopoietic Cell
`Transplantation, BIOL BLOOD MARROW TRANSPLANT, 16:1463-66
`(2010).
`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).
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`1
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`

`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`EXHIBIT DESCRIPTION
`Levine JE, et al., Etanercept plus methylprednisolone as initial
`therapy for acute graft-versus-host disease. BLOOD, 111(4):2470-75
`(2008).
`Davis JE & Ritchie DS. B cells in GVHD: friend or foe? BLOOD,
`115(12):2558-59, author reply (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).
`
`2020
`2021
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`2022
`
`2024
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`2
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`

`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`
`2026
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`EXHIBIT DESCRIPTION
`Buggy JJ & Elias L, Bruton Tyrosine Kinase (BTK) and Its Role in
`2025
`B-cell Malignancy. INT REV IMMUNOL, 31:119-32 (2012).
`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.
`2027
`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).
`
`2035
`2036
`
`2037
`
`2038
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`3
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`

`

`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`
`2041
`
`2042
`
`2043
`
`2044
`
`2040
`
`EXHIBIT DESCRIPTION
`Pharmacyclics LLC v. Fresenius Kabi USA, LLC, Scheduling Order,
`2039
`Case 1:18-cv-00192-CFC Consolidated, D.I. 85 (Jan. 28, 2019).
`Pharmacyclics LLC v. Fresenius Kabi USA, LLC, Docket Sheet,
`Case 1:18-cv-00192-CFC Consolidated (accessed May 31, 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).
`The Mount Sinai Hospital, Test predicts response to treatment for
`complication of leukemia stem cell treatment. Medical Xpress, Dec.
`22, 2014, https://medicalxpress.com/news/2014-12-response-
`treatment-complication-leukemia-stem.html (last visited Dec. 4,
`2019).
`Lawrence L, Ibrutinib Approval Expanded to Include Chronic
`GVHD. CancerNetwork, Aug. 4, 2017,
`https://www.cancernetwork.com/cancer-complications/ibrutinib-
`approval-expanded-include-chronic-gvhd (last visited Dec. 2, 2019).
`FDA approves Imbruvica as first therapy for chronic graft-versus-
`host disease. Healio, Aug. 2, 2017,
`https://www.healio.com/hematology-oncology/bone-marrow-
`transplantation/news/online/%7B9e5cb76a-cd54-4f5f-ae24-
`fa1284d83a41%7D/fda-approves-imbruvica-as-first-therapy-for-
`chronic-graft-versus-host-disease (last visited Nov. 25, 2019).
`GVHD management improves, but questions remain about risk
`stratification, prophylaxis. Healio, June 10, 2018,
`https://www.healio.com/hematology-oncology/bone-marrow-
`transplantation/news/print/hemonc-today/%7B5c381d14-ccc4-426d-
`8012-2250dc78319a%7D/gvhd-management-improves-but-
`questions-remain-about-risk-stratification-prophylaxis (last visited
`Dec. 3, 2019).
`Filipovich AH, et al. National Institutes of Health consensus
`development project on criteria for clinical trials in chronic graft-
`versus-host disease: I. Diagnosis and staging working group report.
`BIOL BLOOD MARROW TRANSPLANT, 11:945-56 (2005).
`
`2045
`
`2046
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`2047
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`4
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`

`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`
`2048
`
`2049
`
`2050
`
`2051
`
`2052
`
`2053
`
`2054
`
`EXHIBIT DESCRIPTION
`Pavletic SZ, et al. Measuring therapeutic response in chronic graft-
`versus host disease: National institutes of health consensus
`development project on criteria for clinical trials in chronic graft-
`versus-host disease: IV.Response criteria working group report.
`BIOL BLOOD MARROW TRANSPLANT, 12:252-66 (2006).
`Renteria AS, et al. Therapeutic targets and emerging treatment
`options in gastrointestinal acute graft-versus-host disease. EXPERT
`OPIN ORPHAN DRUGS, 4(5):469-84 (2016).
`Wolff D, et al. Consensus conference on clinical practice in chronic
`GVHD: second-line treatment of chronic graft-versus-host disease.
`BIOL BLOOD MARROW TRANSPLANT, 17:1-17 (2011).
`Ferrara JL & Yanik G. Acute graft versus host disease:
`pathophysiology, risk factors, and prevention strategies. CLIN ADV
`HEMATOL ONCOL, 3(5):415-19 (2005).
`Kharfan-Dabaja MA, et al. Efficacy of rituximab in the setting of
`steroid-refractory chronic graft-versus-host disease: a systematic
`review and meta-analysis. BIOL BLOOD MARROW TRANSPLANT,
`15:1005-13 (2009).
`George M, et al. Lack of efficacy of rituximab in refractory
`sclerodermatous chronic GVHD. BONE MARROW TRANSPLANT,
`47:737-38 (2012).
`Reddy P & Ferrara JLM. Mouse models of graft-versus-host
`disease, in StemBook, 1-23. (The Stem Cell Research Community,
`eds, 2009) http://www.stembook.org (last visited November 25,
`2019).
`Declaration of Dr. John Koreth, MBBS, D.Phil.
`Deposition Transcript of James L. Ferrara, M.D. (dated Dec. 5,
`2019).
`Sullivan KM, et al. Prednisone and azathioprine compared with
`prednisone and placebo for treatment of chronic graft-v-host
`disease: prognostic influence of prolonged thrombocytopenia after
`allogeneic marrow transplantation. BLOOD, 72(2):546-54 (1988).
`Amendment and Response to Final Office Action in U.S. Patent
`Application No. 14/523,650 (Apr. 27, 2017).
`Linhares YPL, et al. Chronic GVHD: Where are we? Where do we
`want to be? Will immunomodulatory drugs help? BONE MARROW
`TRANSPLANT, 48:203-09 (2013).
`
`2055
`2056
`
`2057
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`2058
`
`2059
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`5
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`

`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`
`2060
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`2061
`
`2062
`
`2063
`
`2064
`
`2065
`
`EXHIBIT DESCRIPTION
`Chakraverty R, et al. T cell depletion: Excessive T cell depletion of
`peripheral blood stem cells has an adverse effect upon outcome
`following allogeneic stem cell transplantation. BONE MARROW
`TRANSPLANT, 28:827-34 (2001).
`Prescribing Information for Rituxan™ dated Nov. 1997.
`Ritter ML & Pirofski L. Mycophenolate mofetil: effects on cellular
`immune subsets, infectious complications, and antimicrobial
`activity. TRANSPL INFECT DIS, 11:290-97 (2009).
`Tareyeva IE, et al. The effects of azathioprine and prednisolone on
`T- and B-lymphocytes in patients with lupus nephritis and chronic
`glomerulonephritis. CLIN NEPHROL, 14(5):233-37 (1980).
`Wolff D, et al. Consensus conference on clinical practice in chronic
`graft-versus-host disease (GVHD): first-line and topical treatment
`of chronic GVHD. BIOL BLOOD MARROW TRANSPLANT, 16:1611-28
`(2010).
`D’Cruz OJ & Uckun FM. Novel Bruton’s tyrosine kinase inhibitors
`currently in development. ONCOTARGETS THER, 6:161-76 (2013).
`Arora M, et al. Randomized clinical trial of thalidomide,
`cyclosporine, and prednisone versus cyclosporine and prednisone
`as initial therapy for chronic graft-versus-host disease. BIOL BLOOD
`MARROW TRANSPLANT 7:265-73 (2001).
`Koc S, et al. Thalidomide for treatment of patients with chronic
`graft-versus-host disease. BLOOD, 96(12):3995-96 (2000).
`Ferrara JL, et al. Monoclonal antibody and receptor antagonist
`therapy for GVHD, in Advances in Allogeneic Hematopoietic Stem
`Cell Transplant, 331-68. (Burt RK & Brush MM, eds, 1999).
`Toubai T, et al. GVHD pathophysiology: is acute different from
`chronic? BEST PRACT RES CLIN HAEMATOL, 21(2):101-17 (2008).
`Vargas L, et al. Inhibitors of BTK and ITK: state of the new drugs
`for cancer, autoimmunity and inflammatory diseases. SCAND J
`IMMUNOL, 78:130-39 (2013).
`Christensen H & Hermann M. Immunological response as a source
`to variability in drug metabolism and transport. FRONT
`PHARMACOL, 3(8):1-10 (2012).
`Pharmacyclics LLC, IMBRUVICA® (Ibrutinib, PCI-32765, JNJ-
`54179060), Overall Reviewer’s Guide. IMBPCYC00294345-54.
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`U.S. Patent No. 9,795,604
`
`2073
`
`2074
`
`2075
`
`EXHIBIT DESCRIPTION
`Waller EK, et al. Ibrutinib for chronic graft-versus-host disease
`after failure of prior therapy: 1-year update of a phase 1b/2 study.
`BIOL BLOOD MARROW TRANSPLANT, 25:2002-07 (2019).
`Ryan W. Jacobs, MD, Levine Cancer Institute (Mar. 5, 2019, video).
`Arai S, et al. A randomized phase II crossover study of imatinib or
`rituximab for cutaneous sclerosis after hematopoietic cell
`transplantation. CLIN CANCER RES, 22(2):319-27 (2016).
`Reserved
`
`2076
`
`2077
`
`2078
`
`2079
`
`2080
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`2081
`2082 Weisdorf DJ. Chronic graft-versushost disease: where is promise
`for the future? LEUKEMIA, 19:1532-35 (2005).
`2083
`Reserved
`
`2084
`
`2085
`
`2086
`
`2087
`
`Reserved
`
`Reserved
`
`Reserved
`Osterweil N. Ibrutinib dons new anti-GVHD hat. MDedge, June 24,
`2017, https://www.mdedge.com/hematology-
`oncology/article/141170/patient-survivor-care/ibrutinib-dons-new-
`anti-gvhd-hat (last visited Nov. 25, 2019).
`
`7
`
`

`

`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`
`2088
`
`EXHIBIT DESCRIPTION
`AbbVie Announces Fourth Breakthrough Therapy Designation
`Granted by the U.S. Food and Drug Administration (FDA) for
`Ibrutinib (IMBRUVICA®) for Chronic Graft-Versus-Host-Disease
`(cGVHD), a Rare Condition with Limited Treatment Options.
`AbbVie, June 29, 2016,
`https://news.abbvie.com/article_print.cfm?article_id=11353 (last
`visited Nov. 26, 2019).
`Ricci M. Imbruvica granted fourth Breakthrough status.
`Pharmaphorum, June 30, 2016, pharmaphorum.com/news/abbvies-
`imbruvica-granted-breakthrough-therapy-designation-cgvhd/(last
`visited November 28, 2019).
`
`2089
`
`
`
`Date: January 6, 2019
`
`
`
`Respectfully submitted,
`
`
`
`By: / William B. Raich /
`William B. Raich, Reg. No. 54,386
`Erin M. Sommers, Reg. No. 60,974
`Cora R. Holt, Reg. No. 68,332
`Stefan O. Ochiana, Reg. No. 74,850
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`
`Counsel for Patent Owner
`Pharmacyclics LLC
`
`
`
`8
`
`

`

`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
`
`Updated Exhibit List as of January 6, 2020 and Exhibits 2043-2075, 2082,
`
`2087-2089 were served electronically via email on January 6, 2020, 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: January 6, 2020
`
`
`
`By: / William Esper /
`William Esper
`Litigation Legal Assistant
`
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`
`
`
`
`
`
`
`