Filed: February 4, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner,
`
`v.
`
`YEDA RESEARCH & DEVELOPMENT CO. LTD.
`
`Patent Owner.
`
`————————————————
`
`Case IPR2015-00644
`
`Patent No. 8,399,413
`
`————————————————
`
`UPDATED LIST OF PATENT OWNER’S EXHIBITS
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`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner submits the following
`
`current exhibit list.
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` 
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`  
`
`  Exhibit No.
`2001
`2002
`
`2003
`
`2004
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`2005
`2006
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`2007
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`2008
`2009
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`2010
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`2011
`
`
`2012
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`2013
`
`
`2014
`
`2015
`
`
`Description
`Teva Provides Update on Forte Trial (July 7, 2008)
`Franscisco J. Quintana et al., Systems Biology Approaches for the Study
`of Multiple Sclerosis, 12 J. Cellular & Molecular Med. 1087 (2008)
`David Virley, Developing Therapeutics for the Treatment of Multiple
`Sclerosis, 2 J. Am. Soc. Experimental Neurotherapeutics 638 (Oct.
`2005)
`Manuel A. Friese et al., The Value of Animal Models for Drug
`Development in Multiple Sclerosis, 129 Brain 1940 (2006)
`Copaxone Prescribing Information (Jan. 2014)
`Dvora Teitelbaum et al., Suppression of Experimental Allergic
`Encephalomyelitis by a Synthetic Polypeptide, 1Eur. J. Immunology
`242 (1971)
`Jill Conner, Glatiramer Acetate and Therapeutic Peptide Vaccines for
`Multiple Mclerosis,1 J. Autoimmun. & Cell Responses 3 (2014)
`Copaxone, Physicians Desk Reference 3231 (62 ed. 2008)
`Wiebke Schrempf and Tjalf Ziemssen, Glatiramer Acetate:
`Mechanisms of Action In Multiple Sclerosis, 6 Autoimmun. Rev. 469
`(2007)
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`Glatiramer Acetate in MS, 59 Neurology 802 (2002)
`Suhayl Dhib-Jalbut, Mechanisms of Action of Interferons and
`Glatiramer Acetate in Multiple Sclerosis, 58 Neurology S3 (Supp. 4
`2002)
`O. Neuhaus et al., Pharmacokinetics and Pharmacodynamics of the
`Interferon-Betas, Glatiramer Acetate, and Mitoxantrone in Multiple
`Sclerosis, 259 (1-2) J. Neurol. Sci. 27 (2007)
`Oded Abramsky et al., Effect of A Synthetic Polypeptide (COP 1) on
`Patients with Multiple Sclerosis and with Acute Disseminated
`Encephalomyelitis, 31 J. Neurol. Sci. 433 (1977)
`Murry B. Bornstein et al., Treatment of Multiple Sclerosis with a
`Synthetic Polypeptide: Preliminary Results, 105 Tran. Am. Neurol.
`Assoc. 348 (1980)
`Murry B. Bornstein et al., Multiple Sclerosis: Trial of a Synthetic
`Polypeptide, 11 Annals Neurology 317 (1982)
`
` 
`
`2
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`

`
` 
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` 
`
`2016
`
`2017
`
`2018
`
`
`2019
`
`
`2020
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`
`2027
`2028
`
`Murry B. Bornstein et al., A Pilot Trial of COP 1 in Exacerbating-
`Remitting Multiple Sclerosis, 13 New Engl. J. Med. 408 (1987)
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`Yuval Ramot et al., Comparative Long-Term Preclinical Safety
`Evaluation of Two Glatiramoid Compounds (Glatiramer Acetate,
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`U.S. Patent Application No. 2007/0161566 A1
`T. Ziemssen et al., Risk-benefit Assessment of Glatiramer Acetate in
`Multiple Sclerosis, 24(13) Drug Safety 979 (2001)
`Teva News Release, Phase III Data Published in Annals of Neurology
`Show That a Higher Concentration Dose of Glatiramer Acetate Given
`Three Times a Week Reduced Annualized Relapse Rates in the
`Treatment of Relapsing-Remitting Multiple Sclerosis (July 1, 2013)
`Omar Khan et al., Three Times Weekly Glatiramer Acetate in
`Relapsing–Remitting Multiple Sclerosis, 73 Annals Neurology 705
`(2013)
`Teva Press Release, Teva Reports First Quarter 2015 Results (April 30,
`2015)
`Kate McKeage, Glatiramer Acetate 40 mg/mL in Relapsing-Remitting
`Multiple Sclerosis: A Review, CNS Drugs (April 24, 2015)
`K.P. Johnson et al., Copolymer 1 reduces relapse rate and improves
`disability in relapsing-remitting multiple sclerosis: Results of Phase III
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`Intentionally left Blank
`Giancarlo Comi, Forte: Results from a phase II, 1-year, Randomized,
`Double-blind, Parallel-Group, Dose-Comparison Study with
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`Presented at World Congress on Treatment and Research in Multiple
`Sclerosis: 2008 Joint Meeting of the American, European, and Latin
`America Committees on Treatment and Research in Multiple Sclerosis,
`San Raffaele, Italy (ACTRIMS, ECTRIMS, LACTRIMS) (2008)
`
`3
`
`

`
` 
`
` 
`
`2029
`
`
`2030
`
`
`2031
`
`2032
`
`2033
`
`
`2034
`
`
`2035
`
`2036
`
`2037
`2038
`
`
`2039
`
`
`2040
`
`
`2041
`
`2042
`
`
`Jerry S. Wolinsky et al., GLACIER: An Open-Label, Randomized,
`Multicenter Study to Assess the Safety and Tolerability of Glatiramer
`Acetate 40 mg Three-times Weekly Versus 20 mg Daily in Patients with
`Relapsing-Remitting Multiple Sclerosis, 4 Multiple Sclerosis & Related
`Disorders 370 (2015).
`Cinthia Farina et al., Treatment of Multiple Sclerosis with Copaxone
`(COP): Elispot Assay Detects COP-Induced Interleukin-4 and
`Interferon-Gamma Response in Blood Cells, 124 Brain 705 (2001).
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`Pharmacological Variation Between Human and Rodent 5-HT1B
`Receptors, 360 Nature 161 (1992) (Peroutka Dep. Ex. 9).
`M. Shalit et al., Abstract, Copolymer-1 (Copaxone®) Induces a Non-
`Immunologic Activation of Connective Tissue Type Mast Cells, 97 J.
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`11-cv-00717, Document 310 (D. Del. Apr. 8, 2014) (Peroutka Dep.
`Ex.15).
`Masha Fridkis-Hareli et al., Binding Motifs of Copolymer 1 to Multiple
`Sclerosis- and Rheumatoid Arthritis-Associated HLA-DR Molecules,
`162 J. Immunology 4697 (1999).
`Notice of Abandonment, APN 11/651,212, USPTO (Mar. 9, 2010).
`Bernd Meibohm & Hartmut Derendorf, Basic Concepts of
`Pharmacokinetic/Pharmacodynamic (PK/PD) Modelling, 35 Int’l J.
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`Delivery: Will New Delivery Systems Transform Vaccine
`Administration?, 26 Vaccine 3197 (2008).
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`Immunostimulant Strategies: Capitalizing on the Immunocompetence of
`the Skin, 2 Expert Rev. Vaccines 253 (2003).
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`Topical Delivery of Vaccines, 21 Vaccine 776 (2003).
`Chandrabali Ghose et al., Transcutaneous Immunization with
`Clostridium difficile Toxoid A Induces Systemic and Mucosal Immune
`Responses and Toxin A-Neutralizing Antibodies in Mice, 75 Infection &
`Immunity 2826 (2007).
`
`4
`
`

`
` 
`
` 
`
`2043
`
`
`2044
`
`
`2045
`
`
`2046
`
`2047
`
`2048
`(corrected)
`
`2049
`(corrected)
`
`2050
`(corrected)
`
`2051
`(corrected)
`
`2052
`(corrected)
`2053
`(corrected)
`2054
`(corrected)
`
`2055
`(corrected)
`
`2056
`(corrected)
`
`Gregory M. Glenn et al., Cutting Edge: Transcutaneous Immunization
`with Cholera Toxin Protects Mice Against Lethal Mucosal Toxin
`Challenge, 161 J. Immunology 3211 (1998).
`Rina Aharoni et al., Specific Th2 Cells Accumulate in the Central
`Nervous System of Mice Protected Against Experimental Autoimmune
`Encephalomyelitis by Copolymer 1, 97 Proc. Nat’l Acad. Sci. U.S.A.
`11,472 (2000).
`Ruth Arnon & Rina Aharoni, Mechanism of Action of Glatiramer
`Acetate in Multiple Sclerosis and Its Potential for the Development of
`New Applications, 101 Proc. Nat’l Acad. Sci. U.S.A. 14,593 (2004).
`Haim Varkony et al., The Glatiramoid Class of Immunomodulator
`Drugs, 10 Expert Opinion Pharmacotherapy 657 (2009).
`G. Comi & L. Moiola, Glatiramer Acetate, 17 Neurologia 244 (2002).
`
`S. Chabot et al., Cytokine Production in T Lymphocyte-Microglia
`Interaction Is Attenuated by Glatiramer Acetate: A Mechanism for
`Therapeutic Efficacy in Multiple Sclerosis, 8 Multiple Sclerosis 299
`(2002).
`Tjalf Ziemssen, Neuroprotection and Glatiramer Acetate: The Possible
`Role in the Treatment of Multiple Sclerosis, in Frontiers in Clinical
`Neuroscience 111 (2004).
`Hana Schmeisser et al., Radioiodination of Human Interferon-α2
`Interferes with Binding of C-Terminal Specific Antibodies, 238 J.
`Immunological Methods 81 (2000).
`Y. M. Efimova et al., Changes in the Secondary Structure of Proteins
`Labeled with 125I: CD Spectroscopy and Enzymatic Activity Studies, 264
`J. Radioanalytical & Nuclear Chemistry 91 (2005).
`P. L. Toutain & A. Bousquet-Mélou, Plasma Terminal Half-Life, 27 J.
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`Graeme B. Ryan & Guido Majno, Acute Inflammation: A Review, 86
`Am. J. Pathology 183 (1977).
`M. Shalit et al., Abstract, Copolymer-1 (Copaxone®) Induces in Non-
`Immunologic Activation of Connective Tissue Type Mast Cells, 97 J.
`Allergy & Clinical Immunology 345 (1996)
`Peter Imming et al., Drugs, Their Targets and the Nature and Number
`of Drug Targets, 5 Nature Revs. Drug Discovery 821 (2006) (Erratum
`in: 6 Nature Revs. Drug Discovery 126 (2007)).
`Candace B. Pert & Solomon H. Snyder, Properties of Opiate-Receptor
`Binding in Rat Brain,70 Proc. Nat’l Acad. Sci. U.S.A. 2243 (1973).
`
`5
`
`

`
` 
`
` 
`
`2057
`(corrected)
`
`2058
`(corrected)
`2059
`(corrected)
`
`2060
`(corrected)
`2061
`(corrected)
`
`2062
`(corrected)
`
`2063
`(corrected)
`
`2064
`(corrected)
`
`2065
`(corrected)
`2066
`(corrected)
`
`2067
`(corrected)
`
`2068
`(corrected)
`
`2069
`(corrected)
`
`2070
`(corrected)
`
`Brent G. Petty et al., The Effect of Systemically Administered
`Recombinant Human Nerve Growth Factor in Healthy Human Subjects,
`36 Annals Neurology 244 (1994)
`Stephen J. Peroutka, Antimigraine Drug Interactions with Serotonin
`Receptor Subtypes in Human Brain, 23 Annals Neurology 500 (1988).
`ALK Hestvik et al., Multiple Sclerosis: Glatiramer Acetate Induces
`Anti-Inflammatory T Cells in the Cerebrospinal Fluid, 14 Multiple
`Sclerosis 749 (2008).
`Rina Aharoni, The Mechanism of Action of Glatiramer Acetate in
`Multiple Sclerosis and Beyond, 12 Autoimmunity Revs. 543 (2013).
`Danielle Burger et al., Glatiramer Acetate Increases IL-1 Receptor
`Antagonist but Decreases T Cell-Induced IL-1β in Human Monocytes
`and Multiple Sclerosis, 106 Proc. Nat’l Acad. Sci. U.S.A. 4355 (2009).
`Amélia Mendes & Maria José Sá, Classical Immunomodulatory
`Therapy in Multiple Sclerosis: How It Acts, How It Works, 69 Arquivos
`Neuropsiquiatria 536 (2011).
`Rina Aharoni et al., Copolymer 1 Induces T Cells of the T Helper Type 2
`That Crossreact with Myelin Basic Protein and Suppress Experimental
`Autoimmune Encephalomyelitis, 94 Proc. Nat’l Acad. Sci. U.S.A. 10821
`(1997).
`Rina Aharoni et al., Bystander Suppression of Experimental
`Autoimmune Encephalomyelitis by T Cell Lines and Clones of the Th2
`Type Induced by Copolymer 1, 91 J. Neuroimmunology 135 (1998).
`Oliver Neuhaus et al., Mechanisms of Action of Glatiramer Acetate in
`Multiple Sclerosis, 56 Neurology 702 (2001).
`Tjalf Ziemssen et al., Glatiramer Acetate-Specific T-Helper 1- and 2-
`Type Cell Lines Produce BDNF: Implications for Multiple Sclerosis
`Therapy, 125 Brain 2381 (2002).
`Ariel Miller et al., Treatment of Multiple Sclerosis with Copolymer-1
`(Copaxone®): Implicating Mechanisms of Th1 to Th2/Th3 Immune-
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`Oliver Neuhaus et al., Multiple Sclerosis: Comparison of Copolymer-1-
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`Cytokine Shift from T Helper 1 to T Helper 2 Cells, 97 Proc. Nat’l Acad.
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`Petra W. Duda et al., Glatiramer Acetate (Copaxone®) Induces
`Degenerate, Th2-Polarized Immune Responses in Patients with Multiple
`Sclerosis, 105 J. Clinical Investigation 967 (2000).
`Shohei Hori et al., Control of Regulatory T Cell Development by the
`Transcription Factor Foxp3, 299 Science 1057 (2003).
`
`6
`
`

`
` 
`
` 
`
`2071
`(corrected)
`
`2072
`(corrected)
`
`2073
`
`
`2074
`
`2075
`
`
`2076
`
`2077
`
`2078
`
`
`2079
`
`
`2080
`
`
`2081
`
`
`2082
`
`
`2083
`
`2084
`
`
`Mary E. Brunkow et al., Disruption of a New Forkhead/Winged-Helix
`Protein, Scurfin, Results in the Fatal Lymphoproliferative Disorder of
`the Scurfy Mouse, 27 Nature Genetics 68 (2001).
`Vissia Viglietta et al., Loss of Functional Suppression by CD4+ CD25+
`Regulatory T Cells in Patients with Multiple Sclerosis, 199 J.
`Experimental Med. 971 (2004).
`Jian Hong et al., Induction of CD4+CD25+ Regulatory T Cells by
`Copolymer-I Through Activation of Transcription Factor Foxp3, 102
`Proc. Nat’l Acad. Sci. U.S.A. 6449 (2005).
`H. Wekerle et al., Cellular Immune Reactivity within the CNS, 9 Trends
`Neurosci. 271 (1986).
`William F. Hickey, Migration of Hematogenous Cells Through the
`Blood-Brain Barrier and the Initiation of CNS Inflammation, 1 Brain
`Pathology 97 (1991).
`Martin S. Weber et al., Multiple Sclerosis: Glatiramer Acetate Inhibits
`Monocyte Reactivity in Vitro and in Vivo, 127 Brain 1370 (2004).
`Til Menge et al., Disease-Modifying Agents for Multiple Sclerosis:
`Recent Advances and Future Prospects, 68 Drugs 2445 (2008).
`J. C. Sodoyez et al., 125I-Insulin: Kinetics of Interaction with Its
`Receptors and Rate of Degradation in Vivo, 239 Am. J. Physiology E3
`(1980).
`Victor J. Wroblewski VJ, Mechanism of Deiodination of 125I-Human
`Growth Hormone in Vivo: Relevance to the Study of Protein
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`Alastair Monro, The Paradoxical Lack of Interspecies Correlation
`Between Plasma Concentrations and Chemical Carcinogenicity, 18
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`Robert T. O’Neill, Secondary Endpoints Cannot Be Validly Analyzed If
`the Primary Endpoint Does Not Demonstrate Clear Statistical
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`Karsten Beer et al., The Prevalence of Injection-Site Reactions with
`Disease-Modifying Therapies and Their Effect on Adherence in Patients
`with Multiple Sclerosis: An Observational Study, 11 BMC Neurology
`144 (2011).
`Tjalf Ziemssen & Wiebke Schrempf, Glatiramer Acetate: Mechanisms
`of Action in Multiple Sclerosis, 79 Int’l Rev. Neurobiology 537 (2007).
`Tjalf Ziemssen, Modulating Processes Within the Central Nervous
`System Is Central to Therapeutic Control of Multiple Sclerosis, 252 J.
`Neurology V/38 (2005) (Suppl. 5).
`
`7
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`

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` 
`
` 
`
`2085
`
`
`2086
`
`2087
`
`2088
`
`2089
`
`
`2090
`
`
`2091
`
`
`2092
`
`
`2093
`
`2094
`
`2095
`(corrected)
`2096
`
`2097
`
`Tjalf Ziemssen et al., Presence of Glatiramer Acetate-Specific TH2
`Cells in the Cerebrospinal Fluid of Patients with Multiple Sclerosis 12
`Months After the Start of Therapy with Glatiramer Acetate, 1 J.
`Neurodegeneration & Regeneration 1 (2008).
`H.P. Rang et al., Pharmacology (5th ed. 2005).
`
`Donald W. Paty, The Interferon-β1b Clinical Trial and Its Implications
`for Other Trials, 36 Annals Neurology S113 (1994) (Supp.).
`Leonora K. Fisniku et al., Gray Matter Atrophy Is Related to Long-Term
`Disability in Multiple Sclerosis, 64 Annals Neurology 247 (2008).
`Omar Khan et al., Three Times Weekly Glatiramer Acetate in
`Relapsing–Remitting Multiple Sclerosis, 73 Annals Neurology 705
`(2013).
`Phillip D. Rumrill Jr., Multiple Sclerosis: Medical and Psychosocial
`Aspects, Etiology, Incidence, and Prevalence, 31 J. Vocational
`Rehabilitation 75 (2009).
`H.T. Katz et al., Successful Desensitization to Glatiramer Acetate
`(Copaxone) in Two Patients with Multiple Sclerosis, 92 Abstract Book
`167 (2004) (Presented at the American College of Allergy, Asthma &
`Immunology 2003 Annual Meeting, New Orleans, LA (Nov. 7-12,
`2015)).
`Maria Zellner et al., Quantitative Validation of Different Protein
`Precipitation Methods in Proteome Analysis of Blood Platelets, 26
`Electrophoresis 2481 (2005).
`Mariana Castells, Rapid Desensitization for Hypersensitivity Reactions
`to Medications, 29 Immunology & Allergy Clinics N. Am. 585 (2009).
`Robert Zivadinov et al., MRI Indicators of Brain Tissue Loss: 3-Year
`Results of the Glatiramer Acetate Low-Frequency Administration
`(GALA) Open-Label Extension Study in Relapsing- Remitting Multiple
`Sclerosis, Presented at The American Academy of Neurology 2015
`Annual Meeting, Washington, DC (Apr. 18-25,2015)
`E. Rubinchik et al., Responsiveness of Human Skin Mast Cells to
`Repeated Activation: An in Vitro Study, 53 Allergy 14 (1998).
`Daniel Wynn et.al., Patient Experience with Glatiramer Acetate 40mg/1
`ml Three-Times Weekly Treatment for Relapsing-Remitting Multiple
`Sclerosis: Results from the GLACIER Extension Study, Presented at
`The 8th Congress of the Pan-Asian Committee for Treatment and
`Research in Multiple Sclerosis, Seoul, Republic of Korea (Nov. 19-21,
`2015).
`Press Release, Biogen Idec, Inc., Avonex® (Interferon beta-1a) IM
`Injection (Oct. 2008) (on file with author).
`
`8
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`

`
` 
`
` 
`
`2098
`(corrected)
`2099
`
`2100
`2101
`
`2102
`
`2103
`2104
`2105
`2106
`2107
`2108
`
`2109
`2110
`2111
`2112
`
`2113
`
`2114
`
`2115
`2116
`
`2117
`2118
`
`2119
`2120
`2121
`
`2122
`
`Prescribing Information, EMD Serono, Rebif Prescribing Information
`(Sept. 2009) .
`Prescribing Information, (Interferon beta-1b) Kit for subcutaneous use
`Highlights of Prescribing Information (Aug. 2009) (on file with author).
`Curriculum Vitae of Edward J. Fox. MD., PhD., FAAN
`Per Soelberg Sorensen et al., Clinical Importance of Neutralizing
`Antibodies Against Interferon Beta in Patients with Relapsing-Remitting
`Multiple Sclerosis, 362 Lancet 1184 (2003).
`Jan J. M. de Vijlder, Primary Congenital Hypothyroidism: Defects in
`Iodine Pathways, 149 Eur. J. Endocrinology 247 (2003).
`Peptide and Protein Drug Delivery (Vincent H. L. Lee ed., 1991).
`Curriculum Vitae of Dr. Henry George Grabowski
`List of Testimony of Henry G. Grabowski
`Documents Relied Upon (Grabowski)
`Table: Approval Timeline, Multiple Sclerosis Drugs
`Figure: Copaxone® 40mg/mL Wholesale Dollar Sales (Q1 2014-Q3
`2015)
`Figure: Copaxone® 40mg/mL Extended Units (Q1 2014- Q3 2015)
`Figure: Copaxone® 40mg/mL Total Prescriptions (Q1 2014- Q3 2015)
`Figure: Copaxone® 40mg/mL New Prescriptions (Q1 2014- Q3 2015)
`Figure: Multiple Sclerosis Drugs Share of Wholesale Dollar Sales (Q4
`2009- Q3 2015)
`Figure: Multiple Sclerosis Drugs Share of Total Prescriptions (Q4 2009-
`Q3 2015)
`Figure: Multiple Sclerosis Drugs Share of New Prescriptions (Q4 2009-
`Q3 2015)
`Figure: Rationale for Requesting Copaxone
`Figure: Perception of 3-times-a-week Copaxone 40mg compared to
`Daily Copaxone 20mg
`Figure: Rationale for Discussing 20mg and 40mg for First Line Patients
`Figure: Perceptions of Copaxone® 40mg compared to Daily Generic
`GA
`Figure: Perceptions of Copaxone® 40mg vs. 20mg
`Figure: Copaxone® Total Prescriptions (Q4 2009- Q3 2015)
`Figure: Copaxone® 20 mg/mL, Copaxone® 40 mg/mL, and Glatopa™
`Net Prescriptions Flow (10/26/12-10/9/15)
`Table: Total Promotional Spending to Sales Ratio
`
`9
`
`

`
` 
`
` 
`
`2123
`
`
`2124
`
`2125
`
`2126
`
`
`2127
`
`2128
`
`2129
`(corrected)
`2130
`2131
`(corrected)
`2132
`2133
`(corrected)
`2134
`(corrected)
`2135
`2136
`
`2137
`
`2138
`
`2139
`
`G. Comi et al., Effect of Glatiramer Acetate on Conversion to Clinically
`Definite Multiple Sclerosis in Patients with Clinically Isolated
`Syndrome (PreCISe study): A Randomised, Double-Blind, Placebo-
`Controlled Trial, 374 Lancet 1503 (2009).
`R.M. Valenzuela et al., Clinical Response to Glatiramer Acetate
`Correlates with Modulation of IFN-γ and IL-4 Expression in Multiple
`Sclerosis, 13 Multiple Sclerosis 754 (2007).
`Y. Blanco et al., Effect of Glatiramer Acetate (Copaxone®) on the
`Immunophenotypic and Cytokine Profile and BDNF Production in
`Multiple Sclerosis: A Longitudinal Study, 406 Neurosci. Letters 270
`(2006).
`M. Chen et al., Sustained Immunological Effects of Glatiramer Acetate
`in Patients with Multiple Sclerosis Treated for over 6 Years, 201 J.
`Neurological Sci. 71 (2002).
`Zhao Rong Chen et al., MU Receptor Binding of Some Commonly Used
`Opioids and Their Metabolites, 48 Life Sci. 2165 (1991).
`Alison Palkhivala, Doubling the Dose of Glatiramer Acetate Does Not
`Increase Efficacy, Medscape Medical News (Sept. 22, 2008).
`Declaration of Edward J. Fox, MD., PhD
`
`Curriculum Vitae of Robert William Gristwood PhD
`Curriculum Vitae of Tjalf Ziemssen
`
`Ziemssen’s MS clinical trials
`Corrected Declaration of Henry G. Grabowski, Ph.D.
`
`Declaration of Robert William Gristwood, Ph.D.
`
`Declaration of Tjalf Ziemssen, M.D., Ph.D
`Declaration of John T. Bennett in support of Patent Owner’s Motion for
`Pro Hac Vice Admission of John T. Bennett Under 37 C.F.R. § 42.10(c)
`Declaration of Daryl L. Wiesen in support of Patent Owner’s Motion
`for Pro Hac Vice Admission of Daryl L. Wiesen Under 37 C.F.R. §
`42.10(c)
`Declaration of Nicholas K. Mitrokostas in support of Patent Owner’s
`Motion for Pro Hac Vice Admission of Nicholas K. Mitrokostas Under
`37 C.F.R. § 42.10(c)
`Patent Owner’s Proposed Supplemental Exhibits
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`Letter from Brandon M. White to Eleanor M. Yost, re: Mylan
`Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd. Case
`Nos. IPR2105-00643, IPR2015-00644 and IPR2015-00830 (Jan. 12,
`2016).
`Analyst Report: “Spec Pharmaceuticals,” Morgan Stanley (Mar. 3,
`2014)
`U.S. Patent No. 8,377,885
`Analyst Report: “Global Biotechnology and Pharmaceuticals – AAN
`2014,” Credit Suisse (Apr. 30, 2014)
`Analyst Report: “Multiple Sclerosis: It’s a Revolution! (vs. Evolution),”
`Credit Suisse (Dec. 12, 2013)
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`2140
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`2141
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`2142
`2143
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`2144
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`Pursuant to the Board’s Order dated February 1, 2016 (Paper 49), Patent Owner
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`Yeda Research and Development Co. Ltd. hereby files Exhibits 2141, 2142, 2143, and
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`2144. Also filed herewith, pursuant to the same, is Corrected Exhibit 2133.
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`Respectfully submitted,
`
`/Elizabeth J. Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`Tel: 212-813-8800
`Fax: 212-355-3333
`
`Counsel for Patent Owner Yeda Research
`and Development Co. Ltd
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`12
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`Dated: February 4, 2016
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`CERTIFICATION OF SERVICE
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`The undersigned hereby certifies that the foregoing UPDATED LIST OF
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`PATENT OWNER’S EXHIBITS and accompanying Exhibits 2133 and 2141-
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`2144 were served electronically via e-mail on February 4, 2016 on the following:
`
`Jeffrey W. Guise
`
`jguise@wsgr.com
`
`Brandon M. White
`
`BMWhite@perkinscoie.com
`
`Shannon Bloodworth
`
`Sbloodworth@perkinscoie.com
`
`David Anstaett
`
`DAnstaett@perkinscoie.com
`
`Richard Torczon
`
`rtorczon@wsgr.com
`
`Vince Capuano
`
`vcapuano@duanemorris.com
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`Christopher Kroon
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`CSKroon@duanemorris.com
`
`
`/Nicholas K. Mitrokostas/
`Nicholas K. Mitrokostas
`
`Dated:
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`February 4, 2016
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