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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`KOIOS PHARMACEUTICALS LLC
`
`Petitioner
`
`
`v.
`
`
`MEDAC GESELLSCHAFT FÜR
`KLINISCHE SPEZIALPRÄPARATE MBH
`
`Patent Owner
`
`____________
`
`
`IPR2016-01370
`Patent 8,664,231 B2
`
`____________
`
`
`Petitioner’s Second Updated Exhibit List
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`

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`IPR2016-01370
`Patent 8,664,231 B2
`
`
`Petitioner’s Second Updated Exhibit List
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`
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`Exhibit 1001
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`Exhibit 1002
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`Exhibit 1003
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`Exhibit 1004
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`Exhibit 1005
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`Exhibit 1006
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`Exhibit 1007
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`Exhibit 1008
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`List of Exhibits
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`U.S. 8,664,231 to Heiner Will, titled, “Concentrated Methotrexate
`Solutions,” filed on March 4, 2009, and issued on March 4, 2014
`(“the ’231 Patent”).
`Excerpts from File History for U.S. Patent No. 8,664,231.
`
`U.S. 6,544,504 to Paul Grint et al., titled, “Combined Use of
`Interleukin 10 and Methotrexate for Immunomodulatory
`Therapy,” filed on June 26, 2000, and issued on April 8, 2003
`(“Grint”).
`Hoekstra et al. (2004) J. Rheumatol. 31(4):645-47 (“Hoekstra”).
`
`Jørgensen et al. (1996) Ann. Pharmacother. 30:729-32
`(“Jørgensen”).
`Alsufyani et al. (2003) J. Rheumatol. 31:179-82 (“Alsufyani”).
`
`Declaration of Dr. Elena Massarotti, dated June 2, 2016, in
`support of Medac’s Preliminary Response in IPR2016-00649.
`Brooks et al. (1990) Arthritis and Rheum. 33(1):91-94 (“Brooks”).
`
`Exhibit 1010
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`Exhibit 1009 Medac’s Preliminary Response in IPR2016-00649, dated June
`2, 2016.
`Zackheim (1992) J. Am. Acad. of Derm. 23(6) p. 1008
`(“Zackheim”).
`Exhibit 1011 Müller-Ladner (2010) The Open Rheumatology Journal 4:15-22.
`(“Müller-Ladner”).
`Exhibit 1012 Weinblatt Declaration; Dated June 17, 2014 (“Weinblatt Decl.”).
`
`Exhibit 1013
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`Gammon Declaration; Dated June 27, 2014 (“Gammon Decl.”).
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`Exhibit 1014
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`Exhibit 1015
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`Exhibit 1016
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`Exhibit 1017
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`Pincus et al. (2003) Clin. Exp. Rheumatol. (Suppl. 31):S179-S185
`(“Pincus”).
`Insulin Administration, Diabetes Care, 26:1 S121-S124 (2003)
`(“Insulin Admin”).
`Complaint in Medac Pharma, Inc. v. Antares Pharma, Inc., Nos.
`1:14-cv-01498-JBS-KMW.
`Portion of EPO prosecution for EP Application No. 07 786 239.9
`and Certified English Translation of the same.
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`Petitioner’s Second Updated Exhibit List
`
`Exhibit 1019
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`IPR2016-01370
`Patent 8,664,231 B2
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`Exhibit 1018 Weinblatt (1993) “Methotrexate,” in Textbook of Rheumatology,
`4th Edition, Chapter 47, (Kelley et al., eds. 1993) (“Weinblatt
`1993”).
`Schiff et al., “Head-to-head, randomized, crossover study of
`oral versus subcutaneous methotrexate in patients with
`rheumatoid arthritis,” Ann. Rheum. Dis. 0:1-3 (2014)
`(“Schiff”).
`Exhibit 1020 Weinblatt (1995) Efficacy of Methotrexate in Rheumatoid
`Arthritis, Br. J. Rheum. 34(suppl. 2):43-48 (“Weinblatt 1995”).
`Product Label for the “Methotrexate Sodium for Injection”
`product by Wyeth, Date of First Authorization August 10, 1959,
`Date of Supplement Approval January 27, 2004, Obtained from
`Archive.org as of April 29, 2005 (“Wyeth”), and Internet Archive
`Affidavit.
`2003 Ed. of Physician’s Desk Reference for “Methotrexate
`Sodium for Injection” by Wyeth (“the PDR for Wyeth”).
`Arthur et al. (2002) A Study of Parenteral Use of Methotrexate in
`Rheumatic Conditions, J. Clinical Nursing 2002; 11:256-63
`(“Arthur”).
`Arthur et al. (2001) Self-Injection of Gold and Methotrexate, J.
`Rheumatol. 2001; 28(1):212 (“Arthur 2001”).
`Exhibit 1025 Moitra et al. (2005) Caveats to the use of parenteral methotrexate
`in the treatment of rheumatic disease, Rheumatology 2005;
`44:256-57 (“Moitra”).
`Product Label for “Methotrexate For Injection, USP” by
`Bigmar, Date of First Authorization February 26, 1999,
`Obtained from Archive.org as of February 16, 2005
`(“Bigmar”).
`Feagan et al. (1995) Methotrexate for the Treatment of Crohn’s
`Disease, N. Engl. J. Med. 332(5):292-97 (“Feagan”).
`Furst et al. (1989) Increasing Methotrexate Effect with Increasing
`Dose in the Treatment of Resistant Rheumatoid Arthritis, J.
`Rheum. 16(3):313-20 (“Furst”).
`Giannini et al. (1992) Methotrexate in resistant juvenile
`rheumatoid arthritis—results of the U.S.A.-U.S.S.R. double-blind,
`placebo-controlled trial. N. Engl. J. Med. 326(16):1043, 1045,
`1048-49 (“Giannini”).
`[omitted]
`FDA Arthritis Advisory Committee.
`
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`Exhibit 1030
`Exhibit 1031
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`Exhibit 1021
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`Exhibit 1022
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`Exhibit 1023
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`Exhibit 1024
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`Exhibit 1026
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`Exhibit 1027
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`Exhibit 1028
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`Exhibit 1029
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`IPR2016-01370
`Patent 8,664,231 B2
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`Exhibit 1032
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`Petitioner’s Second Updated Exhibit List
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`Results from Body Surface Area Calculator for Medication
`Doses (“BSA Calculation”).
`Exhibit 1033 Miller Declaration and Curriculum Vitae (“Miller Decl.”).
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`Schiff Declaration and Curriculum Vitae (“Schiff Decl.”).
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`Noroozi Declaration (“Noroozi Decl.”).
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`Kamholz Declaration (“Kamholz Decl.”).
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`Second Kamholz Declaration
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`Exhibit 1034
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`Exhibit 1035
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`Exhibit 1036
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`Exhibit 1037
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`Dated: August 11, 2016
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`Respectfully submitted,
`
` /SCOTT E. KAMHOLZ/
`Scott E. Kamholz, M.D., Ph.D.
`Registration No. 48,543
`Foley Hoag LLP
`Counsel for Petitioner
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`IPR2016-01370
`Patent 8,664,231 B2
`
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`Petitioner’s Second Updated Exhibit List
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`CERTIFICATE OF SERVICE
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`I certify that on August 11, 2016, a copy of this paper and every exhibit filed
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`with this paper was served in its entirety electronically via email to
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`IPR2016-01370_Medac@ropesgray.com.
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` /Scott E. Kamholz/
` Scott E. Kamholz
` Reg. No. 48,543
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