Filed: November 19, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`SAWAI USA, INC., AND
`SAWAI PHARMACEUTICAL CO., LTD.
`Petitioner,
`
`v.
`
`BIOGEN MA, INC.
`Patent Owner.
`
`Case No. IPR2018-014031
`Patent No. 8,399,514
`
`UPDATED LIST OF PETITIONER’S EXHIBITS
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits the following current
`
`exhibit list.
`
`1 Case IPR2019-00789 has been joined with this proceeding.
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`SAWAI USA, INC., AND
`SAWAI PHARMACEUTICAL CO., LTD.
`Petitioner,
`
`v.
`
`BIOGEN MA, INC.
`Patent Owner.
`
`Case No. IPR2018-014031
`Patent No. 8,399,514
`
`UPDATED LIST OF PETITIONER’S EXHIBITS
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits the following current
`
`exhibit list.
`
`1 Case IPR2019-00789 has been joined with this proceeding.
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`U.S. Patent No. 8,399,514, Treatment for Multiple Sclerosis
`(filed Feb. 13, 2012) (issued Mar. 19, 2013)
`
`Declaration of John R. Corboy, M.D.
`
`Declaration of Leslie Benet, Ph.D.
`
`Declaration of Ian McKeague, Ph.D.
`
`Biogen News Release, Phase II Study of Oral Compound BG-
`12 Meets Primary Endpoint in Multiple Sclerosis (Jan. 9, 2006)
`
`S. Schimrigk et al., A Prospective, Open-Label, Phase II Study
`of Oral Fumarate Therapy for the Treatment of Relapsing-
`Remitting Multiple Sclerosis, 10 (Suppl. 2) MULTIPLE
`SCLEROSIS CLIN. & LAB. RES. S258, Abstract P642 (2004)
`
`L. Kappos et al., Efficacy of a Novel Oral Single-Agent
`Fumarate, BG00012, in Patients with Relapsing-Remitting
`Multiple Sclerosis: Results of a Phase 2 Study, 253 (Suppl. 2)
`J. NEUROL. II27, O108 (2006)
`
`International Publication No. WO 2006/0037342 A2
`(published Apr. 13, 2006)
`
`U.S. Patent No. 7,320,999, Dimethyl Fumarate for the
`Treatment of Multiple Sclerosis (filed July 17, 2002)
`(issued Jan. 22, 2008)
`
`CLINICALTRIALS.GOV,
`NCT00168701,
`https://clinicaltrials.gov/ archive/NCT00168701/2005_09_14
`
`ICH HARMONISED TRIPARTITE GUIDELINE - DOSE-RESPONSE
`INFORMATION TO SUPPORT DRUG REGISTRATION E4 (Mar.
`10, 1994)
`
`2
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`S. Schimrigk et al., A Prospective, Open-Label, Phase II
`Study of Oral Fumarate Therapy for the Treatment of
`Relapsing-Remitting Multiple Sclerosis (2004), available at
`http://web.archive.org/web/
`20041021033354/http://www.fumapharm.ch:80/pdf/BG-12_
`Schimrigk_Poster_Final.pdf (“Schimrigk 2004 Poster”)
`
`N. Brune et al., Oral Fumarate Therapy Alters Cytokine
`Production in Patients with Relapsing-Remitting Multiple
`Sclerosis, 10 (suppl. 2) MULTIPLE SCLEROSIS CLIN. & LAB.
`RES. S259, Abstract P643 (2004)
`
`S. Schimrigk et al., An Open-Label, Prospective Study of Oral
`Fumaric Acid Therapy for the Treatment Relapsing-Remitting
`Multiple Sclerosis (RRMS), 64(6)(Suppl. 1) NEUROLOGY
`A392, S46.003 (2005)
`
`L. Kappos et al., A Randomised, Placebo-controlled Phase II
`Trial of a Novel Oral Single-Agent Fumarate Therapy,
`BG00012, in Patients with Relapsing-Remitting Multiple
`Sclerosis, 252 (Suppl. 2) J. NEUROL. II/148, P574 (2005)
`
`Biogen News Release, Oral Compound BG-12 Achieves
`Primary Endpoint in Phase II Study of Relapsing-Remitting
`Multiple Sclerosis; Treatment with BG-12 Led to Statistically
`Significant Reductions in MRI Measures (May 30, 2006)
`
`C. Nieboer et al., Fumaric Acid Therapy in Psoriasis: A
`Double-Blind Comparison between Fumaric Acid
`Compound Therapy and Monotherapy with Dimethylfumaric
`Acid Ester, 181 DERMATOLOGICA 33 (1990)
`
`S. Schimrigk et al., Oral Fumaric Acid Esters for the Treatment
`of Active Multiple Sclerosis: An Open-Label, Baseline-
`Controlled Pilot Study, 13 EUR. J. NEUOL. 604 (2006)
`
`3
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`U. Mrowietz et al., Dimethylfumarate for Psoriasis: More than
`a Dietary Curiosity, 11(1) TRENDS MOL. MED. 43 (2005)
`
`Fumaderm® prescribing information
`
`H.M. Ockenfels et al., The Antipsoriatic Agent
`Dimethylfumarate Immunomodulates T-Cell Cytokine Secretion
`and Inhibits Cytokines of the Psoriatic Cytokine Network, 139
`BR. J. DERM. 390 (1998)
`INTENTIONALLY LEFT BLANK
`
`R. de Jong et al., Selective Stimulation of T Helper 2
`Cytokine Responses by the Anti-Psoriasis Agent
`Monomethylfumarate, 26 EUR. J. IMMUNOL. 2067 (1996)
`
`P. Nibbering et al., Effects of Monomethylfumarate on
`Human Granulocytes, 101 J. INVEST. DERMATOL. 37 (1993)
`
`U.S. Patent No. 6,509,376, Utilization of Dialkyfumarates
`(filed Oct. 29, 1999) (issued Jan 21, 2003)
`
`Biogen News Release, BG-12 Psoriasis Study Meets Primary
`Endpoint; Oral Compound Also Being Studied for MS in
`Phase II Trial (Apr. 7, 2005)
`
`A.D. Ormerod et al., Fumaric Acid Esters, Their Place in the
`Treatment of Psoriasis, 150 BR. J. DERMATOL. 630 (2004)
`
`U. Mrowietz et al., Treatment of Psoriasis with Fumaric Acid
`Esters: Results of a Prospective Multicentre Study, 138(3)
`BR. J. DERMATOL. 456 (1998)
`
`W. Nugteren-Huying et al., Fumaric Acid Therapy for
`Psoriasis: A Randomized, Double-Blind, Placebo-Controlled
`Study,” 22(2) J. AM. ACAD. DERMATOL. 311 (1990)
`
`4
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`P. Altmeyer et al., Antipsoriatic Effect of Fumaric Acid
`Derivatives: Results of a Multicenter Double-Blind Study
`in 100 Patients, 30 J. AM. ACAD. DERMATOL. 977 (1994)
`C. Nieboer et al., Systemic Therapy with Fumaric Acid
`Derivatives: New Possibilities in the Treatment of Psoriasis, 20
`J. AM. ACAD. DERM. 601 (1989)
`
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`TH2-Type Cytokine Production of Peripheral Blood
`Mononuclear cells (PBMCs) in Patients with Relapsing-
`Remitting Multiple Sclerosis (RRMS) Undergoing an Oral
`Fumaric-Acid Ester Therapy, 4(4) MULTIPLE SCLEROSIS:
`CLINICAL AND LABORATORY RESEARCH P3038 (1998)
`(ECTRIMS 98:14th Congress of the European Committee for
`Treatment and Research in Multiple Sclerosis, Sept. 9-12,
`1998, Stockholm, Sweden)
`
`S. Schimrigk et al., Oral Fumaric Acid Ester (FAE) in
`Relapsing-Remitting Multiple Sclerosis (RRMS). A Short
`Term, Open, clinical, Immunological and Magnetic Resonance
`Imaging (MRI) Controlled Phase II Trial, 246 (Suppl. 1) J.
`NEUROL. I/36, 144 (1999) (Ninth Meeting of the European
`Neurological Society, June 5-9, 1999, Milan, Italy)
`
`L. Kappos et al., A Randomized, Placebo-Controlled Phase 2
`Trial of a Novel Oral Fumarate, BG00012, in Patients with
`Relapsing-Remitting Multiple Sclerosis (15th Meeting of the
`European Neurological Society, June 18-22, 2005), and
`Declaration of Gilmore O'Neill, M.D.
`
`A. Wierinckx et al., Detoxication Enzyme Inducers Modify
`Cytokine Production in Rat Mixed Glial Cells, 166 J.
`NEUROIMMUNOL. 132 (2005)
`
`5
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`R. Fox et al., Dimethyl Fumarate to Treat Multiple Sclerosis,
`in MULTIPLE SCLEROSIS THERAPEUTICS 387 (Jeffrey A. Cohen
`et al. eds., 4th ed. 2011)
`
`European Medicines Agency, Assessment Report,
`Tecfidera (Nov. 26, 2013)
`
`R. Gold et al., Placebo-Controlled Phase 3 Study of Oral
`BG-12 for Relapsing Multiple Sclerosis, 367 NEW ENG. J.
`MED. 1098 (2012) (“Define Study”)
`
`R.Fox et al., Placebo-Controlled Phase 3 Study of Oral BG-
`12 or Glatiramer in Multiple Sclerosis, 367 NEW ENG. J.
`MED. 1087 (2012) (“Confirm Study”)
`
`E. Frohman et al., Multiple Sclerosis - The Plaque and its
`Pathogenesis, 354 NEW ENG. J. MED. 942 (2006)
`
`J. Miller, The Importance of Early Diagnosis of Multiple
`Sclerosis, 10(3) J. MANAG. CARE PHARM. S4 (2004)
`
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`CARE PHARM. S26 (2004)
`
`D. Meier et al., Monitoring Treatment Efficacy with Magnetic
`Resonance Imaging (MRI) in an Open Phase II Study with
`Fumaric-Acid Esters (Fumaderm®) in Patients with relapsing-
`Remitting MS (RRMS), 4(4) MULTIPLE SCLEROSIS: CLINICAL
`AND LABORATORY RESEARCH P3037 (1998) (ECTRIMS
`98:14th Congress of the European Committee for Treatment
`and Research in Multiple Sclerosis, Sept. 9-12, 1998,
`Stockholm, Sweden)
`
`6
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`N. Brune et al., Oral Fumaric-Acid Ester Therapy (FAE)
`Influence T-Helper Cell Apoptosis in Peripheral Blood
`Lymphocytes (PBLS) and Soluble Intercellular Adhesion
`Molecule-I (SICAM-1) in Serum of Patients with Relapsing-
`Remitting Multiple Sclerosis (RRMS), 246 (Suppl. 1) J.
`NEUROL. I/61, P272 (1999) (Ninth Meeting of the European
`Neurological Society, June 5-9, 1999, Milan, Italy)
`
`L. Kappos et al., Efficacy of a Novel Oral Single-Agent
`Fumarate, BG00012, in Patients with Relapsing-Remitting
`Multiple Sclerosis: Results of a Phase II Study (16th Meeting
`of the European Neurological Society, May 30, 2006)
`attached as Exhibit C to the Declaration of Katherine T.
`Dawson in Biogen U.S. Patent App. No. 12/526,296 and
`marked as Ex. 1018 in Biogen MA Inc. v. Forward Pharma
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`
`Leon Shargel et al., APPLIED BIOPHARMACEUTICS
`& PHARMACOKINETICS 575-611 (5th ed. 2005)
`
`L. Kappos et al., Efficacy and Safety of Oral Fumarate in
`Patients with Relapsing-Remitting Multiple Sclerosis: A
`Multicentre, Randomised, Double-Blind, Placebo-Controlled
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`
`FDA GUIDANCE FOR INDUSTRY - NON-INFERIORITY
`CLINICAL TRIALS TO ESTABLISH EFFECTIVENESS (Nov. 2016)
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`
`A. Paes et al., Impact of Dosage Frequency on Patient
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`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`7
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1052
`
`1053
`
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`1063
`
`S. Eisen et al., The Effect of Prescribed Daily Dose
`Frequency on Patient Medication Compliance, 150 ARCH.
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`
`Prosecution History Excerpts, U.S. Patent No. 8,399,514
`
`Declaration of Robert Mihail
`
`Declaration of Jennifer Rock
`
`Declaration of David L. Anstaett In Support of Motion for
`Pro Hac Vice Admission of David L. Anstaett
`
`NCT00168701, CLINICALTRIALS.GOV, https://clinicaltrials.gov/
`ct2/history/NCT00168701?A=1&B=1&C=merged (last visited
`Feb. 26, 2019)
`
`Biogen News Release, Biogen Idec to Acquire Fumapharm
`AG; Consolidates Ownership of Oral Compound BG-12 being
`Studied for Multiple Sclerosis (May 31, 2006), available at
`https://www.businesswire.com/news/home/20060531005276/e
`n/Biogen-Idec-Acquire-Fumapharm-AG-Consolidates-
`Ownership
`
`Deposition of Jennifer Rock (May 2, 2019)
`INTENTIONALLY LEFT BLANK
`Declaration of Michael A. Chajon in Support of Motion for
`Pro Hac Vice Admission of Michael A. Chajon
`
`Declaration of Shannon M. Bloodworth in Support of Motion
`for Pro Hac Vice Admission of Shannon M. Bloodworth
`INTENTIONALLY LEFT BLANK
`
`8
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1064
`
`1065
`
`1066
`
`1067
`
`1068
`
`1069
`
`1070
`
`1071
`
`1072
`
`1073
`
`1074
`
`1075
`
`D. Wynn, Enduring Clinical Value of Copaxone® (Glatiramer
`Acetate) in Multiple Sclerosis after 20 Years of Use, MULTIPLE
`SCLEROSIS INTERNATIONAL (2019)
`J. Cohen et al., Randomized, Double-Blind, Dose-Comparison
`Study of Glatiramer Acetate in Relapsing-Remitting MS, 68
`NEUROLOGY 939 (2007)
`
`J. Phillips et al., BG-12 in Multiple Sclerosis, 33
`SEMIN. NEUROL. 56 (2013)
`INTENTIONALLY LEFT BLANK
`INTENTIONALLY LEFT BLANK
`INTENTIONALLY LEFT BLANK
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`(filed Oct. 29, 1999) (issued Jan 21, 2003)
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`
`9
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1076
`
`1077
`
`1078
`
`1079
`
`1080
`
`1081
`
`1082
`
`1083
`
`1084
`
`1085
`
`1086
`
`1087
`
`Biogen Idec Inc. Form 10-K for the fiscal year
`ended December 31, 2003
`
`Biogen Idec Inc. Form 10-K for the fiscal year
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`
`Biogen Idec Inc. Form 10-K for the fiscal year
`ended December 31, 2006
`
`Biogen Idec Inc. Form 10-K for the fiscal year
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`Biogen Idec Inc. Form 10-K for the fiscal year
`ended December 31, 2012
`
`Biogen Inc. Form 10-K for the fiscal year ended December
`31, 2016
`
`Biogen Inc. Form 10-K for the fiscal year ended December
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`Biogen 2012 Annual Report
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`Biogen 2017 Annual Report
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`Biogen 2018 Annual Report
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`
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`
`10
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1088
`
`1089
`
`1090
`
`1091
`
`1092
`
`1093
`
`1094
`
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`12, 2018), http://investors.biogen.com/static-files/7231b9d3-
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`
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`20060531005276/en/Biogen-Idec-Acquire-Fumapharm-
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`
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`11
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`EXHIBIT
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`
`DESCRIPTION
`
`1095
`
`1096
`
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`
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`
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`
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`
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`
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`
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`
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`12
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`EXHIBIT
`NO.
`
`DESCRIPTION
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`1105
`
`1106
`
`1107
`
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`
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`13
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`NO.
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`DESCRIPTION
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`1114
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`
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`
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`
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`Clinical and MRI Disease Activity in Relapsing-Remitting
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`Reply Declaration of Joel W. Hay, Ph.D.
`
`Reply Declaration of Benjamin M. Greenberg, M.D.
`
`Declaration of Jennifer Rock
`
`Deposition of John C. Jarosz (Aug. 1, 2019)
`
`History, EAN.ORG, https://www.ean.org/history.2723.0.html
`(last visited Oct. 2, 2019)
`Deposition of Martin Duddy (July 29, 2019)
`
`Deposition of Daniel Wynn, M.D. (July 16, 2019)
`
`14
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`EXHIBIT
`NO.
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`DESCRIPTION
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`1127
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`1128
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`1129
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`1130
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`1131
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`1132
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`1133
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`1134
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`1135
`
`Deposition of Gilmore Neil O’Neill (Sept. 13, 2019)
`
`Deposition of Cara Christann Lansden, Coalition for
`Affordable Drugs V LLC v. Biogen MA, Inc., IPR2015-
`01993 (PTAB Aug. 24, 2016)
`Deposition of Rebecca Conaghan (July 19, 2019)
`
`Deposition of Eva Havrdova (Aug. 20, 2019)
`
`Deposition of Richard Brundage (July 10, 2019)
`
`Deposition of Matvey Lukashev (Aug. 27, 2019)
`
`Deposition of Ronald A. Thisted (July 2, 2019)
`
`Declaration of Emily J. Greb
`
`Settlement and License Agreement (Filed “Board Only”)
`
`
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