`Filed: December 14, 2015
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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.,
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD., BAUCSH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner
`_________________
`Case IPR2015-00903
`U.S. Patent 8,129,431
`_________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
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`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., and Mylan Inc..
`
`Exhibits
`Exhibit 2001
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`Exhibit 2002
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`Exhibit 2003
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`Exhibit 2004
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`Exhibit 2005
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`Exhibit 2006
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`Exhibit 2007
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`Exhibit 2008
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`Exhibit 2009
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`Exhibit 2010
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`Exhibit 2011
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`
`
`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. Nov. 3,
`2014), ECF No. 1.
`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
`
`2
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`
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`Case IPR2015-00903
`U.S. Patent 8,129,431
`
`(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. Feb. 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 by Bausch + Lomb, dated April 8, 2013,
`entitled “Bausch + Lomb Receives FDA Approval for
`Prolensa™ (bromfenac ophthalmic solution) 0.07%.”
`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, INT’L
`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, http://www.lupin.com/pdf/14/20140203%20-
`%20Lupin%203QFY14%20-%20HSBC.pdf
`APOTEX ALL PRODUCTS,
`https://www.apotex.com/us/en/products/search.asp?qt=All&
`qs=&t=All%20Products.
`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.
`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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`3
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`Exhibit 2012
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`Exhibit 2013
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`Exhibit 2014
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`Exhibit 2015
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`Exhibit 2016
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`Exhibit 2017
`Exhibit 2018
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`Exhibit 2019
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`Exhibit 2020
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`Exhibit 2021
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`Exhibit 2022
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`Exhibit 2023
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`Exhibit 2024
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`Exhibit 2025
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`Exhibit 2026
`Exhibit 2027
`Exhibit 2028
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`Exhibit 2029
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`Exhibit 2030
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`Exhibit 2031
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`Exhibit 2032
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`Exhibit 2033
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`Exhibit 2034
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`Exhibit 2035
`
`
`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`
`Xibrom® Prescribing Information.
`Bromday® Prescribing Information.
`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=BROMFE
`NAC%20SODIUM.
`Sheryl Gay Stolberg, New Painkiller is Withdrawn After 4
`Deaths, N.Y. Times, Jun. 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.
`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
`
`
`
`Respectfully submitted,
`
`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`Finnegan, Henderson, Farabow, Garrett
` & Dunner, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`
`Counsel for Patent Owner
`
`Dated: December 14, 2015
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`CERTIFICATE OF SERVICE
`
`Case IPR2015-00903
`U.S. Patent 8,129,431
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Updated Exhibit List and Exhibit 2035 were served on December 14,
`
`2015, via email directed to counsel of record for the Petitioner at the following:
`
`Jitendra Malik
`jitty.malik@alston.com
`
`Bryan Skelton
`bryan.skelton@alston.com
`
`Lance Soderstrom
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`James.abe@alston.com
`
`
`Date: December 14, 2015
`
`/Ashley F. Cheung/
`Ashley F. Cheung
`Case Manager
`
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
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