UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.
`Petitioners
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`
`____________________
`
`
`
`IPR2015-01097 (US Patent No. 8,754,131)
`IPR2015-01099 (US Patent No. 8,669,290)
`IPR2015-01100 (US Patent No. 8,927,606)
`IPR2015-01105 (US Patent No. 8,871,813)1
`____________________
`
`
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`
`
`
`
`
`1 The word-for-word identical paper is filed in each proceeding identified in the
`heading. IPR2016-00089 has been joined with IPR2015-01097; IPR2016-00091 has
`been joined with IPR2015-01100; and IPR2016-00090 has been joined with
`IPR2015-01105. Each of these joined proceedings includes Petitioners InnoPharma
`Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc., Mylan
`Pharmaceuticals Inc., and Mylan Inc. (collectively, “InnoPharma”) in addition to the
`parties identified above.
`
`
`
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.
`Petitioners
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`
`____________________
`
`
`
`IPR2015-01097 (US Patent No. 8,754,131)
`IPR2015-01099 (US Patent No. 8,669,290)
`IPR2015-01100 (US Patent No. 8,927,606)
`IPR2015-01105 (US Patent No. 8,871,813)1
`____________________
`
`
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`
`
`
`
`
`1 The word-for-word identical paper is filed in each proceeding identified in the
`heading. IPR2016-00089 has been joined with IPR2015-01097; IPR2016-00091 has
`been joined with IPR2015-01100; and IPR2016-00090 has been joined with
`IPR2015-01105. Each of these joined proceedings includes Petitioners InnoPharma
`Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc., Mylan
`Pharmaceuticals Inc., and Mylan Inc. (collectively, “InnoPharma”) in addition to the
`parties identified above.
`
`
`
`I. INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioners Lupin Ltd. And Lupin
`
`Pharmaceuticals Inc. (collectively “Petitioners”) hereby submit a current listing of
`
`Petitioner Exhibits to counsel for Patent Owner Senju Pharmaceutical Co., Ltd.,
`
`Bauch & Lomb, Inc., and Bausch & Lomb Pharma Holdings Corp. (collectively
`
`“Patent Owner”).
`
`Exhibit
`#
`
`Description
`
`1001
`
`1002
`
`1003
`
`Sawa et al., U.S. Patent No. 8,669,290, "Aqueous Liquid Preparation
`Containing 2-Amino-3-(4-Bromobenzoyl) Phenylacetic Acid," issued
`March 11, 2014.
`
`Sawa et al., U.S. Patent No. 8,754,131, "Aqueous Liquid Preparation
`Containing 2-Amino-3-(4-Bromobenzoyl) Phenylacetic Acid," issued
`June 17, 2014.
`
`Sawa et al., U.S. Patent No. 8,871,813, "Aqueous Liquid Preparation
`Containing 2-Amino-3-(4-Bromobenzoyl) Phenylacetic Acid," issued
`October 28, 2014.
`
`1004
`
`Sawa et al., U.S. Patent No. 8,927,606, "Aqueous Liquid Preparation
`Containing 2-Amino-3-(4-Bromobenzoyl) Phenylacetic Acid," issued
`January 6, 2015.
`1005 Declaration of Dr. Jayne Lawrence
`1006 Hara, Y., "Bromfenac sodium hydrate," Clinics & Drug Therapy
`19:1014-1015 (2002).
`
`1007
`
`Yanni et al., U.S. Patent No. 5,475,034, "Topically Administrable
`Compositions Containing 3-Benzoylphenylacetic Acid Derivatives for
`Treatment of Ophthalmic Inflammatory Disorders,” issued December 12,
`1995.
`
`1008
`
`FDA Approved “Xibrom™ (bromfenac ophthalmic solution, 0.09%)
`Product Label,” ISTA Pharmaceuticals, Inc.
`
`2
`
`
`
`1009
`
`1010
`
`1011
`
`1012
`
`FDA Approved “BROMDAY™ (bromfenac ophthalmic solution, 0.09%)
`Product Label,” U.S. Approval March 24, 2005, ISTA Pharmaceuticals,
`Inc.
`Ogawa et al., U.S. Patent No. 4,910,225, "Locally Administrable
`Therapeutic Composition for Inflammatory Disease," issued March 20,
`1990.
`Sallmann et al., U.S. Patent No. 6,107,343, "Ophthalmic And Aural
`Compositions Containing Diclofenac Potassium," issued August 22,
`2000.
`
`Desai et al., U.S. Patent No. 5,603,929, "Preserved Ophthalmic Drug
`Compositions Containing Polymeric Quaternary Ammonium
`Compounds," issued February 18, 1997.
`
`1013 Desai et al., U.S. Patent No. 5,558,876, "Topical Ophthalmic Acidic
`Drug Formulations,” issued September 24, 1996.
`
`1014
`
`1015
`
`Fu et al., European Patent Application No. 88114804.3, “Preservative
`System for Ophthalmic Formulations,” published as EP 0 306 984 A1 on
`March 15, 1989.
`Schott, H., "Comparing the Surface Chemical Properties and the Effect of
`Salts on the Cloud Point of a Conventional Nonionic Surfactant,
`Octoxynol 9 (Triton X-100), and of Its Oligomer, Tyloxapol (Triton WR-
`1339)," Journal of Colloid and Interface Science 205: 496-502 (1998).
`
`1016
`
`"Acular®" and "Azopt™," Physician’s Desk Reference, 54:486-487, and
`491-492 (2000).
`1017 Doughty, M., "Medicines Update for optical practitioners - Part 11,"
`Optician, 5853:223 (2002).
`
`FDA approved "ALREX™ (loteprednol etabonate ophthalmic
`suspension) 0.2% Product Label," U.S. Approval: 1998, Bausch &
`Lomb Pharmaceuticals.
`
`FDA approved "LOTEMAX™ (loteprednol etabonate ophthalmic
`suspension) 0.5% Product Label," U.S. Approval: 1998, Bausch & Lomb
`Pharmaceuticals.
`“Alomide®”, Physician’s Desk Reference, 50:469 (1996).
`
`1018
`
`1019
`
`1020
`
`3
`
`
`
`1021
`
`1022
`
`1027
`
`Sallmann et al., U.S. Patent No. 5,891,913, “Ophthalmic and Aural
`Compositions Containing Diclofenac Potassium,” issued April 6, 1999.
`Yasueda et al., U.S. Patent No. 6,274,609, "Aqueous Liquid
`Pharmaceutical Composition Containing as Main Component
`Benzopyran Derivative," issued August 14, 2001.
`1023 Claim Chart, U.S. Patent No. 8,669,290.
`1024 Claim Chart, U.S. Patent No. 8,754,131.
`1025 Claim Chart, U.S. Patent No. 8,871,813.
`1026 Claim Chart, U.S. Patent No. 8,927,606.
`Wong, M., International Patent Application No. PCT/US94/00188,
`“Ophthalmic Compositions Comprising
`Benzyllauryldimethylammonium Chloride,” published July 21, 1994 as
`WO 94/15597.
`Regev et al., "Aggregation Behavior of Tyloxapol, a Nonionic
`Surfactant Oligomer, in Aqueous Solution," Journal of Colloid and
`Interface Science, 210: 8-17 (1999).
`"TOBRADEX®" Physician’s Desk Reference 54: 490-491 (2000).
`Orange Book Listing, Nevanac:
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_
`No= 021862&TABLE1=OB_Rx
`1031 Nevanac Label: http://ecatalog.alcon.com/ PI/Nevanac_us_en.pdf
`1032 Wong, W., U.S. Patent No. 7,834,059, “Topical Nepafenac
`Formulations,” issued November 16, 2010.
`Gamache et al., International Patent No. PCT/US01/25319, “Method of
`Treating Neurodegenerative Disorders of the Retina and Optic Nerve
`Head,” published February 21, 2002 as WO 02/13805.
`
`1028
`
`1029
`
`1030
`
`1033
`
`1034
`
`1035
`
`Gamache et al., U.S. Patent Application Publication No. 2002/0049255,
`“Method of Treating Neurodegenerative Disorders of the Retina and
`Optic Nerve Head,” published April 25, 2002.
`Gamache et al., U.S. Patent No. 6,638,976, “Method of Treating
`Neurodegenerative Disorders of the Retina and Optic Nerve Head,”
`issued October 28, 2003.
`
`4
`
`
`
`1036
`
`1037
`
`1041
`
`1042
`
`1039
`
`Kapin et al., International Patent No. PCT/US01/25318, “Method for
`Treating Angiogenesis-Related Disorders Using Benzoyl Phenylacetic
`Acid,” published February 21, 2002 as WO 2002/13804.
`Patani, G. and LaVoie, E., “Bioisosterism: A Rational Approach in Drug
`Design,” Chem. Rev. 96: 3147-3176 (1996).
`1038 Ostrovskii et al., “Acid-Base Properties of 5-Substituted Tetrazoles,”
`Chemistry of Heterocyclic Compounds, 17:412-416 (1981).
`Bergamini et al., U.S. Patent No. 5,597,560, "Diclofenac And
`Tobramycin Formulations For Ophthalmic And Otis Topical Use," issued
`January 28, 1997.
`1040 Ali et al., U.S. Patent No. 6,071,904, "Process for Manufacturing
`Ophthalmic Suspensions,” issued June 6, 2000.
`Shupe, I., U.S. Patent No. 3,272,700, “Stabilized Aqueous Solution of
`Tetracine Salt,” issued September 13, 1966.
`Guttman et al., "Solubilization of Anti-inflammatory Steroids by
`Aqueous Solutions of Triton-WR-1339," Journal of Pharmaceutical
`Sciences, 50: 305-307 (1961).
`1043 U.S. Patent No. 8,129,431 (App. No. 10/525,006) - PAIR File History
`1044 U.S. Patent No. 8,497,304 (App. No. 13/353,653) - PAIR File History
`1045 U.S. Patent No. 8,669,290 (App. No. 13/687,242) - PAIR File History
`1046 U.S. Patent No. 8,754,131 (App. No. 14/165,976) - PAIR File History
`1047 U.S. Patent No. 8,871,813 (App. No. 14/261,720) - PAIR File History
`1048
`8,927,606 (App. No. 14493903) - PAIR File History
`FDA approved “PROLENSA® Product Label,” approved April 5, 2013,
`Bausch & Lomb Inc.
`“Benzalkonium chloride,” Remington: The Science and Practice of
`Pharmacy, A.R. Gennaro (Ed.), Mack, PA, 1995, p. 1264.
`“Tyloxapol,” Remington: The Science and Practice of Pharmacy, A.R.
`Gennaro (Ed.), Mack, PA, 1995, pp. 1415-1416
`Senju Pharmaceutical Co., Ltd. Press Release, “The approval of
`BRONUCK® (bromfenac sodium hydrate ophthalmic solution) as an
`import drug in China.”
`
`1049
`
`1050
`
`1051
`
`1052
`
`5
`
`
`
`1057
`
`1062
`
`1064
`
`1055
`
`1053 Certified English translation of “Bromfenac sodium hydrate,” Japanese
`Pharmacopoeia 2001, 27-29, Yukuji Nippo Ltd.
`1054 Curriculum Vitae of Dr. Jayne Lawrence
`Fan et al., “Determination of Benzalkonium Chloride in Ophthalmic
`Solutions Containing Tyloxapol by Solid-Phase Extraction and
`Reversed-Phase High-Performance Liquid Chromatography,” J. of
`Pharmaceutical Sciences, 82:11 (November 1993).
`1056 Moser et al., “Comparison of Compendial Antimicrobial Effectiveness
`Tests: A Review,” AAPS PharmaSciTech, 12:222-26 (March 2011).
`Prince et al., “Analysis of Benzalkonium Chloride and its Homologs:
`HPlC versus HPCE,” J. of Pharmaceutical and Biomedical Analysis,
`19:877 (1999).
`1058 Hecht, G., “Ophthalmic Preparations,” Remington: The Science and
`Practice of Pharmacy, 3:1563–1576 (Genaro, A.R. ed., 19th ed. 1995).
`FDA Approved Drug Products web page for Voltaren® by Novartis
`1059
`FDA Approved Drug Products web page for Ocufen®, Allergan
`1060
`FDA Approved Drug Products web page for Profenal® Alcon
`1061
`“Indocin® (Indomethacin)”, Physicians’ Desk Reference, 55:1946-1950
`(2001).
`1063 Walsh et al., “Antiinflamatory Agents,” J. Medicinal Chemistry,
`27:1379-88(1984).
`Lucero, J., U.S. Patent No. 5,504,113, “Enhancement Of Benzalkonium
`Chloride Preservative Activity In Formulations Containing An
`Incompatible Drug,” issued April 2, 1996.
`1065 Amselem et al., U.S. Patent No. 5,747,061, “Suspension of Loteprednol
`Etabonate for Ear, Eye, or Nose Treatment,” issued May 5, 1998.
`Lang et al., Design and Evaluation of Ophthalmic Pharmaceutical
`Products, Modern Pharmaceutics, 415-472 (Banker et al. eds. 4h ed.
`2002).
`Dennis et al., International Patent Application No. PCT/US01/24167,
`“Novel Microemulsion and Micelle Systems for Solubilizing Drugs,”
`published February 7, 2002 as WO 02/09671.
`
`1066
`
`1067
`
`6
`
`
`
`1068
`
`1069
`
`Aviv et al., International Patent Application No. PCT/US93/00044,
`“Submicron Emulsions as Ocular Drug Delivery Vehicles,” published
`March 17, 1994 as WO 94/05298.
`Inada et al., U. S. Patent No. 5,916,550, “Aqueous Suspension of
`Loteprednol Etabonate,” issued June 29, 1999.
`Naka et al., U. S. Patent No. 6,624,193, “Preventive and Therapeutic
`Agents for Eye Diseases,” issued September 23, 2003 (PCT published
`March 15, 2001).
`1071 Guy et al., U. S. Patent No. 5,540,930, “Suspension of Loteprednol
`Etabonate for Ear, Eye or Nose Treatment,” issued July 30, 1996.
`1072 Elworthy et al., “Physiological Activity of Nonionic Surfactants,”
`Nonionic Surfactants, 923-970 (Schick, M. ed., Marcel Dekker 1967)
`1073 Cagle et al., U.S. Patent No. 6,440,964, “Compositions and Methods for
`Treating Ophthalmic and Otic Infections,” issued August 27, 2002.
`“<51> Antimicrobial Effectiveness Testing,” The United States
`1074
`Pharmacopeia, USP 37, Vol. 1 (May 1, 2014).
`1076 Notice of Cross-Examination of John. Jarosz, previously filed as Paper
`30.
`1077 Arise Health Plan
`1078
`2015 Aetna Pharmacy Plan Drug List Three Tier Open
`1079 Urban Article
`1080 Galderma Laboratories v Tolmar
`1081 Rajpal ProPublica
`1082
`Jackson ProPublica
`1083 Donnenfield ProPublica
`1084
`Silverstein ProPublica
`1085 Trattler ProPublica
`Petitioner's Notice of Cross-Examination of Shirou Sawa, previously
`1086
`filed as Paper 30.
`1087 Reserved
`1088 Reserved
`1089 Deposition transcript of John Jarosz, March 16, 2016.
`
`1070
`
`7
`
`
`
`1091
`
`1090 Deposition transcript of Shirou Sawa, March 18, 2016.
`Hunter, et al., “Bromfenac(Duract)-Associated Hepatic Failure
`Requiring Liver Transplantation, American Journal of Gastroenterology
`94, 2299-2301 (1999).
`1092 Helfgott, et al., “Diclofenac-Associated Hepatotoxicity,” Vol. 264, No.
`20, Journal of American Medical Association, pp. 2660-2662 (1990).
`Banks, et al., “Diclofenac-Associated Hepatotoxicity: Analysis of 180
`Cases Reported to the Food and Drug Administration as Adverse
`Reactions,” Hepatology, Vol. 22, No. 3, pp. 820-827 (1995).
`
`1093
`
`1094
`
`Lawrence Reply Declaration
`
`1095
`
`1096
`
`1097
`
`1098
`
`Irwin, US. Patent No. 3,272,700, “Stabilized Aqueous Solution of
`Tetracaine Salt,” issued September 13, 1966.
`The Merck Index, An Encyclopedia of Chemicals, Drugs, and
`Biologicals, Thirteenth Edition, p.1751 (2001).
`Hofmann, U.S. Application Publication No. 2003/0053956, “Alkylaryl
`Polyether Alcohol Polymers for Treatment and Prophylaxis of Snoring,
`Sleep Apnea, Sudden Infant Death Syndrome and for Improvement of
`Nasal Breathing,” published March 20, 2003.
`Summanus Pharma, Inc., et al., International Patent Application No.
`PCT/US02/02240, “Alkyl Aryl Polyether Alcohol Polymers for
`Improvement of Nasal Breathing,” published August 1, 2002 as WO
`2002/058610.
`1099 Deposition transcript of Robert O. Williams, III in IPR2015-00902 and
`IPR2015-00903, March 9, 2016.
`Kennedy, U.S. Patent No. 6,165,445, “Pharmaceutical Compositions
`Containing Alkylaryl Polyether Alcohol Polymer,” issued December 26,
`2006.
`Ghio, et al., U.S. Patent No. 5,474,760, “Method of Inhibiting
`Oxidants Using Alkylaryl Polyether Alcohol Polymers,” issued
`December 12, 1995.
`Ghio, et al., “Synthetic surfactant scavenges oxidants and protects
`against hyperoxic lung injury,” American Physiological Society, pp.
`1217-1223 (1994).
`
`1100
`
`1101
`
`1102
`
`8
`
`
`
`1105
`
`1106
`
`1107
`
`1108
`
`1109
`
`1104
`
`1103 Deposition transcript of Dr. Stephen G. Davies in Senju et al. v. Lupin et
`al., 14-cv-00667, consolidated cases (D.N.J.), February 22, 2016.
`Deposition transcript of Robert O. Williams, III, Ph.D., Senju Pharm.
`Co., Ltd. et al. v. InnoPharma Licensing, Inc. et al., No.14-cv-04149
`(D.N.J.), February 25, 2016.
`Chen, et al., US Patent No. 6,383,471, “Compositions and Methods for
`Improved Delivery of Ionizable Hydrophobic Therapeutic Agents,”
`issued May 7, 2002.
`Herr, “5-Substituted-1H-tetrazoles as Carboxylic Acid Isosteres:
`Medicinal Chemistry and Synthetic Methods,” Bioorganic & Medicinal
`Chemistry 10 (2002) 3379–3393.
`Fassihi, “Preservation of Medicines Against Microbial Contamination,”
`Disinfection, Sterilization, and Preservation, Fourth Ed., Seymour S.
`Block, Ph.D., Lea & Febiger, Chapter 50, pp. 871-886 (1991).
`Sigma-Aldrich Product Information, Benzalkonium Chloride
`Kohn et al., “Effectiveness of Antibacterial Agents Presently Employed
`in Ophthalmic Preparations as Preservatives Against Pseudomonas
`aeruginosa,” Journal of Pharmaceutical Sciences, Vol. 52, No. 10,
`October 1963, pp. 967-674.
`Cherng-Chyi, et al., U.S. Patent No. 5,110,493, “Ophthalmic NSAID
`Formulations Containing a Quaternary Ammonium Preservative and a
`Nonionic Surfactant,” issued May 5, 1992.
`1111 Bowman, et al., U.S. Patent No. 6,265,444, “Ophthalmic Composition,”
`issued July 24, 2001.
`1112 Miyagi, et al., US Patent No. 6,281,224, “Pranoprofen Eyedrops
`Containing Organic Amine,” issued August 28, 2001.
`1113 Gennaro, Remington: The Science and Practice of Pharmacy, 20th ed.
`Pages 830-832
`1114 Deposition transcript of Stephen G. Davies in IPR2015-00902 and
`IPR2015- 00903, February 29, 2016.
`Kirkman, et al., “Isolation and Identification of Bromfenac Glucoside
`From Rat Bile,” Vol. 26, No. 7, Drug Metabolism and Disposition, pp.
`720-723 (1998).
`
`1110
`
`1115
`
`9
`
`
`
`1116
`
`1117
`
`1118
`
`1119
`
`Sawa, U.S. Patent No. 6,274,592, “Method For Stabilizing
`Arylcarboxylic Acid, Stabilizer Thereof And Aqueous Solution
`Containing Stabilized Arylcarboxylic Acid,” issued August 14, 2001.
`Williams, et al., U.S. Patent No. 6,509,028, “Methods And
`Compositions For Treating Pain Of The Mucous Membrane,” issued
`January 21, 2003.
`Inactive Ingredient Guide, Division of Drug Information Resources,
`FDA CDER Office of Management, January 1996.
`Kawabata et al., Canadian Patent No. CA 2 383 971 A1,”Medicaments
`Therapeutique ET Prophylactique Pour Traiter Les Maladies
`Ophtalmiques,” issued May 09, 2000.
`1120 Deposition transcript of William B. Trattler in IPR2015-00902 and
`related cases, February 23, 2016.
`1121 Deposition transcript of John C. Jarosz, IPR2015-00902 and IPR2015-
`00903, dated March 3, 2016.
`1122 Hofmann Reply Declaration
`1123 Deposition transcript of Daryl S. Paulson in IPR2015-00902 and related
`cases, February 19, 2016.
`Ohta et al., “Molecular Characterization of the Gene Operon of Heat
`Shock Proteins HSP60 and HSP10 in Methicillin-Resistant
`Staphylococcus aureus,” Biochemical and Biophysical Research
`Communications, Vol. 193 No. 2, p. 730-737 (June 1993).
`1125 Deposition transcript of Adam C. Myers, IPR2015-00902 and related
`cases, February 24, 2016.
`IPR2015-00903, Senju EX2105 – Davies Declaration in related IPR
`Proceeding
`
`1124
`
`1126
`
`1127
`ISTA Pharm. 2010 Form 10-K
`1128 Bausch + Lomb Press Release, 3/26/12, http://www.bausch.com/our-
`company/newsroom/2012-archive/ista- pharmaceuticals
`1129 Valeant 2014 Form 10-K
`Orange Book Approved Drug Products,
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?A
`ppl_No=021664&TABLE1=OB_Disc
`
`1130
`
`10
`
`
`
`1131
`
`1132
`
`ISTA Nov. 2, 2010 Press Release,
`http://www.sec.gov/Archives/edgar/data/930553/000119312510244
`332/dex991.htm
`
`News Medical Press Release, 11/18/2010, http://www.news-
`medical.net/news/20101118/FDA-grants-three-years-of-marketing-
`exclusivity-to-ISTAs-BROMDAY.aspx
`
`1133
`Patent Owner Confidential Document
`1134 Rx Prescription Products B+L,
`http://www.bausch.com/our-products/rx-pharmaceutical
`Orange Book Approved Drug Products, Patent Data,
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm
`?Appl_No=203168&Product_No=001&table1 =OB_Rx
`1136 Complaint, CA No 15-5591 (D.N.J.).
`1137
`Screen Printout of IPRs for ‘290 and ‘431 Patents.
`
`1135
`
`1140
`
`1138
`
`Facts About Cataract, National Eye Institute,
`https://nei.nih.gov/health/cataract/cataract_facts
`1139 Medscape, Ophthalmic NSAIDs,
`http://reference.medscape.com/drugs/ophthalmic-nsaids
`Patient, Anti-inflammatory Eye Preparations,
`http://patient.info/doctor/anti-inflammatory-eye-preparations
`1141 Valeant Form 10-Q, Q2 2015.
`1142
`IPR2015-001100 DI, Paper 9
`1143 VRX Profile_Valeant Pharm. Intern. Stock – Yahoo! Finance,
`http://finance.yahoo.com/q/pr?s=VRX+Profile
`1144 Valeant Acquisition FAQ’s,
`http://www.valeant.com/about/acquisition-faqs
`1145 Valeant Pharm. CEO Hosts Definitive Agreement to Acquire B+L
`Conference Transcript.
`1146 Udland, Business Insider, Valeant Business Model, June 12, 2014,
`http://www.businessinsider.com/valeant-business-model-2014-6
`
`11
`
`
`
`1147
`
`1148
`
`1149
`
`1150
`
`1151
`
`1152
`
`Valeant Pharm. Internal Management Discusses Q2 2013 Results,
`Earnings Call Transcript, http://seekingalpha.com/article/1614832-
`valeant-pharmaceuticals- international-management-discusses-q2-2013-
`results-earnings-call- transcript?all=true&find=valeant
`Press Release, ISTA Pharm. Receives FDA Approval for Bromday,
`http://www.prnewswire.com/news-releases/ista-pharmaceuticals-
`receives-fda-approval-for-bromday-105100004.html
`Patent Owner Confidential Document
`Prescott et al., Pharmacy Times, Alcon Laboratories, Inc.’s Ilevro,
`Published May 17, 2013.
`B+L Website, Prolensa, http://www.bausch.com/ecp/our-products/rx-
`pharmaceuticals/rx- pharmaceuticals/prolensa-bromfenac-ophthalmic-
`solution
`B+L Website, Prolensa, http://www.bausch.com/our-products/rx-
`pharmaceutical/prolensa- bromfenac-ophthalmic-solution-007/no-
`generic-equivalent-for- prolensa
`B+L Website, About Prolensa, http://www.bausch.com/our-products/rx-
`pharmaceutical/prolensa-bromfenac- ophthalmic-solution-007/about-
`prolensa#.VpO9K_krKUk
`1154 Confidential Patent Owner Document
`Prolensa Co-Pay Assistance, http://www.bausch.com/our-products/rx-
`pharmaceutical/prolensa- bromfenac-ophthalmic-solution-007/co-pay-
`assistance
`Press Release, March 28, 2005,
`http://www.sec.gov/Archives/edgar/data/930553/000119312505063
`654/dex992.htm
`Baklayan, et al., “24-Hour Evaluation of the Ocular Distribution of 14C-
`Labeled Bromfenac Following Topical Instillation into the Eyes of New
`Zealand White Rabbits” Journal of Ocular Pharmacology and
`Therapeutics, pp. 392-98 (2008).
`
`1153
`
`1155
`
`1156
`
`1157
`
`1158
`
`Excerpts from the Deposition Transcript of Tracy Valorie, Senju Pharm.
`Co., Ltd. et al. v. InnoPharma Licensing, Inc. et al., No.14- cv-04149
`(D.N.J.), dated December 17, 2015.
`1159 Reserved
`
`12
`
`
`
`1160
`
`1169
`
`1170
`
`1172
`
`1163
`
`John Jarosz & Robert L. Vigil, “Assessing Commercial Success at the
`U.S. Patent Trial and Appeal Board,” 8 Int’l In-house Counsel Journal
`No. 32, Summer 2015.
`1161 Handbook of Pharmaceutical Excipients, Third Edition, Arthur H.
`Kibbe, Ph.D., ed., pp. 33-35 (2000).
`1162 Mylan Press Release, May 16, 2011.
`Prolensa® (bromfenac ophthalmic solution 0.07%) Prescribing
`Information.
`1164 Xibrom® Prescribing Information.
`1165 Bromday® Prescribing Information.
`1166
`FDA Approval, Nevanac.
`1167
` Handbook of Pharmaceutical Excipients, (Kibbe, 3rd ed. 2000) at 206.
`1168
` Handbook of Pharmaceutical Excipients, (Kibbe, 3rd ed. 2000) at 341.
` Edwards & Prausnitz, "Predicted Permeability of the Cornea to Topical
` Drugs," 18(11) Pharm. Res. 1497-508 (2001).
` Eyjofsson, "Diclofenac Sodium: Oxidative Degradation in Solution and
` Solid State," 26(4) Drug Develop. Indus. Pharm. 451-453 (2000).
`1171 Gu et al., "Light degradation of ketorolac tromethamine," 41 Int'l J.
`Pharms., 105-113 (1988).
`Kennedy, U.S. Patent No. 6,165,445, “Pharmaceutical Compositions
`Containing Alkylaryl Polyether Alcohol Polymer,” issued December 26,
`2000.
`Ghio et al., "Tyloxapol Inhibits NF- kB and Cytokine Release, Scavenges
`HOCl, and Reduces Viscosity of Cystic Fibrosis Sputum," 154 Am. J.
`Respir. Crit. Care Med. 783-88 (1996).
`Schick, ed., “Configuration of the polyoxyethylene chain in bulk,” Non-
`Ionic Surfactants (1967) 753-793.
`Desai et al. International Patent Application No. PCT/US96/01976,
`“Topical Ophthalmic Formulations Comprising an Acidic Drug, Vitamin
`E TPGS, Benzalkonium Chloride and Caffeine,” published as WO
`1996/030022, on October 3, 1996
`1176 DeRuiter, "Non-steroidal Antiinflammatory Drugs (NSAIDs)," Principles
`of Drug Action 2 (Fall 2002).
`
`1173
`
`1174
`
`1175
`
`13
`
`
`
`1178
`
`1179
`
`1177 Remington: The Science and Practice of Pharmacy (Allen, ed., 22nd ed.
`2013) at 922.
`FDA Approval for Prolensa,
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fus
`eaction=Search.DrugDetails
`Attwood et al., “Biological implications of surfactant presence in
`formulations,” Surfactant Systems, Their Chemistry, Pharmacy and
`Biology,” Chapter 7, 1983, pp. 388-468.
`DeLuca et al., “Binding of Quaternary Ammonium Compounds by
`Nonionic Agents,” Interaction of Preservatives With macromolecules
`IV, July 1960, pp. 430-437.
`
`1180
`
`1181 Deposition transcript of Ivan T. Hofmann in IPR2015-00902 and
`IPR2015-00903, March 25, 2016.
`
`1182
`
`Excerpts from the Deposition Transcript of John Jarosz, Senju Pharm.
`Co., Ltd. et al. v. Lupin Ltd. et al., No.14- cv-00667 (D.N.J.), dated
`February 17, 2016.
`
`
`May 18, 2016
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
` /Deborah Yellin/
`Deborah H. Yellin
`Reg. No. 45,904
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
`
`14
`
`
`
`
`
`CERTIFICATION OF SERVICE
`
`The undersigned hereby certifies that the foregoing document entitled
`
`PETITIONERS’ UPDATED EXHIBIT LIST was served electronically via email on
`
`May 18, 2016 to Patent Owner’s counsel of record and counsel of record for
`
`Petitioners InnoPharma at the following:
`
`Patent Owner
`
`Bryan.Diner@finnegan.com
`
`Justin.Hasford@finnegan.com
`
`Joshua.Goldberg@finnegan.com
`
`Petitioners InnoPharma
`
`Jitty.malik@alston.com
`
`bryan.skelton@alston.com
`
`James.abe@alston.com
`
`Lance.soderstrom@alston.com
`
`Joe.janusz@alston.com
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Shannon M. Lentz/
`Shannon M. Lentz
`Reg. No. 65,382
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
`
`15
`
`
`
`May 18, 2016
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