`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`CIPLA LIMITED,
`Petitioner
`
`v.
`
`ALCON RESEARCH, LTD.,
`Patent Owner.
`
`U.S. Patent No. 8,791,154 to Gamache et al.
`Issue Date: July 29, 2014
`Title: High Concentration Olopatadine Ophthalmic Composition
`
`
`
`Inter Partes Review No.: IPR2018-01020
`
`
`
`
`
`
`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,791,154 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
`
`Page
`INTRODUCTION ...............................................................................1
`I.
`II. OVERVIEW .......................................................................................1
`III. 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)) ..........................2
`1.
`Judicial Matters .................................................................2
`2.
`Administrative Matters .......................................................3
`C. 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)) .................3
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(a)).......................................4
`VI. THE ’154 PATENT .............................................................................4
`A.
`Claim Construction .....................................................................4
`VII. NONE OF THE CLAIMS ARE ENTITLED TO THE PRIORITY
`DATE OF PROVISIONAL APPLICATION 61/487,789 ..........................7
`VIII. A PERSON OF ORDINARY SKILL IN THE ART .................................8
`IX.
`IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b)) ................9
`X.
`INVALIDITY ANALYSIS ................................................................. 10
`A. Ground 1: Claims 1-27 Are Rendered Obvious by Bhowmick in
`View of Yanni, and Castillo ....................................................... 10
`1.
`The Level of Ordinary Skill in the Pertinent Art and the
`Scope and Content of the Prior Art ..................................... 11
`
`V.
`
`i
`
`

`

`2.
`
`(ii)
`
`(iii)
`
`(i)
`Bhowmick .................................................... 12
`(ii) Yanni ........................................................... 13
`(iii) Castillo ......................................................... 14
`Differences between the Claims and the Prior Art ................ 14
`a.
`Claim 1 ................................................................. 14
`(i)
`“An aqueous ophthalmic
`solution
`for
`treatment of ocular allergic conjunctivitis,
`the solution comprising” ................................. 14
`“at least 0.67 w/v % olopatadine dissolved
`in the solution” .............................................. 15
`“PEG having a molecular weight of 300 to
`500” ............................................................. 17
`“polyvinylpyrrolidone” ................................... 19
`(iv)
`“hydroxypropyl-γ-cyclodextrin” ...................... 20
`(v)
`“benzalkonium chloride” ................................ 21
`(vi)
`(vii) “Water” ........................................................ 21
`(viii) The Fact That Yanni May Teach
`Suspensions In Certain Instances Should
`Not Dissuade the Board from Instituting IPR ..... 21
`(ix) The Skilled Artisan Would Not Be
`Dissuaded from Using Multiple Solubilizing
`Agents.......................................................... 25
`(x) Reasonable Expectation of Success .................. 26
`Claims 4 and 8........................................................ 27
`b.
`Claim 21................................................................ 30
`c.
`Claims 2, 5, and 9 ................................................... 33
`d.
`Claims 3, 6, 10 and 18 ............................................. 34
`e.
`Claims 7 and 11 ...................................................... 35
`f.
`Claims 19 and 20 .................................................... 35
`g.
`Claim 24................................................................ 36
`h.
`Claims 12–14 and 25–27.......................................... 37
`i.
`Claims 15–17 and 22 ............................................... 38
`j.
`Claim 23................................................................ 38
`k.
`B. Ground 2: Claims 1–27 Are Rendered Obvious by Schneider in
`View of Hayakawa, Bhowmick, and Castillo ................................ 40
`1.
`The Level of Ordinary Skill in the Pertinent Art and the
`Scope and Content of the Prior Art ..................................... 42
`
`ii
`
`

`

`2.
`
`b.
`
`(ii)
`
`(iii)
`
`Differences between the Claims and the Prior Art ................ 42
`a.
`The Prior Art .......................................................... 42
`(i)
`Schneider...................................................... 42
`(ii) Hayakawa ..................................................... 43
`Claim 1 ................................................................. 44
`(i)
`“An aqueous ophthalmic
`solution
`for
`treatment of ocular allergic conjunctivitis,
`the solution comprising” ................................. 44
`“at least 0.67 w/v % olopatadine dissolved
`in the solution” .............................................. 44
`“PEG having a molecular weight of 300 to
`500” ............................................................. 45
`“polyvinylpyrrolidone” ................................... 47
`(iv)
`“hydroxypropyl-γ-cyclodextrin” ...................... 47
`(v)
`“benzalkonium chloride” ................................ 48
`(vi)
`(vii) “Water” ........................................................ 48
`(viii) Reasonable Expectation of Success .................. 48
`Claim 4 and 8 ......................................................... 49
`c.
`Claim 21................................................................ 53
`d.
`Claims 2, 5, and 9 ................................................... 56
`e.
`Claims 3, 6, 10 and 18 ............................................. 56
`f.
`Claims 7 and 11 ...................................................... 57
`g.
`Claims 19 and 20 .................................................... 58
`h.
`Claim 24................................................................ 59
`i.
`Claims 12–14 and 25–27.......................................... 59
`j.
`Claims 15–17 and 22 ............................................... 60
`k.
`Claim 23................................................................ 61
`l.
`The District Court’s Decision Not to Invalidate the ’154 Patent
`Should Not Dissuade the PTAB from Instituting Review ............... 62
`1.
`The Challenge before the Board Is Not the Same
`Challenge That Was before the District Court ...................... 62
`The District Court Focused Too Heavily on Preferred
`Embodiments .................................................................. 63
`The District Court Focused Too Heavily on the
`Commercial Formulations ................................................. 64
`
`C.
`
`2.
`
`3.
`
`iii
`
`

`

`D. Objective Indicia of Non-Obviousness......................................... 65
`1.
`No Unexpected Results..................................................... 65
`2.
`No Commercial Success ................................................... 66
`3.
`No Failure of Others......................................................... 67
`XI. CONCLUSION ................................................................................. 67
`
`
`iv
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Alcon Research, Ltd. v. Apotex Inc.,
`687 F.3d (Fed. Cir. 2012) ........................................................................ 17
`Alcon Research, Ltd. v. Apotex Inc. et al.,
`1-16-cv-00906 (D. Del.) ............................................................................ 2
`Alcon Research, Ltd. v. Cipla Limited et al.,
`1-17-cv-01244 (D. Del.) ...................................................................... 2, 68
`Alcon Research, Ltd. v. Lupin Limited et al.,
`1-16-cv-00195 (D. Del.) ............................................................................ 2
`Alcon Research, Ltd. v. Watson Labs.,
`1-15-cv-01159 (D. Del.) ................................................................... passim
`Amneal Pharm. LLC., v. Purdue Pharma L.P.,
`IPR2016-01412...................................................................................... 65
`Amneal Pharms. LLC v. Hospira, Inc.,
`IPR2016-01577, Paper 11 (Decision to Institute) at 13 (PTAB at
`Feb. 9 2017) .......................................................................................... 66
`Amneal Pharms., LLC v. Supernus Pharms., Inc.,
`IPR2013-00368...................................................................................... 66
`Apotex, Inc. v. Alcon Research Ltd.,
`IPR2016-01640.................................................................................... 1, 3
`Argentum Pharm. LLC v. Alcon Research, Ltd.,
`IPR2016-00544............................................................................... passim
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) .................................................... 7
`Bayer Pharma AG v. Watson Laboratories, Inc.,
`874 F.3d 1316 (Fed. Cir. 2017) ................................................................ 65
`
`i
`
`

`

`Celanese International Corp. v. Daicel Corporation,
`IPR2017-00163, 25 (PTAB May 3, 2018).................................................. 65
`Chi Mei Innolux Corp. v. Semiconductor Energy Lab. Co., Ltd.,
`IPR2013-00028................................................................................. 11, 42
`CRS Advanced Techs., Inc. v. Frontline Techs., Inc.,
`CBM2012-00005 ..................................................................................... 5
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .............................................................................. 6
`Ethicon, Inc. v. Quigg,
`849 F.2d 1422 (Fed. Cir. 1988) ................................................................ 63
`Gnosis S.P.A., et al. v. South Alabama Medical Science Foundation,
`IPR2013-00116...................................................................................... 65
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966) ................................................................................... 10
`In re Aller,
`220 F.2d 454 (C.C.P.A. 1955) ............................................................. 31, 53
`In re Fulton,
`391 F.3d 1195 (Fed. Cir. 2004) ......................................................... passim
`In re Mouttet,
`686 F.3d 1322 (Fed. Cir. 2012) ......................................................... passim
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2005) ......................................................... passim
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) .................................................................. 6
`In re Woodruff,
`919 F.2d 1575 (Fed. Cir. 1990) ........................................................... 31, 53
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ................................................................ 19
`
`ii
`
`

`

`Koios Pharm LLC v. Medac Gesellschaft Fur Klinische
`Spezialpraparate,
`IPR2016-01370...................................................................... 15, 21, 64, 66
`Kyocera Corp. v. Softview LLC,
`IPR2013-00007........................................................................................ 5
`Newell Cos., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) .................................................................. 65
`Novartis AG v. Noven Pharm. Inc.,
`853 F.3d 1289 (Fed. Cir. 2017) ................................................................ 63
`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 2006) ................................................................ 67
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2008) ................................................................ 66
`Pharmacosmos A/S v. Luitpold Pharms., Inc.,
`IPR2015-01490................................................................................. 36, 59
`Polaris Wireless, Inc. v. TruePosition, Inc.,
`IPR2013-00323........................................................................................ 7
`PowerOasis, Inc. v. T-Mobile USA,
`522 F.3d 1299 (Fed. Cir. 2008) .................................................................. 7
`SAP America, Inc. v. Pi-Net Int’l., Inc.,
`IPR2014-00414........................................................................................ 7
`Titanium Metals Corp. of America v. Banner,
`778 F.2d 775 (Fed. Cir. 1985) .................................................. 37, 39, 60, 62
`Vandenberg v. Dairy Equip. Co.,
`740 F.2d 1560 (Fed. Cir. 1984) ................................................................ 67
`Watson Labs., Inc. v. United Therapeutics Corp.,
`IPR2017-01621...................................................................................... 41
`Statutes
`35 U.S.C. § 102(a) ...................................................................................... 41
`
`iii
`
`

`

`35 U.S.C. § 102(b) ...................................................................... 11, 12, 36, 41
`35 U.S.C. § 102(b) ...................................................................... 11,12, 36,41
`35 U.S.C. § 102(e) ...................................................................................... 41
`35 U.S.C. § 102(6) ...................................................................................... 41
`35 U.S.C. § 103(a) ............................................................................. 9, 10, 41
`35 U.S.C. § 103(a) ............................................................................. 9, 10,41
`35 U.S.C. § 112 ............................................................................................ 7
`35 U.S.C. § 112 ............................................................................................ 7
`35 U.S.C. § 119 ............................................................................................ 7
`35 U.S.C. § 119 ............................................................................................ 7
`35 U.S.C. § 325(d) ...................................................................................... 42
`35 U.S.C. § 325(d) ...................................................................................... 42
`Regulations
`Regulations
`37 C.F.R. § 42.6(d) ....................................................................................... 9
`37 CPR. § 42.6(d) ....................................................................................... 9
`37 C.F.R. § 42.10(b)...................................................................................... 2
`37 CPR. § 42.10(b)...................................................................................... 2
`37 C.F.R. § 42.63(e) ...................................................................................... 2
`37 CPR. § 4263(6) ...................................................................................... 2
`37 C.F.R. § 42.100(b) .................................................................................... 6
`37 CPR. § 42.100(b) .................................................................................... 6
`37 C.F.R. § 42.106(a) .................................................................................... 2
`37 CPR. § 42.106(a) .................................................................................... 2
`
`
`iv
`
`iv
`
`

`

`TABLE OF EXHIBITS
`
`
`
`Exhibit
`Ex #
`1001 U.S. Patent No. 8,791,154 B2 (“’154 Patent”)
`1002 U.S. Patent No. 9,533,053 B2 (“’053 Patent”)
`1003 WO 2008/015695 A2 (“Bhowmick”)
`1004 YANNI et al., “The In Vitro and In Vivo Ocular Pharmacology of
`Olopatadine (AL-4943A), an Effective Anti-Allergic/Antihistaminic
`Agent,” Journal of Ocular Pharmacology and Therapeutics, Volume
`12, Number 4, 1996, pp. 389-400 (“Yanni”)
`1005 U.S. Pat. No. 6,995,186 B2 (“Castillo”)
`1006 U.S. Pat. Pub. No. 2011/0082145 A1 (“Schneider”)
`1007 U.S. Pat. No. 5,641,805 (“Hayakawa”)
`File Wrapper for U.S. Patent No. 8,791,154 B2
`1008
`1009
`File Wrapper for U.S. Provisional Appl. No. 61/487,789
`1010
`File Wrapper for U.S. Provisional Appl. No. 61/548,957
`1011
`Physician’s Desk Reference - PATANOL®; PATADAY® (“PDR”)
`1012 Handbook of Pharmaceutical Excipients
`David B. Troy, Remington: The Science and Practice of Pharmacy,
`Philadelphia College of Pharmacy and Science 21st Ed., 229, 856-866
`(2005)
`1014 Declaration of Dr. Laskar
`1015
`Argentum Pharm. LLC v. Alcon Research, Ltd., IPR2016-00544,
`Paper 8 (PTAB July 18, 2016)
`
`1013
`
`1016
`
`Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 2 (PTAB
`Aug. 18, 2016)
`
`i
`
`

`

`1017
`
`Alcon Research, Ltd. v. Watson Labs., 1-15-cv-01159 (D. Del.) Paper
`69 (November 18, 2016)
`
`1018 Abelson & Gomes, “Olopatadine 0.2% ophthalmic solution: the first
`ophthalmic antiallergy agent with once-daily dosing,” Expert
`Opinion on Drug Metabolism & Toxicology, 4:4, 453-461 (2008)
`(“Ab l
`”)
`Pharmaceutical Calculations, 13th Ed., Ansell, 2010
`
`1019
`
`1020 U.S. Patent No. 6,770,675
`
`1021
`
`1022
`
`1023
`
`1024
`
`Argentum Pharm. LLC v. Alcon Research, Ltd., IPR2016-00544,
`Paper 1 (PTAB Feb. 2, 2016)
`
`Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 3 (PTAB
`Aug. 18, 2016)
`
`Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 8 (PTAB
`Oct. 5, 2016)
`
`Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 9 (PTAB
`Nov. 30, 2016)
`
`1026
`
`1025 Abelson & Loeffler, Conjunctival Allergen Challenge: Models in the
`Investigation of Ocular Allergy, Current Allergy and Asthma Reports
`3:363-368 (2003)
`Eiichi Uchio, Treatment of allergic conjunctivitis with olopatadine
`hydrochloride eye drops, Clinical Ophthalmology 2(3):525-531, 527-
`528 (2008)
`1027 Abelson et al., “Efficacy of Once-Daily Olopatadine 0.2%
`Ophthalmic Solution Compared to Twice-Daily Olopatadine 0.1%
`Ophthalmic Solution for the Treatment of Ocular Itching Induced by
`Conjunctival Allergen Challenge,” Current Eye Research 32:1017-
`1022 (2007)
`
`ii
`
`

`

`1028
`
`Leonardi, et al., “The anti-allergic effects of a cromolyn sodium-
`chlorpheniramine combination compared
`to ketotifen
`in
`the
`challenge model,” European
`J. of
`conjunctival allergen
`Ophthalmology 13(2):128-133 (2003)
`
`1029 U.S. Patent Publication No. 2008/0085922
`
`1030
`
`1031
`
`Alcon Research, Ltd. v. Watson Labs., 1-15-cv-01159 (D. Del.) Paper
`155 (March 1, 2018)
`https://www.pazeodrops.com/
`
`1032 Orange Book entry for PAZEO®
`
`1033
`
`EP 0214779
`
`1034 U.S. Pat. No. 4,871,865
`
`1035
`
`EP 0235796
`
`1036 U.S. Pat. No. 5,116,863
`
`1037 CV of Dr. Paul Laskar
`
`1038 Handbook of Chemistry and Physics 2006, 87th Ed.
`
`1039 U.S. Publication No. 2004/0198828 (“Abelson”)
`
`1040 Nandi et al., “NANDI et al., “Synergistic Effect of PEG-400 and
`Cyclodextrin
`to Enhance Solubility of Progesterone,” AAPS
`PharmSciTech 2003; 4 (1), pp 1-5.”
`
`iii
`
`

`

`1041
`
`LOFTSSON et al., “Cyclodextrins in eye drop formulations:
`enhanced topical delivery of corticosteroids to the eye,” Acta
`Ophthamologica Scandinavica, 2002, pp. 144-150.
`
`1042
`
`June 5, 2018 Letter to PTAB Re: Corrected Petition
`
`iv
`
`

`

`
`
`I.
`
`INTRODUCTION
`
`Cipla Limited (“Petitioner”) petitions for Inter Partes Review (“IPR”), and
`
`seeks cancellation of Claims 1–27 (“challenged claims”) of U.S. Patent
`
`No. 8,791,154 (“the ’154 patent”) (EX1001).
`
`II. OVERVIEW
`The ’154 patent already has a troubled past before the PTAB. On
`
`February 2, 2016, Argentum filed an IPR seeking cancellation of Claims 1–4, 8,
`
`12–13, and 21–22 of the ’154 patent on two separate grounds. Argentum Pharm.
`
`LLC v. Alcon Research, Ltd., IPR2016-00544, Paper 1 (PTAB Feb. 2, 2016)
`
`(EX1021). In response, the PTAB instituted review of the ’154 patent on every
`
`challenged claim on every ground. Id., Paper 8 (EX1015). Shortly thereafter,
`
`Apotex filed another petition seeking joinder with Petitioner Argentum, which the
`
`PTAB granted. Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 2
`
`(PTAB Aug. 18, 2016) (EX1016); id., Paper 3 (EX1022); id., Paper 8 (EX1023).
`
`Rather than allowing the IPR challenges to proceed, Alcon settled them both. Id.,
`
`Paper 9 (EX1024). Petitioner Cipla, therefore, picks up the challenge from here.
`
`But rather than challenging a subset of the claims of the ’154 patent, Petitioner
`
`challenges every claim using the same art combinations the PTAB had previously
`
`used to institute IPR (“Grounds 1 and 2”).
`
`
`
`
`
`

`

`
`III. STANDING (37 C.F.R. § 42.104(a); PROCEDURAL STATEMENTS)
`Petitioner certifies that: (1) the ’154 patent is available for IPR; and
`
`Petition for Inter Partes Review
` of U.S. Patent No. 8,791,154
`
`(2) Petitioner is not barred or estopped from requesting IPR of any claim of the
`
`’154 patent on the grounds identified herein. This Petition is filed in accordance
`
`with 37 C.F.R. § 42.106(a). Filed herewith are a Power of Attorney and an Exhibit
`
`List pursuant to § 42.10(b) and § 42.63(e). The required fee is paid through an
`
`online credit card, and the Office is authorized to charge any fee deficiencies and
`
`credit overpayments to Deposit Acct. No. 501710 (Customer ID No. 27160).
`
`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))
`Petitioner Cipla Limited is the real party-in-interest. Out of an abundance of
`
`caution, and for purposes of this Petition only, Petitioner additionally discloses the
`
`following entities as additional real parties-in-interest: Cipla USA, Inc., InvaGen
`
`Pharmaceuticals, Inc., and Cipla (EU) Limited.
`
`B. Notice of Related Matters (37 C.F.R. § 42.8(b)(2))
`Judicial Matters
`1.
`To Petitioner’s knowledge, the ’154 patent is (or was) the subject of the
`
`following litigations: Alcon Research, Ltd. v. Watson Labs., 1-15-cv-01159 (D.
`
`Del.); Alcon Research, Ltd. v. Lupin Limited et al., 1-16-cv-00195 (D. Del.); Alcon
`
`Research, Ltd. v. Apotex Inc. et al., 1-16-cv-00906 (D. Del.); Alcon Research, Ltd.
`
`2
`
`

`

`
`v. Cipla Limited et al., 1-17-cv-01244 (D. Del.).
`
`Petition for Inter Partes Review
` of U.S. Patent No. 8,791,154
`
`The ’154 patent was the subject of the following IPRs: Argentum
`
`Pharmaceuticals, LLC v. Alcon Research Ltd., IPR2016-00544 and Apotex, Inc. v.
`
`Alcon Research Ltd., IPR2016-01640. The IPRs were joined and terminated after
`
`institution. Argentum Pharmaceuticals, LLC v. Alcon Research Ltd., IPR2016-
`
`00544, Paper 30 (PTAB Nov. 30, 2016).
`
`Administrative Matters
`2.
`At least the following related ’154 patent family members exist: U.S. Patent
`
`No. 9,533,053 (“the ’053 patent”) and U.S. Application No. 15/358,367, now
`
`abandoned. Concurrently filed herewith is a petition for inter partes review of the
`
`’053 patent (IPR2018-01021).
`
`C. 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))
`
`Lead Counsel
`Jitendra Malik, Ph.D.
`Reg. No. 55,823
`Katten Muchin Rosenman LLP
`555 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`jitty.malik@kattenlaw.com
`
`
`Back-Up Counsel
`Brian Sodikoff
`Reg. No. 54,697
`Katten Muchin Rosenman LLP
`525 West Monroe Street
`Chicago, IL 60661-3693
`brian.sodikoff@kattenlaw.com
`
`Alissa M. Pacchioli
`Reg. No. 74,252
`Katten Muchin Rosenman LLP
`555 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`alissa.pacchioli@kattenlaw.com
`
`3
`
`

`

`
`
`V.
`
`Petition for Inter Partes Review
` of U.S. Patent No. 8,791,154
`
`Petitioner consents to email service.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(a))
`Petitioner requests IPR and cancellation of Claims 1–27 of the ’154 patent.
`
`Petitioner’s full statement of the reasons for the relief requested is set forth in
`
`detail below.
`
`VI. THE ’154 PATENT
`The ’154 patent has four independent claims (Claims 1, 4, 8, and 21).
`
`EX1001. Claim 1 recites an aqueous ophthalmic solution for treatment of ocular
`
`allergic conjunctivitis: at least 0.67 w/v % olopatadine dissolved in the solution;
`
`PEG having a molecular weight of 300
`
`to 500; polyvinylpyrrolidone;
`
`hydroxypropyl-γ-cyclodextrin; benzalkonium chloride; and water. EX1001,
`
`26:28-36. Claims 4, 8 and 21 are generally similar to Claim 1 but include amounts
`
`of each recited compound. EX1001, 26:39-51; 26:58-67; 27:31-28:11. Claim 21
`
`additionally recites the pH and osmolality of the solution. EX1014, ¶38.
`
`A. Claim Construction
`The PTAB provided the following preliminary construction for the
`
`’154 patent:
`
`Term
`Preamble
`“w/v %”
`
`Construction
`
`Non-limiting
`The mass of the component in grams per 100 milliliters of
`solution multiplied by 100 (EX1014, ¶42)
`
`4
`
`

`

`Petition for Inter Partes Review
` of U.S. Patent No. 8,791,154
`
`
`
`
`
`EX1015, 7.
`
`The PTAB declined to construe the preambles of the claims, as well as the
`
`phrase “solution comprising. . . at least 0.67 w/v % olopatadine. . . dissolved in the
`
`solution,” finding no construction was necessary in light of “comprising.” Id., 6.
`
`Although the PTAB is not bound,1 the District of Delaware provided the
`
`following constructions with respect to the ’154 patent:
`
`Term
`
`Construction
`The preamble is limiting
`
`aqueous
` “An
`solution
`ophthalmic
`for the treatment of
`ocular
`allergic
`conjunctivitis,
`the
`solution comprising . .
`.”
`“at least 0.67 w/v %
`olopatadine dissolved
`in the solution” and “at
`least 0.67 w/v % but
`no greater than 1.0 w/v
`%
`olopatadine
`dissolved
`in
`the
`solution.”
`
`
`1 See Kyocera Corp. v. Softview LLC, IPR2013-00007, Order, Paper 31 at 4 (PTAB
`
`An aqueous ophthalmic solution for treatment of ocular
`allergic conjunctivitis that contains at least 0.67 w/v %
`[but no greater than 1.0 w/v % olopatadine] dissolved in
`the solution.
`
`Oct. 8, 2013); CRS Advanced Techs., Inc. v. Frontline Techs., Inc., CBM2012-
`
`00005, Final Decision, Paper 66 at 6 (PTAB Jan. 26, 2015).
`
`5
`
`

`

`
`EX1017, 2.
`
`Petition for Inter Partes Review
` of U.S. Patent No. 8,791,154
`
`As to the preamble, the PTAB does not have to resolve any discrepancy
`
`between the PTAB and the District Court’s constructions because, as the PTAB
`
`noted, it is not necessary to determine the limiting nature of the preamble because
`
`the evidence in IPR2016-00544 was sufficient to show that the preambles were
`
`taught. EX1015, 6. Petitioner relies upon the same evidence.
`
`As to the District Court’s construction of “at least 0.67 w/v % olopatadine
`
`dissolved in the solution” and “at least 0.67 w/v % but no greater than 1.0 w/v %
`
`olopatadine dissolved in the solution,” Petitioner submits that the broadest
`
`reasonable interpretation (“BRI”) would at least encompass the District Court’s
`
`construction. 37 C.F.R. § 42.100(b). In any event, Petitioner contends that the
`
`evidence presented herein addresses these limitations.
`
`
`
`All remaining claim terms should be given their BRI, i.e., their ordinary and
`
`customary meaning as would have been understood by a person of skill in the art
`
`(“POSA”) at the time, in the context of the entire patent disclosure. Id.; 37 C.F.R.
`
`§ 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016);
`
`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007); EX1014, ¶45.
`
`6
`
`

`

`
`VII. NONE OF THE CLAIMS ARE ENTITLED TO THE PRIORITY
`DATE OF PROVISIONAL APPLICATION 61/487,789
`
`Petition for Inter Partes Review
` of U.S. Patent No. 8,791,154
`
`The ’154 patent claims priority under 35 U.S.C. § 119 to two U.S.
`
`Provisional Applications, 61/487,789 (EX1009, “the ’789 Provisional”) and
`
`61/548,957 (EX1010), filed May 19, 2011, and October 19, 2011, respectively.
`
`The Office never considered the issue of priority during prosecution and no
`
`presumption of priority applies. PowerOasis, Inc. v. T-Mobile USA, 522 F.3d
`
`1299, 1305 (Fed. Cir. 2008).
`
`Raising a priority issue involves “identifying, specifically, the features,
`
`claims, and ancestral applications allegedly lacking § 112, first paragraph, written
`
`description and enabling disclosure support for the claims based on the identified
`
`features.” Polaris Wireless, Inc. v. TruePosition, Inc., IPR2013-00323, Paper 9 at
`
`29 (PTAB Nov. 15, 2013); SAP America, Inc. v. Pi-Net Int’l., Inc., IPR2014-
`
`00414, Paper 11 at 13-14 (PTAB Aug. 8, 2014). The test for sufficiency under the
`
`written description requirement of 35 U.S.C. § 112 ¶1 is whether the application
`
`disclosure relied on reasonably conveys to a POSA that the inventors had
`
`possession of the claimed subject matter. Ariad Pharms., Inc. v. Eli Lilly & Co.,
`
`598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).
`
`None of the claims of the ’154 patent are supported by the ’789 Provisional.
`
`Every independent claim of the ’154 patent recites a “hydroxypropyl-γ-
`
`7
`
`

`

`
`cyclodextrin” or as
`
`Petition for Inter Partes Review
` of U.S. Patent No. 8,791,154
`
`shorthand “HP-γ-cyclodextrin.”
`
` EX1001.
`
` The
`
`’789 Provisional (i.e., the specification and the claims) fails to even mention any γ-
`
`cyclodextrins or derivatives of γ-cyclodextrins; instead, the ’789 Provisional
`
`exclusively focuses on “includ[ing] a β-cyclodextrin derivative to aid in the
`
`solubility of the olopatadine” (EX1009, Bates page 9, lines 2-7), with all examples
`
`relying on a β-cyclodextrin derivative (id., Tables A-H). The ’789 Provisional fails
`
`to reasonably convey to the skilled artisan the inclusion of hydroxypropyl-γ-
`
`cyclodextrin in the compositions. EX1014, ¶¶27-29. Because Claims 1–27 of the
`
`’154 patent find no support in the ’789 Provisional, and cannot benefit from the
`
`filing date of the ’789 Provisional (i.e., May 19, 2011), the ’154 patent should be
`
`afforded the October 19, 2011 priority date of Provisional Application No.
`
`61/548,957 (EX1010).
`
`VIII. A PERSON OF ORDINARY SKILL IN THE ART
`As of the relevant priority date2, a POSA in the relevant field would have
`
`had: (i) an M.D., Pharm. D. or Ph.D. in chemistry, biochemistry, pharmaceutics, or
`
`in a related field, and at least about two years of relevant experience in the
`
`treatment of ocular diseases and developing formulations used to treat ocular
`
`2 Even if the PTAB decides the correct priority date is May 19, 2011, as Dr. Laskar
`
`explains, the understanding of a POSA would not change. EX1014, ⁋⁋30n.4, 48.
`
`8
`
`

`

`
`diseases, including topical eye pharmaceuticals; (ii) a master’s degree in chemistry,
`
`Petition for Inter Partes Review
` of U.S. Patent No. 8,791,154
`
`biochemistry, pharmaceutics, or in a related field, and at least about five years of
`
`the same relevant experience; or (iii) a bachelor’s degree in pharmacy, chemistry,
`
`biochemistry, or in a related field, and have at least about 10 years of the same
`
`relevant experience.
`
`Further, a POSA would typically work as part of a multidisciplinary team
`
`and draw upon not only his or her own skills, but also take advantage of certain
`
`specialized skills of others in the team to solve a given problem should the need
`
`arise. EX1014, ¶¶30-35.
`
`IX.
`
`IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b))
`Petitioner respectfully requests IPR of Claims 1-27 of the ’154 patent on
`
`each specific ground of unpatentability outlined below. Per 37 C.F.R. § 42.6(d),
`
`copies of the references are filed herewith. In support of the proposed grounds,
`
`this Petition includes the declaration of Dr. Paul Laskar (EX1014) explaining what
`
`the art would have conveyed to a POSA as of the priority date of the ’154 patent.
`
`Ground
`
`References
`
`Bhowmick in view of Yanni
`and Castillo
`of
`view
`in
`Schneider
`Hayakawa, Bhowmick, and
`Castillo
`
`1
`
`2
`
`
`
`Basis
`
`35 U.S.C. §
`103(a)
`35 U.S.C. §
`103(a)
`
`Claims
`Challenged
`1–27
`
`1–27
`
`9
`
`

`

`Prior art references in addition to the primary references listed above provide
`
`Petition for Inter Partes Review
` of U.S. Patent No. 8,791,154
`
`
`
`further background in the art,