`_________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________________
`
`
`NOVEN PHARMACEUTICALS, INC.
`AND MYLAN PHARMACEUTICALS INC.,
`
`Petitioners
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`_________________________________
`
`
`Inter Partes Review No.: 2014-005491
`
`U.S. Patent 6,316,023
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`
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`PETITIONER’S EXHIBIT LIST 3
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`Case IPR2015-00265 has been joined with this proceeding.
`1
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`Pursuant to 37 C.F.R. §42.63(e), Petitioners submit the following current
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`exhibit list.
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`Noven
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`.
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`Ex. 1001
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`U-S- Patent NO- 6,316,023, issued November 13, 2001
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`published September 18, 1985 (“Kissel”)
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`UK Patent Application GB 2,203,040 A, to Enz, published
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`October 12, 1988 (“Enz”)
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`Handbook of Pharmaceutical Excipients, A. Wade and P. J.
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`Weller (eds_) 1994, 2nd Edition, The Pharmaceutical Press
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`London (the “Handbook”)
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`Japanese Patent Application Publication No. JP 59-184121 to
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`Sasaki et al., published October 19, 1984
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`Certified English Translation of Japanese Patent Application
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`Publication No. JP 59—184121 to Sasaki et a1. (“Sasaki”)
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`PCT Publication No. W0 95/024172 to Ebert et al, published
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`September 14, 1995 (“Ebert”)
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`European Patent Application No. 0155 229 A2 to Kissel et al.,
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`Ex. 1008 U.S. Patent No. 4,948,807 (“Rosin”)
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`Ex. 1009
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`Elmalem et al. 1991, Neuropharmacology 30: 1059-1064
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`(“Elmalem”)
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`Ex. 1010 Declaration of Agis Kydonieus, Ph.D.
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`Ex. 1011 Declaration of Christian Schöneich, Ph.D.
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`Ex. 1012
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`“Safety/Tolerability Trial of SDZ ENA 713 in Patients with
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`Probable Alzheimer’s Disease,” John J. Sramek et al., Life
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`Sciences, Vol. 58, No. 15, pp. 1201-1207 (1996) (“Sramek”)
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`Ex. 1013
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`“New acetylcholinesterase inhibitor shows promise in largest
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`Alzheimer’s trial to date,” Formulary, Vol. 32, Dec. 1997
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`(“Formulary Article”)
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`Ex. 1014
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`ICH Topic Q 1 A, Stability Testing Guidelines: Stability
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`Testing of New Drug Substances and Products
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`(CPMP/ICH/380/95)
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`2
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`Ex. 1015
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`Connors, Amidon, & Stella, Oxidation and Photolysis in
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`Chemical Stability of Pharmaceuticals – A Handbook for
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`Pharmacists (2nd Edition), John Wiley & Sons, NY (1986), pp.
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`82-114
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`Ex. 1016 Howard C. Ansel, Introduction to Pharmaceutical Dosage
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`Forms, 4th Edition, Lea & Febiger, Philadelphia (1985), pp.
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`83-116
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`Ex. 1017 Ho-Leung Fung, Chapter 7 – Chemical Kinetics and Drug
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`Stability in MODERN PHARMACEUTICS (G.S. Banker and
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`C.T. Rhodes, eds.), Marcel Dekker, NY (1979), pp. 227-62
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`Ex. 1018
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`Carey & Sundberg, ADVANCED ORGANIC CHEMISTRY,
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`Part A: Structure and Mechanism, 3rd Edition (Plenum Press,
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`NY), pp. 651-727 (1990)
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`Ex. 1019 Miguel-Hidalgo, J., 2000, Current Opinion in CPNS
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`Investigations Drugs, 2000 2(4):438-453
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`Ex. 1020
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`Boccardi G. et al. Photochemical Iron(III)-Mediated
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`Autoxidation of Dextromethorphan. Chemical &
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`Pharmaceutical Bulletin. Vol. 37, 308–310 (1989)
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`3
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`Ex. 1021
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`Bateman, L., Olefin Oxidation, Quarterly Review (1954) Vol.
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`8, pp. 147–167
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`Ex. 1022
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`Linnell, R.H., The Oxidation of Nicotine. I. Kinetics of the
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`Liquid Phase Reaction Near Room Temperature. Tobacco
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`Science, Vol. 4, pp. 89–91 (1960)
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`Ex. 1023
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`Resume/ Curriculum Vitae of Agis Kydonieus, Ph.D.
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`Ex. 1024
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`Resume/ Curriculum Vitae of Christian Schöneich, Ph.D.
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`Ex. 1025 U.S. Patent No. 5,602,176, issued Feb. 11, 1997
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`Ex. 1026
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`Redacted Copy of Bench Trial Transcript (Day 1). C.A. No.
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`13-527, D.I. 154 (D. Del).
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`Ex. 1027
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`Redacted Copy of Bench Trial Transcript (Day 2). C.A. No.
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`13-527, D.I. 155 (D. Del).
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`Ex. 1028
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`Redacted Copy of Bench Trial Transcript (Day 3). C.A. No.
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`13-527, D.I. 156 (D. Del).
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`Ex. 1029 U.S. Patent No. 5,061,480. [Not Filed]
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`Ex. 1030
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`Transcript of 1/13/2015 Deposition of Dr. Agis Kydonieus
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`Ex. 1031
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`Reply Declaration of Agis Kydonieus
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`4
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`Ex. 1032
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`Ex. 1033
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`Reply Declaration of Christian Schoneich, Ph.D.
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`Internal Novartis memorandum written by Dr. Tiemessen.
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`(N0272228-29.)
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`Ex. 1034
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`Internal Novartis e-mail communication from Dr. Tiemessen to
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`O. Garinot. (N0272563.)
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`Ex. 1035 Meeting Minutes of the LTS-Sandoz (Novartis) Working
`Group. (N0317247-64.)
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`Ex. 1036
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`Excerpts of the confidential transcript of the October 17-18,
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`2012 deposition of Dr. Henricus L.G.M. Tiemessen.
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`Ex. 1037 Webster’s II New Riverside University Dictionary, 93, 819
`(1994) (entries for alkene and olefin)
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`Ex. 1038 Morrison and Boyd, Organic Chemistry, Chapter 1 Structure
`and Properties & Chapter 5 Alkyl Halides, 1-38 & 165-212 (6th
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`ed. 1992).
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`Ex. 1039
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`PDR Medical Dictionary, 1130 (First Edition 1995) (Entry for
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`morphine)
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`Ex. 1040
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`CRC Handbook of Chemistry and Physics 6-3, 6-6 (David R.
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`Lide & H.P.R. Frederikse eds., 78th ed. 1997-1998)
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`Ex. 1041 U.S. Patent No. 7,683,205
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`5
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`Ex. 1042 U.S. Patent No. 8,324,429
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`Ex. 1043 Declaration of Christopher J. Coulson
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`Ex. 1044
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`Toronto Research Chemicals Inc., rac Rivastigmine-d6 Tartrate
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`Salt, available at https://www.trc-canada.com/index.php
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`(Search the following: “rivastigmine-d6 tartrate” and select
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`“Details/Order” for rac Rivastigmine-d6 Tartrate Salt)
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`(accessed: March 23, 2015).
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`Ex. 1045
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`Times of Israel, Alzheimer Drug Pioneer to get Israel Prize
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`(March 4, 2014), available at
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`www.timesofisrael.com/alzheimer-drug-pioneer-to-get-israel-
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`prize.
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`Ex. 1046
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`Fred W. Billmeyer, Jr., Textbook of Polymer Science, Chapter
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`9 Radical Chain (Addition) Polymerization, 280 (2d. ed. 1971).
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`Ex. 1047
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`J.E. Leffler, A Short Course of Organic Chemistry, Chapter 4
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`Functional Groups, 46 (1959).
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`Transcript of April 18, 2015 Deposition of Dr. Schoneich
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`Transcript of April 20, 2015 Deposition of Dr. Kydonieus
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`Ex. 1048
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`Ex. 1049
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`Ex. 1050 Noven’s 1-27-2015 Objections to Patent Owners’ Evidence
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`6
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`Ex. 1051
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`Petitioners’ 4-24-2015 Objections to Patent Owners’ Evidence
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`Ex. 1052 April 28, 2015 Certification of Peter McArdle
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`Dated: April 28, 2015
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`Respectfully submitted,
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`/Michael K. Levy/
`Michael K. Levy (Reg. No. 40,699)
`KENYON & KENYON LLP
`One Broadway
`New York, NY 10004-1007
`Tel: 212-425-7200
`Fax: 212-425-5288
`Counsel for Petitioner Noven Pharmaceuticals,
`Inc.
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`7
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`CERTIFICATE OF SERVICE
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` I
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` certify pursuant to 37 C.F.R. §42.6(e) that a copy the foregoing Exhibit
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`List 3 and copies of Exhibits 1048-1052 were served electronically on April 28,
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`2015 pursuant to 37 C.F.R. §42.63(e) to counsel for Patent Owners at the following
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`email address: ExelonPatchIPR@fchs.com.
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`Dated: April 28, 2015
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`/Christopher J. Coulson/
`Christopher J. Coulson (Reg. No. 61,771)
`KENYON & KENYON LLP
`One Broadway
`New York, NY 10004-1007
`Tel: 212-425-7200
`Fax: 212-425-5288
`Counsel for Petitioner Noven Pharmaceuticals,
`Inc.
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`8
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