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
`
`LIST OF EXHIBITS
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`Exhibit 1005
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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”).
`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 Mü ller-Ladner (2010) The Open Rheumatology Journal 4:15-
`22. (“Mü ller-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.
`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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`Exhibit 1017
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`IPR2016-01370
`PETITIONER’S UPDATED EXHIBIT LIST
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`Exhibit 1019
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`Exhibit 1021
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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”).
`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”).
`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”).
`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”).
`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]
`FDA Arthritis Advisory Committee.
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`Exhibit 1030
`Exhibit 1031
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`Exhibit 1026
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`Exhibit 1027
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`Exhibit 1028
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`IPR2016-01370
`PETITIONER’S UPDATED EXHIBIT LIST
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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.”).
`Exhibit 1034
`Schiff Declaration and Curriculum Vitae (“Schiff Decl.”).
`Exhibit 1035 Noroozi Declaration (“Noroozi Decl.”).
`Exhibit 1036 Kamholz Declaration.
`Exhibit 1037
`Second Kamholz Declaration.
`Exhibit 1038 Declaration of Kayvan B. Noroozi in Support of Motion for
`Admission Pro Hac Vice.
`Exhibit 1039 Deposition Transcript of Dr. Thomas Zizic, taken August 25,
`2017.
`Exhibit 1040 Deposition Transcript of Terri Shoemaker, taken August 30,
`2017.
`Exhibit 1041 Correspondence between counsel for Koios and Medac,
`beginning April 26, 2017.
`Exhibit 1042 Decision of the U.K. High Court in Accord Healthcare Limited
`v. Medac Gesellschaft für Klinische Spezialpräparate mbH,
`January 13, 2016.
`Practical Law report on the Court of the Hague Decision,
`published August 31, 2016.
`Exhibit 1044 Non-Final Rejection of U.S. Patent Application No.
`14/635,542, filed November 14, 2106.
`Exhibit 1045 Notice of Abandonment of U.S. Patent Application No.
`14/635,542, filed June 6, 2017.
`Exhibit 1046 Decision of the Court of the Hague in Accord Healthcare Ltd v.
`Medac Gesellschaft für Klinische Spezialpräparate mbH, July
`27, 2016.
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`Exhibit 1043
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`IPR2016-01370
`PETITIONER’S UPDATED EXHIBIT LIST
`Respectfully submitted,
`
`/s/ William P. Rothwell
`
`DeAnn F. Smith (Lead Counsel)
`Reg. No. 36,683
`FOLEY HOAG LLP
`155 Seaport West
`Boston, MA 02210
`dsmith@foleyhoag.com
`
`William P. Rothwell (Back-Up Counsel)
`Reg. No. 72,522
`NOROOZI PC
`2245 Texas Drive, Suite 300
`Sugar Land, TX 77479
`william@noroozipc.com
`
`Kayvan B. Noroozi (Back-Up Counsel)
`Admitted Pro Hac Vice
`NOROOZI PC
`1299 Ocean Ave., Suite 450
`Santa Monica, CA 90401
`kayvan@noroozipc.com
`
`Counsel for Petitioner
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`Date: October 9, 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 1046 was served electronically
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`via e-mail on October 9, 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 P. 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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`
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`Date: October 9, 2017
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