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,
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`v.
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`MEDAC GESELLSCHAFT FÜR KLINISCHE
`SPEZIALPRÄPARATE MBH,
`Patent Owner.
`____________________
`
`Case IPR2016-01370
`Patent No. 8,664,231
`____________________
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`PETITIONER’S UPDATED EXHIBIT LIST
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`IPR2016-01370
`PETITIONER’S UPDATED EXHIBIT LIST
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`LIST OF EXHIBITS
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`Exhibit 1001 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”).
`Exhibit 1002 Excerpts from File History for U.S. Patent No. 8,664,231.
`
`Exhibit 1003 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”).
`Exhibit 1004 Hoekstra et al. (2004) J. Rheumatol. 31(4):645-47
`(“Hoekstra”).
`Jørgensen et al. (1996) Ann. Pharmacother. 30:729-32
`(“Jørgensen”).
`Exhibit 1006 Alsufyani et al. (2003) J. Rheumatol. 31:179-82 (“Alsufyani”).
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`Exhibit 1005
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`Exhibit 1007 Declaration of Dr. Elena Massarotti, dated June 2, 2016, in
`support of Medac’s Preliminary Response in IPR2016-00649.
`Exhibit 1008 Brooks et al. (1990) Arthritis and Rheum. 33(1):91-94
`(“Brooks”).
`Exhibit 1009 Medac’s Preliminary Response in IPR2016-00649, dated June
`2, 2016.
`Exhibit 1010 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 Gammon Declaration; Dated June 27, 2014 (“Gammon
`Decl.”).
`Exhibit 1014 Pincus et al. (2003) Clin. Exp. Rheumatol. (Suppl. 31):S179-
`S185 (“Pincus”).
`Insulin Administration, Diabetes Care, 26:1 S121-S124 (2003)
`(“Insulin Admin”).
`Exhibit 1016 Complaint in Medac Pharma, Inc. v. Antares Pharma, Inc.,
`Nos. 1:14-cv-01498-JBS-KMW.
`Exhibit 1017 Portion of EPO prosecution for EP Application No. 07 786
`239.9 and Certified English Translation of the same.
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`Exhibit 1015
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`IPR2016-01370
`PETITIONER’S UPDATED EXHIBIT LIST
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`Exhibit 1022
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`Exhibit 1018 Weinblatt (1993) “Methotrexate,” in Textbook of
`Rheumatology, 4th Edition, Chapter 47, (Kelley et al., eds.
`1993) (“Weinblatt 1993”).
`Exhibit 1019 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”).
`Exhibit 1021 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”).
`Exhibit 1023 Arthur et al. (2002) A Study of Parenteral Use of
`Methotrexate in Rheumatic Conditions, J. Clinical Nursing
`2002; 11:256-63 (“Arthur”).
`Exhibit 1024 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”).
`Exhibit 1026 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”).
`Exhibit 1027 Feagan et al. (1995) Methotrexate for the Treatment of
`Crohn’s Disease, N. Engl. J. Med. 332(5):292-97 (“Feagan”).
`Exhibit 1028 Furst et al. (1989) Increasing Methotrexate Effect with
`Increasing Dose in the Treatment of Resistant Rheumatoid
`Arthritis, J. Rheum. 16(3):313-20 (“Furst”).
`Exhibit 1029 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]
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`Exhibit 1030
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`IPR2016-01370
`PETITIONER’S UPDATED EXHIBIT LIST
`Exhibit 1031 FDA Arthritis Advisory Committee.
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`Exhibit 1032 Results from Body Surface Area Calculator for Medication
`Doses (“BSA Calculation”).
`Exhibit 1033 Miller Declaration and Curriculum Vitae (“Miller Decl.”).
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`Exhibit 1034 Schiff Declaration and Curriculum Vitae (“Schiff Decl.”).
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`Exhibit 1035 Noroozi Declaration (“Noroozi Decl.”).
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`Exhibit 1036 Kamholz Declaration (“Kamholz Decl.”).
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`Exhibit 1037 Second Kamholz Declaration
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`Exhibit 1038 Declaration of Kayvan B. Noroozi in Support of Motion for
`Admission Pro Hac Vice
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`Respectfully submitted,
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`/DeAnn F. Smith/
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`DeAnn F. Smith (Lead Counsel)
`Reg. No. 36,683
`FOLEY HOAG LLP
`155 Seaport West
`Boston, MA 02210
`dsmith@foleyhoag.com
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`William P. Rothwell (Back-Up Counsel)
`Reg. No. 72,522
`NOROOZI PC
`2245 Texas Drive, Suite 300
`Sugar Land, TX 77479
`william@noroozipc.com
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`Counsel for Petitioner
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`Date: August 18, 2017
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`IPR2016-01370
`PETITIONER’S UPDATED EXHIBIT LIST
`CERTIFICATION OF SERVICE
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`The undersigned hereby certifies that the foregoing PETITIONER’S
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`UPDATED EXHIBIT LIST and new Exhibit 1038 was served electronically
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`via e-mail on August 18, 2017, in its entirety on the following counsel of record
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`for Patent Owner:
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`
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`James F. Haley (Lead Counsel)
`Brian Gummow (Back-up Counsel)
`Service E-mail address
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`james.haley@hglaw.com
`brian.gummow@hglaw.com
`IPR2016-01370_Medac@ropesgray.com
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`Respectfully submitted,
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`/s/ William Rothwell
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`William P. Rothwell, Reg. No. 72,522
`NOROOZI PC
`2245 Texas Drive, Suite 300
`Sugar Land, TX 77479
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`Counsel for Petitioner
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`Date: August 18, 2017
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`5
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