UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`FRONTIER THERAPEUTICS, LLC
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`Petitioner
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`v.
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`MEDAC GESELLSCHAFT FÜR KLINISCHE
`SPEZIALPRÄPARATE MBH
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`Patent Owner
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`____________________
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`Inter Partes Review Case No. IPR2016-00649
`Patent No. 8,664,231
`Title: Concentrated Methotrexate Solutions
`____________________
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`TABLE OF EXHIBITS
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`TABLE OF EXHIBITS
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`Description
`Exhibit No.
`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 Jun. 26, 2000, and issued on April 8, 2003
`(“Grint”).
`Exhibit 1004 Hoekstra et al. (2004) J. Rheumatol. 31(4):645-648
`(“Hoekstra”).
`Exhibit 1005 Jørgensen et al. (1996) Ann. Pharmacother. 30:729-32
`(“Jørgensen”).
`Exhibit 1006 Alsufyani et al. (2003) J. Rheumatol. 31:179-82 (“Alsufyani”).
`Exhibit 1007 1985 Ed. Physician’s Desk Reference for Mexate® (“PDR”).
`Exhibit 1008 Brooks et al. (1990) Arthritis and Rheum. 33(1): 91-94
`(“Brooks”).
`Exhibit 1009 Product Summary for the “Methotrexate 100 mg/ml Injection”
`product by Hospira UK Ltd., Date of First Authorization 13
`March 1987, Date of Revision of the Text 22 November 2005
`(“Hospira”).
`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 Dr. Gershwin Declaration (“Gershwin Decl.”).
`Exhibit 1013 Mr. Gammon Declaration (“Gammon Decl.”).
`Exhibit 1014 Pincus et al. (2003) Clin Exp Rheumatol (Suppl. 31):S179-
`S185 (“Pincus”).
`Insulin Administration, Diabetes Care, 26:1 S121-124 (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.
`Exhibit 1018 Weinblatt (1993) “Methotrexate,” in Textbook of
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`Exhibit 1015
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`Patent No. 8,664,231
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`Rheumatology, 4th Edition, Chapter 47, (Kelley et al., eds.
`1993) (“Weinblatt 1993”)
`Exhibit 1019 Hoffmeister (1983) “Methotrexate therapy in rheumatoid
`arthritis: 15 years experience,” Am J Med 75:69-73
`(“Hoffmeister 1983”)
`Exhibit 1020 Weinblatt (1995) Efficacy of Methotrexate in Rheumatoid
`Arthritis, Br. J. Rheum. 34(suppl. 2):43-48 (“Weinblatt 1995”)
`Exhibit 1021 Weinblatt et al. (1985) “Efficacy of Low-Dose Methotrexate in
`Rheumatoid Arthritis,” N. Engl. J. Med. 312:818-822
`(“Weinblatt 1985”)
`Exhibit 1022 Hoffmeister (1972) Methotrexate in rheumatoid arthritis.
`Arthritis Rheum. 15 (Suppl.): S114 (abstract) (“Hoffmeister
`1972”)
`Exhibit 1023 Weinblatt et al. (1994) Methotrexate in Rheumatoid Arthritis: a
`5 Year Prospective Multicenter Study, Arth. Rheum.
`37(10):1492-1498 (“Weinblatt 1994”)
`Exhibit 1024 Weinblatt et al. (1992) Long-Term Prospective Study of
`Methotrexate the Treatment of Rheumatoid Arthritis: 84-Month
`Update, Arth. Rheum. 35(2): 129-137 (“Weinblatt 1992”)
`Exhibit 1025 Gubner et al. (1951) Therapeutic suppression of tissue
`reactivity. I. Comparison of the Effects of Cortisone and
`Aminopetrin, Am. J. Med. Sci., 22:176-82 (“Gubner”)
`Exhibit 1026 Black et al. (1964) Methotrexate therapy in psoriatic arthritis.
`Doubleblind study on 21 patients. J. Am. Med. Assoc. 189:743-
`7 (“Black”)
`Exhibit 1027 Feagan et al. (1995) Methotrexate for the Treatment of Crohn’s
`Disease, N. Engl. J. Med. 332(5): 292-297 (“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. 326:1043
`(“Giannini”)
`Exhibit 1030 Michaels, et al. (1992) Weekly Intravenous Methotrexate in the
`Treatment of Rheumatoid Arthritis, Arthritis and Rheumatism
`25(3): 339-341 (“Michaels”)
`Exhibit 1031 Dr. Gershwin’s Curriculum Vitae
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`Patent No. 8,664,231
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`Exhibit 1032 Mr. Gammon’s Curriculum Vitae
`Exhibit 1033 Petition for Inter Partes Review by Antares Pharma Inc. et al.,
`PTAB-IPR2014-01091, Paper No. 7, January 6, 2015 (’091
`IPR Institution).
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`Respectfully submitted,
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`/s/ Dr. Gregory J. Gonsalves
`Dr. Gregory J. Gonsalves
`Reg. No. 43,639
`2216 Beacon Lane
`Falls Church, Virginia 22043
`(571) 419-7252
`gonsalves@gonsalveslawfirm.com
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`Patent No. 8,664,231
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`Certificate of Service
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`In accordance with 37 CFR §§ 42.6(e) and 42.105, I certify that I caused to
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`be served a true and correct copy of the foregoing Table of Exhibits by overnight
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`courier on the 8th of March, 2016 on the patent owner’s address of record for the
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`subject patent listed below.
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`Christopher J. Harnett
`James F. Haley, Jr.
`Ching-Lee Fukuda
`Hassen A. Sayeed
`Jacqueline M. James
`Steven K. Mossey
`ROPES & GRAY LLP
`1211 Avenue of the Americas
`New York, New York 10036
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`Edward Grolz
`SCULLY SCOTT MURPHY & PRESSER, PC
`400 Garden City Plaza, Suite 300
`Garden City, New York 11530
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`/s/ Gregory J. Gonsalves
`Dr. Gregory J. Gonsalves
`Reg. No. 43,639
`2216 Beacon Lane
`Falls Church, Virginia 22043
`(571) 419-7252
`gonsalves@gonsalveslawfirm.com
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