Filed: March 8, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`————————————————
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`————————————————
`MYLAN PHARMACEUTICALS INC. and
`AMNEAL PHARMACEUTICALS LLC,
`
`Petitioners,
`
`v.
`
`YEDA RESEARCH & DEVELOPMENT CO. LTD.
`
`Patent Owner.
`————————————————
`Case IPR2015-00644
`Patent No. 8,399,413
`————————————————
`
`THIRD UPDATED LIST OF PETITIONERS’ EXHIBITS
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioners submit the following current
`
`exhibit list.
`
`Exhibit No.
`1001
`
`Description
`U.S. Patent No. 8,399,413, Low Frequency Glatiramer Acetate
`Therapy (filed Aug. 19, 2010) (issued May 19, 2013)
`
`1002
`
`1003
`
`1003A
`
`1003B
`
`1004
`
`File History for U.S. Patent No. 8,399,413
`
`[Corrected] Declaration of Stephen J. Peroutka, M.D., Ph.D.
`
`Curriculum Vitae of Stephen J. Peroutka, M.D., Ph.D.
`
`Materials Reviewed by Stephen J. Peroutka, M.D., Ph.D.
`
`Expert Declaration of Ari Green, M.D.
`
`1004A
`
`Curriculum Vitae of Ari Green, M.D.
`
`
`
`1
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`————————————————
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`————————————————
`MYLAN PHARMACEUTICALS INC. and
`AMNEAL PHARMACEUTICALS LLC,
`
`Petitioners,
`
`v.
`
`YEDA RESEARCH & DEVELOPMENT CO. LTD.
`
`Patent Owner.
`————————————————
`Case IPR2015-00644
`Patent No. 8,399,413
`————————————————
`
`THIRD UPDATED LIST OF PETITIONERS’ EXHIBITS
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioners submit the following current
`
`exhibit list.
`
`Exhibit No.
`1001
`
`Description
`U.S. Patent No. 8,399,413, Low Frequency Glatiramer Acetate
`Therapy (filed Aug. 19, 2010) (issued May 19, 2013)
`
`1002
`
`1003
`
`1003A
`
`1003B
`
`1004
`
`File History for U.S. Patent No. 8,399,413
`
`[Corrected] Declaration of Stephen J. Peroutka, M.D., Ph.D.
`
`Curriculum Vitae of Stephen J. Peroutka, M.D., Ph.D.
`
`Materials Reviewed by Stephen J. Peroutka, M.D., Ph.D.
`
`Expert Declaration of Ari Green, M.D.
`
`1004A
`
`Curriculum Vitae of Ari Green, M.D.
`
`
`
`1
`
`
`
`Exhibit No.
`1004B
`
`Description
`Materials Reviewed by Ari Green, M.D.
`
`Case IPR2015-00644
`Patent No. 8,399,413
`
`
`1005
`
`1006
`
`Irit Pinchasi: International Publication No. WO 2007/081975
`(published July 19, 2007)
`
`J.A. Cohen et al., Randomized, double-blind, dose-comparison
`study of glatiramer acetate in relapsing-remitting MS, 68:12
`NEUROLOGY, 939-44 (2007)
`
`1007
`
`Affidavit of Marlene S. Bobka dated December 9, 2014
`
`1007A
`
`John J. Jessop, Review and Evaluation of Pharmacology
`Toxicology Data Original NDA Review (1996) (the 1996 FDA
`SBOA) (attached as Exhibit A to Exh. 1007)
`
`1008
`
`1009
`
`1010
`
`1011
`
`Shlomo Flechter et al., Copolymer 1 (Glatiramer Acetate) in
`Relapsing Forms of Multiple Sclerosis: Open Multicenter Study
`of Alternate-Day Administration. 25:1 CLINICAL
`NEUROPHARMACOLOGY, 11-15 (2002) (Flechter 2002A)
`
`Zeev Meiner et al., Copolymer 1 in relapsing-remitting multiple
`sclerosis: a multi-centre trial, in FRONTIERS IN MULTIPLE
`SCLEROSIS: CLINICAL RESEARCH AND THERAPY (Oded
`Abramsky and Haim Ovadia, eds., 1997)
`
`Omar Khan et al., Randomized, prospective, rater-blinded,
`four-year, pilot study to compare the effect of daily versus
`every-other-day glatiramer acetate 20 mg subcutaneous
`injections in relapsing-remitting multiple sclerosis, 14
`MULTIPLE SCLEROSIS, S296 (2008)
`
`Christina Caon et al., Randomized, Prospective, Rater-Blinded,
`Four Year Pilot Study to Compare the Effect of Daily Versus
`Every Other Day Glatiramer Acetate 20 mg Subcutaneous
`Injections in RRMS, 72:11(3) NEUROLOGY, A317 (2009)
`
`2
`
`
`
`Case IPR2015-00644
`Patent No. 8,399,413
`
`
`Description
`Shlomo Flechter et al., Comparison of glatiramer acetate
`(Copaxone) and interferon β-1b (Betaferon) in multiple
`sclerosis patients: an open-label 2-year follow up, 197
`JOURNAL OF THE NEUROLOGICAL SCIENCES, 51-55 (2002).
`(“Flechter 2002B”)
`
`James R Miller, The importance of early diagnosis of multiple
`sclerosis, 10(3) (Suppl. S-b) J. MANAG. CARE PHARM., S4-11
`(2004)
`
`M.B. Bornstein, Multiple Sclerosis: Trial of a Synthetic
`Polypeptide, 11:3 ANNALS OF NEUROLOGY, 317-19 (1982)
`
`M.B. Bornstein et al., Clinical Trial of Copolymer I in Multiple
`Sclerosis, 436 ANNALS NEW YORK ACADEMY OF SCIENCES,
`366-372 (1984)
`
`M.B. Bornstein et al., A Pilot Trial of COP 1 in Exacerbating-
`Remitting Multiple Sclerosis, 317:7 THE NEW ENGLAND
`JOURNAL OF MEDICINE, 408-14 (1987)
`
`FDA, GUIDELINE FOR INDUSTRY: Dose-Response
`Information to Support Drug Registration (1994)
`
`K.P. Johnson, et al., Copolymer 1 reduces relapse rate and
`improves disability in relapsing-remitting multiple sclerosis, 43
`NEUROLOGY, 1268-1276 (1995)
`
`Exhibit No.
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`Affidavit of Marlene S. Bobka dated January 5, 2015
`
`1019A
`
`1020
`
`1996 FDA Meeting Agenda minutes from the Peripheral and
`Central Nervous System Drug Advisory Committee (dated
`September 19, 1996) (Exhibit A to Exhibit 1019)
`Ruth Arnon, The development of Cop 1(Copaxone®), an
`innovative drug for the treatment of multiple sclerosis: personal
`reflections, 50 IMMUNOLOGY LETTERS 1-15 (1996)
`
`3
`
`
`
`Case IPR2015-00644
`Patent No. 8,399,413
`
`
`Description
`Leslie Z. Benet et al., Pharmacokinetics: The Dynamics of
`Drug Absorption, Distribution, and Elimination, in THE
`PHARMACOLOGICAL BASIS OF THERAPEUTICS, 3 (Alfred
`Goodman Gilman ed. 1996)
`
`E. Lobel, et al., Copolymer-1, 21(2) DRUGS OF THE FUTURE,
`131-134 (1996)
`
`Haines et al., Linkage of the MHC to familial multiple sclerosis
`suggests genetic heterogeneity. The multiple sclerosis genetics
`group, HUM. MOL. GENET. 7:1229-34 (Aug 1998)
`
`U.S. Patent No. 6,342,476, Copolymer-1 Improvements in
`Compositions of Copolymers (2002).
`
`Y. Ge et al., Glatiramer acetate (Copaxone) treatment in
`relapsing-remitting MS: Quantitative MR assessment, 54
`NEUROLOGY, 813-17 (2000)
`
`Giancarlo Comi et al., European/Canadian multicenter, double-
`blind, randomized, placebo-controlled study of the effects of
`glatiramer acetate on magnetic resonance imaging-measured
`disease activity and burden in patients with relapsing multiple
`sclerosis: European/Canadian Glatiramer Acetate Study
`Group, 49:3 ANN. NEUROL., 290-97 (2001)
`
`Boissel and Nony, Using pharmacokinetic-pharmacodynamic
`relationships to predict the effect of poor compliance, CLIN.
`PHARMACOL. 41:1-6 (2002)
`
`Exhibit No.
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`McBride, INT’L J. MS CARE 4:85 (2002)
`
`1029
`
`1030
`
`Dene Simpson, Adis Drug Evaluation Glatiramer Acetate – A
`Review of its use in Relapsing-Remitting Multiple Sclerosis,
`16:12 CNS DRUGS, 825-50, 834 (2002)
`
`Catherine M. Edgar, et al., Lipoatrophy in Patients with
`Multiple Sclerosis on Glatiramer Acetate, 31 CAN. J. NEUROL.
`SCI., 58-63 (2004)
`
`4
`
`
`
`Exhibit No.
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`Case IPR2015-00644
`Patent No. 8,399,413
`
`
`Description
`Rich et al., Stepped-care approach to treating MS: A managed
`care treatment algorithm, J. MANAGED CARE PHARM. 10:S26-
`S32 (June 2004)
`
`Stuart, Clinical management of multiple sclerosis: The
`treatment paradigm and issues of patient management, J.
`MANAGED CARE PHARMACY 10:S19-S25 (June 2004)
`
`Rohit Bakshi et al., Imaging of Multiple Sclerosis: Role in
`Neurotherapeutics, 2(2) NEURORX, 277–303 (2005)
`
`Paul Beringer et al., Clinical Pharmacokinetics and
`Pharmacodynamics, in REMINGTON: THE SCIENCE AND
`PRACTICE OF PHARMACY, 1191-1205, 1197, 1201 (Paul
`Beringer ed., 2005)
`
`Michael Franklin et al., Drug Absorption, Action, and
`Disposition, in REMINGTON: THE SCIENCE AND PRACTICE OF
`PHARMACY, 1142-1170, 1167 (Paul Beringer ed., 2005)
`
`James Rasmussen: International Patent Publication No. WO
`2005/120542 A2 (published December 22, 2005)
`
`Devonshire et al., The Global Adherence Project – A
`multicentre observational study on adherence to disease-
`modifying therapies in patients suffering from relapsing-
`remitting multiple sclerosis, MULTIPLE SCLEROSIS 12:S1 (P316)
`(2006)
`
`C.C. Ford et al., A prospective open-label study of glatiramer
`acetate: over a decade of continuous use in multiple sclerosis
`patients, 12 MULTIPLE SCLEROSIS, 309-320 (2006)
`
`Frohman, Multiple Sclerosis – The Plaque and its Pathogenesis,
`NEW ENGLAND J. MED. 354:942-55 (2006)
`
`J.J. Kragt et al., How similar are commonly combined criteria
`for EDSS progression in multiple sclerosis?, 12(6) MULTIPLE
`SCLEROSIS782-786 (2006)
`
`5
`
`
`
`Case IPR2015-00644
`Patent No. 8,399,413
`
`
`Description
`Peter J. Manso et al., Life cycle management of ageing
`pharmaceutical assets, 3:7 PHARMACEUTICAL LAW INSIGHT,
`(2006)
`
`Soares et al., Localized panniculitis secondary to subcutaneous
`glatiramer acetate injections for the treatment of multiple
`sclerosis: a clinicopathologic and immunohistochemical study,
`J. AM. ACAD. DERM. 55:968-74 (2006)
`
`Klauer and Zettl, Compliance, adherence and the treatment of
`multiple sclerosis, J. NEUROL. 255 [Suppl. 6]:87-92 (2008)
`
`Pelidou et al., Multiple sclerosis presented as clinically isolated
`syndrome: the need for early diagnosis and treatment, THER.
`CLIN. RISK MANAGEMENT 4:627-30 (June 2008)
`
`Tjalf Ziemssen et al., Effects of glatiramer acetate on fatigue
`and days of absence from work in first-time treated relapsing-
`remitting multiple sclerosis, 6 HEALTH AND QUALITY OF LIFE
`OUTCOMES 67 (2008)
`
`Teva Provides Update on Forte Trial Jerusalem, Israel
`(July 7, 2008)
`Copaxone® U.S. Product Label (2001)
`Betaseron® U.S. Product Label (2003)
`Rebif® U.S. Product Label (2003)
`Avonex® Product Label (2006)
`Tysabri® Product Label (2008)
`Copaxone® U.S. Product Label (Feb. 2009)
`Extavia® Product Label (2009)
`
`Exhibit No.
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`6
`
`
`
`Exhibit No.
`
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`1065
`
`1066
`
`1067
`
`1068
`
`Case IPR2015-00644
`Patent No. 8,399,413
`
`
`Description
`Jacobs et al., Intramuscular interferon beta-1a therapy initiated
`during a first demyelinating event in multiple sclerosis, NEW
`ENGL. J. MED 343:898-904 (2000) (“Jacobs”)
`
`Stedman’s Medical Dictionary for Health Professionals (2008)
`
`U.S. Patent Publication No. 2009/0149541A1 (filed Nov. 26,
`2008)
`
`Concepts in clinical pharmacokinetics, in INTRODUCTION TO
`PHARMACOKINETICS AND PHARMACODYNAMICS, Tozer and
`Rowland eds (Lippincott Williams & Wilkins 2006)
`
`M. Tintore et al., Baseline MRI predicts future attacks and
`disability in clinically isolated syndromes, 67 NEUROLOGY 968-
`972, (2006).
`
`FDA GUIDANCE FOR INDUSTRY - POPULATION
`PHARMACOKINETICS (1999)
`
`REBIF® Product Label (June 2005)
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.
`cfm?Appl_No=020622&Product_No=003&table1=OB_Rx
`(accessed February 5, 2015)
`
`https://scamparoo.wordpress.com/2008/04/11/ms-therapies-
`copaxone/ (dated April 11, 2008 (accessed February 5, 2015))
`
`October 22, 2015 Deposition of Dr. Ari Green
`
`October 29, 2015 Deposition of Dr. Stephen Peroutka
`
`Petitioners’ Notice of Deposition of Dr. Edward J. Fox
`
`O. Khan, et al., Glatiramer acetate 20mg subcutaneous twice -
`weekly versus daily injections: results of a pilot, prospective,
`randomised, and rater-blinded clinical and MRI 2-year study in
`relapsing-remitting multiple sclerosis, MULTIPLE SCLEROSIS
`2009; 15:S151-S269, S249-S250 (2009)
`
`7
`
`
`
`Exhibit No.
`
`1069
`
`1070
`
`1071
`
`1072
`
`1073
`
`1074
`
`1075
`
`1076
`
`1077
`
`1078
`
`1079
`
`Case IPR2015-00644
`Patent No. 8,399,413
`
`
`Description
`G. Pardo, et al., Impact of an oral antihistamine on local
`injection site reactions with glatiramer acetate, MULTIPLE
`SCLEROSIS, 2007; 13:S7-S2753, S134 (2007)
`
`S. Bains, et al., Glatiramer acetate: successful desensitazation
`for treatment of multiple sclerosis, ANNALS OF ALLERGY,
`ASTHMA & IMMUNOLOGY, 2010;104:321-325.
`
`E. Fisher, et al., Gray Matter Atrophy in Multiple Sclerosis: A
`Longitudinal Study, ANNALS OF NEUROLOGY, 2008;64:255-265
`
`Fourth Declaration of Edward J. Fox, M.D., Ph.D., In re
`Copaxone 40 mg Consolidated Cases, Civil Action No. 1:14-
`cv-001171, ECF No. 155 (D. Del.)
`
`G. Anderson, et al., Tolerability and safety of novel half
`milliliter formulation of glatiramer acetate for subcutaneous
`injection: an open-label, multicenter, randomized comparative
`study, JOURNAL OF NEUROLOGY (2010) 257:1917-1923
`
`G. Shaw, Exorbitant Drug Costs May Price Out Patients, THE
`WASHINGTON DIPLOMAT (April 27, 2011).
`
`Letter, Mitrokostas to White dated January 19, 2016
`
`Stipulated Protective Order in In re Copaxone 40 mg
`Consolidated Cases, No. 1:14-cv-01171 (GMS) (entered by
`minute entry on May 27, 2015)
`
`Jazz Pharmaceuticals Inc. v. Amneal Pharmaceuticals LLC et
`al., No. 2:13-cv-00391, Order January 22, 2016
`
`Transcript of January 21, 2016 Teleconference
`
`T. Ziemssen, et al., A 2-year observational study of patients
`with relapsing-remitting multiple sclerosis converting to
`glatiramer acetate from other disease-modifying therapies: the
`COPTIMIZE trial, JOURNAL OF NEUROLOGY (2014) 261:2101–
`2111
`
`8
`
`
`
`Exhibit No.
`
`1080
`
`1081
`
`1082
`
`1083
`
`1084
`
`Case IPR2015-00644
`Patent No. 8,399,413
`
`
`Description
`T. Ziemssen, et al., Sub-analysis of geographical variations
`inthe 2-year observational COPTIMIZE trial of patients with
`relapsing–remitting multiple sclerosis converting to glatiramer
`acetate, BMC NEUROLOGY (2015) 15:189
`
`T. Ziemssen, et al., QualiCOP: An Open-Label, Prospective,
`Observational Study of Glatiramer Acetate in Patients with
`Relapsing-Remitting Multiple Sclerosis
`
`N. Kleiner, et al., Immunological Response to Glatiramer
`Acetate in MS Patients after Different Pretreatments – The
`CopImmunoNet Study, P06.178, A554 NEUROLOGY 74, Suppl 2
`(March 2, 2010)
`
`Teva News Release, New Study Demonstrated Significant
`Reduction in Annualized Relapse Rate and Halting of Disability
`Progression in MS Patients Switching to Copaxone® (April 14,
`2011)
`
`R. Aharoni, et al., Glatiramer acetate-specific T cells in the
`brain express T helper 2/3 cytokines and brain-derived
`neurotrophic factor in situ, PNAS 100(24):14157-14162
`(November 25, 2003)
`
`
`
`Dated: March 8, 2016
`
`
`
`
`
`
`
`
`
`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
`
`PERKINS COIE LLP
`700 13th Street, NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6204
`Facsimile: (202) 654-6211
`Email: bmwhite@perkinscoie.com
`
`Attorneys for Mylan Pharmaceuticals Inc.
`
`9
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing Third Updated List of
`
`Petitioners’ Exhibits and Exhibits 1067-1074 and 1079-1084 were served
`
`electronically via email as follows:
`
`Patent Owners:
`
`
`Elizabeth Holland
`Goodwin Procter LLP
`eholland@goodwinprocter.com
`
`William James
`Goodwin Procter LLP
`wjames@goodwinprocter.com
`
`Eleanor Yost
`Goodwin Procter LLP
`eyost@goodwinprocter.com
`
`Nicholas Mitrokostas
`Goodwin Procter LLP
`nmitrokostas@goodwinprocter.com
`
`Daryl Wiesen
`Goodwin Procter LLP
`dwiesen@goodwinprocter.com
`
`John Bennett
`Goodwin Procter LLP
`jbennett@goodwinprocter.com
`
`
`Petitioner Amneal Pharmaceuticals, LLC:
`
`
`Vincent L. Capuano
`Duane Morris LLC
`VCapuano@duanemorris.com
`
`Christopher S. Kroon
`Duane Morris LLC
`CSKroon@duanemorris.com
`
`
`Dated: March 8, 2016
`
`
`
`
`
`
`
`/Brandon M. White/
`Brandon M. White
`
`Attorneys for Mylan Pharmaceuticals Inc.
`
`
`
`
`
`1
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