`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`METRICS, INC.
`Petitioner
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner
`
`U.S. Patent No. 8,669,290 to Sawa et al.
`Issue Date: March 11, 2014
`Title: Aqueous Liquid Preparation Containing 2-Amino-3-(4-
`bromobenzoyl) Phenylacetic Acid
`
`_____________________
`
`Inter Partes Review No.: IPR2014-01043
`_____________________
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`DM2\5378190.1
`
`
`
`
`
`Petitioner’s Updated Exhibit List
`January 21, 2015
`
`Exhibit
`#
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`Description
`
`Sawa et al., U.S. Patent No. 8,669,290, "Aqueous Liquid
`Preparation Containing 2-Amino-3-(4-Bromobenzoyl) Phenylacetic
`Acid"
`Hara, Yoshiyuki , "Bromfenac sodium hydrate," Clinics & Drug
`Therapy 19:1014-1015 (2002)
`Second Corrected Declaration of Professor Uday B. Kompella,
`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 "BROMDAY™ (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"
`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"
`
`
`
`
`
`
`
`
`
`Exhibit
`#
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`Petitioner’s Updated Exhibit List
`January 21, 2015
`
`Description
`
`"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?A
`ppl_No=203168&TABLE1=OB_Rx, last accessed on January 24,
`2014
`U.S. Patent Application No. 13/687,242, 2/11/14, Notice of
`Allowance
`“ophthalmic,” Webster’s Deluxe Unabridged Dictionary: 1254, New
`Twentieth Century Dictionary/Simon and Shuster (1979)
`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)
`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"
`Bergamini et al., U.S. Patent No. 5,597,560, "Diclofenac And
`Tobramycin Formulations For Ophthalmic And Otis Topical Use"
`
`
`
`2
`
`
`
`
`
`Exhibit
`#
`
`Petitioner’s Updated Exhibit List
`January 21, 2015
`
`Description
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`U.S. Patent Application No. 13/687,242, Applicant Remarks in
`support of amendment, November 28, 2012
`November 16, 1994 Desai Declaration under 37 CFR §1.132(Desai
`I) and July 2, 1996 Desai Declaration under 37 CFR §1.132 (Desai
`II)
`U.S. Patent Application No. 13/687,242, Applicant
`Arguments/Remarks Made in an Amendment, 10/22/2013, pp. 9-15
`"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?A
`ppl_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".
`"ISTA Pharmaceuticals Submits New Drug Application for
`Xibrom™ QD (once-daily), News Release, ISTA Pharmaceuticals
`(December 20, 2007)
`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)
`"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).
`Reddy, Indra K., Ocular Therapeutics and Drug Delivery: A Multi-
`Disciplinary Approach: 42-43, 390 (1996).
`
`
`
`3
`
`
`
`
`
`Exhibit
`#
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`1040
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`Petitioner’s Updated Exhibit List
`January 21, 2015
`
`Description
`
`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)..
`Wong, Michelle, International Patent No. WO 94/15597,
`"Ophthalmic Compositions Comprising
`Benzyllauryldimethylammonium Chloride" (filed January 11, 1993;
`issued July 21, 1994).
`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).
`"Alomide® 0.1%" Physician’s Desk Reference 50: 469 (1996).
`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".
`Kawabata et al., Canadian Patent No. CA 2 383 971 A1,
`“Prophylactic and Therapeutic Medicaments for Ophthalmic Uses”.
`Patani, G., et al., "Bioisoterism: A Rational Approach in Drug
`Design," Chem. Rev. 96: 3147-3176 (1996).
`FDA approved "XIBROM™ (bromfenac ophthalmic solution,
`.09%) Product Label," ISTA Pharmaceuticals, Inc.
`
`
`
`4
`
`
`
`Petitioner’s Updated Exhibit List
`January 21, 2015
`
`Description
`
`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
`"Borax (Sodium tetraborate)," Biochemicals and Reagents: 175,
`Sigma-Aldrich (2000-2001).
`Ali, et al., U.S. Patent No. 6,071,904, "Process for Manufacturing
`Ophthalmic Suspensions".
`Story, M., et al., European Patent No. 0274870, "Micelles
`containing a non-steroidal antiinflammatory compound" (filed
`December 12, 1987; issued July 7, 1988)
`“Duract™,” Physician’s Desk Reference 52:3035-3037 (1998).
`Curriculum Vitae of Professor Uday B. Kompella, Ph.D.
`Intentionally Left Blank
`Corporate Certificate of Assumed Name dated 4/2/2007
`Declaration of Stefan Cross in a related litigation
`Selected pages from 10/3/2014 Transcript of Proceedings
`Dismissal Order, Senju Pharmaceutical Co., Ltd. et al. v. Metrics,
`Inc.et al, Case No. 1:14-cv-04964 (D.N.J. Dec. 30, 2014), ECF No.
`20.
`
`5
`
`Exhibit
`#
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`1052
`1053
`1054
`1055
`1056
`1057
`
`
`
`
`
`
`
`
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