Paper No. __
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC., LUPIN LTD., and LUPIN
`PHARMACEUTICALS, INC.
`Petitioner,
`
`v .
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`__________________
`
`Case IPR2015-009031
`Patent 8,129,431
`__________________
`
`Filed: March 18, 2016
`__________________
`
`Petitioner’s Updated Exhibit List
`
`
`
`
`
`
`
`1 IPR2015-01871 has been joined with IPR2015-00903.
`
`
`
`

`
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioners InnoPharma Licensing, Inc.,
`
`InnoPharma Licensing LLC, InnoPharma Inc., InnoPharma LLC, Mylan
`
`Pharmaceuticals Inc., Mylan Inc., Lupin Ltd., and Lupin Pharmaceuticals, Inc.
`
`(collectively “Petitioners”) hereby submits 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
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`
`
`Sawa et al., U.S. Patent No. 8,129,431 B2, “Aqueous Liquid
`Preparation Containing 2-Amino-3-(4-Bromobenzoyl) Phenylacetic
`Acid”
`Certified English translation of Hara, Yoshiyuki , “Bromfenac
`sodium hydrate,” Clinics & Drug Therapy 19:1014-1015 (2002)
`
`Declaration of Paul A. Laskar, Ph.D.
`
`Ogawa et al., U.S. Patent No. 4,910,225 “Locally Administrable
`Therapeutic Composition for Inflammatory Disease”
`Desai et al., U.S. Patent No. 5,603,929, “Preserved Ophthalmic Drug
`Compositions Containing Polymeric Quaternary Ammonium
`Compounds”
`Desai, et al., U.S. Patent No. 5,558,876, “Topical Ophthalmic Acidic
`Drug Formulations”
`Certified English translation of “Bromfenac sodium hydrate” in the
`Japanese Pharmacopoeia 2001 Edition: 27-29, Yakuji Nippo
`Limited (2001)
`FDA approved “BROMDAYTM (bromfenac ophthalmic solution,
`.09%) Product Label,” U.S. Approval: March 24, 2005, ISTA
`Pharmaceuticals, Inc.
`Sallmann et al., U.S. Patent No. 6,107,343, “Ophthalmic And Aural
`Compositions Containing Diclofenac Potassium”
`
`1
`
`

`
`
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`
`
`Guttman et al., “Solubilization of Anti-inflammatory steroids by
`Aqueous Solutions of Triton-WR-1339,” Journal of Pharmaceutical
`Sciences 50: 305-307 (1961)
`Fu et al., Australian Patent No. AU-B-22042/88, “Preservative
`System For Ophthalmic Formulations”
`Yasueda et al., U.S. Patent No. 6,274,609, “Aqueous Liquid
`Pharmaceutical Composition Containing as Main Component
`Benzopyran Derivative”
`“Orange Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations,” Appl. No. N203168, U.S. FDA, accessed
`at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?
`Appl_No=203168&Product_No=001&table1=OB_Rx
`“Orange Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations,” Appl. No. N203168, Active Ingredient
`Bromfenac
`Sodium,
`accessed
`at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?App
`l_No=203168&TABLE1=OB_Rx, last accessed on February 14, 2014
`Reserved
`
`Kapin, et al., International Patent No. WO 2002/13804, “Method For
`Treating Angiogenesis-Related Disorders Using Benzoyl
`Phenylacetic Acid”
`Flach, Allan., “Topical Nonsteroidal Antiinflammatory Drugs for
`Ophthalmic Uses,” Ophthalmic NSAIDS: 77-83 (1996)
`Prince, S., et al., “Analysis of benzalkonium chloride and its
`homologs: HPLC versus HPCE,” Journal of Pharmaceutical and
`Biomedical Analysis 19: 877-882, Elsevier Science B.V.,
`Netherlands (1999)
`Bergamini et al., U.S. Patent No. 5,597,560, “Diclofenac And
`Tobramycin Formulations For Ophthalmic And Otis Topical use”
`Wong, Michelle, International Patent No. WO 94/15597, “Ophthalmic
`Compositions Comprising Benzyllauryldimethylammonium Chloride”
`(filed January 11, 1993); issued July 21, 1994)
`Reddy, Indra K., Ocular Therapeutics and Drug Delivery: A Multi-
`Disciplinary Approach: 42-43, 390 (1996)
`Story, M., et al., European Patent No. 0274870, “Micelles containing
`a non-steroidal antiinflammatory compound” (filed December 12,
`1987; issued July 7, 1988)
`
`2
`
`

`
`
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`
`
`“Borax (Sodium tetraborate),” Biochemicals and Reagents: 175,
`Sigma-Aldrich (2000-2001)
`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)
`Regev, O., et al., “Aggregation Behavior of Tyloxapol, a Nonionic
`Surfactant Oligomer, in Aqueous Solution,” Journal of Colloid and
`Interface Science 210: 8-17 (1999)
`Aviv, H., International Patent No. WO 94/05298, “Submicron
`Emulsions as Ocular Drug Delivery Vehicles”
`Gennaro, A., “Boric Acid,” Remington: The Science and Practice of
`Pharmacy 20: 1041, University of Sciences, United States (2000)
`Wade, A., and Weller, P., “Edetic Acid,” and “Sodium
`Metabisulfite,” Handbook of Pharmaceutical Excipients 2: 176-179,
`451-453, American Pharmaceutical Association, United States (1994)
`
`Selected pages from the file history of U.S. Patent No. 8,129,431,
`March 28, 2005 Amendment.
`"DuractTM," Physician’s Desk Reference 52:3035-3037 (1998)
`
`"monohydrate," Webster’s New World Dictionary of the American
`Language: 920, New World Dictionaries / Simon and Schuster (1980)
`"Voltaren," Orange Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations, Appl. No. N020037, U.S. FDA, accessed at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?App
`l No=020037&TABLE1=OB Rx
`Yanni et al., U.S. Patent No. 5,475,034, "Topically Administrable
`Compositions Containing 3-Benzoylphenylacetic Acid Derivatives
`for Treatment of Ophthalmic Inflammatory Disorders"
`for
`"ISTA Pharmaceuticals Submits New Drug Application
`Xibrom™ QD (once-daily), News Release, ISTA Pharmaceuticals
`(December 20, 2007)
`"Acular®" and "Azopt™," Physician’s Desk Reference 54: 486-487,
`491-492 (2000)
`Doughty, M., "Medicines Update for optical practitioners- Part 11.,"
`Optician 5853 (223), (2002)
`
`3
`
`

`
`
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`Fan, T., "Determination of Benzalkonium Chloride in Ophthalmic
`Solutions Containing Tyloxapol by Solid-Phase Extraction and
`Reversed-Phase High-Performance Liquid Chromatography," Journal
`of Pharmaceutical Sciences 82
`(11): 1172-1174, American
`Pharmaceutical Association, United States (1993)
`Guy et al., U.S. Patent No. 5,540,930, "Suspension of Loteprednol
`Etabonate for Ear, Eye, or Nose Treatment" (filed October 25, 1993;
`issued July 30, 1996)
`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
`"TOBRADEX®" Physician’s Desk Reference 54: 490 (2000)
`
`1042
`
`"Alomide® 0.1%" Physician’s Desk Reference 50: 469 (1996)
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`
`
`Kawabata et al., Canadian Patent No. CA 2 383 971 A1,
`"Prophylactic and Therapeutic Medicaments for Ophthalmic Uses"
`Johnson, R., et al., U.S. Patent No. 2,880,130, "Anti-Inflammatory
`Steroid Solutions"
`Johnson, R., et al., U.S. Patent No. 2,880,138, "Anti-Inflammatory
`Steroid Solutions"
`Patani, G., et al., "Bioisoterism: A Rational Approach in Drug
`Design," Chem. Rev. 96: 3147-3176 (1996)
`Ostrovskii, V.A., et al., "Acid-base properties of 5-substituted
`tetrazoles," Chemistry of Heterocyclic Compounds 17: 412-416
`(1981)
`FDA approved "XIBROM™ (bromfenac ophthalmic solution, .09%)
`Product Label," ISTA Pharmaceuticals, Inc.
`Senju Pharmaceutical Co., Ltd. Press Releases, "The approval of
`BRONUCK® (bromfenac sodium hydrate ophthalmic solution) as an
`import drug
`in China," http://www.senju.co.jp/, accessed at
`http://www.senju.co.jp/english/news/__icsFiles/afieldfile/2009/11/1
`8/2009111814br.pdf, published November 17, 2009, 1 page
`FDA approved "PROLENSA™ (bromfenac ophthalmic solution,
`0.07%) Product Label," U.S. Approval: April 5, 2013, Bausch &
`Lomb Incorporated
`
`4
`
`

`
`
`
`1051
`
`1052
`
`1053
`
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`1063
`
`The United States Pharmacopeia 24: The National Formulary 19:
`1809-1813,
`1864-1866, The United States Pharmacopeial
`Convention, Inc. (1999)
`Ali, et al., U.S. Patent No. 6,071,904, "Process for Manufacturing
`Ophthalmic Suspensions"
`Curriculum Vitae of Paul A. Laskar, Ph.D.
`
`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, I
`Reserved
`
`Valeant Q2 2013 Earnings Call Transcript, August 7, 2013, at pg. 4,
`14, 15 (Statements made by Valeant CEO J. Michael Pearson a nd
`CFO, Howard Schiller), at http://seekingalpha.com/article/1614832-
`valeant-pharmaceuticals-international-management-discusses-q2-
`2013-results-earnings-calltranscript?
`all=true&find=valeant.
`Inactive Ingredient Guide, Division of Drug Information Resources,
`FDA CDER Office of Management, January 1996
`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)
`Gennaro, Remington: The Science and Practice of Pharmacy, 20th
`ed. Pages 830-832
`European Pharmacopeia 7.0, Biochemical and Biophysical Research
`Comm., Vol. 193, No. 2, 730-737 (1993)
`Transcript of Deposition of Dr. Stephen G. Davies in Senju et al. v.
`Lupin et al., 14-cv-00667, consolidated cases (D.N.J.) dated Feb. 22,
`2016
`Roger Fu, Cherng-Cyl, European Patent Application Publication
`No. 0 306 984, “Preservative System Forophthalmic
`[sic]
`Formulations”
`Roger F. Cherng-Chyi, et al., U.S. Patent No. 5,110,493,
`“Ophthalmic NSAID Formulations Containing a Quaternary
`Ammonium Preservative and a Nonionic Surfactant”
`
`
`
`5
`
`

`
`
`
`1064
`
`1065
`
`1066
`
`1067
`
`1068
`
`1069
`
`1070
`
`1071
`
`1072
`
`1073
`
`1074
`
`1075
`
`1076
`
`1077
`
`1078
`
`1079
`
`1080
`
`
`
`Lucero, U.S. Patent No. 5,504,113, “Enhancement of Benzalkonium
`Chloride Preservative Activity in Formulations Containing an
`Incompatible Drug”
`Bowman, et al., U.S. Patent No. 6,265,444, “Ophthalmic
`Composition”
`Reserved
`
`Deposition 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.), dated February 25, 2016
`Reserved
`
`Miller, et al., U.S. App. Pub. No. 2008/0274194, “Stabilized HME
`Composition with Small Drug Particles”
`McCoy, et al., US Pat. No. 6,495,120, “Formulation and System for
`Intra-oral Delivery of Pharmaceutical Agents”
` Williams, et al., US Patent No. 6,638,981, “Topical Compositions
`and Methods for Treating Pain”
`
`Williams, et al., US Patent No. 6,509,028, “Methods and
`Compositions for Treating Pain of the Mucous Membrane”
`Cremophor® RH 40, Technical Information, BASF (1997)
`
`Handbook of Pharmaceutical Excipients, Fourth Edition, Rowe,
`Shesky, & Weller, eds. (2003) (Cremophor excerpt)
`Disinfection, Sterilization, and Preservation, Fourth Ed., Seymour S.
`Block, Ph.D. (1991)
`Kohn et al., “Effectiveness of Antibacterial Agents Presently
`Employed in Ophthalmic Preparations as Preservatives Against
`Pseudomonas aeruginosa,” J. of Pharmaceutical Sciences, Vol. 52,
`No. 10, p. 967-974 (October 1963).
`Reserved
`
`Miyagi et al., US Patent No. 6,281,224, “Pranoprofen Eyedrops
`Containing Organic Amine”
`Transcript of Robert O. Williams, III in IPR2015-00902 and
`IPR2015-00903, March 9, 2016
`Transcript of Stephen G. Davies in IPR2015-00902 and IPR2015-
`00903, February 29, 2016
`
`6
`
`

`
`
`
`1081
`
`1082
`
`1083
`
`1084
`
`1085
`
`1086
`
`1087
`
`1088
`
`1089
`
`1090
`
`1091
`
`1092
`
`1093
`
`1094
`
`1095
`
`1096
`
`Transcript of William B. Trattler in IPR2015-00902 and related
`cases, Feb. 23, 2016
`Transcript of Daryl S. Paulson in IPR2015-00902 and related cases,
`Feb. 19, 2016
`Transcript of Adam C. Myers, IPR2015-00902 and related cases,
`Feb. 24, 2016
`Transcript of Mr. Shirou Sawa in IPR2015-00902 and IPR2015-
`00903, March 1, 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)
`Hunter, et al., “Bromfenac(Duract)-Associated Hepatic Failure
`Requiring
`Liver
`Transplantation, American
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`of
`Gastroenterology 94, 2299-2301 (1999)
`stabilizing
`for
`Sawa, US Patent No. 6,274,592, “Method
`arylcarboxylic acid, stabilizer
`thereof and aqueous solution
`containing stabilized arylcarboxylic acid”
`Williams, et al., US Patent No. 6,509,028, “Methods and
`compositions for treating pain of the mucous membrane“
`The Merck Index, Thirteenth Edition, p. 9902 (2001)
`
`Amselem, et al., US Patent No. 5,747,061, “Suspension of
`loteprednol etabonate for ear, eye, or nose treatment”
`Irwin, US. Patent No. 3,272,700, “Stabilized Aqueous Solution of
`Tetracaine Salt”
`Kennedy, U.S. Patent No. 6,165,445, “Pharmaceutical compositions
`containing alkylaryl polyether alcohol polymer “
`Ghio, et al., U.S. Patent No. 5,474,760, “Method of inhibiting
`oxidants using alkylaryl polyether alcohol polymers”
`Ghio, et al., “Synthetic surfactant scavenges oxidants and protects
`against
`hyperoxic lung injury,” American Physiological Society, pp. 1217-
`1223 (1994)
`Chen, et al., US Patent No. 6,383,471, “Compositions and methods
`for improved delivery of ionizable hydrophobic therapeutic agents”
`Herr, “5-Substituted-1H-tetrazoles as Carboxylic Acid Isosteres:
`Medicinal Chemistry and Synthetic Methods,” Bioorganic &
`Medicinal Chemistry 10 (2002) 3379–3393
`
`
`
`7
`
`

`
`
`
`1097
`
`Reserved
`
`1098
`
`Sigma-Aldrich Product Information, Benzalkonium Chloride
`
`1099
`
`Reserved
`
`1100
`
`Reserved
`
`1101
`
`1102
`
`1103
`
`1104
`
`1105
`
`1106
`
`1107
`
`1108
`
`1109
`
`1110
`
`1111
`
`1112
`
`
`
`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
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`Nishihata, et al., US Patent No. 9,107,888, “Aqueous liquid
`bromfenac composition having preservative efficacy”
`Reply Declaration of Dr. Paul Laskar
`
`Hofmann, U.S. App. 2003/0053956, “Alkylaryl polyether alcohol
`polymers for treatment and prophylaxis of snoring, sleep apnea,
`sudden infant death syndrome and for improvement of nasal
`breathing”
`Gennaro, Remington: The Science and Practice of Pharmacy,
`Volume II, 19th Edition, pp. 1415-1416 (1995)
`Handbook of Pharmaceutical Excipients, Third Edition, Arthur H.
`Kibbe, Ph.D., ed., pp. 33-35 (2000)
`Handbook of Pharmaceutical Excipients, Fourth Edition, Rowe,
`Shesky, & Weller, eds., pp. 45-47 (2003)
`Prolensa,
`for
`FDA
`Approval
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fus
`eaction=Search.DrugDetails
`ISTA Pharm. 2010 Form 10-K
`
`Bausch + Lomb Press Release, 3/26/12,
`http://www.bausch.com/our-company/newsroom/2012-archive/ista-
`pharmaceuticals
`Valeant 2014 Form 10-K
`
`8
`
`

`
`
`
`1113
`
`1114
`
`1115
`
`1116
`
`1117
`
`1118
`
`1119
`
`1120
`
`1121
`
`1122
`
`1123
`
`1124
`
`1125
`
`
`
`Orange Book Approved Drug Products,
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?A
`ppl_No=021664&TABLE1=OB_Disc
`
`Nov. 2, 2010 Press Release,
`http://www.sec.gov/Archives/edgar/data/930553/000119312510244
`332/dex991.htm
`
`Mylan Press Release, 5/16/11,
`http://newsroom.mylan.com/press-releases?item=122986
`
`News Medical Press Release, 11/10/10,
`http://www.news-medical.net/news/20101118/FDA-grants-three-
`years-of-marketing-exclusivity-to-ISTAs-BROMDAY.aspx
`
`Patent Owner Confidential Document
`
`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
`
`Complaint, CA No 15-5591 (D.N.J.)
`
`Screen Printout of IPRs for 290 and 431 Patents
`
`Facts About Cataract, National Eye Institute,
`https://nei.nih.gov/health/cataract/cataract_facts
`
`Medscape, Ophthalmic NSAIDs,
`http://reference.medscape.com/drugs/ophthalmic-nsaids
`
`Patient, Anti-inflammatory Eye Preparations,
`http://patient.info/doctor/anti-inflammatory-eye-preparations
`
`Reserved
`
`9
`
`

`
`
`
`1126
`
`1127
`
`1128
`
`1129
`
`1130
`
`1131
`
`1132
`
`1133
`
`1134
`
`1135
`
`1136
`
`
`
`Valeant Form 10-Q, Q2 2015,
`https://www.sec.gov/Archives/edgar/data/885590/00008855901500
`0064/valeantq22015.htm
`
`IPR2015-001100 DI, Paper 9
`
`VRX Profile_Valeant Pharm. Intern. Stock – Yahoo! Finance,
`http://finance.yahoo.com/q/pr?s=VRX+Profile
`
`Valeant Acquisition FAQ’s,
`http://www.valeant.com/about/acquisition-faqs
`
`Valeant Pharm. CEO Hosts Definitive Agreement to Acquire B+L
`Conference Transcript,
`http://seekingalpha.com/article/1464591-valeant-pharmaceuticals-
`ceo-hosts-definitive-agreement-to-acquire-bausch-lomb-holdings-
`conference-transcript?part=single
`
`Business Insider, Valeant Business Model,
`http://www.businessinsider.com/valeant-business-model-2014-6
`
`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
`
`Pharmacy Times, Alcon Laboratories, Inc.’s Ilevro,
`http://www.pharmacytimes.com/publications/issue/2013/may2013/a
`lcon-laboratories-incs-ilevro
`
`FDA Approval, Nevanac,
`
`10
`
`

`
`
`
`1137
`
`1138
`
`1139
`
`1140
`
`1141
`
`1142
`
`1143
`
`1144
`
`1145
`
`1146
`
`1147
`
`1148
`
`1149
`
`1150
`
`
`
`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,
`
`
`Confidential Patent Owner Document
`
`Prolensa Co-Pay Assistance,
`http://www.bausch.com/our-products/rx-pharmaceutical/prolensa-
`bromfenac-ophthalmic-solution-007/co-pay-assistance
`
`Reserved
`
`Reserved
`
`IPR2015-01097 DI, Paper 9
`
`IPR2015-01099 DI, Paper 9
`
`IPR2015-01105 DI, Paper 9
`
`2005,
`28,
`March
`Release,
`Press
`http://www.sec.gov/Archives/edgar/data/930553/000119312505063
`654/dex992.htm
`Verny, WO 2002/058610, “Alkyl Aryl Polyether Alcohol Polymers
`for Improvement of Nasal Breathing”
`Deposition Transcript of John C. Jarosz, IPR2015-00902 and
`IPR2015-00903, dated March 3, 2016
`Declaration of Ivan T. Hofmann
`
`11
`
`

`
`
`
`1151
`
`1152
`
`
`
`Date: March 18, 2015
`
`
`
`
`
`
`
`
`
`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)
`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 Dec. 17, 2015
`
`RESPECTFULLY SUBMITTED,
`
`ALSTON & BIRD LLP
`
`
`
`
`
`
`
`/Jitendra Malik/
`
`Jitendra Malik (Reg. No. 55823)
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Lead Counsel for Petitioner
`
`
`
`
`
`
`12
`
`

`
`
`
`CERTIFICATION OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4) and 42.105, the undersigned
`
`certifies that on the 18th day of March, 2016, a complete copy of the foregoing
`
`Petitioner’s Updated Exhibit List and Exhibits 1054, 1056-1065, 1067, 1069-1076,
`
`1078-1096, 1098, 1101-1124, 1126-1141, and 1144-1152 were served on counsel
`
`of record for the Patent Owner:
`
`Senju Pharmaceutical Co., Ltd., et al.
`
`Bryan C. Diner
`bryan.diner@finnegan.com
`
`Justin J. Hasford
`justin.hasford@finnegan.com
`
`Joshua L. Goldberg
`Joshua.goldberg@finnegan.com
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Reg. No. 50893
`
`
`
`
`
`
`
`

`
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`bryan.skelton@alston.com
`
`Lance Soderstrom
`Reg. No. 65405
`Alston & Bird LLP
`90 Park Avenue
`15th Floor
`New York, NY 10016-1387
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`Reg. No. 61,182
`Alston & Bird LLP
`333 South Hope Street
`16th Floor
`Los Angeles, CA 90071
`james.abe@alston.com
`
`Joseph M. Janusz
`Reg. No. 70396
`ALSTON & BIRD LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28205
`Telephone: 704-444-1000
`Fax: 704-444-1111
`joe.janusz@alston.com
`
`Attorneys for Petitioners InnoPharma
`Licensing, Inc., InnoPharma Licensing LLC,
`InnoPharma Inc., InnoPharma LLC, Mylan
`Pharmaceuticals Inc., and Mylan Inc.
`
`
`
`Deborah H. Yellin (Reg. No. 45,904)
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`
`2
`
`
`
`
`
`

`
`
`
`
`
`Washington, DC 20004-2595
`Telephone No.: (202) 624-2947
`Facsimile No.: (202) 628-5116
`DYellin@Crowell.com
`
`Jonathan Lindsay (Reg. No. 45,810)
`Crowell & Moring LLP
`Intellectual Property Group
`3 Park Plaza, 20th Floor
`Irvine, CA 92614-8505
`Telephone No.: (949) 798-1325
`Facsimile No.: (949) 263-8414
`JLindsay@Crowell.com
`
`Attorneys for Petitioners Lupin Ltd. and
`Lupin Pharmaceuticals, Inc.
`
`
`3