UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`KOIOS PHARMACEUTICALS LLC
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`Petitioner
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`v.
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`MEDAC GESELLSCHAFT FUER KLINISCHE SPEZIALPRÄPARATE MBH
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`Patent Owner
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`____________
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`IPR2016-01370
`Patent No. 8,664,231
`Title: Concentrated Methotrexate Solutions
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`Declaration of Scott E. Kamholz
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`Koios Exhibit 1036
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`KOIOS PHARMACEUTICALS LLC
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`Petitioner
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`v.
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`MEDAC GESELLSCHAFT FUER KLINISCHE SPEZIALPRÄPARATE MBH
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`Patent Owner
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`____________
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`
`IPR2016-01370
`Patent No. 8,664,231
`Title: Concentrated Methotrexate Solutions
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`
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`Declaration of Scott E. Kamholz
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`Koios Exhibit 1036
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`I, Scott E. Kamholz, declare:
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`1.
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`I am an attorney at Foley Hoag LLP, and counsel of record for Koios
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`Pharmaceuticals LLC in the above-captioned matter. I am registered to practice
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`before the United States Patent and Trademark Office.
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`2.
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`Attached as Ex. 1004 is a true and correct copy of Hoekstra et al.
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`(2004) J. Rheumatol. 31(4):645-47 (“Hoekstra”). Hoekstra was published in a
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`periodical that is published in regular intervals.
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`3.
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`Attached as Ex. 1005 is a true and correct copy of Jørgensen et al.
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`(1996) Ann. Pharmacother. 30:729-32 (“Jørgensen”). Jørgensen was published in
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`a periodical that is published in regular intervals.
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`4.
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`Attached as Ex. 1006 is a true and correct copy of Alsufyani et al.
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`(2003) J. Rheumatol. 31:179-82 (“Alsufyani”). Alsufyani was published in a
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`periodical that is published in regular intervals.
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`5.
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`Attached as Ex. 1007 is a true and correct copy of the Declaration of
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`Dr. Elena Massarotti, dated June 2, 2016, in support of Medac’s Preliminary
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`Response in IPR2016-00649, obtained from the docket in that proceeding.
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`6.
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`Attached as Ex. 1008 is a true and correct copy of Brooks et al. (1990)
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`Arthritis and Rheum. 33(1):91-94 (“Brooks”). Brooks was published in a periodical
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`that is published in regular intervals.
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`1
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`7. Attached as Ex. 1009 is a true and correct copy of Medac’s
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`Preliminary Response in IPR2016-00649, dated June 2, 2016, obtained from the
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`docket in that proceeding.
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`8.
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`Attached as Ex. 1010 is a true and correct copy of Zackheim (1992) J.
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`Am. Acad. of Derm. 23(6) p. 1008 (“Zackheim”). Zackheim was published in a
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`periodical that is published in regular intervals.
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`9.
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`Attached as Ex. 1011 is a true and correct copy of Mü ller-Ladner
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`(2010) The Open Rheumatology Journal 4:15-22 (“Mü ller-Ladner”). Mü ller-
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`Ladner was published in a periodical that is published in regular intervals.
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`10. Attached as Ex. 1012 is a true and correct copy of the Declaration of
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`Dr. Michael E. Weinblatt, dated June 17, 2014, in support of Antares Pharma’s
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`Petition in IPR2014-01091, obtained from the docket in that proceeding.
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`11. Attached as Ex. 1013 is a true and correct copy of the Declaration of
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`David C. Gammon, dated June 27, 2014, in support of Antares Pharma’s Petition
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`in IPR2014-01091, obtained from the docket in that proceeding.
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`12. Attached as Ex. 1014 is a true and correct copy of Pincus et al. (2003)
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`Clin. Exp. Rheumatol. (Suppl. 31):S179-S185 (“Pincus”). Pincus was published in
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`a periodical that is published in regular intervals.
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`2
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`13. Attached as Ex. 1015 is a true and correct copy of Insulin
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`Administration, Diabetes Care, 26:1 S121-S124 (2003) (“Insulin Admin”). Insulin
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`Admin was published in a periodical that is published in regular intervals.
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`14. Attached as Ex. 1016 is a true and correct copy of the Complaint in
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`Medac Pharma, Inc. v. Antares Pharma, Inc., Nos. 1:14-cv-01498-JBS-KMW,
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`obtained from the docket in that proceeding.
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`15. Attached as Ex. 1018 is a true and correct copy of the provided pages
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`from Weinblatt (1993) “Methotrexate,” in Textbook of Rheumatology, 4th Edition,
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`Chapter 47, (Kelley et al., eds. 1993) (“Weinblatt 1993”).
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`16. Attached as Ex. 1019 is a true and correct copy of Schiff et al., “Head-
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`to-head, randomized, crossover study of oral versus subcutaneous methotrexate in
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`patients with rheumatoid arthritis,” Ann. Rheum. Dis. 0:1-3 (2014) (“Schiff”).
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`Schiff was published in a periodical that is published in regular intervals.
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`17. Attached as Ex. 1020 is a true and correct copy of Weinblatt (1995)
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`Efficacy of Methotrexate in Rheumatoid Arthritis, Br. J. Rheum. 34(suppl. 2):43-
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`48 (“Weinblatt 1995”). Weinblatt 1995 was published in a periodical that is
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`published in regular intervals.
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`18. Attached as Ex. 1021 are two true and correct copies of the Product
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`Label for the “Methotrexate Sodium for Injection” product by Wyeth (“Wyeth”),
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`3
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`date of first authorization August 10, 1959, date of supplement approval January
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`27, 2004, archived by Archive.org as of April 29, 2005.
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`19. The first page of Ex. 1021 is a true and correct excerpt of the FDA’s
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`CDER New and Generic Drug Approvals webpage as of April 29, 2005, as saved
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`by the Internet Archive, with the entry corresponding to Wyeth identified in the red
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`bracket, and the link to the Wyeth reference shown in the far right in purple. The
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`first page of Ex. 1021 is available at the URL shown in the browser bar, i.e.,
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`https://web.archive.org/web/20050405214343/http://www.fda.gov/cder/approval/in
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`dex.htm, under the letter M. Pages 2 through 28 of Ex. 1021 contain a copy of the
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`Wyeth reference accessed by clicking on the purple link at the far right of page 1.
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`The URL for pages 2 through 28 is shown in the header of those pages, i.e.,
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`https://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/
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`2004/11719slr106_methotrexate_lbl.pdf.
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`20. Also attached as Ex. 1021, at Page 29 of 82 of the exhibit, is a true
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`and correct copy of the Affidavit of Christopher Butler on behalf of the Internet
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`Archive, authenticating a second copy of the Wyeth reference attached as Exhibit A
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`to the Butler Declaration. The two copies of the Wyeth reference contained in Ex.
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`1021 are substantively identical except that the version provided by Mr. Butler
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`omits bolding contained in the original copy of Wyeth.
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`4
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`21. Mr. Butler’s declaration explains the meaning of the URL structure
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`used by the Internet Archive, and how those URLs specify the date, hour, minute,
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`and seconds as of which the particular page was archived. See Ex. 1021 at 29 ¶ 5.
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`Thus, the URL contained in the footer of Pages 31 to 54 of Ex. 1021 shows that
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`those pages were archived by the Internet Archive (and thus publicly accessible on
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`the internet) as of April 5, 2005, at 9:43PM and 43 seconds. Page 40 of Exhibit
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`1021 shows the same entry for Wyeth—and the same link to that reference in the
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`far right hand corner—as bracketed on Page 1 of Ex. 1021.
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`22. Page 55 of Ex. 1021 shows the URL corresponding to the copy of
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`Wyeth provided by the Internet Archive at Pages 56 to 82. See Butler Declaration
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`(Page 29 of Ex. 1021) at ¶ 6. That URL (which is identical to the one discussed in
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`Paragraph 9 of this declaration, supra) shows that this copy of Wyeth (like the one
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`discussed in Paragraph 9 of this declaration, supra) was publicly available and
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`accessible on the internet as of December 10, 2004 at 2:48AM and 09 seconds.
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`23. Attached as Ex. 1022 is a true and correct copy of the 2003 Ed. of
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`Physician’s Desk Reference for “Methotrexate Sodium for
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`Injection” by Wyeth (“the PDR for Wyeth”). Ex. 1022 was obtained from a copy of
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`the 2003 PDR that is resident in the library of Foley Hoag LLP. The PDR is
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`published in regular annual intervals.
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`5
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`24. Attached as Ex. 1023 is a true and correct copy of Arthur et al. (2002)
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`A Study of Parenteral Use of Methotrexate in Rheumatic Conditions, J. Clinical
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`Nursing 2002;11:256-63 (“Arthur”). Arthur was published in a periodical that is
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`published in regular intervals.
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`25. Attached as Ex. 1024 is a true and correct copy of Arthur et al. (2001)
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`Self-Injection of Gold and Methotrexate, J. Rheumatol. 2001;28(1):212 (“Arthur
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`2001”). Arthur 2001 was published in a periodical that is published in regular
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`intervals.
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`26. Attached as Ex. 1025 is a true and correct copy of Moitra et al. (2005)
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`Caveats to the use of parenteral methotrexate in the treatment of rheumatic disease,
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`Rheumatology 2005;44:256-57 (“Moitra”). Moitra was published in a periodical
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`that is published in regular intervals.
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`27. Attached as Ex. 1026 is a true and correct copy of the Product Label
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`for “Methotrexate For Injection, USP” by Bigmar, date of first authorization
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`February 26, 1999, archived by the Internet Archive as of February 16, 2005 and
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`available via Archive.org at
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`https://web.archive.org/web/20050216215806/http://www.fda.gov/cder/foi/anda/99
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`/40266_Methotrexate_Prntlbl.pdf.
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`28. Attached as Ex. 1027 is a true and correct copy of Feagan et al. (1995)
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`Methotrexate for the Treatment of Crohn’s Disease, N. Engl. J. Med. 332(5):292-
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`6
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`97 (“Feagan”). Feagan was published in a periodical that is published in regular
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`intervals.
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`29. Attached as Ex. 1028 is a true and correct copy of Furst et al. (1989)
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`Increasing Methotrexate Effect with Increasing Dose in the Treatment of Resistant
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`Rheumatoid Arthritis, J. Rheum. 16(3):313-20 (“Furst”). Furst was published in a
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`periodical that is published in regular intervals.
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`30. Attached as Ex. 1029 is a true and correct copy of Giannini et al.
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`(1992) Methotrexate in resistant juvenile rheumatoid arthritis—results of the
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`U.S.A.-U.S.S.R. double-blind, placebo-controlled trial. N. Engl. J. Med.
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`326(16):1043, 1045, 1048-49 (“Giannini”). Giannini was published in a periodical
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`that is published in regular intervals.
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`31. Attached as Ex. 1031 is a true and correct copy of the home page for
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`the “FDA Arthritis Advisory Committee” obtained from FDA.gov at:
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`http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Art
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`hritisAdvisoryCommittee/default.htm as of July 19, 2016.
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`32. Attached as Ex. 1032 is a true and correct copy of results from “Body
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`Surface Area Calculator for Medication Doses” obtained from Halls.md at:
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`http://halls.md/body-surface-area/bsa.htm.
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`33. Attached as Ex. 1033 is a true and correct copy of the Declaration of
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`Dr. Donald Miller, Pharm.D. dated July 16, 2016, in support of Koios’s Petition in
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`this proceeding.
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`34. Attached as Ex. 1034 is a true and correct copy of the Declaration of
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`Dr. Michael H. Schiff, dated July 15, 2016, in support of Koios’s Petition in this
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`proceeding.
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`35. Attached as Ex. 1035 is a true and correct copy of the Declaration of
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`Kayvan B. Noroozi, dated July 18, 2016, in support of Koios’s Petition in this
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`proceeding.
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` declare, under penalty of perjury under the laws of the United States, that
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` I
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`the foregoing is true and accurate.
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`Dated: July 20, 2016
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`/SCOTT E. KAMHOLZ/
`Scott E. Kamholz
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`8
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