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. 8,754,131 to Sawa et al.
`Issue Date: June 17, 2014
`Title: Aqueous Liquid Preparation Containing
`2-Amino-3-(4-
`bromobenzoyl) Phenylacetic Acid
`
`Inter Partes Review No.: IPR2016-00089
`
`Petition for Inter Partes Review of U.S. Patent No. 8,754,131 Under
`35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`

`

`TABLE OF CONTENTS
`
`I.
`II.
`III.
`
`Page
`INTRODUCTION ...........................................................................................1
`OVERVIEW....................................................................................................1
`STANDING (37 C.F.R. § 42.104(a); PROCEDURAL
`STATEMENTS)..............................................................................................2
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))......................................2
`A.
`Each Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) ...........................2
`B.
`Notice of Related Matters (37 C.F.R. § 42.8(b)(2))..............................3
`1.
`Judicial Matters...........................................................................3
`2.
`Administrative Matters ...............................................................3
`Designation of Lead and Back-Up Counsel and Service (37
`C.F.R. §§ 42.8(b)(3), 42.8(b)(4), 42.10(a), and 42.10(b)):...................5
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE (37 C.F.R. § 42.22(a))..........................................6
`THE ’131 PATENT.........................................................................................6
`A.
`CLAIM CONSTRUCTION ..................................................................7
`VII. PERSON OF SKILL IN THE ART (“POSA”) & STATE OF THE
`ART .................................................................................................................7
`VIII. IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b)).................10
`A.
`The Scope and Content of the Prior Art..............................................11
`1.
`Aqueous Ophthalmic Preparation of Bromfenac......................11
`2.
`Tyloxapol and Related Surfactants in NSAID Aqueous
`Ophthalmic Preparations.......................................................12
`
`V.
`
`VI.
`
`C.
`
`i
`
`

`

`B.
`
`C.
`
`Ground 1: Claims 1-30 Are Unpatentable Under 35 U.S.C.
`§ 103(a) Over Ogawa In Light Of Sallmann.......................................13
`1.
`Ogawa (EX1004) and Sallmann (EX1009) ..............................13
`2.
`Independent Claims 1, 7, and 13...............................................16
`3.
`Dependent Claims.....................................................................26
`Ground 2: Claims 1-30 Are Unpatentable Under 35 U.S.C.
`§ 103(a) over Ogawa in light of Sallmann and Fu..............................41
`1.
`Overview of Fu (EX1011) ........................................................41
`2.
`Independent Claims 1, 7, and 13...............................................43
`3.
`Dependent Claims.....................................................................45
`Ground 3: Claims 1-30 Are Unpatentable Under 35 U.S.C.
`§ 103(a) over Ogawa in light of Sallmann and Yasueda.....................48
`1.
`Overview of Yasueda (EX1012) ...............................................48
`2.
`Independent Claims 1, 7, and 13...............................................50
`3.
`Dependent Claims.....................................................................53
`Objective Indicia of Nonobviousness .................................................55
`1.
`No Unexpected Results Over the Closest Prior Art..................55
`2.
`Other Objective Indicia.............................................................58
`IX. CONCLUSION..............................................................................................60
`
`D.
`
`E.
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`Amneal Pharms., LLC v. Supernus Pharms., Inc., IPR2013-00368........................55
`Chapman v. Casner,
`315 Fed. App’x 294 (Fed. Cir. 2009) ...........................................................29, 35
`Friskit, Inc. v. Real Networks, Inc.,
`306 F. App’x 610 (Fed. Cir. 2009) .....................................................................58
`Galderma Labs., L.P., v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013)......................................................................29, 31
`
`In re Aller,
`220 F.2d 456 ..................................................................................... 23-24, 31, 40
`In re Baxter Travenol Labs.,
`952 F.2d 388 (Fed. Cir. 1991) ................................................................24, 37, 39
`In re De Blauwe,
`736 F.2d 699 (Fed. Cir. 1984) ............................................................................56
`
`In re Malagari,
`499 F.2d 1297 (C.C.P.A. 1974)..........................................................................35
`In re Merchant,
`575 F.2d 865 (C.C.P.A. 1978)............................................................................56
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003) .................................................. 22-24, 31, 35, 57
`InnoPharma Licensing, Inc. v. Senju Pharm. Co., Ltd.,
`IPR2015-00902............................................................................................passim
`In re Woodruff,
`919 F.2d 1575 (Fed. Cir. 1990) ....................................................................23, 35
`Iron Grip Barbell Co., Inc., v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004)..........................................................................29
`iii
`
`

`

`KSR International Co. v. Teleflex Inc.,
`550 U.S. 398 (2007)..............................................................................2, 7, 21, 32
`Lupin Ltd.. v. Senju Pharm. Co., Ltd., IPR2015-01097....................................passim
`Metrics, Inc. v. Senju Pharm. Co., Ltd., IPR2014-01043......................24, 25, 37, 39
`
`Newell Cos., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) ............................................................................55
`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 2006) ..........................................................................59
`Purdue Pharma Prods. L.P. v. Par Pharm., Inc.,
`377 Fed App’x 978 (Fed. Cir. 2010) ..................................................................59
`
`Sakraida v. AG Pro, Inc.,
`425 U.S. 273 (1976)...........................................................................................21
`Santarus v. Par Pharm,
`694 F.3d 1344 (Fed. Cir. 2012) ..............................................................24, 37, 39
`Sinclair & Carroll Co., v. Interchemical Corp.,
`325 U.S. 327 (1945)............................................................................................19
`Stratoflex, Inc. v. Aeroquip Corp.,
`713 F.2d 1530 (Fed. Cir. 1983) ....................................................................59, 60
`Sundance, Inc. v. DeMonte Fabricating Ltd.,
`550 F.3d 1356 (Fed Cir. 2008) ...........................................................................13
`Titanium Metals Corp. of Amer. v. Banner,
`778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)...................................... 30-31, 46
`Tokai Corp. v. Eason Enters., Inc.,
`632 F.3d 1358 (Fed. Cir. 2011) ..........................................................................60
`Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC,
`683 F.3d 1356 (Fed Cir. 2012).....................................................................21, 53
`STATUTES
`35 U.S.C. § 102(b) .................................................................................13, 15, 41, 48
`
`iv
`
`

`

`35 U.S.C. § 103(a) .......................................................................................13, 41, 48
`
`
`
`35 U.S.C.§103(a) ..................................................................................... ..13,41,4835 U.S.C.§103(a) ..................................................................................... ..13,41,4835 U.S.C. § 103(a) ....................................................................................... 13, 41, 4835 U.S.C. § 103(a) ....................................................................................... 13, 41, 48
`35 U.S.C. § 315(c) .....................................................................................................4
`
`
`
`35 U.S.C. § 315(c) ................................................................................................... ..435 U.S.C. § 315(c) ................................................................................................... ..435 U.S.C. § 315(c) ..................................................................................................... 435 U.S.C. § 315(c) ..................................................................................................... 4
`37 C.F.R. § 42.6(d) ..................................................................................................10
`
`
`
`37 C.F.R. § 42.6(d) ................................................................................................ ..1o37 C.F.R. § 42.6(d) ................................................................................................ ..1o37 C.F.R. § 42.6(d) .................................................................................................. 1037 C.F.R. § 42.6(d) .................................................................................................. 10
`37 C.F.R. § 42.8(b)(1)................................................................................................2
`
`
`
`37 C.F.R. § 42.8(b)(1) .............................................................................................. ..237 C.F.R. § 42.8(b)(1) .............................................................................................. ..237 C.F.R. § 42.8(b)(1) ................................................................................................ 237 C.F.R. § 42.8(b)(1) ................................................................................................ 2
`37 C.F.R. § 42.8(b)(2)................................................................................................3
`
`
`
`37 C.F.R. § 42.8(b)(2) .............................................................................................. ..337 C.F.R. § 42.8(b)(2) .............................................................................................. ..337 C.F.R. § 42.8(b)(2) ................................................................................................ 337 C.F.R. § 42.8(b)(2) ................................................................................................ 3
`37 C.F.R. § 42.8(b)(3)................................................................................................5
`
`
`
`37 C.F.R. § 42.8(b)(3) .............................................................................................. ..537 C.F.R. § 42.8(b)(3) .............................................................................................. ..537 C.F.R. § 42.8(b)(3) ................................................................................................ 537 C.F.R. § 42.8(b)(3) ................................................................................................ 5
`37 C.F.R. § 42.8(b)(4)................................................................................................5
`
`
`
`37 C.F.R. § 42.8(b)(4) .............................................................................................. ..537 C.F.R. § 42.8(b)(4) .............................................................................................. ..537 C.F.R. § 42.8(b)(4) ................................................................................................ 537 C.F.R. § 42.8(b)(4) ................................................................................................ 5
`37 C.F.R. § 42.10(b) ..................................................................................................2
`
`
`
`37 C.F.R. § 42.10(b) ................................................................................................ ..237 C.F.R. § 42.10(b) ................................................................................................ ..237 C.F.R. § 42.10(b) .................................................................................................. 237 C.F.R. § 42.10(b) .................................................................................................. 2
`37 C.F.R. § 42.22 .......................................................................................................4
`
`37 C.F.R. § 42.22 ..................................................................................................... ..437 C.F.R. § 42.22 ..................................................................................................... ..4
`
`37 C.F.R. § 42.22 ....................................................................................................... 437 C.F.R. § 42.22 ....................................................................................................... 4
`37 C.F.R. § 42.22(a)...................................................................................................6
`
`
`
`37 C.F.R. § 42.22(a) ................................................................................................. ..637 C.F.R. § 42.22(a) ................................................................................................. ..637 C.F.R. § 42.22(a) ................................................................................................... 637 C.F.R. § 42.22(a) ................................................................................................... 6
`37 C.F.R. § 42.63(e)...................................................................................................2
`
`
`
`37 C.F.R. § 42.63(e) ................................................................................................. ..237 C.F.R. § 42.63(e) ................................................................................................. ..237 C.F.R. § 42.63(e) ................................................................................................... 237 C.F.R. § 42.63(e) ................................................................................................... 2
`37 C.F.R. § 42.100(b) ................................................................................................7
`
`
`
`37 C.F.R. § 42.100(b) .............................................................................................. ..737 C.F.R. § 42.100(b) .............................................................................................. ..737 C.F.R. § 42.100(b) ................................................................................................ 737 C.F.R. § 42.100(b) ................................................................................................ 7
`37 C.F.R. § 42.104(a).................................................................................................2
`
`
`
`37 C.F.R. § 42.104(a) ............................................................................................... ..237 C.F.R. § 42.104(a) ............................................................................................... ..237 C.F.R. § 42.104(a) ................................................................................................. 237 C.F.R. § 42.104(a) ................................................................................................. 2
`37 C.F.R. § 42.104(b) ..............................................................................................10
`
`
`
`37 C.F.R. § 42.104(b) ............................................................................................ ..1o37 C.F.R. § 42.104(b) ............................................................................................ ..1o37 C.F.R. § 42.104(b) .............................................................................................. 1037 C.F.R. § 42.104(b) .............................................................................................. 10
`37 C.F.R. § 42.106(a).................................................................................................2
`
`
`
`37 C.F.R. § 42.106(a) ............................................................................................... ..237 C.F.R. § 42.106(a) ............................................................................................... ..237 C.F.R. § 42.106(a) ................................................................................................. 237 C.F.R. § 42.106(a) ................................................................................................. 2
`37 C.F.R. § 42.122(b) ................................................................................................4
`
`
`
`37 C.F.R. § 42.122(b) .............................................................................................. ..437 C.F.R. § 42.122(b) .............................................................................................. ..437 C.F.R. § 42.122(b) ................................................................................................ 437 C.F.R. § 42.122(b) ................................................................................................ 4
`
`v
`
`

`

`InnoPharma
`Exhibit #
`1001
`
`1002
`
`1003
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`Petitioner’s Exhibit List
`
`Description
`
`Sawa et al., U.S. Patent No. 8,754,131, “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”
`U.S. Patent Application No. 13/687,242, Office Action of
`August 1, 2013
`
`vi
`
`

`

`InnoPharma
`Exhibit #
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`Description
`
`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).
`
`U.S. Patent Application No. 13/687,242, Applicant Remarks in
`support of amendment, October 22, 2013
`
`vii
`
`

`

`InnoPharma
`Exhibit #
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`Description
`
`"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).
`
`viii
`
`

`

`InnoPharma
`Exhibit #
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`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
`FDA approved
`"LOTEMAXTM (loteprednol
`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 "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.
`
`ix
`
`

`

`InnoPharma
`Exhibit #
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`1052
`
`1053
`
`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
`
`x
`
`

`

`I.
`
`INTRODUCTION
`InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc.,
`
`InnoPharma LLC, Mylan Pharmaceuticals Inc., and Mylan Inc. (collectively,
`
`“Petitioner”) petition for Inter Partes Review, seeking cancellation of claims 1-30
`
`(“challenged claims”) of U.S. Patent No. 8,754,131 (“the ’131 patent”) (EX1001),
`
`owned by Senju Pharmaceutical Co., Ltd. (“Patent Owner”).
`
`II. OVERVIEW
`The Board has already issued its Decision Instituting Inter Partes Review
`
`(“Decision”) on all challenged claims of
`
`the ’131 patent based on the
`
`Ogawa/Sallmann prior art. Lupin Ltd. v. Senju Pharm. Co., Ltd., IPR2015-01097
`
`[Paper No. 9, p. 9]. In its Decision, the Board found that Petitioner Lupin Ltd. and
`
`Lupin Pharmaceuticals Inc. (collectively “Lupin”) had demonstrated a reasonable
`
`likelihood that claims 1-30 of the ’131 patent are obvious over Ogawa and
`
`Sallmann.
`
`Id. Petitioner hereby files its own petition that raises obviousness in
`
`view of Ogawa and Sallmann and concurrently seeks to join the instituted IPR
`
`proceedings.
`
`The challenged claims of the ’131 patent mainly relate to stable aqueous
`
`formulations of bromfenac (a non-steroidal anti-inflammatory drug (“NSAID”))
`
`with tyloxapol (a non-ionic surfactant). At the relevant time, tyloxapol was a
`
`known non-ionic surfactant in aqueous formulations of NSAIDs while bromfenac
`
`1
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,754,131
`was a known NSAID previously formulated with another non-ionic surfactant,
`
`polysorbate 80. Thus, the purported inventors of the aqueous preparations of the
`
`challenged claims simply switched polysorbate 80 for tyloxapol (both well-
`
`known non-ionic surfactants). Swapping known alternatives from the prior art,
`
`according to their known functions to achieve predictable results,
`
`is not
`
`innovation. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)
`
`(“[W]hen a patent claims a structure already known in the prior art that is altered
`
`by the mere substitution of one element for another known in the field, the
`
`combination must do more than yield a predictable result.”).
`
`III.
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`STANDING (37 C.F.R. § 42.104(a); PROCEDURAL STATEMENTS)
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`Petitioner certifies that (1) the ’131 patent is available for IPR; and (2)
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`Petitioner is not barred or estopped from requesting IPR of any claim of the ’131
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`patent on the grounds identified herein. This Petition is filed in accordance with 37
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`C.F.R. § 42.106(a). Filed herewith are a Power of Attorney and an Exhibit List
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`pursuant to § 42.10(b) and § 42.63(e). The required fee is paid through online
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`credit card, and the Office is authorized to charge any fee deficiencies and credit
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`overpayments to Deposit Acct. No. 160605 (Customer ID No. 00826).
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
`A.
`Each Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))
`The real parties in interest for this petition are InnoPharma Licensing Inc.,
`
`2
`
`

`

`InnoPharma Licensing LLC,
`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,754,131
`InnoPharma LLC, Mylan
`
`InnoPharma Inc.,
`
`Pharmaceuticals Inc., and Mylan Inc.
`
`B.
`
`Notice of Related Matters (37 C.F.R. § 42.8(b)(2))
`1.
`Judicial Matters
`The ’131 patent is currently the subject of the following litigations: Senju
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`Pharm. Co., Ltd. et al. v. InnoPharma Licensing, Inc. et al., C.A. 1:15-cv-03240
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`(D.N.J.); Senju Pharm. Co., Ltd., et al. v. Metrics, Inc. et al., C.A. No. 1:14-cv-
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`03962-JBS-KMW (D.N.J); Senju Pharm. Co., Ltd. et al. v. Lupin, Ltd. et al., C.A.
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`No. 1:14-cv-05144-JBS-KMW (D.N.J); Senju Pharm. Co., Ltd., et al. v. Metrics,
`
`Inc. et al., C.A. No. 1:14-cv-04964-JBS-KMW (D.N.J.); Senju Pharm. Co., Ltd., et
`
`al. v. Metrics, Inc. et al., C.A. No. 4:14-cv-00141-BO (E.D.N.C.); Senju Pharm.
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`Co., Ltd. et al. v. InnoPharma Licensing, Inc., et al., C.A. No. 1:14-cv-06893-JBS-
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`KMW (D.N.J.); Senju Pharm. Co., Ltd. et al. v. Apotex Inc. et al., C.A. No. 1:15-
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`cv-00336-JBS-KMW (D.N.J.); Senju Pharm. Co., Ltd., et al. v. Paddock
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`Laboratories, LLC et al., C.A. No. 1:15-cv-00337-JBS-KMW (D.N.J.); Senju
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`Pharm. Co., Ltd., et al.. v. Paddock Labs., LLC et al., C.A. No. 1:15-cv-00087-
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`SLR (D. Del.); and Senju Pharm. Co., Ltd., et al v. Watson Labs., Inc., C.A. No.
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`1:15-cv-05591-JBS-KMW (D.N.J.).
`
`Administrative Matters
`2.
`U.S. Patent No. 8,754,131 (“the ’131 patent”) is the subject of a petition for
`
`inter partes
`
`reviews
`
`(IPR2015-01097)
`3
`
`filed by Lupin Ltd.
`
`and Lupin
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,754,131
`Pharmaceuticals (collectively “Lupin”) on April 23, 2015, which was instituted on
`
`October 27, 2015 as to claims 1-30. Petitioner seeks joinder with that IPR, for the
`
`reasons expressed in the concurrently filed Motion for Joinder under 35 U.S.C. §
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`315(c), 37 C.F.R. §§ 42.22 and 42.122(b).
`
`Petitioner is also aware of at least the following related family members:
`
`application No. 14/483,903 (“the ’903 application”), now U.S. Patent No.
`
`8,927,606, which is a division of application No. 14/261,720 (“the ’720
`
`application”), now U.S. Patent No. 8,871,813 (“the ’813 patent”), which is a
`
`division of application No. 14/165,976 (“the ’976 application”), now the ’131
`
`patent, which is a division of application No. 13/687,242 (“the ’242 application”),
`
`now U.S. Patent No. 8,669,290 (“the ’290 patent”), which is a division of
`
`application No. 13/353,653 (“the ’653 application”), now U.S. Pat. No. 8,497,304
`
`(“the ’304 patent”), which is a division of application No. 10/525,006 (“the ’006
`
`application”), now U.S. Patent No. 8,129,431 (“the ’431 patent”), which was the
`
`U.S. National Stage of PCT Application No. PCT/JP2004/000350 (“the ’350
`
`application”), which claimed priority to Japanese Application No. 2003-12427.
`
`Related family member applications U.S. Application Serial Nos. 14/269,692 and
`
`14/502,014 are currently pending before the Patent Office.
`
`U.S. Patent No. 8,669,290 (“the ’290 patent”) is the subject of the following
`
`inter partes reviews: IPR2014-01043 filed by Metrics Inc., which was settled on
`
`4
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,754,131
`July 8, 2015; IPR2015-00902 filed by Petitioner on March 19, 2015, which was
`
`instituted on August 7, 2015 as to claims 1-30; IPR2015-01099 filed by Lupin on
`
`April 23, 2015, which was instituted on October 27, 2015 as to claims 1-30.
`
`U.S. Patent No. 8,129,431 (“the ’431 patent”) is the subject of the following
`
`inter partes reviews: IPR2014-01041 filed by Metrics Inc., which was settled on
`
`July 8, 2015, as t