Paper No. ____
`Filed: May 5, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner
`_________________
`Case IPR2015-01100
`U.S. Patent 8,927,6061
`_________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
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`1 Case IPR 2016-00091 has been joined with this proceeding.
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`

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`Case IPR2015-01100
`U.S. Patent 8,927,606
`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
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. Public Exhibit 2323 was filed on the
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`PRPS and served via email to counsel of record for the Petitioner. Confidential
`
`Exhibit 2323 was filed on the PRPS as “BOARD AND PARTIES ONLY” and
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`served on Petitioner Counsel Deborah Yellin , Jonathan Lindsay, Jitendra Malik,
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`Lance Soderstrom, and Hidetada James Abe, who were the only counsel that
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`executed the Acknowledgment Form of the Proposed Stipulation Order.
`
`Description
`Exhibits
`Exhibit 2001 U.S. Patent No. 8,129,431 to Sawa et al., “Aqueous Liquid
`Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic
`acid.”
`Exhibit 2002 Lupin’s Paragraph IV Notice Letter dated December 19, 2013.
`Exhibit 2003 Lupin’s Paragraph IV Notice Letter dated May 13, 2014.
`Exhibit 2004 Lupin’s Paragraph IV Notice Letter dated July 3, 2014.
`Exhibit 2005 Lupin’s Paragraph IV Notice Letter dated December 17, 2014.
`Exhibit 2006 Lupin’s Paragraph IV Notice Letter dated February 19, 2015.
`Exhibit 2007 Complaint, Senju Pharm. Co., Ltd. et al. v. Lupin, Ltd. et al., No.
`14-cv-00667 (D.N.J. Jan. 31, 2014), ECF No. 1.
`Exhibit 2008 Complaint, Senju Pharm. Co., Ltd. et al. v. Lupin, Ltd. et al., No.
`14-cv-04149 (D.N.J. June 26, 2014), ECF No. 1.
`Exhibit 2009 Complaint, Senju Pharm. Co., Ltd. et al. v. Lupin, Ltd. et al., No.
`14-cv-05144 (D.N.J. Aug. 15, 2014), ECF No. 1.
`Exhibit 2010 Complaint, Senju Pharm. Co., Ltd. et al. v. Lupin, Ltd. et al., No.
`15-cv-00335 (D.N.J. Jan. 16, 2015), ECF No. 1.
`Exhibit 2011 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.
`Exhibit 2012 Amended scheduling order, Senju Pharm. Co., Ltd. et al. v.
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`1
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`

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`Exhibit 2016
`
`Exhibit 2015
`
`Case IPR2015-01100
`U.S. Patent 8,927,606
`Lupin, Ltd. et al., No. 14-cv-00667 (D.N.J. Feb. 27, 2015), ECF
`No. 63.
`Exhibit 2013 U.S. Patent No. 5,630,793 to Rowe, “Aqueous Ophthalmic
`Sprays.”
`Exhibit 2014 Press Release by Bausch + Lomb, dated April 8, 2013, entitled
`“Bausch + Lomb Receives FDA Approval for Prolensa™
`(bromfenac ophthalmic solution) 0.07%.”
`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.
`Exhibit 2017
`InnoPharma’s Paragraph IV Notice Letter dated June 12, 2015.
`Exhibit 2018
`Exhibit 2019 Metrics’ Paragraph IV Notice Letter dated June 26, 2014.
`Exhibit 2020 Paddock’s Paragraph IV Notice Letter dated December 15, 2014.
`Exhibit 2021 Paddock’s Paragraph IV Notice Letter dated January 20, 2015.
`Exhibit 2022 Apotex’s Paragraph IV Notice Letter dated December 10, 2014.
`Exhibit 2023 Watson’s Paragraph IV Notice Letter dated June 1, 2015.
`Exhibit 2024 Masson et al., Stabilisation of ionic drugs through complexation
`with non-ionic and ionic cyclodextrins, 164 INT’L J.
`PHARMACEUTICS 45 (1998).
`Exhibit 2025 Loftsson et al., Pharmaceutical Applications of Cyclodextrins, 85
`J. PHARMACEUTICAL SCIENCES 1017 (1996).
`Exhibit 2026 HSBC Global Research Lupin Company Report, Feb. 3, 2014,
`http://www.lupin.com/pdf/14/20140203%20-
`%20Lupin%203QFY14%20-%20HSBC.pdf
`Exhibit 2027 Consent judgment, Senju Pharm. Co., Ltd. et al. v. Apotex Inc. et
`al., No. 15-cv-00336 (D.N.J. May 18, 2015), ECF No. 26.
`Exhibit 2028 Consent judgment, Senju Pharm. Co., Ltd. et al. v. Paddock
`Labs., LLC et al., No. 15-cv-00337 (D.N.J. June 5, 2015), ECF
`No. 33.
`Exhibit 2029 Consent judgment, Senju Pharm. Co., Ltd. et al. v. Metrics, Inc. et
`al., No. 14-cv-03962 (D.N.J. July 1, 2015), ECF No. 108.
`Exhibit 2030 U.S. Patent No. 5,856,345 to Doi et al., “Method for Stabilizing
`Pranoprofen and Stable Liquid Preparation of Pranoprofen.”
`
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`2
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`Case IPR2015-01100
`U.S. Patent 8,927,606
`Exhibit 2031 Drugs@FDA, Listing of FDA-approved bromfenac ophthalmic
`solution 0.09% products,
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
`fuseaction=Search.Overview&DrugName=BROMFENAC%20S
`ODIUM.
`Exhibit 2032 Sheryl Gay Stolberg, New Painkiller is Withdrawn After 4
`Deaths, N.Y. TIMES, Jun. 23, 1998.
`Exhibit 2033 Baklayan et al., The ocular distribution of 14C-labeled bromfenac
`ophthalmic solution 0.07% in a rabbit model, CLINICAL 2014:8
`OPHTHALMOLOGY 1717 (2014).
`Exhibit 2034 Schott, Effect of inorganic additives on solutions of nonionic
`surfactants – XVI. Limiting cloud points of highly
`polyoxyethylated surfactants, 186 COLLOIDS AND SURFACES A:
`PHYSICOCHEMICAL AND ENGINEERING ASPECTS 129 (2001).
`Exhibit 2035 European Patent No. 0274870 to Story, M., et al., “Micelles
`containing a non-steroidal antiinflammatory compound” (filed
`December 12, 1987; issued July 7, 1988).
`Exhibit 2036 Reddy, Indra K., Ocular Therapeutics and Drug Delivery: A
`Multi-Disciplinary Approach, 42-43, 390 (1996).
`Exhibit 2037 Declaration of Uday B. Kompella in Support of Plaintiffs’
`Proposed Claim Constructions, Insite Vision Inc. et al. v. Sandoz
`Inc. et al., No. 11-cv-03080, 2012 WL8667473 (D.N.J. April 12,
`2012).
`Exhibit 2038 Transcript of Teleconference with the Board, dated December 11,
`2015
`Exhibit 2039 Reserved
`Exhibit 2040 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.
`Exhibit 2041 Andrew Streitwieser and Clayton H. Heathcock, Introduction to
`Organic Chemistry, 3rd ed. (Macmillan, 1985) 696-697.
`Exhibit 2042 Andrew Streitwieser and Clayton H. Heathcock, Introduction to
`Organic Chemistry, 3rd ed. (Macmillan, 1985) 456-458.
`Exhibit 2043 D. Attwood and A. T. Florence, "Pharmaceutical Aspects of
`Solubilization," Surfactant Systems: Their Chemistry, Pharmacy,
`and Biology. (Chapman and Hall, 1983) 293-387.
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`Case IPR2015-01100
`U.S. Patent 8,927,606
`
`Exhibit 2044 Drugs@FDA, Voltaren®.
`Exhibit 2045 Ronald Breslow and Peter Cambell, “Selective Aromatic
`Substitution Within A Cyclodextrin Mixed Complex”,
`Communications to the Editor. Received Feb. 14, 1969.
`Exhibit 2046 Masami Sawada et al., "Measurement of Chiral Amino Acid
`Discrimination by Cyclic Oligosaccharides: A Direct FAB Mass
`Spectrometric Approach," Chemical Communications, 1998,
`1453-1454.
`Exhibit 2047 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.
`Exhibit 2048 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.
`Exhibit 2049 CV of Stephen G. Davies, D.Phil.
`Exhibit 2050 List of Publications of Stephen G. Davies, D.Phil.
`Exhibit 2051 CV of William B. Trattler, MD
`Exhibit 2052 Majed Alkharashi et al., "Advances in Cataract Surgery," Expert
`Review of Ophthalmology Vol. 8 No. 5, 2013, 447-456.
`Exhibit 2053 Ocufen® Product Label (2001)
`Exhibit 2054 Drugs@FDA, Ocufen®
`Exhibit 2055 Drugs@FDA, Profenal®
`Exhibit 2056 Profenal® Product Label (1998)
`Exhibit 2057 Voltaren® Product Label
`Exhibit 2058 Allan J. Flach, "Corneal Melts Associated With Topically
`Applied Nonsteroidal Anti-inflammatory Drugs," Transactions of
`the American Ophthalmology Society Vol. 99, 2001, 205-212.
`Exhibit 2059 Drugs@FDA, Acular®
`Exhibit 2060 Acular®/ Acular® PF Product Label (2002)
`Exhibit 2061 Drugs@FDA, Acular® PF
`Exhibit 2062 Drugs@FDA, Xibrom®
`Exhibit 2063 Drugs@FDA, Bromday®
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`4
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`Case IPR2015-01100
`U.S. Patent 8,927,606
`Exhibit 2064 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.
`Exhibit 2065 Markman Opinion, Senju Pharm. Co., Ltd. v. Lupin Ltd., No.
`1:14-CV-00667-JBS-KMW (D.N.J., dated November 18, 2015)
`(No. 107).
`Exhibit 2066 Lara C. Pullen, “FDA Approves Prolensa for Cataract Surgery
`Postop Pain,” Medscape, April 8, 2013 (published at
`http://www.medscape.com/viewarticle/782115)
`Exhibit 2067 Definition of Cataract from The Merck Manual of Diagnostics
`and Therapy, 19th ed., (2011)
`Exhibit 2068 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.
`Exhibit 2069 Norman S. Jaffe, "History of Cataract Surgery," Ophthalmology,
`1996, S5-S16.
`Exhibit 2070 C. Janet Giffney and J. O'Connor, "Acid Catalysed Hydrolysis of
`Substituted Acetanilides. Part II," Journal of the Chemical Society
`Perkin Transactions II, 1975, 1357-1360.
`Exhibit 2071 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.
`Exhibit 2072 P. W. Atkins, General Chemistry, (Scientific American Books,
`1989) 400-405.
`Exhibit 2073 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.
`Exhibit 2074 E. F. Panarin and M. V. Solovskii, "Acid Hydrolysis of
`Benzylpenicillin Anilides," Pharmaceutical Chemistry Journal,
`1967, 72-74.
`J. W. Barnett and C. J. O'Connor, "The Acid-Catalysed
`Hydrolysis of Acetanilide," Journal of the Chemical Society,
`Perkin Transactions II, 1973, 220-222.
`Exhibit 2076 H. Ślebocka-Tilk, R. S. Brown, and J. Olekszyk, "Reversible
`
`Exhibit 2075
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`Exhibit 2077
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`Exhibit 2084
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`Exhibit 2085
`
`Case IPR2015-01100
`U.S. Patent 8,927,606
`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 C. J. O'Connor, "Evidence for a First Order
`Mechanism in Amide Hydrolysis," Journal of the Chemical
`Society, Chemical Communications, 1972, 525.
`Exhibit 2078 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.
`Exhibit 2079 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.
`Exhibit 2080 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.
`Exhibit 2081 Margarita Calogne, "The Treatment of Dry Eye," Survey of
`Ophthalmology Vol. 45 No. 2, 2001, S227-S239.
`Exhibit 2082 Robert O. Williams, III, Ph.D., Declaration
`Exhibit 2083
`’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.
`Exhibit 2086 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).
`Exhibit 2088 Dr. Paul M. Laskar’s declaration in IPR2015-00902, EX1003.
`Exhibit 2089 Robert Noecker, "Effects of Common Ophthalmic Preservatives
`on Ocular Health," Advances in Therapy Vol. 18. No. 5, 2001,
`
`Exhibit 2087
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`Case IPR2015-01100
`U.S. Patent 8,927,606
`
`205-215.
`Exhibit 2090 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.
`Exhibit 2091 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.
`Exhibit 2092 Drugs@FDA, Alphagan® P
`Exhibit 2093 Alphagan® P Product Label (2000)
`Exhibit 2094 A. Bianco Prevot et al., "Determination of Micelle/water Partition
`Coefficients of Cosmetic Preservatives," Analytica Chimica Acta
`Vol. 412, 2000, 141-148
`Exhibit 2095 Certified translation of the Japanese counterpart application to
`Ogawa, the ’225 patent
`Exhibit 2096 Confidential Excerpt from Prolensa® NDA Disclosing Prolensa®
`Components
`Exhibit 2097 M. Donbrow, E. Azaz, and A. Pillersdorf, "Autoxidation of
`Polysorbates," Journal of Pharmaceutical Sciences Vol. 67 No.
`12, 1978, 1676-1681.
`Exhibit 2098 Declaration of Shirou Sawa
`Exhibit 2099 Rob Lewis and Wynne Evans. Chemistry. 2d ed. (Palgrave, 2001)
`170-171.
`Exhibit 2100 T. Aree & N. Chaichit, “Crystal Structure of β-cyclodextrin-
`benzoic acid inclusion complex,” Carbohydrate Research 338
`(2003) 439-446
`Exhibit 2101 Francis A. Carey, Organic Chemistry, (McGraw-Hill 1987), 917-
`920.
`Exhibit 2102 Confidential Excerpt from NDA of Xibrom®/Bromday® Annual
`Report in 2006
`Exhibit 2103 Confidential Prolensa® NDA section 3.2.P.8.1 Stability Summary
`And Conclusions
`Exhibit 2104 Carl R. Noller, "Aromatic Amines and Phosphines," Chemistry of
`Organic Compounds. 3d ed. (W.B. Saunders, 1965) 523-535.
`
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`Case IPR2015-01100
`U.S. Patent 8,927,606
`
`Exhibit 2105 Stephen G. Davies, D.Phil, Declaration
`Exhibit 2106 Paragraph IV Certification List from FDA website (last updated
`Oct. 6 2015).
`Exhibit 2107 Content and Format of an Abbreviated Application, Food and
`Drug Administration, 21 C.F.R. § 314.94
`Exhibit 2108 Watson’s Paragraph IV Notice Letter, dated June 1, 2015
`Exhibit 2109 Confidential Quality Summary Report in Lupin’s ANDA for
`Lupin’s generic bromfenac ophthalmic solution
`Exhibit 2110 Confidential Prolensa® NDA Justification of specifications
`Exhibit 2111 Certified Translation of Bronuck Package Insert (May 2000)
`Exhibit 2112 Certified Translation of Bronuck Package Insert (June 2002)
`Exhibit 2113 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.
`Exhibit 2114 Deposition Transcript of Dr. Paul A. Laskar, dated November 4,
`2015
`Exhibit 2115 CV of Robert O. Williams, III, Ph.D.
`Exhibit 2116 Declaration of William B. Trattler, M.D.
`Exhibit 2117
`John Nichols and Robert W. Snyder, "Topical Nonsteroidal Anti-
`inflammatory Agents in Ophthalmology," Current Opinion in
`Ophthalmology Vol. 9 No. 4, 1998, 40-44.
`Exhibit 2118 Thomas R. Walters et al., "Bromfenac Ophthalmic Solution
`0.07% Dosed Once Daily for Cataract Surgery," Ophthalmology
`Vol. 121 No. 1, 2014, 25-33.
`Exhibit 2119 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.
`Exhibit 2120 N. M. Emanuel G. E. Zaikov, and Z. K. Maizus, Oxidation of
`Organic Compounds: Medium Effects in Radical Reactions
`(Pergamon, 1984) 384-395.
`Exhibit 2121 WO Patent No. 00/00179 to Lee, “Solid Dispersed Preparation of
`Poorly Water-Soluble Drug Containing Oil, Fatty Acid of
`Mixtures Thereof”
`Exhibit 2122 Reserved.
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`Case IPR2015-01100
`U.S. Patent 8,927,606
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`Exhibit 2123 Reserved.
`Exhibit 2124 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
`Exhibit 2125 Declaration of Robert O. Williams, III in Opening Markman
`Brief, Senju Pharm. Co. Ltd. v. Lupin Ltd., No. 1:14-CV-00667-
`JBS-KMW (D.N.J., dated August 10, 2015) (No. 80).
`Exhibit 2126 Declaration of Dr. Adam C. Myers
`Exhibit 2127 CV of Dr. Adam C. Myers
`Exhibit 2128 Declaration of Dr. Daryl S. Paulson
`Exhibit 2129 CV of Dr. Daryl S. Paulson
`Exhibit 2130 Declaration of John C. Jarosz
`Exhibit 2131 Patent Owner’s Notice of Cross-Examination of Dr. Paul A.
`Laskar, Ph.D. in IPR2015-00903
`Exhibit 2132 Retraction: Sclera-Choroid-RPE Transport of Eight β-Blockers in
`Human, Bovine, Porcine, Rabbit, and Rat Models, Inv.
`Ophthalmology& Visual Science
`Exhibit 2133 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
`Exhibit 2134 Opinion, Allergan, Inc. v. Sandoz Inc. et al., Case No. 2014-1275
`(Fed. Cir. August 4, 2015)
`Exhibit 2135 Allergan, Inc. v. Sandoz Inc. et al., 818 F. Supp. 2d 974 (E.D.
`Tex. 2011)
`Exhibit 2136 Transcript of Bench Trial before the Honorable Judge T. John
`Ward, Allergan, Inc. v. Sandoz Inc., Case No. 2:09-cv-00097
`(E.D. Tex. August 3, 2011)
`Exhibit 2137 Transcript of Bench Trial before the Honorable Judge T. John
`Ward, Allergan, Inc. v. Sandoz Inc., Case No. 2:09-cv-00097
`(E.D. Tex. August 4, 2011)
`Syntex (U.S.A.) LLC v. Apotex, Inc., 2006 U.S. Dist. LEXIS
`36089 (N.D. Cal. June 2, 2006)
`
`Exhibit 2138
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`Exhibit 2141
`
`Case IPR2015-01100
`U.S. Patent 8,927,606
`Exhibit 2139 M. Jayne Lawrence. "Surfactant Systems: Their Use in Drug
`Delivery." Chemical Society Reviews Vol. 23 No. 6, 1994, 417-
`424.
`Exhibit 2140 Video Deposition Transcript of M. Jayne Lawrence, Senju
`Pharmaceutical Co. Ltd. v. Lupin Ltd. 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.
`Exhibit 2142 Andrea Coscelli, “The Importance of Doctors’ and Patients’
`Preferences in the Prescription Decision,” The Journal of
`Industrial Economics, Vol. 48, No. 3 (September 2000)
`Exhibit 2143 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)
`Exhibit 2144 Dana P. Goldman, Geoffrey F. Joyce, and Yuhui Zheng,
`“Prescription Drug Cost Sharing: Associations With Medication
`and Medical Utilization and Spending and Health,” JAMA, Vol.
`298, No. 1, 2007, 61-69
`Exhibit 2145 David Dranove, Edward F.X. Hughes and Mark Shanley,
`“Determinants of HMO Formulary Adoption Decisions,” Health
`Services Research, Vol. 38, No. 1, 2003, 169-190
`Exhibit 2146 Don Mogelefsky, “Smooth Operators,” Incentive, 174: 104-105
`(2000)
`Exhibit 2147 E.M. Kolassa, “Physicians’ Perceptions of Prescription Drug
`Prices: Their Accuracy and Effect on the Prescribing Decision,”
`Journal of Research in Pharmaceutical Economics, Vol. 6, No. 1,
`1995, 23-37
`Exhibit 2148 Ernst R. Berndt, “The U.S. Pharmaceutical Industry: Why Major
`Growth In Times of Cost Containment?” Health Affairs, Vol. 20,
`No. 2, 2001
`Exhibit 2149 Ernst R. Berndt, Ashoke Bhattacharjya, David N. Mishol,
`Almudena Arcelus and Thomas Lasky, “An Analysis of the
`Diffusion of New Antidepressants: Variety, Quality, and
`Marketing Efforts,” The Journal of Mental Health Policy and
`
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`Case IPR2015-01100
`U.S. Patent 8,927,606
`
`Economics, Vol. 5, 2002, 3-19
`Exhibit 2150 Ernst R. Berndt, Iain M. Cockburn and Zvi Griliches,
`“Pharmaceutical Innovations and Market Dynamics: Tracking
`Effects on Price Indexes for Antidepressant Drugs,” Brookings
`Papers on Economic Activity: Microeconomics, (1996), 133-188
`Exhibit 2151 Ernst R. Berndt, Linda T. Bui, David H. Lucking-Reiley and Glen
`L. Urban, “The Roles of Marketing, Product Quality, and Price
`Competition in the Growth and Composition of the U.S. Antiulcer
`Drug Industry,” in Timothy F. Bresnahan and Robert J. Gordon,
`eds., The Economics of New Goods (The University of Chicago
`Press, 1997)
`Exhibit 2152 FDA Approval Letter for NDA 203168, April 5, 2013, available
`at
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203168
`Orig1s000Approv.pdf (viewed November 16, 2015)
`Exhibit 2153 FDA Drug Approval Package for Prolensa, Summary Review,
`April 5, 2013, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203168
`Orig1s000SumR.pdf (viewed November 16, 2015)
`Exhibit 2154 Frank H. Pinkerton and Evan Stover, “Ista Pharmaceuticals, Inc.,”
`SunTrust Robinson Humphrey, May 3, 2012
`Exhibit 2155 Garrick Chak et al. “Topical Corticosteroid and NSAID
`Therapies for Ocular Inflammation,” Cataract & Refractive
`Surgery Today, November/December 2014
`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.
`Exhibit 2157 Glen L. Urban, Theresa Carter, Steven Gaskin, and Zofia Mucha,
`“Market Share Rewards to Pioneering Brands: An Empirical
`Analysis and Strategic Implications,” Management Science, Vol.
`32, No. 6 (June 1986).
`Exhibit 2158 GMR Data, “Ophthalmic Drugs – Data, Analysis and Forecasts to
`2024,” March 2014.
`Exhibit 2159 Reserved.
`Exhibit 2160 Ophthalmology Times, “Brand vs. Generic: Which is best
`cataract surgery medicine?” (available at
`http://ophthalmologytimes.modernmedicine.com/ophthalmologyti
`
`Exhibit 2156
`
`
`
`11
`
`

`
`Case IPR2015-01100
`U.S. Patent 8,927,606
`mes/content/tags/brand/brand-vs-generic-which-best-cataract-
`surgery-medicine?page=full) (viewed October 27, 2015).
`Exhibit 2161 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).
`Exhibit 2162 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).
`Exhibit 2163 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).
`Exhibit 2164 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).
`Exhibit 2165 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).
`Exhibit 2166 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).
`Exhibit 2167 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).
`Exhibit 2168 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).
`Exhibit 2169 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).
`Exhibit 2170 FDA, Diclofenac Sodium 0.1%® Orange Book (available at
`
`
`
`12
`
`

`
`Case IPR2015-01100
`U.S. Patent 8,927,606
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?
`Appl_No=078553&TABLE1=OB_Rx) (viewed November 10,
`2015).
`Exhibit 2171 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).
`Exhibit 2172 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 November 16,
`2015).
`Exhibit 2173 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).
`Exhibit 2174 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).
`Exhibit 2175 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).
`Exhibit 2176 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).
`Exhibit 2177 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).
`Exhibit 2178 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).
`Exhibit 2179 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&tabl
`e1=OB Rx) (viewed November 10, 2015).
`
`
`
`13
`
`

`
`Case IPR2015-01100
`U.S. Patent 8,927,606
`Exhibit 2180 FDA, Orange Book Patent Exclusivity Search (available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cf
`m?Appl_No=020037&Product_No=001&table1=OB_Rx)
`(viewed November 10, 2015).
`Exhibit 2181 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=002&t
`able1=OB_Disc) (viewed November 10, 2015).
`Exhibit 2182 FDA, Xibrom and Bromday® Orange Book Patent Exclusivity
`Search (available at http://www.accessdata.fda.
`gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=022122&Pro
`duct_No=001&table1=OB_Rx) (viewed November 10, 2015).
`Exhibit 2183 Acuvail® Product Label (available at
`http://www.allergan.com/assets/pdf/acuvail_pi.pdf) (viewed
`October 30, 2015).
`Exhibit 2184 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).
`Exhibit 2186 Company Overview of Bausch & Lomb (available at
`http://www.bloomberg.com/research/stocks/private/snapshot.asp?
`privcapId=19095) (viewed November 16, 2015).
`Exhibit 2187 Reserved.
`Exhibit 2188 “FDA Approves Bromday” (available at
`http://www.drugs.com/newdrugs/ista-pharmaceuticals-receives-
`fda-approval-bromday-2374.html) (viewed November 16, 2015).
`Exhibit 2189 “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).
`Exhibit 2190 Xibrom Information (available at
`http://www.drugs.com/pro/xibrom.html) (viewed October 22,
`2015).
`Exhibit 2191 “Pharmaceutical Focus: Getting the Scoop on NSAIDs for
`Cataract Surgery” (available at http://www.eyeworld.org/
`
`Exhibit 2185
`
`
`
`14
`
`

`
`Exhibit 2192
`
`Case IPR2015-01100
`U.S. Patent 8,927,606
`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/research
`ers/npa_data_brief.pdf) (viewed October 30, 2015).
`Exhibit 2193 Definition of q.i.d. (on prescription) (available at
`http://www.medicinenet.com/script/main/art.asp?articlekey=5157
`) (viewed November 3, 2015).
`Exhibit 2194 Senju Business Activities: Ethical Products for Medical
`Professionals (available at http://www.senju.co.jp/english/
`about/business/mp.html) (viewed November 17, 2015).
`Exhibit 2195 About Senju (available at http://www.senju.co.jp/english/
`about/outline.html (viewed November 17, 2015).
`Exhibit 2196 Senju Company Profile (available at http://www.senju.co.jp/
`english/about/pdf/profile.pdf) (viewed November 17, 2015)
`Exhibit 2197 Reserved.
`Exhibit 2198
`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).
`ISTA Pharmaceuticals, Inc. SEC Form 10-K for the fiscal year
`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.
`Exhibit 2201 Kyle Bagwell, “The Economic Analysis of Advertising” in
`Handbook of Industrial Organization, Vol. 3, eds. M. Armstrong
`and R. Porter, Elsevier B.V., 2007.
`Exhibit 2202 Line Kessel et al., “Post-cataract Prevention of Inflammation and
`Macular Edema by Steroid and Nonsteroidal Anti-inflammatory
`Eye Drops,” Ophthalmology Vol. 121, No. 10, October 2004,
`1915-1924.
`Exhibit 2203 Marc Goodman and Ami Fadia, UBS Global Research, “Valeant
`Pharmaceuticals International Where is the Faith?,” October 19,
`2015.
`Exhibit 2204 Marc Goodman, UBS Global Research, “U.S. Specialty
`Pharmaceuticals Valeant Rx Tracker,” June 15, 2014.
`Exhibit 2205 Michael J. de la Merced, “Eye Care Company is Being Sold to
`
`Exhibit 2199
`
`Exhibit 2200
`
`
`
`15
`
`

`
`Case IPR2015-01100
`U.S. Patent 8,927,606
`
`Valeant,” N.Y. Times, May 27, 2013.
`Exhibit 2206 Reserved.
`Exhibit 2207 Natalie Mizik and Robert Jacobson, “Are Physicians ‘Easy
`Marks’?: Quantifying the Effects of Detailing and Sampling on
`New Prescriptions,” INFORMS, Vol. 50, No. 12, 2004, 1704-715.
`Exhibit 2208 Peter Lattman, “Bausch & Lomb to Buy ISTA Pharmaceuticals
`for $500 Million,” The New York Times, March 26, 2012.
`Exhibit 2209 Pierre Azoulay, “Do Pharmaceutical Sales Respond to Scientific
`Evidence?,” Journal of Economics and Management Strategy
`Vol. 11, 2002.
`Exhibit 2210 Press Release, Bausch & Lomb Incorporated, “Bausch & Lomb
`Completes the Acquisition of ISTA Pharmaceuticals,” dated June
`6, 2012.
`Exhibit 2211 Press Release, Bausch & Lomb Incorporated, “Bausch + Lomb
`Launches PROLENSATM and Showcases Innovative Additions to
`its Surgical Product Portfolio at the ASCRS Annual Meeting,”
`dated April 17, 2013.
`Exhibit 2212 Press Release, Bausch & Lomb Incorporated, “Warburg Pincus
`Completes Acquisition of Bausch & Lomb,” dated October 26,
`2007.
`Exhibit 2213 Press Release, ISTA Pharmaceuticals, Inc., “ISTA
`Pharmaceuticals Receives FDA Approval for Xibrom(TM) for the
`Treatment of Ocular Inflammation Following Cataract Surgery,”
`dated March 28, 2005.
`Exhibit 2214 Press Release, Mylan Inc., “Mylan Launches First Generic
`Version of Xibrom Ophthalmic Solution,” dated May 16, 2011.
`Exhibit 2215 Reserved.
`Exhibit 2216 Reserved.
`Exhibit 2217 Bausch & Lomb, Introducing Prolensa®, copyright 2013.
`Exhibit 2218
`Bausch & Lomb, “Bausch + Lomb Receives FDA Approval for
`PROLENSA™ (bromfenac ophthalmic solution) 0.07%,” Baus