`
`
`
`
`For the Petitioner
`Lead counsel: James T. Carmichael, Reg. No. 45,306
`Backup counsel: Carol A. Spiegel, Reg. No. 68,033
`Carmichael IP, PLLC
`
`
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`
`
`
`Paper No. __
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`COALITION FOR AFFORDABLE DRUGS V LLC;
`HAYMAN CREDES MASTER FUND, L.P.;
`HAYMAN ORANGE FUND SPC – PORTFOLIO A;
`HAYMAN CAPITAL MASTER FUND, L.P.;
`HAYMAN CAPITAL MANAGEMENT FUND, L.P.;
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`HAYMAN INVESTMENTS, LLC;
`NXN PARTNERS, LLC;
`IP NAVIGATION GROUP, LLC;
`J KYLE BASS, and ERICH SPANGENBERG,
`Petitioners,
`v.
`BIOGEN MA INC.,
`Patent Owner.
`____________________
`
`Case IPR2015-01993
`Patent 8,399,514 B2
`____________________
`
`CORRECTED PETITIONER’S EXHIBIT LIST
`AS OF 28 SEPTEMBER 2016
`
`
`
`
`
`Page 1 of 9
`
`Biogen Exhibit 2037
`Mylan v. Biogen
`IPR2018-01403
`
`
`
`EXHIBIT
`
`1001
`
`
`DESCRIPTION
`
`U.S. Patent 8,399,514, “Treatment for Multiple Sclerosis,” issued to
`Lukashev et al. (the ‘514 patent).
`
`1002 Wakkee M. et al., “Drug evaluation: BG-12, an immunomodulatory
`dimethylfumarate,” Curr. Opin. Investig. Drugs, 2007 Nov;
`8(11):955-62.
`
`1003A Kappos et al., “Efficacy of a novel single-agent fumarate, BG00012,
`in patients with relapsing-remitting multiple sclerosis: results of a
`phase 2 study,” J. Neurol. (2006) 253 [Supp 2]: II/I-II/170; p. II/27
`O108.
`
`International Conference on Harmonization of Technical
`Requirements for Registration of Pharmaceuticals for Human Use,
`ICH Harmonized Tripartite Guideline, Dose-Response Information to
`Support Drug Registration E4, Current Step 4 version, dated 10
`March 1994.
`
`Declaration of Steven E. Linberg, Ph.D.
`
`European Medicines Agency, Assessment Report, Tecfidera, 26
`November 2013.
`
`“Preliminary Amendment Under 37 C.F.R. § 1.115, In re application
`of: LUKASHEV et al.,” Application No. 13/372,426 that issued as
`U.S. Patent 8,399,514.
`
`“Amendment and Reply Under 37 C.F.R. § 1.111, In re application
`of: LUKASHEV et al., Application No. 13/372,426” that issued as
`U.S. Patent 8,399,514.
`
`Office Action with mail date of 05/03/2012 for Application No.
`13/372,426 that issued as U.S. Patent 8,399,514.
`
`Paper 178, Interference 106,023.
`
`
`1008
`
`1004
`
`1005
`
`1006
`
`1007
`
`1009
`
`1010
`
`Page 2 of 9
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`
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`Case No. IPR2015-01993
`Patent 8,399,514
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`PCT Application No. PCT/US2008/001602.
`
`Certified copy of U.S. Provisional Application No. 60/888,921.
`
`Assignment Record for U.S. Patent 8,399,514 from USPTO’s
`Assignments on the Web.
`
`Paper 179, Interference 106,023.
`
`Reserved.
`
`D. Werdenberg, et al., “Presystemic Metabolism and Intestinal
`Absorption of Antipsoriatic Fumaric Acid Esters,” 2003,
`BIOPHARMACEUTICALS & DRUG DISPOSITION, Biopharm.
`Drug Dispos. 24:259-273 (2003), Published online in Wiley
`InterScience (www.interscience.wiley.com). DOI: 10.1002/bdd.364.
`
`CV of Steven E. Linberg, Ph.D.
`
`U.S. Application 13/372,426, filed on February 13, 2012.
`
`Nieboer et al., “Fumaric Acid Therapy in Psoriasis: A Double-Blind
`Comparison between Fumaric Acid Compound Therapy and
`Monotherapy with Dimethylfumaric Acid Ester,” Dermatologica
`1990; 181:33-37.
`
`Declaration of Scott Bennett.
`
`Reserved.
`
`“View of NCT00168701 on 2005_09_14,” from URL
`https://clinicaltrials.gov/archive/NCT00168701/2005_09_14.
`
`Reserved.
`
`Declaration of Robert Mihail.
`
`Reserved.
`
`3
`
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`Page 3 of 9
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`
`Case No. IPR2015-01993
`Patent 8,399,514
`
`Reserved.
`
`Begleiter et al., “Dietary induction of NQO1 increases the antitumour
`activity of mitomycin C in human colon tumours in vivo,” 2004,
`British Journal of Cancer, 1624-1631.
`
`Reserved.
`
`Hartung et al., “The cost of multiple sclerosis drugs in the US and the
`pharmaceutical industry,” American Academy of Neurology, 2015.
`
`U.S. Patent 7,320,999, “Dimethyl Fumarate For The Treatment of
`Multiple Sclerosis,” issued to Joshi et al.
`
`U.S. Application 2003/0018072 to Joshi et al.
`
`Reserved.
`
`Reserved.
`
`Reserved.
`
`IPR2015-01136, Paper 23, Decision Denying Institution of Inter
`Partes Review.
`
`U.S. Patent 6,436,992, “Use of Fumaric Acid Derivatives,” issued to
`Joshi et al.
`
`Reserved.
`
`Reserved.
`
`Reserved.
`
`
`Current view of ClinicalTrials NCT00168701 on URL
`https://clinicaltrials.gov/show/NCT00168701.
`
`
`4
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
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`1033
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`1034
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`1035
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`1036
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`1037
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`1038
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`1039
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`1040
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`Page 4 of 9
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`Case No. IPR2015-01993
`Patent 8,399,514
`
`History of Changes and the ClinicalTrials.gov Archive Site on URL
`https://clinicaltrials.gov/ct2/archive/NCT00168701.
`
`History of ClinicalTrials NCT00168701 on URL
`https://clinicaltrials.gov/archive/NCT00168701.
`
`ClinicalTrials.gov Background on URL
`https://www.clinicaltrials.gov/ct2/about%ADsite/background.
`
`Hendricks, Steve, “The Rise of Bib Generic: Why Knockoff
`Prescriptions Now Cost $1,200,” 08/08/2015, on URL
`http://www.truth-out.org/news/item/32182-the-rise-of-big-generic-
`why-knockoff-prescriptions-now-cost-1-200.
`
`Declaration of Samuel J. Pleasure, M.D., Ph.D.
`
`CV of Samuel J. Pleasure, M.D., Ph.D.
`
`Hauser et al., “Multiple Sclerosis and Other Demyelinating
`Diseases,” Chapter 359 in HARRISON’S PRINCIPLES OF INTERNAL
`MEDICINE, 16th ed. (2005), pp. 2461-2471.
`
`Friese et al., “The value of animal models for drug development in
`multiple sclerosis,” Brain (2006); 129:1940-1952.
`
`Sriram et al., “Experimental Allergic Encephalomyelitis: A
`Misleading Model of Multiple Sclerosis,” Ann. Neurol. (2005);
`58:939-945.
`
`Daniel Wynn, M.D., FACNS FAASM, deposition transcript.
`
`Reserved.
`
`Gilmore O’Neill, M.D., deposition transcript.
`
`Richard A. Rudick, M.D., deposition transcript.
`
`Tammy Sarnelli deposition transcript.
`
`
`5
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
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`1050
`
`1051
`
`1052
`
`1053
`
`1054
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`
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`Page 5 of 9
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`
`
`Case No. IPR2015-01993
`Patent 8,399,514
`
`Cara Lansden deposition transcript.
`
`Reserved.
`
`Reserved.
`
`Fletcher et al., “Comparison of glatiramer acetate (Copaxone®) and
`interferon β-1b (Betaferon®) in multiple sclerosis patients: an open-
`label 2-year follow-up,” J. Neurol. Sci. (2002); 197:51-55 (Fletcher
`I).
`
`Fletcher et al., “Copolymer 1 (Glatiramer Acetate) in Relapsing
`Forms of Multiple Sclerosis: Open Multicenter Study of Alternative-
`Day Administration,” Clinical Neurology (2002); 25(1):11-15
`(Fletcher II).
`
`J. Wolinsky, “Glatiramer acetate for the treatment of multiple
`sclerosis,” Expert Opinion on Pharmacotherapy (2004); 5(4):875-
`891.
`
`Teva Pharmaceuticals News Release, “Teva Announces U.S. FDA
`Approval of Three-Times-A-Week Copaxone® (Glatiramer Acetate
`Injection) 40mg/ml,” January 28, 2014, available at
`http://news.tevausa.com/phoenix.zhtml?c=251945&p=irol-
`newsArticle_print&ID=1894511.
`
`FDA News Release, “FDA Approves Resumed Marketing of Tysabri
`Under a Special Distribution Program,” June 5, 2006, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0
`576lbl.pdf.
`
`Schilling et al., “Fumaric acid esters are effective in chronic
`experimental autoimmune encephalomyelitis and suppress
`macrophage infiltration,” Clinical and Experimental Immunology
`(2006); 145:101-107.
`
`FDA Full Prescribing Information for Avonex®, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5
`189lbl.pdf.
`
`6
`
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`1063
`
`1064
`
`
`
`
`
`Page 6 of 9
`
`
`
`Case No. IPR2015-01993
`Patent 8,399,514
`
`FDA Full Prescribing Information for Gilenya®, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s0
`08lbl.pdf.
`
`FDA Full Prescribing Information for Tecfidera®, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204063s0
`14lbl.pdf.
`
`Reserved.
`
`FDA Full Prescribing Information for Aubagio®, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202992s0
`00lbl.pdf.
`
`FDA Full Prescribing Information for Rebif®, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5
`178s5179lbl.pdf.
`
`FDA Full Prescribing Information for Betaseron®, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5
`063s5067s5079s5088s5120s5124s5136s5138lbl.pdf
`
`FDA Full Prescribing Information for Copaxone®, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020622s0
`57lbl.pdf.
`
`FDA Full Prescribing Information for Tysabri®, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0
`576lbl.pdf.
`Litjens et al., “In vitro pharmacokinetics of anti-psoriatic fumaric
`acid esters,” BMC Pharmacology (2004); 4:22
`
`
`7
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`
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`1065
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`1066
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`1067
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`1068
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`1069
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`1070
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`1071
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`1072
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`1073
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`Page 7 of 9
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`Dated: 28 September 2016
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`Case No. IPR2015-01993
`Patent 8,399,514
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`Respectfully submitted,
`
`By: /Carol A. Spiegel/_____
`James T. Carmichael, Reg. No. 45,306
`Carol A. Spiegel, Reg. No. 68,033
`Carmichael IP, PLLC
`8000 Towers Crescent Drive, Ste. 1350
`Tysons Corner, VA 22182
`(703) 646-9255
`
`Counsel for Petitioner
`IPR2015-01993
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`Page 8 of 9
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`Case No. IPR2015-01993
`Patent 8,399,514
`
`37 C.F.R. §42.6(e) CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing CORRECTED
`
`PETITIONER’S EXHIBIT LIST AS OF 28 SEPTEMBER 2016 was served on
`
`28 September 2016, via electronic mail directed to counsel of record for the Patent
`
`Owner at the following:
`
`Michael J. Flibbert
`Maureen D. Queler
`Erin M. Sommers
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`michael.flibbert@finnegan.com
`maureen.queler@finnegan.com
`erin.sommers@finnegan.com
`
`Patent Owner has agreed to electronic service.
`
`
`
`Dated: 28 September 2016
`
`
`
`By: /Carol A. Spiegel /
`Carol A. Spiegel, Reg. No. 68,033
`CARMICHAEL IP, PLLC
`8000 Towers Crescent Drive, Ste. 1350
`Tysons Corner, VA 22182
`(703) 646-9255
`
`9
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`Page 9 of 9
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