Filed: January 20, 2016
`
`Paper No. 9
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`LOWER DRUG PRICES FOR CONSUMERS, LLC
`
`PETITIONER
`
`V.
`
`FOREST LABORATORIES HOLDINGS LIMITED
`
`PATENT OWNER
`
`___________________
`
`CASE NO.: IPR2016-00379
`PATENT NO. 6,545,040
`FILED: JANUARY 24, 1992
`ISSUED: 4/8/2003
`INVENTORS: XHONNEUX AND VAN LOMMEN
`TITLE: METHOD OF LOWERING THE BLOOD PRESSURE
`___________________
`
`PETITIONER’S UPDATED EXHIBIT LIST AS OF JANUARY 20, 2016
`
`
`
`1
`
`
`
`Paper No. 9
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`LOWER DRUG PRICES FOR CONSUMERS, LLC
`
`PETITIONER
`
`V.
`
`FOREST LABORATORIES HOLDINGS LIMITED
`
`PATENT OWNER
`
`___________________
`
`CASE NO.: IPR2016-00379
`PATENT NO. 6,545,040
`FILED: JANUARY 24, 1992
`ISSUED: 4/8/2003
`INVENTORS: XHONNEUX AND VAN LOMMEN
`TITLE: METHOD OF LOWERING THE BLOOD PRESSURE
`___________________
`
`PETITIONER’S UPDATED EXHIBIT LIST AS OF JANUARY 20, 2016
`
`
`
`1
`
`
`
`Exhibit #
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`Description
`
`U.S. Patent No. 6,545,040 B1 to Xhonneux, et al. (“the
`’040 Patent”), Apr. 8, 2003.
`
`Excerpts of Prosecution History for the ‘040 Patent
`(application No. 07/825,488).
`
`Excerpts of Ex Parte Reexamination Prosecution
`History for the ’040 Patent (Reexamination Request
`90/008,356).
`
`U.S. Patent No. 4,654,362 to Van Lommen et al. (“the
`’362 Patent”), Mar. 31, 1987.
`
`HANDBOOK OF CHROMATOGRAPHY, Vol. II, at 1-101
`(Zweig and Sherma, ed.) (1972).
`
`Yoshio Okamoto, et al., Optical Resolution of β-
`Blockers by HPLC on Cellulose Triphenylcarbamate
`Derivatives, 15 Chemistry Letters at 1237-1240 (1986).
`
`Daniel W. Armstrong, et al., Separation of Drug
`Stereoisomers by the Formation of β-Cyclodextrin
`Inclusion Complexes, 232 SCIENCE at 1132-1135
`(1986).
`
`Daniel W. Armstrong, Chiral Stationary Phases for
`High Performance Liquid Chromatographic Separation
`of Enantiomers: A Mini-Review, 7(S-2) Journal of
`Liquid Chromatography at 353-376 (1984).
`
`Daniel W. Armstrong, et al., Enantiomeric Separations
`in Chromatography, 19 CRC Critical Reviews in
`Analytical Chemistry at 175-190 (1988).
`
`
`
`2
`
`
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`Veronika R. Meyer, PRACTICAL HIGH-PERFORMANCE
`LIQUID CHROMATOGRAPHY, (Valerie Cottrell
`translation), Ch. 22 at 246-253 (1988).
`
`Veronika R. Meyer, PRACTICAL HIGH-PERFORMANCE
`LIQUID CHROMATOGRAPHY, (Valerie Cottrell
`translation), Ch. 25 at 269-301 (1988).
`
`Stig G. Allenmark, CHROMATOGRAPHIC
`ENANTIOSEPARATION – METHODS AND APPLICATIONS,
`Ch. 4 at 42-63 (1988).
`
`Stig G. Allenmark, CHROMATOGRAPHIC
`ENANTIOSEPARATION – METHODS AND APPLICATIONS,
`Ch. 5 at 64-74 (1988).
`
`Stig G. Allenmark, CHROMATOGRAPHIC
`ENANTIOSEPARATION – METHODS AND APPLICATIONS,
`Ch. 7 at 90-145 (1988).
`
`Stig G. Allenmark, CHROMATOGRAPHIC
`ENANTIOSEPARATION – METHODS AND APPLICATIONS,
`Ch. 8.3 at 158-177 (1988).
`
`Chiral Phase HPLC Columns, Bakerbond™, J.T. Baker
`Research Products (1983).
`
`G. Gŭbitz and S. Mihellyes, Optical Resolution of β-
`blocking Agents by Thin-layer Chromatography and
`High-Performance Liquid Chromatography as
`Diastereomic R-(--)-1-(1-naphthyl)ethylureas, 314
`Journal of Chromatography at 462-466 (1984).
`
`W. Lindner, et al., Liquid Chromatographic Separation
`of Enantiomeric Alkanolamines via Diastereomeric
`Tartaric Acid Monoesters, 316 Journal of
`Chromatography at 605-616 (1984).
`
`
`
`3
`
`
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`Jorgen Hermansson, Resolution of Racemic
`Aminoalcohols β-Blockers), Amines and Acids as
`Enantiomeric Derivatives Using a Chiral α1-Acid
`Glycoprotein Column, 325 Journal of Chromatography
`at 379-384 (1985).
`
`Gȍran Schill, et al., Chiral Separations of Cationic and
`Anionic Drugs on an α1-Acid Glycoprotein-Bonded
`Stationary Phase (Enantiopac®), II. Influence of
`Mobile Phase Additives and pH on Chiral Resolution
`and Retention, 365 Journal of Chromatography at 73-88
`(1986).
`
`CYCLOBOND HANDBOOK, Advanced Separation
`Technologies Inc. (1987).
`
`M. Krstulovic, et al., Direct Enantiomeric Separation of
`Betaxolol with Applications to Analysis of Bulk Drug
`and Biological Samples, 452 Journal of
`Chromatography, at 477-483 (1988).
`
`CHIRAL SEPARATIONS, (D. Stevenson and I. D. Wilson,
`eds., 1988) (excerpts).
`
`H. Y. Aboul-Enein and I. Ali, HPLC enantiomeric
`resolution of nebivolol on normal and reversed amylose
`based chiral phases, 56 Pharmazie, at 214-216 (2001).
`
`Imran Ali and Hassa Y. Aboul-Enein,
`Enantioseparation of some clinically used drugs by
`HPLC using cellulose Tris (3,5-
`dichlorophenylcarbamate) chiral stationary phase, 17
`Biomed. Chromatogr. at 113-117 (2003).
`
`L. A. Fingerhut, et. al., Health and Disease in the
`United States, 1 Ann. Rev. Public Health at 1-36
`(1980).
`
`David S. Goldstein, Plasma Catecholamines and
`Essential Hypertension – an Analytical Review, 5
`HYPERTENSION at 86-99 (1983).
`
`
`
`4
`
`
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`Edward Freis, M.D., Validity of Therapy For Mild
`Hypertension, 30 Ann. Rev. Med. at 81-89 (1979).
`
`L.H. Opie, Hypertension in General Practice, Part I.
`Examination and Investigation of a Patient with
`Hypertension, SA MEDICAL JOURNAL at 955-960
`(1980).
`
`William B. Stason, Opportunities for Improving the
`Cost-Effectiveness of Antihypertensive Treatment, 81
`The American Journal of Medicine at 45-49 (1986).
`
`Van de Water, et al. Cardiovascular effects of dl-
`nebivolol and its enantiomers – a comparison with
`those of atenolol, 156 European Journal of
`Pharmacology at 95-103 (1988).
`
`David B. Bylund, Adrenergic Receptors: Historical
`Perspectives From the 20th Century, The Adrenergic
`Receptors in the 21st Century, Chapter 1 (Dianne M.
`Perez, ed., 2006).
`
`Noboru Toda, et al., Selectivity and Steric Effects of
`Metoprolol Isomers on Isolated Rabbit Atria, Arteries
`and Tracheal Muscles, 207 The Journal of
`Pharmacology and Experimental Therapeutics at 311-19
`(1978).
`
`Keitaro Hashimoto, The Relation Between the Current
`Underlying Pacemaker Activity and Beta-
`Adrenoceptors in Cardiac Purkinje Fibres: A Study
`Using Adrenaline, Procaine, Atenolol and Penbutolol,
`307 Naunyn-Schmiedeberg’s Arch. Pharmacol. at 9-19
`(1979).
`
`J. Kaumann and J. R. Blinks, Stimulant and Depressant
`Effects of β-Adrenoceptor Blocking Agents on Isolated
`Heart Muscle, 311 Naunyn-Schmiedeberg’s Arch.
`Pharmacol. at 205-218 (1980).
`
`
`
`5
`
`
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`James E. Clifton, et al., Arylethanolamines Derived
`from Salicylamide with α- and β-Adrenoceptor Blocking
`Activities. Preparation of Labetalol, Its Enantiomers,
`and Related Salicylamides, 25 Journal of Medicinal
`Chemistry at 670-679 (1982).
`
`David E. McClure, et al., Antihypertensive β-
`Adrenergic Blocking Agents: N-Aralkyl Analogues of
`2-[3](tert-Butylamino)-2-Hydroxypropoxy]-3-
`cyanopyridine, 26 Journal of Medicinal Chemistry at
`649-657 (1983).
`
`A.B. Jeppsson, et al.,Steric Aspects of Agonism and
`Antagonism at β-adrenoceptors; Experiments with the
`Enantiomers of Terbutaline and Pindolol, 54 Acta
`Pharmacol. et Toxicol. at 285-291 (1984).
`
`Arthur A. Hancock, Analysis of the Hypotensive Effects
`of Medroxalol and Its Enantioners, Clin. and Exper.
`Hyper.-Theory and Practice, A6(3), at 659-684 (1984).
`
`Kazuo Honda, et al., Adrenoceptor Blocking and
`Cardiovasucular Effects of the Optical Isomers of
`Amosulalol (YM-09538), a Combined α- and β-
`Adrenoceptor Blocking Agent, and the Corresponding
`Desoxy Derivative (YM-11133) in Rats, 41 Japan. J.
`Pharmacol. at 459-466 (1986).
`
`Petrus J. Pauwels, et al., The Receptor Binding Profile
`of the New Antihypertensive Agent Nebivolol and Its
`Stereoisomers Compared With Various β-Adrenergic
`Blockers, 34 Molecular Pharmacology at 843-861
`(1988).
`
`Van de Water, et al., Pharmacological and
`Hemodynamic Profile of Nebivolol,* a Chemically
`Novel, Potent, and Selective β1-Adrenergic Antagonist,
`11 Journal of Cardiovascular Pharmacology at 552-563
`(1988).
`
`
`
`6
`
`
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`Raymond Xhonneux, et al., The l-enantiomer of
`nebivolol potentiates the blood pressure lowering effect
`of the d-enantiomer, 181 European Journal of
`Pharmacology at 261-265 (1990).
`
`G. Van Lomen, et al., Synthesis and Pharmacological
`Properties of Nebivolol, a new antihypertensive
`compound, 45 Journal de pharmacie de Belgique at 355-
`360 (1990).
`
`M. Midol-Monet, Cardiovascular Effects of
`intracerebroventricular Injections of (+)-Nebivolol and
`its Enantiomers—a Comparison with those of
`Metoprolol in the Rat, 43 J. Pharm. Pharmacol. at 504-
`509 (1991).
`
`Van Peer, et al., Clinical Pharmacokinetics of
`Nebivolol A Review, 3 Drug Investigation at 25-30
`(1991).
`
`Carsten D. Siebert, et al., Stereochemical Comparison
`of Nebivolol with other β-Blockers, 20 Chirality at 103-
`109 (2008).
`
`Irving W. Wainer and Thomas D. Doyle, Stereisomeric
`Separations, 2 LC Magazine (1984).
`
`Actavis UK Limited and Janssen Pharmaceutica N.V.,
`Case No: HC0700 572 (2008),In the High Court of
`Justice, Chancery Division, Patent Court (UK), 2008
`EWHC 1422 (Pat).
`
`Declaration under 37 CFR § 42.53(a) by Dr. Daniel W.
`Armstrong (Dec. 10, 2015).
`
`Daniel W. Armstrong Curriculum Vitae (2015).
`
`Declaration under 37 CFR § 42.53(a) by Ronald W.
`Millard, Ph.D. (Dec. 11, 2015).
`
`Ronald Wesley Millard Curriculum Vitae (Dec. 2015).
`
`
`
`7
`
`
`
`1054
`
`1055
`
`Declaration of Donald Puckett in Support of
`Unopposed Motion for Pro Hac Vice Admission
`
`Declaration of John P. Murphy in Support of
`Unopposed Motion for Pro Hac Vice Admission
`
`
`Dated: January 20, 2016
`
`
`
`
`Respectfully Submitted,
`
`
`
`/s/ Barry J. Bumgardner
`Barry J. Bumgardner (Lead Counsel)
`Registration No. 38,397
`Brent N. Bumgardner (Back-up Counsel)
`Registration No. 48,476
`Attorneys for Patent Owner
`NELSON BUMGARDNER, P.C.
`3131 W. 7th Street, Suite 300
`Fort Worth, Texas 76107
`Telephone: (817) 377-9111
`Facsimile: (817) 377-3485
`
`
`
`8
`
`
`
` CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing document was
`
`electronically filed through the Patent Review Processing System on January 20,
`
`2016, thereby causing all counsel of record who have consented to electronic
`
`service to receive an email notice of the filing. In addition, the following attorneys
`
`of record were separately served by email with a copy of the foregoing document:
`
` /s/ Barry Bumgardner
`
`
`
`
`
`
`
`Jeffrey P. Kushan (jkushan@sidley.com)
`Todd L. Krause (tkrause@sidley.com)
`Sidley Austin LLP
`
`
`
`Date: January 20, 2016
`
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