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`Filed: April 30, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.
`Petitioner,
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`v.
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`BIOGEN MA, INC.
`Patent Owner.
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`Case No. IPR2018-01403
`Patent No. 8,399,514
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`UPDATED LIST OF PETITIONER’S EXHIBITS
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`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits the following current
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`exhibit list.
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`EXHIBIT
`NO.
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`1001
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`DESCRIPTION
`
`U.S. Patent No. 8,399,514, Treatment for Multiple Sclerosis
`(filed Feb. 13, 2012) (issued Mar. 19, 2013)
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`1002
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`1003
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`Declaration of John R. Corboy, M.D.
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`Declaration of Leslie Benet, Ph.D.
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`EXHIBIT
`NO.
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`DESCRIPTION
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`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)
`
`NCT00168701, CLINICALTRIALS.GOV, https://clinicaltrials.gov/
`archive/NCT00168701/2005_09_14
`
`ICH HARMONISED TRIPARTITE GUIDELINE - DOSE-RESPONSE
`INFORMATION TO SUPPORT DRUG REGISTRATION E4 (Mar. 10,
`1994)
`
`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”)
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`2
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`EXHIBIT
`NO.
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`DESCRIPTION
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`1013
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`1014
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`1015
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`1016
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`1017
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`1018
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`1019
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`1020
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`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)
`
`U. Mrowietz et al., Dimethylfumarate for Psoriasis: More than
`a Dietary Curiosity, 11(1) TRENDS MOL. MED. 43 (2005)
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`Fumaderm® prescribing information
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`3
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`EXHIBIT
`NO.
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`DESCRIPTION
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`1021
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`1022
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`1023
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`1024
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`1025
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`1026
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`1027
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`1028
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`1029
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`1030
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`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)
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`P. Nibbering et al., Effects of Monomethylfumarate on Human
`Granulocytes, 101 J. INVEST. DERMATOL. 37 (1993)
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`U.S. Patent No. 6,509,376, Utilization of Dialkyfumarates
`(filed Oct. 29, 1999) (issued Jan 21, 2003)
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`Biogen News Release, BG-12 Psoriasis Study Meets Primary
`Endpoint; Oral Compound Also Being Studied for MS in Phase
`II Trial (Apr. 7, 2005)
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`A.D. Ormerod et al., Fumaric Acid Esters, Their Place in the
`Treatment of Psoriasis, 150 BR. J. DERMATOL. 630 (2004)
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`U. Mrowietz et al., Treatment of Psoriasis with Fumaric Acid
`Esters: Results of a Prospective Multicentre Study, 138(3) BR.
`J. DERMATOL. 456 (1998)
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`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)
`
`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)
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`4
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`EXHIBIT
`NO.
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`1031
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`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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`DESCRIPTION
`
`C. Nieboer et al., Systemic Therapy with Fumaric Acid
`Derivatives: New Possibilities in the Treatment of Psoriasis, 20
`J. AM. ACAD. DERM. 601 (1989)
`
`N. Brune et al., Detection of Altered Intracellular TH1- and
`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)
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`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.
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`A. Wierinckx et al., Detoxication Enzyme Inducers Modify
`Cytokine Production in Rat Mixed Glial Cells, 166 J.
`NEUROIMMUNOL. 132 (2005)
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`R. Fox et al., Dimethyl Fumarate to Treat Multiple Sclerosis, in
`MULTIPLE SCLEROSIS THERAPEUTICS 387 (Jeffrey A. Cohen et
`al. eds., 4th ed. 2011)
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`European Medicines Agency, Assessment Report, Tecfidera
`(Nov. 26, 2013)
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`5
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`EXHIBIT
`NO.
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`DESCRIPTION
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`1038
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`1039
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`1040
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`1041
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`1042
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`1043
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`1044
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`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”)
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`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”)
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`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)
`
`MS Prevalence, NATIONALMSSOCIETY.ORG,
`https://www.nationalmssociety.org/About-the-Society/MS-
`Prevalence (last visited July 9, 2018)
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`S. Rich et al., Stepped-Care Approach to Treating MS: A
`Managed Care Treatment Algorithm, 10(3) J. MANAG. 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)
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`6
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`EXHIBIT
`NO.
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`DESCRIPTION
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`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 A/S, Interference
`No. 106,023 (“Kappos 2006 Presentation”)
`
`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
`Phase IIb Study, 372 LANCET 1463 (2008)
`
`FDA GUIDANCE FOR INDUSTRY - NON-INFERIORITY CLINICAL
`TRIALS TO ESTABLISH EFFECTIVENESS (Nov. 2016)
`
`E. de Klerk et al., Patient Compliance in Rheumatoid Arthritis,
`Polymyalgia Rheumatica, and Gout, 30 J. RHEUMATOLOGY 44
`(2003)
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`A. Paes et al., Impact of Dosage Frequency on Patient
`Compliance, 20(10) DIABETES CARE 1512 (1997)
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`1045
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`1046
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`1047
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`1048
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`1049
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`1050
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`1051
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`7
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`EXHIBIT
`NO.
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`1052
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`1053
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`1054
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`1055
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`1056
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`1057
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`DESCRIPTION
`
`S. Eisen et al., The Effect of Prescribed Daily Dose Frequency
`on Patient Medication Compliance, 150 ARCH. INTERN. MED.
`1881 (1990)
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`Prosecution History Excerpts, U.S. Patent No. 8,399,514
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`Declaration of Robert Mihail
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`Declaration of Jennifer Rock
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`Declaration of David L. Anstaett In Support of Motion for Pro
`Hac Vice Admission of David L. Anstaett
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`NCT00168701, CLINICALTRIALS.GOV, https://clinicaltrials.gov/
`ct2/history/NCT00168701?A=1&B=1&C=merged (last visited
`Feb. 26, 2019)
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`Dated: April 30, 2019
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`
`
`/s/ Brandon M. White
`Brandon M. White
`Reg. No. 52,354
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`E-mail: bmwhite@perkinscoie.com
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that the foregoing Updated List of
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`Petitioner’s Exhibits was severed electronically via email as follows:
`
`Barbara C. McCurdy
`Mark J. Feldstein
`Erin M. Sommers
`Pier D. DeRoo
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`barbara.mccurdy@finnegan.com
`mark.feldstein@finnegan.com
`erin.sommers@finnegan.com
`pier.deroo@finnegan.com
`Counsel for Patent Owner
`Dated: April 30, 2019
`/s/Brandon M. White
`Brandon M. White
`Reg. No. 52,354
`Counsel for Petitioner Mylan Pharmaceuticals Inc.
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