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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`————————————————
`
`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
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`current exhibit list.
`
`Exhibit No.
`
`Description
`
`2001
`2002
`
`2003
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`2004
`
`2005
`2006
`
`2007
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`2008
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`
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`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
`
`
`
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`10
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`
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`2118
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`2119
`2120
`2121
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`2122
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`2123
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`2124
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`2125
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`2126
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`2127
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`2128
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`2129
`2130
`2131
`2132
`2133
`2134
`
`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
`
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`efficacious in delaying conversion to clinically definite multiple
`sclerosis in patients presenting with clinically isolated syndrome
`and brain lesions detected by MRI, 374 Lancet 1503 (Oct. 31, 2009)
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`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 Neuroscience 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. of Neurological Sciences 71 (2002)
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`Alison Palkhivala, Doubling the Dose of Glatiramer Acetate Does
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`Declaration of Edward J. Fox, MD., PhD
`Curriculum Vitae of Robert William Gristwood PhD
`Curriculum Vitae of Tjalf Ziemssen
`Ziemssen’s MS clinical trials
`Declaration of Henry G. Grabowski, Ph.D.
`Declaration of Robert William Gristwood, Ph.D.
`
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`11
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`CERTIFICATION OF SERVICE
`
`The undersigned hereby certifies that the foregoing UPDATED LIST OF
`
`PATENT OWNER’S EXHIBITS was served electronically via e-mail on
`
`November 20, 2015 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
`
`
`
`/Elizabeth Holland/
`Counsel for Patent Owner
`
`
`
`Dated:
`
`November 20, 2015
`
`12