Paper No. ____
`Date Filed: May 12, 2015
`
`Filed On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`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. 2014-005501
`
`U.S. Patent 6,335,031
`
`EXHIBIT LIST 6
`
`1 Case IPR2015-00268 has been joined with this proceeding.
`
`
`Date Filed: May 12, 2015
`
`Filed On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`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. 2014-005501
`
`U.S. Patent 6,335,031
`
`EXHIBIT LIST 6
`
`1 Case IPR2015-00268 has been joined with this proceeding.
`
`
`
`EXHIBIT LIST 6
`
`Pursuant to 37 C.F.R. §42.63(e), Patent Owners Novartis AG and LTS
`
`Lohmann Therapie-Systeme AG submit the following current exhibit list.
`
`Exhibit
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`Description
`Background and Need for the Legislation, House Report of the 112th
`Congress, 1st Session, Rep. 112-98, Part 1, pp. 40-57 (2011),
`reprinted in 2011 U.S.C.C.A.N. 70-87
`
`Novartis Pharm. Corp. v. Watson Labs. Inc., 1:11-cv-01112-RGA (D.
`Del. June 18, 2014) (Trial Opinion)
`
`Novartis Pharm. Corp. v. Watson Labs. Inc., 1:11-cv-01112-RGA (D.
`Del. June 18, 2014) (Trial Opinion)
`
`Novartis Pharm. Corp. v. Watson Labs. Inc., 1:11-cv-01077-RGA (D.
`Del. June 21, 2013) (Order)
`
`Declaration in Support of Patent Owners’ Motion for Pro Hac Vice
`Admission of Charlotte C. Jacobsen Under 37 C.F.R. § 42.10
`
`Declaration of Agis Kydonieus, Ph.D., Filed in IPR2014-00550 as
`Ex. 1010 (not filed)
`
`Declaration of Agis Kydonieus, Ph.D., Filed in IPR2014-00549 as
`Ex. 1010 (not filed)
`U.K. Patent Application No. 2,203,040 A (not filed)
`
`U.S. Patent No. 4,948,807 (not filed)
`Elmalem, E., et al., Antagonism of Morphine-Induced Respiratory
`Depression by Novel Anticholinesterase Agents, 30
`Neuropharmacology 1059 (1991) (not filed)
`
`2011
`
`U.S. Patent No. 6,335,031 (not filed)
`
`1
`
`
`
`Exhibit
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`Description
`Declaration of Alexander M. Klibanov, Ph.D.
`
`Curriculum Vitae of Alexander M. Klibanov, Ph.D.
`
`Guillory, J. & Poust, R., Chemical Kinetics and Drug Stability,
`MODERN PHARMACEUTICS, Chapter 6, 179 (Banker, G & Rhodes, C.,
`eds., 3d ed., 1996)
`
`Minutes SDZ ENA 713 TDS LTS-SANDOZ Working Group
`Meeting (November 28, 1995, Basel), pp. LTS0042712-
`LTS0042732; ENA713 9mg/5cm2, 18mg/10cm2, 27mg/15cm2,
`36mg/20cm2, Transdermal Patch: Drug product pharmaceutical
`development (July 4, 2006), pp. LTS0102239- LTS0102258
`
`Food and Drug Administration, Guidance for Industry, Q3C
`Impurities: Residual Solvents (Dec. 1997)
`
`Remington’s Pharmaceutical Sciences, 1507 (Gennaro, A. et al. eds.,
`18th ed., 1990)
`
`U.S. Patent No. 5,508,038
`
`EMEA, Committee for Proprietary Medicinal Products & Committee
`for Veterinary Medicinal Products, Note for Guidance on Inclusion of
`Antioxidants and Antimicrobial Preservatives in Medicinal Products
`(July 8, 1997)
`
`Ansel, H. et al., PHARMACEUTICAL DOSAGE FORMS AND DRUG
`DELIVERY SYSTEMS, Dosage Form Design, 110 (6th ed., 1995)
`
`Connors, K. et al., CHEMICAL STABILITY OF PHARMACEUTICALS: A
`HANDBOOK FOR PHARMACISTS, Chapter 5: Oxidation, 80 (1979)
`
`2
`
`
`
`Exhibit
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`Description
`Physicians’ Desk Reference, 486-488, 640-644, 672, 680-684, 842-
`845, 878-888, 890-891, 974-975, 1336-1340, 1365-1367, 1413-1414,
`1439-1442, 1553-1554, 1560, 1568-1570, 1572-1576, 1612-1613,
`1623-1624, 1825, 1832-1833, 1878-1881, 1948, 1992-1993, 2007-
`2008, 2015, 2035-2038, 2042-2043, 2233-2234, 2541-2542, 2634-
`2636, 2786, 2872-2874, 2885-2886 (51st ed., 1997) (Entries for
`Prostep®, Nicotrol®, Habitrol®, Duragesic®, Transderm-Scop®,
`Catapres-TTS®, Androderm®, Testoderm®, Deponit®, Minitran®,
`Nitro-Dur®, Transderm-Nitro®, Climara®, Estraderm®, VivelleTM,
`ampicillin, hydroxyzine, meclizine, mirtazapine, benzquinamide,
`dextromethorphan)
`
`U.S. Pharmacopeial Convention, Revision Bulletin, Clonidine
`Transdermal System (Jan. 1, 2011) incorporated into United States
`Pharmacopeia and National Formulary (USP 34-NF 29) Supplement
`2, 5407-5410, Rockville, MD: United States Pharmacopeial
`Convention, 2011
`
`U.S. Patent No. 4,597,961
`
`U.S. Patent No. 6,660,295
`
`Enz, A. et al., Pharmacologic and Clinicopharmacologic Properties of
`SDZ ENA 713, a Centrally Selective Acetylcholinesterase Inhibitor,
`640 Annals N.Y. Acad. Sci. 272 (1991)
`
`Weinstock, M. et al., Pharmacological Evaluation Of Phenyl-
`Carbamates As CNS-Selective Acetylcholinesterase Inhibitors, 43 J.
`Neural Transmission 219 (1994)
`
`2028
`
`Reserved
`
`2029
`
`Excerpts from ’031 Patent Prosecution History: Transmittal and Fee
`Sheet (April 14, 1999), N0000998 – N0001002; Non-Final Office
`Action & Notice of References Cited (May 8, 2000), N0001059 –
`N0001063; Supplemental Information Disclosure Statement (August
`10, 2000), N0001080 – N0001083
`
`3
`
`
`
`Exhibit
`
`2030
`
`2031
`
`2032
`
`Description
`European Patent Application No. 0,193,926
`
`U.S. Patent No. 5,939,095
`
`Project SDZ ENA 713 TDS - Technical Development Plan, pp.
`N0260066-N0260070; Tiemessen Email (December 8, 1997, 1:22
`PM), p. N0821943; Overview LTS-Sandoz cooperation on SDZ ENA
`713 TDS (Exelon ) 1997, pp. N0821944 - N0821949
`
`2033 Main, A., Mode of Action of Anticholinesterases, 6(3) Pharmac.
`Ther. 579 (1979)
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`Larson &Weber, REACTION MECHANISMS IN ENVIRONMENTAL
`ORGANIC CHEMISTRY, Chapter 2: Hydrolysis, 103 (1994)
`
`Chaikin, S., Study of the Hydrolysis of Several Physostigmine
`Analogs, 69(6) J. Am. Chem. Soc. 1266 (1947)
`
`Weinstock, M. et al., Pharmacological Activity of Novel
`Acetylcholinesterase Agents of Potential Use in the Treatment of
`Alzheimer’s Disease, in 29 Advances in Behavioral Biology 539
`(1986)
`
`U.S. Patent No. 5,338,548
`
`Wilson & Gisvold, WILSON AND GISVOLD’S TEXTBOOK OF ORGANIC
`MEDICINAL AND PHARMACEUTICAL CHEMISTRY, 456-457 (Delgado, J.
`& Remers, W. eds., 9th ed. 1991)
`
`Rogers, A. & Smith, G., The Determination of Physostigmine By
`Thin-Layer Chromatography and Ultraviolet Spectrophotometry, 87
`J. Chromatography 125 (1973)
`
`United States Pharmacopeia and National Formulary (USP 20-NF
`15), 624-625, Rockville, MD: United States Pharmacopeial
`Convention, 1980
`
`4
`
`
`
`Exhibit
`
`2041
`
`2042
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`
`Description
`United States Pharmacopeia and National Formulary (USP 22-NF
`17), 1078-1079, Rockville, MD: United States Pharmacopeial
`Convention, 1990
`
`Mabey, W. & Mill, T., Critical Review of Hydrolysis of Organic
`Compounds in Water Under Environmental Conditions, 7(2) J. Phys.
`Chem. Ref. Data 383 (1978)
`
`O’Brien et al., The Reaction of Carbamates with Cholinesterase, 2(6)
`Mol. Pharmacol. 593 (1966)
`
`Aeschlimann, J. & Reinert, M., The Pharmacological Action of Some
`Analogues of Physostigmine, 43 J. Pharmacol. Exp. Ther. 413 (1931)
`
`U.S. Patent No. 1,905,990
`
`Weinstock, M. et al., Antagonism of the Cardiovascular and
`Respiratory Depressant Effects of Morphine in the Conscious Rabbit
`by Physostigmine, 218(2) J. Pharmacol. Exp. Therapeutics 504
`(1981)
`
`List of approved drug products containing the inactive ingredients
`butylated hydroxyanisole, butylated hydroxytoluene, and alpha-
`tocopherol; available at FDA: Inactive Ingredient Search for
`Approved Drug Products,
`http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm (Search the
`following: “butylated”) (results shown at pages 1-3 of 3) (accessed:
`December 20, 2014)
`
`Physicians’ Desk Reference, 2864-2873 (65th ed., 2011) (Entry for
`ButransTM)
`
`Physicians’ Desk Reference, 903-910 (61st ed., 2007) (Entry for
`Emsam®)
`
`Boccardi, G., Autoxidation of Drugs: Predication of Degradation
`Impurities From Results of Reaction with Radical Chain Initiators, 49
`(6) Il Farmaco 431 (1994)
`
`5
`
`
`
`Exhibit
`
`2051
`
`2052
`
`2053
`
`2054
`2055
`
`2056
`
`2057
`
`2058
`
`2059
`
`2060
`
`2061
`
`2062
`
`Description
`Magid, L., Pharmaceutical Aspects of Dextromethorphan
`Hydrobromide, NF. XI: A Safe Non-Narcotic, Effective Antitussive,
`93(5) Drug and Cosmetic Industry 620 (1963)
`
`Physicians’ Desk Reference, 3368-3370 (58th ed., 2004) (Entry for
`Oxytrol®)
`
`August 28, 2013 Trial Testimony of Dr. Tiemessen in Novartis
`Pharms. Corp. et al. v. Watson et al., 11-cv-1077-RGA (D. Del.), pp.
`749-750, 756, 770-771
`
`Declaration of Lisa Butler, Esq.
`
`Redline Version of Default Protective Order
`
`Stipulated Protective Order (Signed March 31, 2015)
`
`Stipulated Protective Order entered in Novartis Pharm. Corp. et al. v.
`Noven Pharmaceuticals, Inc., D. Del. No. 13-CV-527 (RGA)
`
`Prosecution Histories for U.S. Patent Application Nos. 06/835466 and
`07/184541 and U.S. Patent No. 4,948,807
`
`Excerpt from NDA 22-038, Rivastigmine (ENA713-NXA Base) Drug
`substance, p. N0002403
`
`21 C.F.R. § 201.57 (4-1-1997 edition)
`
`August 28, 2013 Trial Testimony of Dr. Tiemessen in Novartis
`Pharms. Corp. et al. v. Watson et al., 11-cv-1077-RGA (D. Del.), pp.
`581, 748, 765-768, 770, 773-775, 777-780
`
`Excerpt from NDA 22-038, Rivastigmine (ENA713-NXA Base) Drug
`substance, pp. N0002374-403 (replacement for Ex. 2059)
`
`6
`
`
`
`Dated: May 12, 2015
`
`Respectfully submitted,
`
`/s/ Raymond R. Mandra
`Raymond R. Mandra
`Registration No. 34,382
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`
`7
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Exhibit List 6 and Exhibit 2062 were
`
`served on May 12, 2015 by causing them to be sent by email to counsel for
`
`Petitioners at the following email addresses:
`
`Steven J. Lee (slee@kenyon.com)
`
`Michael K. Levy (mlevy@kenyon.com)
`
`Chris Coulson (ccoulson@kenyon.com)
`
`Joseph M. Reisman (BoxMylan2@knobbe.com)
`
`Jay R. Deshmukh (BoxMylan2@knobbe.com)
`
`William R. Zimmerman (BoxMylan@knobbe.com)
`
`Dated: May 12, 2015
`
`/s/ Raymond R. Mandra
`Raymond R. Mandra
`Registration No. 34,382
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`8
`
`
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