`_________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________________
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`
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`NOVEN PHARMACEUTICALS, INC.
`AND MYLAN PHARMACEUTICALS INC.,
`Petitioners
`
`v.
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`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`_________________________________
`
`
`
`Inter Partes Review No.: 2014-005501
`
`U.S. Patent No. 6,335,031
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`
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`PETITIONERS’ EXHIBIT LIST 4
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`1
`Case IPR2015-00268 has been joined with this proceeding.
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`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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`Ex. 1001 U.S_ Patent No. 6,335,031, issued January 1, 2002
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`Ex. 1002 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. Weller
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`(eds.) 1994, 2nd Edition, The Pharmaceutical Press London (the
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`“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 al_ (“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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`Carey & Sundberg, ADVANCED ORGANIC CHEMISTRY, Part
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`A: Structure and Mechanism, 3rd Edition (Plenum Press, NY), pp.
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`
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`651-727 (1990)
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`Ex. 1008 U.S. Patent 4,948,807 (“Rosin”)
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`Ex. 1009 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 “Safety/Tolerability Trial of SDZ ENA 713 in Patients with
`
`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 “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 Testing
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`of New Drug Substances and Products (CPMP/ICH/380/95)
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`Ex. 1015 Connors, Amidon, & Stella, Oxidation and Photolysis in Chemical
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`Stability of Pharmaceuticals – A Handbook for Pharmacists (2nd
`
`Edition), John Wiley & Sons, NY (1986), pp. 82-114
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`3
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`Ex. 1016 Howard C. Ansel, Introduction to Pharmaceutical Dosage Forms,
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`4th Edition, Lea & Febiger, Philadelphia (1985), pp. 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 Miguel-Hidalgo, J., 2000, Current Opinion in CPNS Investigations
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`Drugs, 2000 2(4):438-453
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`Ex. 1019 Boccardi G. et al. Photochemical Iron(III)-Mediated Autoxidation
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`of Dextromethorphan. Chemical & Pharmaceutical Bulletin. Vol.
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`37, 308–310 (1989)
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`Ex. 1020 Bateman, L., Olefin Oxidation, Quarterly Review (1954) Vol. 8,
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`pp. 147–167
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`Ex. 1021 Linnell, R.H., The Oxidation of Nicotine. I. Kinetics of the Liquid
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`Phase Reaction Near Room Temperature. Tobacco Science, Vol.
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`4, pp. 89–91 (1960)
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`Ex. 1022 Resume/Curriculum Vitae of Agis Kydonieus, Ph.D.
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`Ex. 1023 Resume/Curriculum Vitae of Christian Schöneich, Ph.D.
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`4
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`Ex. 1024 U.S. Patent No. 5,602,176, issued Feb. 11, 1997
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`Ex. 1025 Redacted Copy of Bench Trial Transcript (Day 1). C.A. No. 13-
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`527, D.I. 154 (D. Del).
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`Ex. 1026 Redacted Copy of Bench Trial Transcript (Day 2). C.A. No. 13-
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`527, D.I. 155 (D. Del).
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`Ex. 1027 Redacted Copy of Bench Trial Transcript (Day 3). C.A. No. 13-
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`527, D.I. 156 (D. Del).
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`Ex. 1028 U.S. Patent No. 5,061,480. [Not Filed]
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`Ex. 1029 Transcript of 1/13/2015 Deposition of Dr. Agis Kydonieus
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`Ex. 1030 Reserved
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`Ex. 1031 Reply Declaration of Agis Kydonieus
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`Ex. 1032 Reply Declaration of Christian Schoneich, Ph.D.
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`Ex. 1033
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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 O.
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`Garinot. (N0272563.)
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`Ex. 1035 Meeting Minutes of the LTS-Sandoz (Novartis) Working Group.
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`5
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`(N0317247-64.)
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`Ex. 1036 Excerpts of the confidential transcript of the October 17-18, 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 ed.
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`1992).
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`Ex. 1039 PDR Medical Dictionary, 1130 (First Edition 1995) (Entry for
`morphine)
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`Ex. 1040 CRC Handbook of Chemistry and Physics 6-3, 6-6 (David R. 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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`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 Toronto Research Chemicals Inc., rac Rivastigmine-d6 Tartrate
`Salt, available at https://www.trc-canada.com/index.php (Search
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`the following: “rivastigmine-d6 tartrate” and select
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`“Details/Order” for rac Rivastigmine-d6 Tartrate Salt) (accessed:
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`6
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`March 23, 2015).
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`Ex. 1045 Times of Israel, Alzheimer Drug Pioneer to get Israel Prize (March
`4, 2014), available at www.timesofisrael.com/alzheimer-drug-
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`pioneer-to-get-israel-prize.
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`Ex. 1046 Fred W. Billmeyer, Jr., Textbook of Polymer Science, Chapter 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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`Ex. 1048 Transcript of April 18, 2015 Deposition of Dr. Schoneich
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`Ex. 1049 Transcript of April 20, 2015 Deposition of Dr. Kydonieus
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`Ex. 1050 Noven’s 1-27-2015 Objections to Patent Owners’ Evidence
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`Ex. 1051 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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`7
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`Dated: April 29, 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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`8
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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 4 and a copy of Exhibit 1052 were served electronically on April 29, 2015
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`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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`/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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`9
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`Dated: April 29, 2015