`
`
`
`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. 8,129,431 to Sawa et al.
`Issue Date: March 6, 2012
`Title: Aqueous Liquid Preparation Containing 2-Amino-3-(4-
`bromobenzoyl) Phenylacetic Acid
`
`_____________________
`
`Inter Partes Review No.: Unassigned
`_____________________
`
`Petition for Inter Partes Review of U.S. Patent No. 8,129,431 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
`
`
`
`
`
`
`
`

`

`
`
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`C. 
`
`III. 
`
`TABLE OF CONTENTS
`TABLE OF AUTHORITIES ................................................................................... iv 
`I. 
`INTRODUCTION .......................................................................................... 1 
`II. 
`OVERVIEW ................................................................................................... 1 
`A. 
`The ’431 Patent ..................................................................................... 2 
`B. 
`The Scope and Content of the Prior Art ................................................ 4 
`1. 
`Aqueous Ophthalmic Preparations of Bromfenac ..................... 4 
`2. 
`Tyloxapol and Related Surfactants in NSAID
`Aqueous Ophthalmic Preparations ............................................ 5 
`The Differences Between the Challenged Claims and the
`Prior Art ................................................................................................. 5 
`STANDING (37 C.F.R. § 42.104(a)); PROCEDURAL
`STATEMENTS .............................................................................................. 8 
`IV.  MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) ................................... 12 
`A. 
`Each Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) ......................... 12 
`B. 
`Notice of Related Matters (37 C.F.R. § 42.8(b)(2)) ............................ 12 
`1. 
`Judicial Matters ........................................................................ 12 
`2. 
`Administrative Matters ............................................................ 12 
`Designation of Lead and Back-Up Counsel (37 C.F.R. §
`42.8(b)(3)) ........................................................................................... 13 
`D.  Notice of Service Information (37 C.F.R. § 42.8(b)(4)) ..................... 13 
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(a)) ......................................... 13 
`VI.  THE ’431 PATENT AND CLAIM CONSTRUCTION .............................. 13 
`VII.  PERSON OF SKILL IN THE ART (“POSA”) & STATE OF THE
`ART .............................................................................................................. 16 
`VIII.  IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b)) ................ 18 
`A. 
`Independent Claims 1 and 18 .............................................................. 19 
`1. 
`Ogawa in View of Sallmann .................................................... 19 
`Dependent Claims 2-17 and 19-22 ...................................................... 35 
`
`V. 
`
`C. 
`
`B. 
`
`ii
`
`

`

`2. 
`
`3. 
`4. 
`5. 
`6. 
`
`C. 
`
`
`
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`1. 
`
`Claims 2-6, 11-17, and 19-22 – sodium salt of
`bromfenac ................................................................................. 35 
`Claims 3, 4, 6, 12, 13, and 20 – bromfenac
`concentration ............................................................................ 37 
`Claims 5 and 22 ........................................................................ 39 
`Claims 11, 15-17, and 21 ......................................................... 40 
`Claims 3-5 and 11 – tyloxapol concentration range ................ 41 
`Claims 6, 15-17, and 20-22 – tyloxapol
`concentration ............................................................................ 43 
`Claims 12-14 – tyloxapol concentration .................................. 46 
`7. 
`Claims 7-10, 13, 14, 16 and 17- additives ............................... 48 
`8. 
`Claims 9 and 10 - pH ............................................................... 49 
`9. 
`Objective Indicia of Nonobviousness ................................................. 50 
`1. 
`No Unexpected Results Over the Closest Prior Art. ................ 50 
`2. 
`Other Objective Indicia ............................................................ 52 
`IX.  CONCLUSION ............................................................................................. 55 
`X.  Appendix: Dependent Claims Would Have Been Obvious Over the
`Prior Art ........................................................................................................ 56 
`CERTIFICATION OF SERVICE
`
`iii
`
`

`

`
`
`
`Cases
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`TABLE OF AUTHORITIES
`
`Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc.,
`IPR2013-00368, Paper 8 (December, 17, 2013) ................................................ 50
`
`Asyst Techs., Inc. v. Emtrak, Inc.,
`544 F.3d 1310 (Fed. Cir. 2008) .......................................................................... 27
`
`Chapman v. Casner,
`315 F. App’x 294 (Fed. Cir. 2009) ................................................... 36, 37, 41, 49
`
`Ecolab, Inc. v. FMC Corp.,
`569 F.3d 1335 ..................................................................................................... 11
`
`Friskit, Inc. v. Real Networks, Inc.,
`306 F. App’x 610 (Fed. Cir. 2009) ..................................................................... 52
`
`Galderma Labs., L.P. v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013) .......................................................... 37, 39, 41, 47
`
`In re Aller,
`220 F.2d 454, (C.C.P.A. 1955) ........................................................................... 46
`
`In re De Blauwe,
`736 F.2d 699 (Fed. Cir. 1984) ............................................................................ 50
`
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003) .............................................................. 40, 46, 51
`
`In re Woodruff,
`919 F.2d 1575 (Fed. Cir. 1990) .......................................................................... 41
`
`Iron Grip Barbell Co., Inc. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ........................................................ 37, 39, 41, 47
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .................................................................................. 1, 14, 23
`
`Newell Cos., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 49
`
`iv
`
`

`

`
`
`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 2006) .......................................................................... 53
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`Purdue Pharma Prods. L.P. v. Par Pharm., Inc.,
`377 F. App’x 978 (Fed. Cir. 2010) ..................................................................... 53
`
`Sinclair & Carroll Co., v. Interchemical Corp.,
`325 U.S. 327 (1945) ............................................................................................ 22
`
`Stratoflex, Inc. v. Aeroquip Corp.,
`713 F.2d 1530 (Fed. Cir. 1983) .................................................................... 52, 53
`
`Sundance, Inc. v. DeMonte Fabricating Ltd.,
`550 F.3d 1356 (Fed. Cir. 2008) .......................................................................... 27
`
`Tokai Corp. v. Eason Enters., Inc.,
`632 F.3d 1358 (Fed. Cir. 2011) .......................................................................... 54
`
`Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC,
`683 F.3d 1356 (Fed. Cir. 2012) .............................................................. 23, 27, 31
`
`Statutes
`
`35 U.S.C. § 102(b) ............................................................................................passim
`
`35 U.S.C. § 112 .................................................................................................passim
`
`Regulations
`
`37 C.F.R. § 42.106(a) ................................................................................................. 9
`
`v
`
`

`

`
`
`
`Metrics
`Exhibit #
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`Petitioner’s Exhibit List
`
`Description
`
`Sawa et al., U.S. Patent No. 8,129,431 B2, "Aqueous Liquid
`Preparation Containing 2-Amino-3-(4-Bromobenzoyl) Phenylacetic
`Acid"
`
`Hara, Yoshiyuki , "Bromfenac sodium hydrate," Clinics & Drug
`Therapy 19:1014-1015 (2002)
`
`Declaration of 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"
`
`vi
`
`

`

`
`
`
`Metrics
`Exhibit #
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`Description
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`Yasueda et al., U.S. Patent No. 6,274,609, "Aqueous Liquid
`Pharmaceutical Composition Containing as Main Component
`Benzopyran Derivative"
`
`"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?App
`l_No=203168&TABLE1=OB_Rx, last accessed on February 14, 2014
`
`“ophthalmic” Webster’s Deluxe Unabridged Dictionary: 1254,
`Webster’s New Twentieth Century Dictionary, Simon and Schuster
`(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)
`
`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)
`
`Bergamini et al., U.S. Patent No. 5,597,560, "Diclofenac And
`Tobramycin Formulations For Ophthalmic And Otis Topical use"
`
`Wong, Michelle, International Patent No. WO 94/15597, “Ophthalmic
`Compositions Comprising Benzyllauryldimethylammonium
`Chloride” (filed January 11, 1993); issued July 21, 1994)
`
`vii
`
`

`

`
`
`
`Metrics
`Exhibit #
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`Description
`
`Reddy, Indra K., Ocular Therapeutics and Drug Delivery: A Multi-
`Disciplinary Approach: 42-43, 390 (1996)
`
`Story, M., et al., European Patent No. 0274870, "Micelles containing
`a non-steroidal antiinflammatory compound" (filed December 12,
`1987; issued July 7, 1988)
`
`"Borax (Sodium tetraborate)," Biochemicals and Reagents: 175,
`Sigma-Aldrich (2000-2001)
`
`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"
`
`Gennaro, A., “Boric Acid,” Remington: The Science and Practice of
`Pharmacy 20: 1041, University of Sciences, United States (2000)
`
`Wade, A., and Weller, P., "Edetic Acid," and "Sodium Metabisulfite,"
`Handbook of Pharmaceutical Excipients 2: 176-179, 451-453,
`American Pharmaceutical Association, United States (1994)
`
`viii
`
`

`

`
`
`I.
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`INTRODUCTION
`Metrics, Inc. (“Petitioner”) petitions for Inter Partes Review, seeking
`
`cancellation of claims 1-22 (“challenged claims”) of U.S. Patent No. 8,129,431 to
`
`Sawa et al. (“the ’431 patent”) (EX1001), which
`
`is owned by Senju
`
`Pharmaceutical Co., Ltd. (“Senju”).
`
`II. OVERVIEW
`
`Claims 1-22 of the ’431 patent are unpatentable for failing to satisfy the
`
`nonobviousness requirement of 35 U.S.C. § 103. The alleged “inventions” involve
`
`only the (i) “simple and obvious substitution of one known element for another to
`
`obtain predictable results” over what was taught in the prior art; (ii) “choosing
`
`from a finite number of identified, predictable solutions,” with a reasonable
`
`expectation of success; and/or (iii) obvious modification of prior art teachings,
`
`with a reasonable expectation of success. Thus, these claims fall squarely, and
`
`fatally, under KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
`
`In essence the challenged claims all are directed to an aqueous formulation
`
`of bromfenac (a non-steroidal anti-inflammatory drug (NSAID)) with tyloxapol (a
`
`non-ionic surfactant). Tyloxapol was a known non-ionic surfactant in aqueous
`
`formulations of NSAIDs and bromfenac was a known NSAID previously
`
`formulated with another non-ionic surfactant, polysorbate 80. Thus, the inventors
`
`of the aqueous preparations of the challenged claims of the ’431 patent simply
`
`1
`
`

`

`
`
`switched tyloxapol for polysorbate 80 (both well-known non-ionic surfactants). Or
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`viewed another way, the inventors of the challenged claims of the ’431 patent
`
`merely switched bromfenac for diclofenac (both well-known structurally similar
`
`NSAIDs). Swapping known alternatives from the prior art, according to their
`
`known functions to achieve predictable results, is not innovation.
`
`A. The ’431 Patent
`The challenged claims of the ’431 patent are directed to aqueous liquid
`
`preparations for ophthalmic administration. Claim 1 is reproduced below.
`
`1. An aqueous liquid preparation consisting essentially
`of the following two components, wherein the first
`2-amino-3-(4-bromobenzoyl)-
`component
`is
`phenylaceticacid or a pharmacologically acceptable salt
`thereof or a hydrate thereof, wherein the hydrate is at
`least one selected from a 1/2 hydrate, 1 hydrate, and 3/2
`hydrate and the second component is tyloxapol, wherein
`said liquid preparation is formulated for ophthalmic
`administration, and wherein when a quaternary
`ammonium compound
`is
`included
`in said
`liquid
`preparation, the quaternary ammonium compound is
`benzalkonium chloride.
`(EX1001, 11:66-12:101) (emphasis added).
`
`
`1 Citations are as follows: X:YY-ZZ (col:lines; patent); X:Y:Z
`
`
`
`2
`
`

`

`
`
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`In pertinent part, claim 1 is directed to an aqueous liquid preparation for
`
`ophthalmic administration consisting essentially of just two components: (1)
`
`bromfenac (or its salts and hydrates); and (2) tyloxapol.2
`
`In the context of the ’431 patent, the “consisting essentially of” transitional
`
`phrase is construed to mean that the claimed ophthalmic formulations may include
`
`additional unrecited ingredients provided they do not materially affect the stability
`
`of the formulation “within a pH range giving no irritation to eyes, and change of
`
`the [bromfenac] over time can be inhibited, and … when the aqueous solution
`
`contains a preservative, deterioration in the preservative effect of said preservative
`
`can be inhibited for a long period of time.” (EX1001, 2:34-47 & Abstract). The
`
`’431 patent specification expressly allows for other ingredients to be present in the
`
`formulation, including a preservative, buffer, thickener, stabilizer, chelating agent,
`
`and pH controlling agent, or an additional active ingredient. (EX1001, claims 7
`
`
`(page:col:para; journal article); X:Y (page:para; journal article).
`
`2 Claim 1 recites that “when a quaternary ammonium compound is
`
`included,” then it is benzalkonium chloride (“BAC”). (EX1001, 12:6-7) (emphasis
`
`added). Thus, BAC is an optional component of the aqueous liquid preparation of
`
`claim 1, since claim 1 also encompasses preparations “when a quaternary
`
`ammonium compound is not included.”
`
`3
`
`

`

`
`
`and 8 and 6:42-44).
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`B.
`
`The Scope and Content of the Prior Art
`1.
`Bromfenac, like diclofenac and ketorolac, was a well-known NSAID useful
`
`Aqueous Ophthalmic Preparations of Bromfenac
`
`for treating inflammation in the eye. (EX1002, 1014:1:2; EX10033, ¶¶27-29).
`
`Each of bromfenac, diclofenac and ketorolac are in the class of NSAIDs possessing
`
`a carboxylic acid group (-COOH), and as discussed below this class of NSAIDs
`
`was known to interact with BAC in aqueous ophthalmic formulations in a way that
`
`weakens the preservative efficacy of BAC. By January 21, 2003, bromfenac had
`
`been formulated with BAC along with non-ionic surfactants in aqueous
`
`preparations for ophthalmic delivery.
`
`The Ogawa patent (EX1004) described an aqueous ophthalmic formulation
`
`containing (1) bromfenac, (2) polysorbate 80, and (3) BAC. (EX1004, 9:5-10:19;
`
`see also Hara (EX1002), the Desai patents (EX1005 and EX1006), BRONUCK
`
`Japanese Pharmacopeia (EX1007), BROMDAY Prescribing Information (EX1008)).
`
`
`3 This Petition is accompanied by the Declaration of Professor Uday B.
`
`Kompella, Ph.D. (Kompella Dec. (EX1003)).
`
`4
`
`

`

`
`
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`2.
`Tyloxapol and Related Surfactants in NSAID Aqueous
`Ophthalmic Preparations
`
`By January 21, 2003, tyloxapol and related alkylaryl polyether surfactants
`
`were well-known non-ionic surfactants formulated in the prior art with NSAIDs.
`
`For example, Sallmann described liquid ophthalmic formulations containing (1)
`
`diclofenac sodium (an NSAID), (2) tyloxapol surfactant, and (3) BAC. (EX1009,
`
`8:1-15).
`
`Tyloxapol, like polysorbate 80, was successfully used to stabilize aqueous
`
`ophthalmic formulations as early as the 1960’s. (EX1009, 8:1-15; EX1010,
`
`306:2:2-4; EX1003, ¶¶32, 34-37, 39). Notably, the prior art taught that tyloxapol
`
`was effective in stabilizing NSAIDs, like bromfenac. (EX1003,¶37; EX1016, 5:8-
`
`9, 7:13-22, Formulation 3, EX1011.). The prior art also disclosed examples where
`
`tyloxapol is a preferred non-ionic surfactant for use in ophthalmic formulations
`
`containing acidic NSAIDs, like bromfenac (EX1009, 4:62; EX1003, ¶¶34, 39, 56),
`
`and where tyloxapol was superior to polysorbate 80 as a surfactant in aqueous
`
`liquid formulations of an acidic compound. (EX1012, 7:20-43). In the prior art a
`
`finite number of non-ionic surfactants, including tyloxapol and polysorbate 80, had
`
`been used in approved ophthalmic formulations. (EX1012, 4:51-63; EX1009,
`
`4:52-62).
`
`C. The Differences Between the Challenged Claims and the Prior Art
`Petitioner relies on its primary prior art references, the Ogawa patent
`
`5
`
`

`

`
`
`(EX1004) and the Sallmann patent (EX1009) in combination with each other.
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`Each discloses a prior art ophthalmic formulation of an NSAID, BAC and a non-
`
`ionic surfactant, similar to what is claimed in the ’431 patent. The challenged
`
`claims of the ’431 patent differ from prior art aqueous liquid ophthalmic
`
`formulations of an NSAID only in the replacement of bromfenac for another
`
`NSAID, or alternately, in the replacement of tyloxapol for another non-ionic
`
`surfactant (polysorbate 80), as illustrated in the following chart.
`
`
`
`’431 Patent
`Claim 1
`
`Ogawa
`Example 6
`(EX1004)
`
`NSAID
`
`Bromfenac
`
`Bromfenac
`
`Sallmann
`Example 2
`(EX1009)
`
`Diclofenac
`
`Surfactant
`
`Tyloxapol
`
`Polysorbate 80
`
`Tyloxapol
`
`BAC
`
`Optional
`
`Yes
`
`Yes
`
`When viewed against the prior art, what becomes clear is that the inventors
`
`of the ’431 patent did nothing more than swap one well-known component from a
`
`prior art formulation with another component known to be used for the same
`
`purpose. Thus, the inventors of the aqueous preparations of the challenged claims
`
`of the ’431 patent simply switched tyloxapol for polysorbate 80 (both well-known
`
`non-ionic surfactants). Alternately, the inventors merely switched bromfenac for
`
`diclofenac (both well-known structurally similar NSAIDs). Swapping known
`
`alternatives from the prior art is not innovation. All the inventors of the ’431
`
`6
`
`

`

`
`
`patent accomplished was the mere obvious replacement of known components,
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`according to their known functions, to achieve predictable results. (EX1003, ¶¶55-
`
`58). A person of ordinary skill in the art (“POSA”) could have readily performed
`
`these simple component substitutions—tyloxapol for polysorbate 80 or bromfenac
`
`for diclofenac—because the functions of these components were well known in the
`
`art and the results were predictable. (EX1003, ¶¶55-58).
`
`And, finally, the prior art disclosed only a finite number of non-ionic
`
`surfactants for ophthalmic formulations, such that it would have been obvious to
`
`try substituting any of these known non-ionic surfactants (including tyloxapol) for
`
`polysorbate 80 to modify the teachings of Ogawa to arrive predictably at the
`
`claimed inventions, with a reasonable expectation of success.
`
`Sallmann disclosed ophthalmic formulations containing NSAIDs, including
`
`diclofenac and ketorolac, together with ethoxylated octylphenol surfactants,
`
`including tyloxapol, as the non-ionic surfactant. (EX1003, ¶53). Sallmann’s
`
`ophthalmic formulation also included the preservative BAC. A POSA, therefore,
`
`would have been motivated to substitute bromfenac for diclofenac in Sallmann’s
`
`ophthalmic formulations to obtain predictable results because of the structural and
`
`functional similarities between bromfenac and diclofenac (EX1002, 1015:2:2;
`
`EX1003, ¶62), including their similar interaction with BAC, and the known
`
`7
`
`

`

`
`
`preference for bromfenac over diclofenac (EX1002). The prior art also only
`
`Petition for Inter Partes Review of USPN 8,129,431
`
`disclosed a finite number of NSAIDs for ophthalmic application, such that it would
`
`have been obvious to try substituting any of these known anti-inflammatory
`
`compounds (including bromfenac) for diclofenac to modify the teachings of
`
`Sallmann and to arrive predictably at the claimed inventions, with a reasonable
`
`expectation of success. (EX1002, 1014:2:3-1015:1:1; EX1003, ¶62).
`
`The subject matter of many of the challenged claims of the ‘431 patent is
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`commercially embodied by Prolensa®, a product marketed by Bausch & Lomb Inc.
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`(“B&L”). (EX1013; EX1014). The patent owner previously owned patent
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`protection for
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`two other bromfenac ophthalmic products—Xibrom® and
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`Bromday®—in the United States, both of which were covered by the prior art
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`Ogawa patent (EX1004), and over which the ’431 patent is obvious. And while
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`some dependent claims of the ’431 patent recite more particular excipients,
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`concentration ranges, and pH ranges, these nominal differences fall far short of
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`imparting patentability as discussed below.
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`III. STANDING (37 C.F.R. § 42.104(a)); PROCEDURAL STATEMENTS
`Petitioner certifies that (1) the ’431 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 ’431
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`patent on the grounds identified herein. This Petition is filed in accordance with 37
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`CFR § 42.106(a). Concurrently filed herewith are a Power of Attorney and an
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`Exhibit List pursuant to § 42.10(b) and § 42.63(e), respectively. The required fee
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`Petition for Inter Partes Review of USPN 8,129,431
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`is paid through online credit card payment. The Office is authorized to charge fee
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`deficiencies and credit overpayments to Deposit Acct. No. 04-1679 (Customer ID
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`No. 39290).
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`Petitioner is aware that counsel for the patent owner has previously taken the
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`position that the PTAB should exercise its discretion and deny IPR petitions filed
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`by ANDA applicants. Specifically, patent owner’s counsel has asserted that the
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`filing of a Paragraph IV Certification by an ANDA applicant is the equivalent of
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`filing a civil action challenging the validity of a patent, and as such prohibits the
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`applicant from filing a petition for IPR pursuant to 35 U.S.C. 315(a)(1). However,
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`such a position is contrary to the express terms of the IPR provisions and contrary
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`to the stated purpose of AIA. Should the patent owner assert a similar challenge in
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`its Preliminary Patent Owner Response, Petitioner requests that the PTAB set an
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`expedited supplemental briefing schedule to afford the Petitioner due process to
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`fully respond to such assertions.
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`As a preliminary matter, the provisions of the AIA apply equally to Hatch
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`Waxman Act disputes unless otherwise exempted. For example, with respect to
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`the AIA provisions of joinder, the statute expressly exempts Hatch Waxman
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`271(e)(2) cases:
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` § 299 (a) Joinder of accused infringers. With respect to any civil
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`Petition for Inter Partes Review of USPN 8,129,431
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`action arising under any Act of Congress relating to patents, other
`than an action or trial in which an act of infringement under 271(e)(2)
`has been pled…
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`Thus, because Congress has indicated its intention to exempt some provision of the
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`AIA for Hatch Waxman disputes, Congress’ intention to allow the IPR provisions
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`to fully apply to Hatch Waxman disputes is clear. As a result, the PTAB has
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`previously granted Petitions for IPR filed by ANDA applicants. See Amneal
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`Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc., IPR2013-00368, 00371
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`and 00372; Ranbaxy Laboratories, Ltd v. Vertex Pharms., Inc., IPR2013-0024.
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`Importantly, an invalidity determination by the PTAB that is affirmed by the
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`Federal Circuit is immediately binding on a federal district court presiding over a
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`case involving those same claims. See Fresenius USA Inc. v. Baxter Int’l Inc., 721
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`F.3d 1330 (Fed. Cir. 2013). Given the 30 month stay automatically provided upon
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`the filing of an infringement action by a patent owner, the expedited proceeding of
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`an IPR may be a particularly desirable route for ANDA applicants and may assist
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`to resolve the underlying infringement action within the 30 month stay based on
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`the binding effect of the PTAB invalidity decision.
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` Patent Owner’s anticipated argument that the filing of a Paragraph IV
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`Certification challenging the validity of a patent is somehow equivalent to the
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`filing a declaratory judgment action challenging validity is without support. The
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`filing of a Paragraph IV Certification is deemed to be an act of infringement
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`Petition for Inter Partes Review of USPN 8,129,431
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`pursuant to 271e(2), but it is not the equivalent of filing a lawsuit challenging
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`validity. The Hatch Waxman statute imposes stringent timelines in which the
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`ANDA applicant must provide notice of the Paragraph IV Certification to the
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`patent owner which opens the window for the patent owner to file a lawsuit
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`asserting infringement. In support of its argument, the patent owner has
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`previously identified the AIA’s “supplemental examinations” provision as
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`evidence that Paragraph IV Certification is a functional equivalent of a declaratory
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`judgment action. However, the substantive examination provision of AIA provides
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`that once a patent owner receives notice of particularly plead facts regarding
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`invalidity or unenforceability, either in a defense to an infringement complaint, or
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`through notice of a Paragraph IV Certification, the patent owner is no longer
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`permitted to seek supplemental examination of its patent. Thus, the AIA does not
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`treat a Paragraph IV certification as the equivalent of filing a declaratory judgment
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`action, but rather considers both as providing adequate notice to a patent owner to
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`prohibit the subsequent filing of supplemental examination by the patent owner.
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`Thus, there is no conflict between the Hatch Waxman Act and the IPR
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`provisions of the AIA, and patent owner’s anticipated assertions to the contrary are
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`without support.
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`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
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`Petition for Inter Partes Review of USPN 8,129,431
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`A. Each Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))
`The real parties in interest are Metrics, Inc., Mayne Pharma, and Johnson
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`Matthey, Inc.
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`B. Notice of Related Matters (37 C.F.R. § 42.8(b)(2))
`1.
`Judicial Matters
`Senju Pharmaceutical Co., Ltd., Bausch & Lomb, Inc., and Bausch & Lomb
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`Pharma Holdings Corp. v. Lupin, Ltd. and Lupin Pharmaceuticals, Inc., C.A. No.
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`1:14-CV-00667-MAS-LHG (D.N.J.) and Senju Pharmaceutical Co., Ltd., Bausch
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`& Lomb, Inc., and Bausch & Lomb Pharma Holdings Corp. v. Metrics, Inc.,
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`Pharmaceuticals, Inc., Mayne Pharma Group Limited, Mayne Pharma (USA),
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`INC., and Coastal Pharmaceuticals, Inc. C.A. No. 1:14-cv-03962-JBS-KMW
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`(D.N.J.), which involve the ’431 patent.
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`Administrative Matters
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`2.
`Petitioner has filed concurrently with this Petition, a Petition for Inter Partes
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`review of U.S. Patent No. 8,669,290 (“the ’290 patent”), which issued on March
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`11, 2014 and claims priority to the application that issued as the ’431 patent.
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`U.S. Patent No. 8,497,304, a division of the ’431 patent, issued on July 30,
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`2013 and claims the priority to the application that issued as the ’431 patent.
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`U.S. Patent No. 8,754,131, a division of the ’290 patent, issued on June 17,
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`2014 and claims the priority to the application that issued as the ’431 patent.
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`Petition for Inter Partes Review of USPN 8,129,431
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`U.S. Application Serial Nos. 14/261,720 and 14/269,692 are pending and
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`claim priority to the application which issued as the ’431 patent.
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`C. Designation of Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3))
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`Lead Counsel
`Patrick D. McPherson (Reg. No. 46,255 )
`DUANE MORRIS LLP
`505 9th Street, N.W., Suite 1000
`Washington, DC 20004-2166
`202.776.7800 (telephone)
`202.776.7801 (facsimile)
`PDMcPherson@duanemorris.com
`
`
`Back-Up Counsel
`Vincent L. Capuano (Reg. No. 42,385 )
`DUANE MORRIS LLP
`100 High Street, Suite 2400
`Boston, MA 02110
`857.488.4250 (telephone)
`857.488.4202 (facsimile)
`VCapuano@duanemorris.com
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`D. Notice of Service Information (37 C.F.R. § 42.8(b)(4))
`Please direct all correspondence to lead counsel at the above address.
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`Petitioner consents
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`to email service at: VCapuano@duanemorris.com and
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`PDMcPherson@duanemorris.com.
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`V.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(a))
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`Petitioner requests IPR and cancellation of claims 1-22 of the ’431 patent. A
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`detailed statement of the reasons for the relief requested is set forth in Section VIII.
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`VI. THE ’431 PATENT AND CLAIM CONSTRUCTION
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`The ’431 patent issued on March 6, 2012, from U.S. Appl. No. 10/525,006,
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`a U.S. National Stage patent application of Patent Cooperation Treaty Appl. No.
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`PCT/JP2004/000350, filed on January 16, 2004. Accordingly, the effective filing
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`date (“EFD”) of the ’431 patent is January 16, 2004. The earliest possible priority
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`Petition for Inter Partes Review of USPN