Paper No. ____
`Filed: September 21, 2016
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`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., and MYLAN INC.,
`LUPIN LTD., and LUPIN PHARMACEUTICALS INC.,
`Petitioner
`v.
`
`
`
`
`
`
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`_________________
`Case IPR2015-00903*
`U.S. Patent 8,129,431
`_________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`* IPR2015-01871 has been joined with this proceeding.
`
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`
`
`Further to 37 C.F.R. § 42.63(e), Patent Owner Senju Pharmaceutical Co.,
`
`Ltd., hereby submits a current listing of Senju Exhibits to counsel for Petitioner
`
`InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc.,
`
`InnoPharma LLC, Mylan Pharmaceuticals Inc., Mylan Inc., Lupin Ltd., and Lupin
`
`Pharmaceuticals Inc. Revised, redacted public versions of Exhibits 2082, 2116 &
`
`2130 were filed and served via email to counsel of record for the Petitioner.
`
`Exhibits
`Exhibit 2001
`
`Exhibit 2002
`
`Exhibit 2003
`
`Exhibit 2004
`
`Exhibit 2005
`
`Exhibit 2006
`
`Exhibit 2007
`
`Exhibit 2008
`
`Exhibit 2009
`
`
`
`Description
`Transcript of Teleconference with the Board, dated April 15,
`2015
`U.S. Patent No. 8,669,290 to Sawa et al., “Aqueous Liquid
`Preparation Containing 2-amino-3-(4-
`bromobenzoyl)phenylacetic acid”
`U.S. Patent No. 8,754,131 to Sawa et al., “Aqueous Liquid
`Preparation Containing 2-amino-3-(4-
`bromobenzoyl)phenylacetic acid”
`U.S. Patent No. 8,871,813 to Sawa et al., “Aqueous Liquid
`Preparation Containing 2-amino-3-(4-
`bromobenzoyl)phenylacetic acid”
`U.S. Patent No. 8,927,606 to Sawa et al., “Aqueous Liquid
`Preparation Containing 2-amino-3-(4-
`bromobenzoyl)phenylacetic acid”
`InnoPharma’s Paragraph IV Notice Letter, dated September
`19, 2014
`InnoPharma’s Paragraph IV Notice Letter, dated October 30,
`2014
`InnoPharma’s Paragraph IV Notice Letter, dated March 27,
`2015
`Complaint, Senju Pharm. Co., Ltd. et al. v. InnoPharma
`Licensing, Inc. et al., No. 14-cv-06893 (D.N.J. November 3,
`2014), ECF No. 1
`
`1
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`Complaint, Senju Pharm. Co., Ltd. et al. v. InnoPharma
`Licensing, Inc. et al., No.15-cv-03240 (D.N.J. May 8, 2015),
`ECF No. 1
`Consolidated Scheduling Order, Senju Pharm. Co., Ltd. et al.
`v. InnoPharma Licensing, Inc. et al., No. 14-cv-06893
`(D.N.J. April 16, 2015), ECF No. 30
`Amended Scheduling Order, Senju Pharm. Co., Ltd. et al. v.
`Lupin, Ltd. et al., No. 14-cv-00667 (D.N.J. February 27,
`2015), ECF No. 63
`Prolensa® (bromfenac ophthalmic solution 0.07%)
`Prescribing Information.
`U.S. Patent No. 5,630,793 to Rowe, “Aqueous Ophthalmic
`Sprays”
`Press Release, Bausch + Lomb, “Bausch + Lomb Receives
`FDA Approval for Prolensa™ (bromfenac ophthalmic
`solution) 0.07%,” dated April 8, 2013
`Lupin’s Paragraph IV Notice Letter, dated December 19,
`2013
`Metrics’ Paragraph IV Notice Letter, dated June 26, 2014
`Paddock’s Paragraph IV Notice Letter, dated December 15,
`2014
`Apotex’s Paragraph IV Notice Letter, dated December 10,
`2014
`Masson et al., “Stabilisation of ionic drugs through
`complexation with non-ionic and ionic cyclodextrins,”
`International Journal of Pharmaceutics 164 (1998)
`Loftsson et al., “Pharmaceutical Applications of
`Cyclodextrins,” Journal of Pharmaceutical Sciences 85:10
`(1996)
`HSBC Global Research Lupin Company Report, February 3,
`2014 (available at http://www.lupin.com/pdf/14/
`20140203%20-%20Lupin%203QFY14%20-%20HSBC.pdf)
`Apotex, “All Products” (available at
`https://www.apotex.com/us/en/products/search.asp?qt=All&
`qs=&t=All%20Products) (visited December 16, 2015)
`Consent Judgment, Senju Pharm. Co., Ltd. et al. v. Apotex
`
`2
`
`Exhibit 2010
`
`Exhibit 2011
`
`Exhibit 2012
`
`Exhibit 2013
`
`Exhibit 2014
`
`Exhibit 2015
`
`Exhibit 2016
`
`Exhibit 2017
`Exhibit 2018
`
`Exhibit 2019
`
`Exhibit 2020
`
`Exhibit 2021
`
`Exhibit 2022
`
`Exhibit 2023
`
`Exhibit 2024
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`Inc. et al., No. 15-cv-00336 (D.N.J. May 18, 2015), ECF No.
`26
`U.S. Patent No. 5,856,345 to Doi et al., “Method for
`Stabilizing Pranoprofen and Stable Liquid Preparation of
`Pranoprofen”
`Xibrom® Prescribing Information
`Bromday® Prescribing Information
`Drugs@FDA, “Listing of FDA-approved bromfenac
`ophthalmic solution 0.09% products” (available at
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.
`cfm?fuseaction=Search.Overview&DrugName=BROMFEN
`AC%20SODIUM) (visited December 16, 2015)
`Sheryl Gay Stolberg, “New Painkiller is Withdrawn After 4
`Deaths,” N.Y. Times, June 23, 1998
`Baklayan et al., “The ocular distribution of 14C-labeled
`bromfenac ophthalmic solution 0.07% in a rabbit model,”
`Clinical Ophthamology 2014:8, 1717-1724 (2014)
`’431 Patent Prosecution History, Amendment and Remarks,
`dated January 15, 2009
`’431 Patent Prosecution History, Information Disclosure
`Statement, dated April 8, 2010
`’431 Patent Prosecution History, Notice of Allowance, dated
`December 23, 2011
`Hans Schott, “Effect of inorganic additives on solutions of
`nonionic surfactants – XVI. Limiting cloud points of highly
`polyoxyethylated surfactants,” Colloids and Surfaces A:
`Physicochemical and Engineering Aspects 186, 129-136
`(2001)
`Transcript of Teleconference with the Board, dated
`December 11, 2015
`James Knittel and Robin Zavod, "Drug Design and
`Relationship of Functional Groups to Pharmacologic
`Activity," in David A. Williams and Thomas L. Lemke eds.
`Foye's Priniciples of Medicinal Chemistry. 5th ed.
`(Lippincott Williams & Wilkins, 2002) 37-67
`W. D. Motherwell et al., "Crystal Structure Prediction of
`Small Organic Molecules: A Second Blind Test," Acta
`3
`
`Exhibit 2025
`
`Exhibit 2026
`Exhibit 2027
`Exhibit 2028
`
`Exhibit 2029
`
`Exhibit 2030
`
`Exhibit 2031
`
`Exhibit 2032
`
`Exhibit 2033
`
`Exhibit 2034
`
`Exhibit 2035
`
`Exhibit 2036
`
`Exhibit 2037
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`Crystallographica Section B. Vol. 58, 2002, 647-661
`G. Marc Loudon, Organic Chemistry. 2nd ed. Menlo Park:
`Benjamin/Cummings, 1988, 1051-1055
`New Drugs in Japan Translation
`Christopher A. Lipinski et al., "Experimental and
`Computational Approaches to Estimate Solubility and
`Permeability in Drug Discovery and Development Settings,"
`Advanced Drug Delivery Reviews Vol. 23, 1997, 3-25
`Andrew Streitwieser and Clayton H. Heathcock, Introduction
`to Organic Chemistry, 3rd ed. (Macmillan, 1985) 696-697
`Andrew Streitwieser and Clayton H. Heathcock, Introduction
`to Organic Chemistry, 3rd ed. (Macmillan, 1985) 456-458
`D. Attwood and A. T. Florence, "Pharmaceutical Aspects of
`Solubilization," Surfactant Systems: Their Chemistry,
`Pharmacy, and Biology (Chapman and Hall, 1983) 293-387
`Drugs@FDA, Voltaren®
`Ronald Breslow and Peter Cambell, “Selective Aromatic
`Substitution Within A Cyclodextrin Mixed Complex,”
`Communications to the Editor, Received February 14, 1969
`Masami Sawada et al., "Measurement of Chiral Amino Acid
`Discrimination by Cyclic Oligosaccharides: A Direct FAB
`Mass Spectrometric Approach," Chemical Communications,
`1998, 1453-1454
`Samik K. Hait and Satya P. Moulik, "Determination of
`Critical Micelle Concentration (CMC) of Nonionic
`Surfactants by Donor-Acceptor Interaction with Iodine and
`Correlation of CMC with Hydrophile-Lipophile Balance and
`Other Parameters of the Surfactants," Journal of Surfactants
`and Detergents Vol. 4 No. 3, 2001, 303-309
`Kyosuke Yamamoto et al., "In Vitro Effect of Triton WR-
`1339 on Canine Plasma High Density Lipoproteins," Journal
`of Lipid Research Vol. 25, 1984, 770-79
`CV of Stephen G. Davies, D.Phil.
`List of Publications of Stephen G. Davies, D.Phil.
`CV of William B. Trattler, M.D.
`Majed Alkharashi et al., "Advances in Cataract Surgery,"
`
`4
`
`Exhibit 2038
`
`Exhibit 2039
`Exhibit 2040
`
`Exhibit 2041
`
`Exhibit 2042
`
`Exhibit 2043
`
`Exhibit 2044
`Exhibit 2045
`
`Exhibit 2046
`
`Exhibit 2047
`
`Exhibit 2048
`
`Exhibit 2049
`Exhibit 2050
`Exhibit 2051
`Exhibit 2052
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`Expert Review of Ophthalmology Vol. 8 No. 5, 2013, 447-
`456
`Ocufen® Product Label (2001)
`Drugs@FDA, Ocufen®
`Drugs@FDA, Profenal®
`Profenal® Product Label (1998)
`Voltaren® Product Label
`Allan J. Flach, "Corneal Melts Associated With Topically
`Applied Nonsteroidal Anti-inflammatory Drugs,"
`Transactions of the American Ophthalmology Society Vol.
`99, 2001, 205-212
`Drugs@FDA, Acular®
`Acular®/ Acular® PF Product Label (2002)
`Drugs@FDA, Acular® PF
`Drugs@FDA, Xibrom®
`Drugs@FDA, Bromday®
`Caroline Debbasch et al., "Evaluation of the Toxicity of
`Benzalkonium Chloride on the Ocular Surface," Journal of
`Toxicology: Cutaneous and Ocular Toxicology Vol. 19 No.
`2-3, 2000, 105-115
`Markman Opinion, Senju Pharm. Co. v. Lupin, Ltd., No.
`1:14-CV-00667-JBS-KMW (D.N.J., November 18, 2015)
`(No. 107)
`Lara C. Pullen, “FDA Approves Prolensa for Cataract
`Surgery Postop Pain,” Medscape, April 8, 2013 (published at
`http://www.medscape.com/viewarticle/782115)
`Definition of Cataract from The Merck Manual of
`Diagnostics and Therapy, 19th ed., (2011)
`Allan J. Flach, "The Incidence, Pathogenesis and Treatment
`of Cystoid Macular Edema Following Cataract Surgery,"
`Transactions of the American Ophthalmology Society Vol.
`96, 1998, 557-634
`Norman S. Jaffe, "History of Cataract Surgery,"
`Ophthalmology, 1996, S5-S16
`C. Janet Giffney and J. O'Connor, "Acid Catalysed
`Hydrolysis of Substituted Acetanilides. Part II," Journal of
`
`5
`
`Exhibit 2053
`Exhibit 2054
`Exhibit 2055
`Exhibit 2056
`Exhibit 2057
`Exhibit 2058
`
`Exhibit 2059
`Exhibit 2060
`Exhibit 2061
`Exhibit 2062
`Exhibit 2063
`Exhibit 2064
`
`Exhibit 2065
`
`Exhibit 2066
`
`Exhibit 2067
`
`Exhibit 2068
`
`Exhibit 2069
`
`Exhibit 2070
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`the Chemical Society Perkin Transactions II, 1975, 1357-
`1360
`D. D. Karve and B. W. Kelkar, "Kinetics of the Hydrolysis
`of Anilides," Proceedings of the Indian Academy of Sciences
`- Section A Vol. 24 No. 2, 1946, 254-260
`P. W. Atkins, General Chemistry (Scientific American
`Books, 1989) 400-405
`Ahmed M. Aman and R. S. Brown, "Equilibrium Formation
`of Anilides from Carboxylic Acids and Anilinesin Aqueous
`Acidic Media," Journal of the American Chemical Society
`Vol. 121 No. 19, 1999, 4598-4607
`E. F. Panarin and M. V. Solovskii, "Acid Hydrolysis of
`Benzylpenicillin Anilides," Pharmaceutical Chemistry
`Journal, 1967, 72-74
`J. W. Barnett and J. O'Connor, "The Acid-Catalysed
`Hydrolysis of Acetanilide," Journal of the Chemical Society,
`Perkin Transactions II, 1973, 220-222
`H. Ślebocka-Tilk, R. S. Brown, and J. Olekszyk, "Reversible
`Formation of Intermediates during Hydronium-Catalyzed
`Hydrolysis of Amides. Observation of Substantial Oxygen-
`18 Exchange in the Hydrolysis of Acetanilide and N-
`Cyclohexylacetamide," Journal of the American Chemical
`Society Vol. 109 No. 15, 1987, 4620-4622
`J. W. Barnett and J. O'Connor, "Evidence for a First Order
`Mechanism in Amide Hydrolysis," Journal of the Chemical
`Society, Chemical Communications, 1972, 525
`Wilson and Gisvold's Textbook of Organic Medicinal and
`Pharmaceutical Chemistry, Ed. John H. Block and John M.
`Beale, 11th ed. (Lippincott Williams & Wilkins, 2004) 84-99
`Ann C. Guidera, Jodi I. Luchs, and Ira J. Udell, "Keratitis,
`Ulceration, and Perforation Associated with Topical
`Nonsteroidal Anti-inflammatory Drugs," Ophthalmology
`Vol. 108 No. 5, 2001, 936-944
`P. J. Pisella, P. Pouliquen, and C. Baudouin, "Prevalence of
`Ocular Symptoms and Signs with Preserved and Preservative
`Free Glaucoma Medication." British Journal of
`Ophthalmology Vol. 86, 2002, 418-423
`
`6
`
`Exhibit 2071
`
`Exhibit 2072
`
`Exhibit 2073
`
`Exhibit 2074
`
`Exhibit 2075
`
`Exhibit 2076
`
`Exhibit 2077
`
`Exhibit 2078
`
`Exhibit 2079
`
`Exhibit 2080
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`Margarita Calogne, "The Treatment of Dry Eye," Survey of
`Ophthalmology Vol. 45 No. 2, 2001, S227-S239
`Robert O. Williams, III, Ph.D., Declaration
`’431 Patent Prosecution History, Preliminary Amendment,
`dated March 20, 2007
`’431 Patent Prosecution History, Office Action, dated
`September 27, 2007
`’431 Patent Prosecution History, Office Action, dated
`June 3, 2009
`U.S. Patent No. 6,395,746 to Cagle, “Methods of Treating
`Ophthalmic, Otic and Nasal Infections and Attendant
`Inflammation”
`InnoPharma Invalidity Contentions for the ’431, ’290, ’131,
`and ’813 patents (May 7, 2015)
`Dr. M. Jayne Lawrence’s Declaration in IPR2015-01099,
`EX1005
`Robert Noecker, "Effects of Common Ophthalmic
`Preservatives on Ocular Health," Advances in Therapy Vol.
`18. No. 5, 2001, 205-215
`Cherukury Madhu et al., "Effect of Benzalkonium
`Chloride/EDTA on the Ocular Bioavailability of Ketorolac
`Tromethamine following Ocular Instillation to Normal and
`De-epithelialized Corneas of Rabbits," Journal of
`Pharmaceutical Sciences Vol. 85 No. 4, 1996, 415-418
`L. Jay Katz, "Twelve-Month Evaluation of Brimonidine-
`Purite Versus Brimonidine in Patients With Glaucoma or
`Ocular Hypertension," Journal of Glaucoma Vol. 11 No. 2,
`2002, 119-126
`Drugs@FDA, Alphagan® P
`Alphagan® P Product Label (2000)
`A. Bianco Prevot et al., "Determination of Micelle/water
`Partition Coefficients of Cosmetic Preservatives," Analytica
`Chimica Acta Vol. 412, 2000, 141-148
`Certified translation of the Japanese counterpart application
`to Ogawa, the ’225 patent
`Excerpt from NDA Disclosing Prolensa® Components
`
`7
`
`Exhibit 2081
`
`Exhibit 2082
`Exhibit 2083
`
`Exhibit 2084
`
`Exhibit 2085
`
`Exhibit 2086
`
`Exhibit 2087
`
`Exhibit 2088
`
`Exhibit 2089
`
`Exhibit 2090
`
`Exhibit 2091
`
`Exhibit 2092
`Exhibit 2093
`Exhibit 2094
`
`Exhibit 2095
`
`Exhibit 2096
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`M. Donbrow, E. Azaz, and A. Pillersdorf, "Autoxidation of
`Polysorbates," Journal of Pharmaceutical Sciences Vol. 67
`No. 12, 1978, 1676-1681
`Declaration of Shirou Sawa
`Rob Lewis and Wynne Evans, Chemistry, 2nd ed. (Palgrave,
`2001) 170-171
`T. Aree & N. Chaichit, “Crystal Structure of B-cyclodextrin-
`benzoic acid inclusion complex,” Carbohydrate Research
`338 (2003) 439-446
`Francis A. Carey, Organic Chemistry, (McGraw-Hill 1987),
`917-920
`Excerpt from NDA of Xibrom®/Bromday® Annual Report in
`2006 [for shelf-life]
`Prolensa® NDA Section 3.2.P.8.1 Stability Summary and
`Conclusions
`Carl R. Noller, "Aromatic Amines and Phosphines,"
`Chemistry of Organic Compounds. 3rd ed. (W.B. Saunders,
`1965) 523-535
`Stephen G. Davies, D.Phil, Declaration
`Paragraph IV Certification List from FDA website (last
`updated October 6 2015)
`Content and Format of an Abbreviated Application, Food
`and Drug Administration, 21 C.F.R. § 314.94
`Watson’s Paragraph IV Notice Letter, dated June 1, 2015
`Components of InnoPharma Generic Bromfenac Product
`from ANDA
`NDA Justification of Specifications (for preservative
`efficacy)
`Certified Translation of Bronuck Package Insert (May 2000)
`Certified Translation of Bronuck Package Insert (June 2002)
`Steven M. Silverstein et al., "The Efficacy of Bromfenac
`Ophthalmic Solution 0.07% Dosed Once Daily in Achieving
`Zero-To-Trace Anterior Chamber Cell Severity following
`Cataract Surgery," Clinical Ophthalmology, 2014, 965-972
`Deposition Transcript of Dr. Paul A. Laskar, dated
`
`8
`
`Exhibit 2097
`
`Exhibit 2098
`Exhibit 2099
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`Exhibit 2100
`
`Exhibit 2101
`
`Exhibit 2102
`
`Exhibit 2103
`
`Exhibit 2104
`
`Exhibit 2105
`Exhibit 2106
`
`Exhibit 2107
`
`Exhibit 2108
`Exhibit 2109
`
`Exhibit 2110
`
`Exhibit 2111
`Exhibit 2112
`Exhibit 2113
`
`Exhibit 2114
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`
`November 4, 2015
`CV of Robert O. Williams, III, Ph.D.
`Declaration of William B. Trattler, M.D.
`John Nichols and Robert W. Snyder, "Topical Nonsteroidal
`Anti-inflammatory Agents in Ophthalmology," Current
`Opinion in Ophthalmology Vol. 9 No. 4, 1998, 40-44
`Thomas R. Walters et al., "Bromfenac Ophthalmic Solution
`0.07% Dosed Once Daily for Cataract Surgery,"
`Ophthalmology Vol. 121 No. 1, 2014, 25-33
`Rajesh K. Rajpal et al., "Bromfenac Ophthalmic Solution for
`the Treatment of Postoperative Ocular Pain and
`Inflammation: Safety, Efficacy, and Patient Adherence,"
`Patient Preference and Adherence, 2014, 925-931
`N. M. Emanuel, G. E. Zaikov, and Z. K. Maizus, Oxidation
`of Organic Compounds: Medium Effects in Radical
`Reactions (Pergamon, 1984) 384-395
`WO Patent No. 00/00179 to Lee “Solid Dispersed
`Preparation of Poorly Water-Soluble Drug Containing Oil,
`Fatty Acid of Mixtures Thereof”
`Stipulated Consent Judgment and Injunction, Senju Pharm.
`Co. v. Metrics, Inc., No. 1:14-CV-03962-JBS-KMW (D.N.J.,
`July 1, 2015) (No. 108)
`Stipulated Consent Judgment and Injunction, Senju Pharm.
`Co. v. Paddock Labs., No. 1:15-CV-00337-JBS-KMW
`(D.N.J., June 5, 2015) (No. 33)
`Nicole Vu, Kevin Nguyen, and Thomas C. Kupiec, “The
`Essentials of United States Pharmacopeia Chapter <51>
`Antimicrobial Effectiveness Testing and Its Application in
`Pharmaceutical Compounding,” International Journal of
`Pharmaceutical Compounding Vol. 13 No. 2, 2014, 123-130
`Declaration of Robert O. Williams, III in Opening Markman
`Brief, Senju Pharm. Co. v. Lupin, Ltd., No. 1:14-CV-00667-
`JBS-KMW (D.N.J., August 10, 2015) (No. 80)
`Reserved
`Reserved
`Reserved
`
`9
`
`Exhibit 2115
`Exhibit 2116
`Exhibit 2117
`
`Exhibit 2118
`
`Exhibit 2119
`
`Exhibit 2120
`
`Exhibit 2121
`
`Exhibit 2122
`
`Exhibit 2123
`
`Exhibit 2124
`
`Exhibit 2125
`
`Exhibit 2126
`Exhibit 2127
`Exhibit 2128
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`
`Reserved
`Declaration of John C. Jarosz
`Patent Owner’s Notice of Cross-Examination of Dr. Paul A.
`Laskar, Ph.D., in IPR2015-00903
`Retraction: Sclera-Choroid-RPE Transport of Eight β-
`Blockers in Human, Bovine, Porcine, Rabbit, and Rat
`Models, Inv. Ophthalmology & Visual Science
`Notice of Retraction: Kadam RS, Vooturi SK, Kompella UB,
`Immunohistochemical and functional characterization of
`peptide, organic cation, neutral and basic amino acid, and
`monocarboxylate drug transporters in human ocular tissues.
`Drug Metabolism and Disposition Vol. 41, 2013, 466-474
`Opinion, Allergan v. Sandoz Inc. et al., Case No. 2014-1275
`(Fed. Cir. August 4, 2015)
`Allergan v. Sandoz Inc. et al., 818 F. Supp.2d 974 (E.D. Tex.
`2011)
`Transcript of Bench Trial before the Honorable Judge T.
`John Ward, Allergan v. Sandoz Inc., Case No. 2:09-cv-00097
`(E.D. Tex. August 3, 2011)
`Transcript of Bench Trial before the Honorable Judge T.
`John Ward, Allergan v. Sandoz Inc., Case No. 2:09-cv-00097
`(E.D. Tex. August 4, 2011)
`Syntex LLC v. Apotex, Inc., 2006 U.S. Dist. LEXIS 36089
`(N.D. Cal. June 2, 2006)
`M. Jayne Lawrence. "Surfactant Systems: Their Use in Drug
`Delivery." Chemical Society Reviews Vol. 23 No. 6, 1994,
`417-424
`Video Deposition Transcript of M. Jayne Lawrence, Senju
`Pharmaceuticals v. Lupin et al., Case Nos. 1:14-cv-00667,
`1:14-cv-04149, 1:14-cv-05144, 1:15-cv-00335, 1:14-cv-
`06893, 1:15-cv-03240 (September 4, 2015)
`James W. Ayres et al. "Absorption and Distribution of
`Radioactivity from Suppositories Containing 3H-Benzocaine
`in Rats." Journal of Pharmaceutical Sciences Vol. 65 No. 6,
`1976, 832-838.
`Andrea Coscelli, “The Importance of Doctors’ and Patients’
`Preferences in the Prescription Decision,” Journal of
`10
`
`Exhibit 2129
`Exhibit 2130
`Exhibit 2131
`
`Exhibit 2132
`
`Exhibit 2133
`
`Exhibit 2134
`
`Exhibit 2135
`
`Exhibit 2136
`
`Exhibit 2137
`
`Exhibit 2138
`
`Exhibit 2139
`
`Exhibit 2140
`
`Exhibit 2141
`
`Exhibit 2142
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`Industrial Economics, Vol. 48, No. 3 (September 2000)
`Andrew Ching and Masakazu Ishihara, Working Paper.
`“Measuring the Informative and Persuasive Roles of
`Detailing on Prescribing Decisions,” May 5, 2008 (available
`at http://w4.stern.nyu.edu/emplibrary/AChing%20Paper.pdf)
`Dana P. Goldman, Geoffrey F. Joyce, and Yuhui Zheng,
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`Health,” JAMA, Vol. 298, No. 1, 2007, 61-69
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`Almudena Arcelus and Thomas Lasky, “An Analysis of the
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`and Economics, Vol. 5, 2002, 3-19
`Ernst R. Berndt, Iain M. Cockburn and Zvi Griliches,
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`University of Chicago Press, 1997)
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`(available at
`
`11
`
`Exhibit 2143
`
`Exhibit 2144
`
`Exhibit 2145
`
`Exhibit 2146
`
`Exhibit 2147
`
`Exhibit 2148
`
`Exhibit 2149
`
`Exhibit 2150
`
`Exhibit 2151
`
`Exhibit 2152
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/20
`3168Orig1s000Approv.pdf ) (viewed November 16, 2015)
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`Review, April 5, 2013 (available at
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/20
`3168Orig1s000SumR.pdf) (viewed November 16, 2015)
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`Inc.,” SunTrust Robinson Humphrey, May 3, 2012
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`HSBC Global Research, February 3, 2014 (available at
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`Empirical Analysis and Strategic Implications,” Management
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`(available at http://innopharmainc.com/who-we-are/)
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`cataract surgery medicine?” (available at
`http://ophthalmologytimes.modernmedicine.com/ophthalmol
`ogytimes/content/tags/brand/brand-vs-generic-which-best-
`cataract-surgery-medicine?page=full) (viewed October 27,
`2015)
`FDA, Acular® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=019700&TABLE1=OB_Rx) (viewed
`November 10, 2015)
`FDA, Voltaren® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=020037&TABLE1=OB_Rx) (viewed
`November 10, 2015)
`
`12
`
`Exhibit 2153
`
`Exhibit 2154
`
`Exhibit 2155
`
`Exhibit 2156
`
`Exhibit 2157
`
`Exhibit 2158
`
`Exhibit 2159
`
`Exhibit 2160
`
`Exhibit 2161
`
`Exhibit 2162
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`FDA, Acular LS® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=021528&TABLE1=OB_Rx) (viewed
`November 10, 2015)
`FDA, Xibrom® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=021664&TABLE1=OB_Disc) (viewed
`November 10, 2015)
`FDA, Nevanac® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=021862&TABLE1=OB_Rx) (viewed
`November 10, 2015)
`FDA, Voltaren Gel® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=022122&TABLE1=OB_Rx) (viewed
`November 10, 2015)
`FDA, Acuvail® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=022427&TABLE1=OB_Rx) (viewed
`November 10, 2015)
`FDA, Ketorolac Tromethamine 0.5%® Orange Book (availale
`at http://www.accessdata.fda.gov/scripts/cder/ob/docs/
`obdetail.cfm?Appl_No=076109&TABLE1=OB_Rx)
`(viewed November 10, 2015)
`FDA, Ketorolac Tromethamine 0.4%® Orange Book (availale
`at http://www.accessdata.fda.gov/scripts/cder/ob/docs/
`obdetail.cfm?Appl_No=077308&TABLE1=OB_Rx)
`(viewed November 10, 2015)
`FDA, Diclofenac Sodium 0.1%® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=078553&TABLE1=OB_Rx) (viewed
`November 10, 2015)
`FDA, Diclofenac Sodium 3%® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=200936&TABLE1=OB_Rx) (viewed
`November 10, 2015)
`FDA, Bromfenac Sodium® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl No=201941&TABLE1=OB Rx) (viewed
`
`13
`
`Exhibit 2163
`
`Exhibit 2164
`
`Exhibit 2165
`
`Exhibit 2166
`
`Exhibit 2167
`
`Exhibit 2168
`
`Exhibit 2169
`
`Exhibit 2170
`
`Exhibit 2171
`
`Exhibit 2172
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`
`November 16, 2015)
`FDA, Bromfenac Sodium® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=202030&TABLE1=OB_Rx) (viewed
`November 16, 2015)
`FDA, Bromfenac Sodium® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=202435&TABLE1=OB_Rx) (viewed
`November 16, 2015)
`FDA, Bromfenac Sodium® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=202620&TABLE1=OB_Rx) (viewed
`November 16, 2015)
`FDA, Prolensa® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=203168&TABLE1=OB_Rx) (viewed
`November 10, 2015)
`FDA, Bromfenac Sodium® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=203395&TABLE1=OB_Rx) (viewed
`November 16, 2015)
`FDA, Ilevro® Orange Book (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.
`cfm?Appl_No=203491&TABLE1=OB_Rx) (viewed
`November 10, 2015)
`FDA, Acular® Orange Book Patent Exclusivity Search
`(available at http://www.accessdata.fda.gov/scripts/cder/ob/
`docs/patexclnew.cfm?Appl_No=019700&Product_No=001
`&table1=OB Rx) (viewed November 10, 2015)
`FDA, Orange Book Patent Exclusivity Search (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexcln
`ew.cfm?Appl_No=020037&Product_No=001&table1=OB_
`Rx) (viewed November 10, 2015)
`FDA, Voltaren® Orange Book Patent Exclusivity Search
`(available at http://www.accessdata.fda.gov/scripts/cder/
`ob/docs/patexclnew.cfm?Appl_No=021664&Product_No=0
`02&table1=OB_Disc) (viewed November 10, 2015)
`FDA, Xibrom and Bromday® Orange Book Patent
`Exclusivity Search (available at http://www.accessdata.fda.
`
`14
`
`Exhibit 2173
`
`Exhibit 2174
`
`Exhibit 2175
`
`Exhibit 2176
`
`Exhibit 2177
`
`Exhibit 2178
`
`Exhibit 2179
`
`Exhibit 2180
`
`Exhibit 2181
`
`Exhibit 2182
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=022122
`&Product_No=001&table1=OB_Rx) (viewed November 10,
`2015)
`Acuvail® Product Label (available at
`http://www.allergan.com/assets/pdf/acuvail_pi.pdf) (viewed
`October 30, 2015)
`Bausch & Lomb Investor Relations (available at
`http://www.bausch.com/our-company/investor-
`relations#.VkphGivz5Kj) (viewed November 16, 2015)
`ISTA Pharmaceuticals Announces Xibrom Shipments
`(available at http://www.bloomberg.com/apps/news?pid
`=newsarchive&sid=atLsoW6E1aTw) (viewed November 16,
`2015)
`Company Overview of Bausch & Lomb (available at
`http://www.bloomberg.com/research/stocks/private/snapshot.
`asp?privcapId=19095) (viewed November 16, 2015)
`Company Overview of Mylan Pharmaceuticals (available at
`http://www.bloomberg.com/research/stocks/private/snapshot.
`asp?privcapId=4222931) (viewed November 16, 2015)
`“FDA Approves Bromday” (available at
`http://www.drugs.com/newdrugs/ista-pharmaceuticals-
`receives-fda-approval-bromday-2374.html) (viewed
`November 16, 2015)
`“FDA Approves Expanded Indication for Xibrom to Treat
`Pain Following Cataract Surgery” (available at
`http://www.drugs.com/news/fda-approves-expanded-
`indication-xibrom-pain-following-cataract-surgery-
`1703.html) (viewed November 16, 2015)
`Xibrom Information (available at
`http://www.drugs.com/pro/xibrom.html) (viewed October
`22, 2015)
`“Pharmaceutical Focus: Getting the Scoop on NSAIDs for
`Cataract Surgery” (available at http://www.eyeworld.org/
`article-getting-the-scoop-on-nsaids-for-cataract-surgery)
`(viewed October 27, 2015)
`IMS Institute for Healthcare Informatics, HSRN Data Brief:
`National Prescription Audit (available at http://www.
`imshealth.com/deployedfiles/ims/global/content/insights/rese
`archers/npa_data_brief.pdf) (viewed October 30, 2015)
`
`15
`
`Exhibit 2183
`
`Exhibit 2184
`
`Exhibit 2185
`
`Exhibit 2186
`
`Exhibit 2187
`
`Exhibit 2188
`
`Exhibit 2189
`
`Exhibit 2190
`
`Exhibit 2191
`
`Exhibit 2192
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`Definition of q.i.d. (on prescription) (available at
`http://www.medicinenet.com/script/main/art.asp?articlekey=
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`Professionals (available at http://www.senju.co.jp/english/
`about/business/mp.html) (viewed November 17, 2015)
`About Senju (available at http://www.senju.co.jp/english/
`about/outline.html (viewed November 17, 2015)
`Senju Company Profile (available at http://www.senju.co.jp/
`english/about/pdf/profile.pdf) (viewed November 17, 2015)
`Contact Mylan (available at https://www.mylan.com/
`en/contact-mylan) (viewed November 17, 2015)
`Iain M. Cockburn and Aslam H. Anis, “Hedonic Analysis of
`Arthritis Drugs,” in Ernst R. Berndt and David M. Cutler,
`eds., Medical Care Output and Productivity (The University
`of Chicago Press, 2001)
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`Ended December 31, 2011
`Judith K. Hellerstein, “The Importance of the Physician in
`the Generic Versus Trade-Name Prescription Decision,”
`RAND Journal of Economics Vol. 29, 1998, 108-136
`Kyle Bagwell, “The Economic Analysis of Advertising” in
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`and Macular Edema by Steroid and Nonsteroidal Anti-
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`“Valeant Pharmaceuticals International Where is the Faith?,”
`October 19, 2015
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`to Valeant,” N.Y. Times, May 27, 2013
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`31, 2014
`Natalie Mizik and Robert Jacobson, “Are Physicians ‘Easy
`Marks’?: Quantifying the Effects of Detailing and Sampling
`
`16
`
`Exhibit 2193
`
`Exhibit 2194
`
`Exhibit 2195
`
`Exhibit 2196
`
`Exhibit 2197
`
`Exhibit 2198
`
`Exhibit 2199
`
`Exhibit 2200
`
`Exhibit 2201
`
`Exhibit 2202
`
`Exhibit 2203
`
`Exhibit 2204
`
`Exhibit 2205
`
`Exhibit 2206
`
`Exhibit 2207
`
`
`
`

`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`on New Prescriptions,” INFORMS Vol. 50, No. 12, 2004,
`1704-715
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`Pharmaceuticals for $500 Million,” N.Y. Times, March 26,
`2012
`Pierre Azoulay, “Do Pharmaceutical Sales Respond to
`Scientific Evidence?,” Journal of Economics and
`Management Strategy Vol. 11, 2002
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`Lomb Completes the Acquisition of ISTA Pharmaceuticals,”
`dated June 6, 2012
`Press Release, Bausch & Lomb Incorporated, “Bausch +
`Lomb Launches PROLENSATM and Showcases Innovative
`Additions to its Surgical Product Portfolio at the ASCRS
`Annual Meeting,”