UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________________
`
`
`NOVEN PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`_________________________________
`
`
`Inter Partes Review No.: 2014-00550
`U.S. Patent No. 6,335,031
`
`
`PETITIONER’S EXHIBIT LIST 2
`
`
`
`i
`
`
`_________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________________
`
`
`NOVEN PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`_________________________________
`
`
`Inter Partes Review No.: 2014-00550
`U.S. Patent No. 6,335,031
`
`
`PETITIONER’S EXHIBIT LIST 2
`
`
`
`i
`
`
`
`Pursuant to 37 C .F.R. §42.63(e), Petitioner Noven submits the following
`
`current exhibit list.
`
`Ex. 1001 US. Patent No. 6,335,031, issued January 1, 2002
`
`Ex. 1002 UK Patent Application GB 2,203,040 A, to Enz, published
`
`October 12, 1988 (“Enz”)
`
`Handbook of Pharmaceutical Excipients, A. Wade and P. J. Weller
`
`(eds.) 1994, 2“d Edition, The Pharmaceutical Press London (the
`
`“Handbook”)
`
`
`
`Japanese Patent Application Publication No. JP 59-184121 to
`
`Sasaki et al., published October 19, 1984
`
`Certified English Translation of Japanese Patent Application
`
`Publication No. JP 59-184121 to Sasaki et al. (“Sasaki”)
`
`PCT Publication No. W0 95/024172 to Ebert et a1, published
`
`September 14, 1995 (“Ebert”)
`
`Carey & Sundberg, ADVANCED ORGANIC CHEMISTRY, Part
`
`A: Structure and Mechanism, 3rd Edition (Plenum Press, NY), pp.
`
`
`
`651-727 (1990)
`
`Ex. 1008 U.S. Patent 4,948,807 (“Rosin”)
`
`Ex. 1009 Elmalem et al. 1991, Neuropharmacology 30: 1059-1064
`
`(“Elmalem”)
`
`Ex. 1010 Declaration of Agis Kydonieus, Ph.D.
`
`Ex. 1011 Declaration of Christian Schöneich, Ph.D.
`
`Ex. 1012 “Safety/Tolerability Trial of SDZ ENA 713 in Patients with
`
`Probable Alzheimer’s Disease,” John J. Sramek et al., Life
`
`Sciences, Vol. 58, No. 15, pp. 1201-1207 (1996) (“Sramek”)
`
`Ex. 1013 “New acetylcholinesterase inhibitor shows promise in largest
`
`Alzheimer’s trial to date,” Formulary, Vol. 32, Dec. 1997
`
`(“Formulary Article”)
`
`Ex. 1014
`
`ICH Topic Q 1 A, Stability Testing Guidelines: Stability Testing
`
`of New Drug Substances and Products (CPMP/ICH/380/95)
`
`Ex. 1015 Connors, Amidon, & Stella, Oxidation and Photolysis in Chemical
`
`Stability of Pharmaceuticals – A Handbook for Pharmacists (2nd
`
`Edition), John Wiley & Sons, NY (1986), pp. 82-114
`
`
`
`2
`
`
`
`Ex. 1016 Howard C. Ansel, Introduction to Pharmaceutical Dosage Forms,
`
`4th Edition, Lea & Febiger, Philadelphia (1985), pp. 83-116
`
`Ex. 1017 Ho-Leung Fung, Chapter 7 – Chemical Kinetics and Drug
`
`Stability in MODERN PHARMACEUTICS (G.S. Banker and
`
`C.T. Rhodes, eds.), Marcel Dekker, NY (1979), pp. 227-62
`
`Ex. 1018 Miguel-Hidalgo, J., 2000, Current Opinion in CPNS Investigations
`
`Drugs, 2000 2(4):438-453
`
`Ex. 1019 Boccardi G. et al. Photochemical Iron(III)-Mediated Autoxidation
`
`of Dextromethorphan. Chemical & Pharmaceutical Bulletin. Vol.
`
`37, 308–310 (1989)
`
`Ex. 1020 Bateman, L., Olefin Oxidation, Quarterly Review (1954) Vol. 8,
`
`pp. 147–167
`
`Ex. 1021 Linnell, R.H., The Oxidation of Nicotine. I. Kinetics of the Liquid
`
`Phase Reaction Near Room Temperature. Tobacco Science, Vol.
`
`4, pp. 89–91 (1960)
`
`Ex. 1022 Resume/Curriculum Vitae of Agis Kydonieus, Ph.D.
`
`Ex. 1023 Resume/Curriculum Vitae of Christian Schöneich, Ph.D.
`
`
`
`3
`
`
`
`Ex. 1024 U.S. Patent No. 5,602,176, issued Feb. 11, 1997
`
`Ex. 1025 Redacted Copy of Bench Trial Transcript (Day 1). C.A. No. 13-
`
`527, D.I. 154 (D. Del).
`
`Ex. 1026 Redacted Copy of Bench Trial Transcript (Day 2). C.A. No. 13-
`
`527, D.I. 155 (D. Del).
`
`Ex. 1027 Redacted Copy of Bench Trial Transcript (Day 3). C.A. No. 13-
`
`527, D.I. 156 (D. Del).
`
`Ex. 1028 U.S. Patent No. 5,061,480. [Not Filed]
`
`Ex. 1029 Transcript of 1/13/2015 Deposition of Dr. Agis Kydonieus
`
`Ex. 1030 Reserved
`
`Ex. 1031 Reply Declaration of Agis Kydonieus
`
`Ex. 1032 Reply Declaration of Christian Schoneich, Ph.D.
`
`Ex. 1033
`
`Internal Novartis memorandum written by Dr. Tiemessen.
`
`(N0272228-29.)
`
`Ex. 1034
`
`Internal Novartis e-mail communication from Dr. Tiemessen to O.
`
`Garinot. (N0272563.)
`
`Ex. 1035 Meeting Minutes of the LTS-Sandoz (Novartis) Working Group.
`
`
`
`4
`
`
`
`(N0317247-64.)
`
`Ex. 1036 Excerpts of the confidential transcript of the October 17-18, 2012
`deposition of Dr. Henricus L.G.M. Tiemessen.
`
`Ex. 1037 Webster’s II New Riverside University Dictionary, 93, 819 (1994)
`(entries for alkene and olefin)
`
`Ex. 1038 Morrison and Boyd, Organic Chemistry, Chapter 1 Structure and
`Properties & Chapter 5 Alkyl Halides, 1-38 & 165-212 (6th ed.
`
`1992).
`
`Ex. 1039 PDR Medical Dictionary, 1130 (First Edition 1995) (Entry for
`morphine)
`
`Ex. 1040 CRC Handbook of Chemistry and Physics 6-3, 6-6 (David R. Lide
`& H.P.R. Frederikse eds., 78th ed. 1997-1998)
`
`Ex. 1041 U.S. Patent No. 7,683,205
`
`Ex. 1042 U.S. Patent No. 8,324,429
`
`Ex. 1043 Declaration of Christopher J. Coulson
`
`Ex. 1044 Toronto Research Chemicals Inc., rac Rivastigmine-d6 Tartrate
`Salt, available at https://www.trc-canada.com/index.php (Search
`
`the following: “rivastigmine-d6 tartrate” and select
`
`“Details/Order” for rac Rivastigmine-d6 Tartrate Salt) (accessed:
`
`
`
`5
`
`
`
`March 23, 2015).
`
`Ex. 1045 Times of Israel, Alzheimer Drug Pioneer to get Israel Prize (March
`4, 2014), available at www.timesofisrael.com/alzheimer-drug-
`
`pioneer-to-get-israel-prize.
`
`Ex. 1046 Fred W. Billmeyer, Jr., Textbook of Polymer Science, Chapter 9
`Radical Chain (Addition) Polymerization, 280 (2d. ed. 1971).
`
`Ex. 1047
`
`J.E. Leffler, A Short Course of Organic Chemistry, Chapter 4
`
`Functional Groups, 46 (1959).
`
`
`
`
`
`
`
`Dated: March 31, 2015
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/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.
`
`6
`
`
`
`CERTIFICATE OF SERVICE
`
` I
`
` also certify pursuant to 37 C.F.R. §42.6(e) that a copy the foregoing
`
`Exhibit List 2 and copies of Exhibits 1031-1047 were served electronically on
`
`March 31, 2015 pursuant to 37 C.F.R. §42.63(e) to counsel for Patent Owners at
`
`the following email address: ExelonPatchIPR@fchs.com.
`
`
`
`
`
`Dated: March 31, 2015
`
`
`
`
`
`
`
`
`
`
`
`/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.
`
`7
`
`
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