`
`
`Filed on behalf of:
`Mylan Pharmaceuticals Inc.
`Joseph M. Reisman
`Jay R. Deshmukh
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Fax: (949) 760-9502
`Ph.: (949) 760-0404
`E-mail: BoxMylan@knobbe.com
`
`By:
`
`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case No. 2015-00265
`Patent 6,316,023
`
`
`
`
`
`
`
`
`
`
`
`
`CORRECTED EXHIBIT LIST
`
`
`
`
`
`
`Mylan v. Novartis
`IPR2015-00265
`
`
`CORRECTED EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`Ex. 1001
`
`U.S. Patent No. 6,316,023, issued November 13, 2001
`
`Ex. 1002
`
`UK Patent Application GB 2,203,040 A, to Enz, published
`October 12, 1988 (“Enz”)
`
`Ex. 1003
`
`Handbook of Pharmaceutical Excipients, A. Wade and P. J.
`Weller (eds.) 1994, 2nd Edition, The Pharmaceutical Press
`London (the “Handbook”)
`
`Ex. 1004
`
`Japanese Patent Application Publication No. JP 59-184121 to
`Sasaki et al., published October 19, 1984
`
`Ex. 1005
`
`Certified English Translation of Japanese Patent Application
`Publication No. JP 59-184121 to Sasaki et al. (“Sasaki”)
`
`Ex. 1006
`
`PCT Publication No. WO 95/024172 to Ebert et al, published
`September 14, 1995 (“Ebert”)
`
`Ex. 1007
`
`European Patent Application No. 0155 229 A2 to Kissel et al.,
`published September 18, 1985 (“Kissel”)
`
`Ex. 1008
`
`U.S. Patent No. 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.
`
`1
`
`
`
`Mylan v. Novartis
`IPR2015-00265
`
`
`Exhibit No.
`
`Description
`
`Ex. 1012
`
`Ex. 1013
`
`Ex. 1014
`
`Ex. 1015
`
`Ex. 1016
`
`Ex. 1017
`
`Ex. 1018
`
`“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”)
`
`“New acetylcholinesterase inhibitor shows promise in largest
`Alzheimer’s trial to date,” Formulary, Vol. 32, Dec. 1997
`(“Formulary Article”)
`
`ICH Topic Q 1 A, Stability Testing Guidelines: Stability
`Testing of New Drug Substances and Products
`(CPMP/ICH/380/95)
`
`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
`
`Howard C. Ansel, Introduction to Pharmaceutical Dosage
`Forms, 4th Edition, Lea & Febiger, Philadelphia (1985), pp.
`83-116
`
`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.
`
`Carey & Sundberg, ADVANCED ORGANIC CHEMISTRY,
`Part A: Structure and Mechanism, 3rd Edition (Plenum Press,
`NY), pp. 651-727 (1990).
`
`Ex. 1019 Miguel-Hidalgo, J., 2000, Current Opinion in CPNS
`Investigations Drugs, 2000 2(4):438-453
`
`Ex. 1020
`
`Boccardi G. et al. Photochemical Iron(III)-Mediated
`Autoxidation of Dextromethorphan. Chemical &
`Pharmaceutical Bulletin. Vol. 37, 308–310 (1989)
`
`2
`
`
`
`Mylan v. Novartis
`IPR2015-00265
`
`
`Exhibit No.
`
`Description
`
`Ex. 1021
`
`Bateman, L., Olefin Oxidation, Quarterly Review (1954) Vol. 8,
`pp. 147–167
`
`Ex. 1022
`
`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. 1023
`
`Resume/ Curriculum Vitae of Agis Kydonieus, Ph.D.
`
`Ex. 1024
`
`Resume/ Curriculum Vitae of Christian Schöneich, Ph.D.
`
`Ex. 1025
`
`U.S. Patent No. 5,602,176, issued Feb. 11, 1997
`
`3
`
`
`
`Mylan V. Novartis
`IPR Petition - US. Pat. 6,316,023
`
`Respectfully submitted,
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`
`Dated: 1653 Z01 20% By:%W'
`
`oseph M. Reisman
`Reg. No. 43,878
`Customer No. 20,995
`
`Attorneys for Petitioner
`M Y I ,AN PHARMACEUTICALS INC.
`
`(949) 760-0404
`
`
`
`Mylan V. Novartis
`IPR Petition - US. Pat. 6,316,023
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that a true and correct copy of the foregoing CORRECTED
`
`EXHIBIT LIST AND CORRECTED EXHIBITS 1010, 1011, 1018, 1020, AND
`
`1021 are being served on February 20, 2015, Via email pursuant to 37 C.F.R. §
`
`42.6(e) per agreement of the parties,
`
`to counsel
`
`for Novartis AG and LTS
`
`Lohmann Therapie—Systeme AG at the address below:
`
`ExelonPatchIPRngchscom
`
`Raymond R. Mandra
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`
`New York, NY 10104
`
`Dated:
`
`Ill/5’3 Z05 30’;
`
`19241116
`
`
`
`' oseph M. Reisman, Reg. No. 43,878
`Attorney for Petitioner
`Mylan Pharmaceuticals Inc.
`
`
`
`