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`Filed: August 3, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner
`_________________
`Case IPR2015-01097
`U.S. Patent 8,754,131
`_________________
`
`PATENT OWNER’S EXHIBIT LIST
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`Case IPR2015-01097
`U.S. Patent 8,754,131
`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.
`
`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. 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.
`
`Exhibit 2015
`
`Exhibit 2016
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`Case IPR2015-01097
`U.S. Patent 8,754,131
`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.”
`Exhibit 2031 Drugs@FDA, Listing of FDA-approved bromfenac ophthalmic
`solution 0.09% products,
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?f
`useaction=Search.Overview&DrugName=BROMFENAC%20SO
`DIUM.
`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
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`Case IPR2015-01097
`U.S. Patent 8,754,131
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`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 WL 8667473 (D.N.J. April 12,
`2012).
`
`
`
`Respectfully submitted,
`
`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`M. Andrew Holtman, Back-up Counsel
`Reg. No. 53,032
`Justin J. Hasford, Back-up Counsel
`Reg. No. 62,180
`Joshua L. Goldberg, Back-up Counsel
`Reg. No. 59,369
`Finnegan, Henderson, Farabow, Garrett
` & Dunner, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner
`
`
`
`Dated: August 3, 2015
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`CERTIFICATE OF SERVICE
`
`Case IPR2015-01097
`U.S. Patent 8,754,131
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Exhibit List and Exhibits 2001 through 2037 were served on August 3,
`
`2015, via email directed to counsel of record for the Petitioner at the following:
`
`Deborah Yellin
`DYellin@crowell.com
`
`Jonathan Lindsay
`JLindsay@crowell.com
`
`
`Date: August 3, 2015
`
`/Lisa C. Hines/
`Lisa C. Hines
`Litigation Clerk
`
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
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