IN THE 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., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner.
`
`U.S. Patent No. 8,871,813 to Sawa et al.
`Issue Date: October 28, 2014
`Title: Aqueous Liquid Preparation Containing
`2-Amino-3-(4-
`bromobenzoyl) Phenylacetic Acid
`
`
`
`Inter Partes Review No.: IPR2016-00090
`
`Petitioner’s 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
`
`
`
`
`
`
`
`
`
`
`
`
`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., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner.
`
`U.S. Patent No. 8,871,813 to Sawa et al.
`Issue Date: October 28, 2014
`Title: Aqueous Liquid Preparation Containing
`2-Amino-3-(4-
`bromobenzoyl) Phenylacetic Acid
`
`
`
`Inter Partes Review No.: IPR2016-00090
`
`Petitioner’s 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
`
`
`
`
`
`
`
`InnoPharma
`Exhibit #
`
`Petitioner’s Exhibit List
`
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`Sawa et al., U.S. Patent No. 8,871,813, “Aqueous Liquid Preparation
`Containing 2-Amino-3-(4-Bromobenzoyl) Phenylacetic Acid”
`
`Certified English translation of: Hara, Yoshiyuki , “Bromfenac
`sodium hydrate,” Clinics & Drug Therapy 19:1014-1015 (2002)
`
`Declaration of Paul A. Laskar, 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 “BROMDAYTM (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”
`
`1013
`
`U.S. Patent Application No. 13/687,242, Office Action of August 1,
`2013
`
`
`
`
`
`
`
`
`InnoPharma
`Exhibit #
`
`Description
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`U.S. Patent Application No. 10/525,006, Applicant Remarks in
`support of amendment March 26, 2008
`U.S. Patent Application No. 10/525,006, Applicant Remarks in
`support of amendment, September 6, 2011
`
`The Pharmacopeia of the United States of America, Thirty-Eighth
`Revision and the National Formulary, Thirty-Third Edition
`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”
`
`U.S. Patent Application No. 13/687,242, Applicant Remarks in
`support of amendment, November 28, 2012
`
`Excerpt of Plaintiffs’ Opening Markman Brief filed in Senju Pharm.
`Co., Ltd. et al. v. InnoPharma Licensing, Inc. et al., C.A. No. 1:15-
`cv-03240-JBA-KMW (D.N.J.) D.I. 16 (Aug. 10, 2015).
`
`1025
`
`U.S. Patent Application No. 13/687,242, Applicant Remarks in
`support of amendment, October 22, 2013
`
`
`
`
`
`InnoPharma
`Exhibit #
`
`Description
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`"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
`XibromTM 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 "AzoptTM," 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).
`
`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).
`
`
`
`
`
`InnoPharma
`Exhibit #
`
`1035
`
`1036
`
`1037
`
`1038
`
`Description
`
`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 "ALREXTM (loteprednol etabonate ophthalmic
`suspension) 0.2% Product Label," U.S. Approval: 1998, Bausch
`& Lomb Pharmaceuticals.
`
`etabonate
`(loteprednol
`"LOTEMAXTM
`approved
`FDA
`ophthalmic suspension) 0.5% Product Label," U.S. Approval:
`1998, Bausch & Lomb Pharmaceuticals.
`
`1039
`
`"TOBRADEX®" Physician’s Desk Reference 54: 490 (2000).
`
`1040
`
`"Alomide® 0.1%" Physician’s Desk Reference 50: 469 (1996).
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`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 "XIBROMTM (bromfenac ophthalmic
`solution, .09%) Product Label," ISTA Pharmaceuticals, Inc.
`
`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.
`
`
`
`
`
`Description
`
`FDA approved "PROLENSATM (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)
`
`“DuractTM,” Physician’s Desk Reference 52:3035-3037 (1998).
`
`Curriculum Vitae of Paul A. Laskar, Ph.D.
`
`U.S. Patent Application No. 10/525,006, Applicant Remarks in
`support of amendment Oct. 25, 2010
`
`InnoPharma
`Exhibit #
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
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