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UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`
`
`FRESENIUS KABI USA, LLC and FRESENIUS KABI SWISSBIOSIM GmbH
`Petitioners,
`
`v.
`
`CHUGAI SEIYAKU KABUSHIKI KAISHA,
`Patent Owner.
`
`_________________________________________________
`
`
`Case No. IPR2021-01024
`U.S. Patent No. 7,521,052
`
`_________________________________________________
`
`
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
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`
`
`

`

`
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner Chugai Seiyaku Kabushiki
`
`Kaisha hereby submits a current listing of Patent Owner’s exhibits in this
`
`proceeding.
`
`Exhibit
`
`Description
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`Aletaha, D. & Smolen, J.S., The rheumatoid arthritis patient in
`the clinic: comparing more than 1300 consecutive DMARD
`courses, RHEUMATOL., 41:1367-74 (2002).
`
`Bulpitt, K., Biologic Therapies in Rheumatoid Arthritis, CURR.
`RHEUMATOL. REP., 1:157-63 (1999).
`
`Calabrese, L.H., Molecular differences in anitcytokine
`therapies, CLIN. EXPER. RHEUMATOL., 21:241-48 (2003).
`
`Carmichael, S.J., et al., Combination therapy with methotrexate
`and hydroxychloroquine for rheumatoid arthritis increases
`exposure to methotrexate, J. RHEUMATOL., 29(10):2077-83
`(2002).
`
`Combe, B., et al., EULAR recommendations for the
`management of early arthritis: report of a task force of the
`European Standing Committee for International Clinical
`Studies Including Therapeutics (ESCISIT), ANN. RHEUMATOL.
`DIS., 66:34-45 (2007).
`
`Conaghan, P.G. & Brooks, P., Disease-modifying antirheumatic
`drugs, including methotrexate, gold, antimalarials, and D-
`penicillamine, CURR. OP. RHEUMATOL., 7:167-73 (1995).
`
`Cutolo, M., et al., Anti-inflammatory mechanisms of
`methotrexate in rheumatoid arthritis, ANN. RHEUMATOL. DIS.,
`60:729-35 (2001).
`
`Deon, D., et al., Cross-talk between IL-1 and IL-6 signaling
`pathways in rheumatoid arthritis synovial fibroblasts, J.
`IMMUNOL., 167(9):5395-5403 (2001).
`
`2
`
`

`

`
`
`Exhibit
`
`Description
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`
`European Medicines Agency, ICH Topic E 5 (R1) Ethnic
`Factors in the Acceptability of Foreign Clinical Data, Sept.
`1998, https://www.ema.europa.eu/en/documents/scientific-
`guideline/ich-e-5-r1-ethnic-factors-acceptability-foreign-
`clinical-data-step-5_en.pdf.
`
`Felson, D.T., et al., The efficacy and toxicity of combination
`therapy in rheumatoid arthritis, ARTHRITIS RHEUMATOL.,
`37(10):1487-91 (1994).
`
`Fleischmann, R.M., Examining the efficacy of biologic therapy:
`are there real differences?, J. RHEUMATOL., Suppl. 65:27-32
`(2002).
`
`Frei, E., et al., Seminars in Medicine of the Beth Israel
`Hospital, Boston: New Approaches to Cancer Chemotherapy
`with Methotrexate, NEW ENG. J. MED., 292(16):846-51 (1975).
`
`Keyston, E.C., Abandoned therapies and unpublished trials in
`rheumatoid arthritis, CURR. OP. RHEUMATOL., 15:253-58
`(2003).
`
`Kremer, J.M., The mechanism of action of methotrexate in
`rheumatoid arthritis: the search continues, J. RHEUMATOL.,
`21:1-5 (1994).
`
`Kremer, J.M., Methotrexate and Emerging Therapies,
`RHEUMATOL. DIS. CLIN. N. AM., 24(3):651-58 (1998).
`
`Kremer, J.M., Not yet time to change the guidelines for
`monitoring methotrexate liver toxicity: they have served us
`well, J. RHEUMATOL., 29(8):1590-92 (2002).
`
`Elliott, M.J. & Maini, R.N., Anti-cytokine therapy in
`rheumatoid arthritis, BAILLIERES CLIN. RHEUMATOL., 9(4):633-
`52 (1995).
`
`
`3
`
`

`

`
`
`Exhibit
`
`Description
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`Moreland, L.W., Initial experience combining methotrexate
`with biologic agents for treating rheumatoid arthritis, J.
`RHEUMATOL., Suppl. 44:78-83 (1996).
`
`Okuda, O., Anti-IL-6 receptor antibody MRA, Chugai Pharm.
`Co., Ltd., Project Promotion Dep’t (Jan. 21, 2003) (A301).
`
`Okuda, O., Anti-IL-6 receptor antibody MRA, Chugai Pharm.
`Co., Ltd., Project Promotion Dep’t (Jan. 21, 2003) (A302).
`
`Rheumatrex®, Methotrexate Sodium Tablets, Oct. 2003,
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08
`085slr052,scm055_rheumatrex_lbl.pdf.
`
`Verhoeven, A.C., et al., Combination therapy in rheumatoid
`arthritis: updated systematic review, BRIT. J. RHEUMATOL.,
`37:612-19 (1998).
`
`Weinblatt, M.E., et al., A trial of etanercept, a recombinant
`tumor necrosis factor receptor:fc fusion protein, in patients
`with rheumatoid arthritis receiving methotrexate, NEW ENG. J.
`MED., 340:253-59 (1999).
`
`Williams, H.J., et al., Comparison of auranofin, methotrexate,
`and the combination of both in the treatment of rheumatoid
`arthritis, ARTHRITIS RHEUMATOL., 35(3):259-69 (1992).
`
`Xing, Z., et al., IL-6 is an antiinflammatory cytokine required
`for controlling local or systemic acute inflammatory responses,
`J. CLIN. INVEST., 311-20 (1998).
`
`1 Shaun Ruddy et al., KELLEY’S TEXTBOOK OF RHEUMATOLOGY
`Chs. 20, 62, 64, & 65 (6th ed. 2001).
`
`Uchida, K., Acceptability of Foreign Clinical Trial Data in
`Japan, DRUG INF. J., 22:103-08 (1988).
`
`Fresenius Kabi’s tocilizumab biosimilar candidate MSB11456
`
`4
`
`

`

`
`
`
`
`
`Exhibit
`
`Description
`
`shows positive results in two clinical trials, Fresenius Kabi,
`Sept. 7, 2021, https://www.fresenius-kabi.com/news/fresenius-
`kabi-tocilizumab-shows-positive-results-in-two-clinical-trials.
`
`Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence
`Study of MSB11456 (NCT03282851), ClinicalTrials.gov,
`https://clinicaltrials.gov/ct2/show/NCT03282851 (last updated
`Feb. 12, 2020).
`
`MSB11456 in Participants with Moderately to Severely Active
`Rheumatoid Arthritis (NCT04512001), ClinicalTrials.gov,
`https://clinicaltrials.gov/ct2/show/NCT04512001 (last updated
`Mar. 11, 2021).
`
`2021.09.27 Email from K. DeJong to T. Fletcher.
`
`
`
`Declaration of Paul B. Gaffney in support of pro hac vice
`admission.
`
`Declaration of Ana C. Reyes in support of pro hac vice
`admission.
`
`Declaration of Charles L. McCloud in support of pro hac vice
`admission.
`
`Declaration of Kristin L. Froehle in support of pro hac vice
`admission.
`
`2029
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`2030
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`2031
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`2032
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`2033
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`2034
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`2035
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`5
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`December 23, 2021
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`Respectfully submitted,
`
`/Thomas S. Fletcher/
`
`
`
`Thomas S. Fletcher (Reg. No. 72,383)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street NW
`Washington, DC 20005
`Tel: 202-434-5000
`Fax: 202-434-5029
`tfletcher@wc.com
`
`Counsel for Patent Owner Chugai
`Seiyaku Kabushiki
`
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`6
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`

`

`
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that a true
`
`and correct copy of the foregoing was served on December 23, 2021, by delivering
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`a copy via electronic mail on the following counsel of record for Petitioners:
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`Elizabeth J. Holland (Reg. No. 47,657)
`Daniel P. Margolis
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Telephone: (212) 459 7236
`eholland@goodwinlaw.com
`dmargolis@goodwinlaw.com
`
`Daryl Wiesen
`Emily Rapalino
`Kevin J. DeJong (Reg. No. 64,762)
`Goodwin Proctor LLP
`100 Northern Ave.
`Boston, MA 02210
`Telephone: (617) 570 1156
`dwiesen@goodwinlaw.com
`erapalino@goodwinlaw.com
`kdejong@goodwinlaw.com
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`December 23, 2021
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`/Thomas S. Fletcher/
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`
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`Thomas S. Fletcher (Reg. No. 72,383)
`
`7
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`

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