throbber
Paper No. ___
`Filed: September 28, 2017
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC. and AKORN INC.,1
`Petitioners,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`
`_____________________________
`
`Case IPR2016-01127 (US 8,685,930 B2)
`Case IPR2016-01128 (US 8,629,111 B2)
`Case IPR2016-01129 (US 8,642,556 B2)
`Case IPR2016-01130 (US 8,633,162 B2)
`Case IPR2016-01131 (US 8,648,048 B2)
`Case IPR2016-01132 (US 9,248,191 B2)
`
`_____________________________
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`
`
`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017-
`00596, IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017-00599,
`IPR2017-00585 and IPR2017-00600, and IPR2017-00586 and IPR2017-00601,
`have respectively been joined with the captioned proceedings. The word-for-word
`identical paper is filed in each proceeding identified in the caption pursuant to the
`Board’s Scheduling Order (Paper 10).
`
`

`

`
`
`Exhibit
`No.
`
`LIST OF EXHIBITS
`
`Description
`
`1001
`
`U.S. Patent No. 8,685,930 to Acheampong et al.
`
`1002
`
`Declaration of Dr. Mansoor Amiji
`
`1003
`
`Curriculum Vitae of Dr. Mansoor Amiji
`
`1004
`
`File history of U.S. Patent No. 8,685,930 to Acheampong et al.
`
`1005
`
`File history of U.S. Patent Application No. 10/927,857, filed on
`August 27, 2010 to Acheampong et al.
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`U.S. Patent No. 5,474,979 to Ding et al., filed May 17, 1994
`
`K. Sall, et al., Two Multicenter, Randomized Studies of the Efficacy
`and Safety of Cyclosporine Ophthalmic Emulsion in
`Moderate to Severe Dry Eye Disease, 107 OPHTHALMOLOGY
`631 (2000)
`
`A. Acheampong et al., Cyclosporine distribution into the
`conjunctiva, cornea, lacrimal gland, and systemic blood
`following topical dosing of cyclosporine to rabbit, dog, and
`human eyes, 2 LACRIMAL GLAND, TEAR FILM, AND DRY EYE
`SYNDROMES 1001 (1998)
`
`U.S. Patent No. 5,578,586 to Glonek et al., filed February 4, 1994
`
`U.S. Patent No. 5,981,607 to Ding et al., filed January 20, 1998
`
`-1-
`
`

`

`
`
`1011
`
`R. Kaswan, Intraocular Penetration of Topically Applied
`Cyclosporine 20 TRANSPL. PROC. 650 (1988)
`
`1012
`
`1013
`
`1014
`
`1015
`
`K. Kunert et al., Analysis of Topical Cyclosporine Treatment of
`Patients with Dry Eye Syndrome 118 ARCH OPHTHALMOL
`1489 (2000)
`
`Physicians’ Desk Reference for Ophthalmic Medicines (1999)
`
`K. Turner et al., Interleukin-6 Levels in the Conjunctival Epithelium
`of Patients with Dry Eye Disease Treated with Cyclosporine
`Ophthalmic Emulsion 19 CORNEA 492 (2000)
`
`D. Stevenson et al. Efficacy and Safety of Cyclosporin A
`Ophthalmic Emulsion in the Treatment of Moderate-to-Severe
`Dry Eye Disease 107 OPHTHALMOL. 967 (2000)
`
`1016
`
`REMINGTON’S 20TH EDITION: THE SCIENCE AND PRACTICE OF
`PHARMACY (A. Gennaro ed. 2003)
`
`1017
`
`1018
`
`1019
`
`E. Goto et al. Low-Concentration Homogenized Castor Oil Eye
`Drops for Noninflamed Obstructive Meibomian Gland
`Dysfunction 109 OPHTHALMOL. 2030 (2002)
`
`A. Kanpolat et al., Penetration of Cyclosporin A into the Rabbit
`Cornea and Aqueous Humor after Topical Drop and
`Collagen Shield Administration 20 CLAO J 119 (1994)
`
`A. Vieira et al., Effect of ricinoleic acid in acute and subchronic
`experimental models of inflammation, 9 MED. INFLAMM. 223
`(2000)
`
`1020
`
`R. Murphy, The Once and Future Treatment of Dry Eye, REVIEW OF
`OPTOMETRY 1 (2000)
`
`-2-
`
`

`

`
`
`1021
`
`D. Small et al., Blood concentrations of Cyclosporin A During
`Long-Term Treatment with Cyclosporin A Ophthalmic
`Emulsions in Patients with Moderate to Severe Dry Eye
`Disease 18 J. OC. PHARM. THERAP. 411 (2002)
`
`1022
`
`STEDMAN’S MEDICAL DICTIONARY 27TH EDITION (M.B. Pugh ed.
`2000)
`
`1023
`
`Complaint; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Teva
`Pharmaceutical Industries Ltd., Apotex, Inc., Apotex Corp.,
`Akorn, Inc., Mylan Pharmaceuticals Inc., and Mylan Inc., No.
`2:15-cv-01455
`
`1024
`
`Approved Drug Products with Therapeutic Equivalence Evaluations
`(34th Ed.) (2014) (Excerpts)
`
`1025
`(IPR2016-
`01127)
`
`1025
`(IPR2016-
`01132)
`
`File history of U.S. Patent No. 8,629,111 to Acheampong et al.
`(Exhibit Number Reserved in IPR2016-01128, -01129, -
`01130, & -01131)
`
`Complaint; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Teva
`Pharmaceutical Industries Ltd., Apotex, Inc., Apotex Corp.,
`Akorn, Inc., Mylan Pharmaceuticals Inc., No. 2:15-cv-01455
`(Exhibit Number Reserved in IPR2016-01128, -01129, -
`01130, & -01131)
`
`1026
`
`Reserved
`
`1027
`
`Allergan Department of Pharmacokinetics and Drug Metabolism
`Departmental Research Report, Report No: PK-00-163,
`Concentrations of Cyclosporin A in Cornea and Conjunctiva
`After a Single Ophthalmic Dose to New Zealand White
`Rabbits: Evaluation of 7 Ophthalmic Emulsion Formulations
`
`-3-
`
`

`

`
`
`1028
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-2000-7626
`
`1029
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-1998-5709
`
`1030
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-1998-5707
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-2000-7726
`
`Orange Book 29th Edition (2009) (excerpts)
`
`1031
`
`1032
`
`1033 Mayssa Attar Professional Linkedin Profile
`
`1034
`
`PROTECTIVE ORDER MATERIAL - Transcript of May 31, 2017
`Deposition of Robert S. Maness, Ph.D.
`
`1035
`
`1036
`
`1037
`
`Transcript of June 1, 2017 Deposition of Rhett Schiffman, M.D.,
`M.S.Sc.
`
`Transcript of June 7, 2017 Deposition of Thorsteinn Loftsson, Ph.D.
`
`Transcript of June 20, 2017 Deposition of John D. Sheppard, M.D.,
`M.S.Sc.
`
`1038
`
`PROTECTIVE ORDER MATERIAL - Transcript of June 22, 2017
`Deposition of Mayssa Attar, Ph.D.
`
`-4-
`
`

`

`
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`REDACTED - Transcript of June 22, 2017 Deposition of Mayssa
`Attar, Ph.D.
`
`Declaration of Andrew F. Calman, M.D.
`
`Declaration of Daniel A. Bloch, Ph.D.
`
`PROTECTIVE ORDER MATERIAL - Declaration of Ivan T.
`Hofmann
`
`Curriculum Vitae of Andrew F. Calman, M.D.
`
`Curriculum Vitae of Daniel A. Bloch, Ph.D.
`
`Curriculum Vitae of Ivan T. Hofmann
`
`Facts About Dry Eye, NATIONAL EYE INSTITUTE OFFICE OF SCIENCE
`COMMUNICATIONS, PUBLIC LIAISON, AND EDUCATION, 2013,
`https://nei.nih.gov/health/dryeye/dryeye (downloaded June
`26, 2017)
`
`Niederkorn et al., Desiccating Stress Induces T Cell-Mediated
`Sjögren’s Syndrome-Like Lacrimal Keratoconjunctivitis, J.
`IMMUNOL. 176:3950-3957 (2006)
`
`1047
`
`Garralt, S., Dry Eye Syndrome Preferred Practice Pattern,
`AMERICAN ACADEMY OF OPHTHALMOLOGY, 2013
`
`1048
`
`1049
`
`Garralt, S., Dry Eye Syndrome Preferred Practice Pattern Limited
`Revision, AMERICAN ACADEMY OF OPHTHALMOLOGY, 2011
`
`A real tear-jerker: Team creates device to alleviate dry eye,
`STANFORD MEDICINE NEWS CENTER,
`
`-5-
`
`

`

`
`
`https://med.stanford.edu/news/all-news/2015/01/a- real-tear-
`jerker-team-creates-device-to-alleviate-dry-eye.html
`(accessed on June 26, 2017)
`
`Allergan Granted Marketing Authorization by the FDA for
`TrueTearTM, the First Intranasal Neurostimulating Device
`Proven to Temporarily Increase Tear Production,
`https://www.allergan.com/News/News/Thomson-
`Reuters/Allergan-Granted-Marketing-Authorization-by-the-
`FD (accessed on June 26, 2017)
`
`Dalton, M., Novel neurostimulator device uses nasal cavities to
`stimulate tears, OPHTHALMOLOGY TIMES,
`http://ophthalmologytimes.modernmedicine.com/ophthalmolo
`gytimes/news/novel- neurostimulator-device-uses-nasal-
`cavities-stimulate-tears?page=0,1 (accessed on June 26, 2017)
`
`Marsh, P. and Pflugfelder S., Topical Nonpreserved
`Methylprednisolone Therapy for Keratoconjunctivitis Sicca in
`Sjörgen Syndrome, 106 OPHTHALMOL. 811 (1999)
`
`PubMed abstract for Sainz de la Maza Serra et al., Nonpreserved
`Topical Steroids and Punctal Occlusion for Severe
`Keratoconjunctivitis Sicca, ARCH. SOC. ESP. OFTALMOL.
`10:751-756 (2000)
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`Eadie, S. et al., Kerato-Conjunctivitis Sicca Treated With Cortisone
`and ACTH, BRIT. J. OPHTHAL. (1955), 39:90
`
`1055
`
`Gaulhofer, W. K., The Effect of Cortisone on Sjögren’s Syndrome,
`ACTA MEDICA SCANDINAVICA, Vol. CXLIX, fase. VI, 1954
`
`-6-
`
`

`

`
`
`1056
`
`Rolando, M. et al., Topical Non-Preserved Diclofenac Therapy for
`Keratoconjunctivitis Sicca, ADVANCES IN EXPERIMENTAL
`MEDICINE AND BIOLOGY (LACRIMAL GLAND, TEAR FILM &
`DRY EYE SYNDROMES 3) 506:1237-1240 (2002)
`
`1057
`
`Glenn, C. New Thinking Spurs New Products, REV. OPHTHALMOL.
`1(2), FEB. 2003.
`
`1058
`
`Oellerich et al., Lake Louise Consensus Conference on Cyclosporin
`Monitoring in Organ Transplantation: Report of the
`Consnsus Panel, THERAPEUTIC DRUG MONITORING 17:642-
`654 (1995)
`
`1059
`
`Foulks, G.N., et al., 2007 Report of the International Dry Eye
`Workshop (DEWS) 5 OCULAR SURF. (2007) 65-202
`
`1060
`
`Avunduk et al., The Comparison of Efficacies of Topical
`Corticosteroids and Nonsteroidal Anti-inflammatory Drops
`on Dry Eye Patients: A Clinical and Immunocytochemical
`Study, AM. J. OPHTHAL.136:593-602 (2003)
`
`1061
`
`Lamberts, D.W., Clinical Diseases of the Tear Film, in The Cornea,
`3rd Ed., (eds. Smolin & Thoft (1994))
`
`1062
`
`Akpek et al., Ocular Rosacea: Patient Characteristics and Follow-
`up, OPHTHALMOL. 104:1863-67 (1997)
`
`1063
`
`Allergan Form 10-K for the year ended December 31, 2015
`
`1064
`
`Drugs@FDA: FDA Approved Drug Products, New Drug
`Application No. 050790,
`https://www.accessdata.fda.gov/scripts/cder/daf
`/index.cfm?event=overview.process&ApplNo=050790,
`accessed June 20, 2017
`
`-7-
`
`

`

`
`
`1065
`
`Allergan Form 10-K for the year ended December 31, 2009
`
`1066
`
`Allergan Introduces RESTASIS MULTIDOSE (Cyclosporine
`Ophthalmic Emulsion) 0.05 %, a New Delivery System for the
`One and Only FDA Approved Treatment to Help Patients
`Produce More of Their Own Tears, CISION PR NEWSWIRE,
`http://www.prnewswire.com/news-releases/allergan-
`introduces-restasis-multidose-cyclosporine-ophthalmic-
`emulsion-005-a-new-delivery-system-for-the-one-and-only-
`fda-approved-treatment-to-help-patients-produce-more-of-
`their-own-tears-300353429.html#, accessed June 20, 2017
`
`1067
`
`FDA Label for Restasis MultiDose™
`
`1068
`
`Allergan Form 10-K for the year ended December 31, 1993
`
`1069
`
`Orange Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations, Patent and Exclusivity for:
`N050790,
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cf
`m?Product_No=001&Appl_No=050790&Appl_type=N,
`accessed June 21, 2017
`
`1070
`
`Kymionis et al., Treatment of chronic dry eye: focus on
`cyclosporine, CLIN OPTHALMOL., 2(4):829-836, 2008,
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2699789/,
`accessed June 20, 2017
`
`1071
`
`Chronic Dry Eye Disease, https://www.restasis.com/What-Is-
`Chronic-Dry-Eye-Disease, accessed June 21, 2017
`
`1072
`
`Allergan Form 10-K for the year ended December 31, 2002
`
`-8-
`
`

`

`
`
`1073
`
`1074
`
`1075
`
`Keratoconjunctivitis Sicca, MERCK MANUAL,
`http://www.merckmanuals.com/home/eye-disorders/corneal-
`disorders/keratoconjunctivitis-sicca, accessed June 21, 2017
`
`Abelson and Smith, A Stepwise Approach to Acute Dry Eye,
`REVIEW OF OPHTHALMOLOGY,
`https://www.reviewofophthalmology.com/article/a-stepwise-
`approach-to-acute-dry-eye, accessed June 22, 2017
`
`Javadi and Feizi, Dry Eye Syndrome, J. OPHTHALMIC VIS. RES.
`6(3):192-198, 2011,
`https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC3306104/,
`accessed June 21, 2017
`
`1076
`
`https://www.xiidra.com/, accessed June 22, 2017
`
`1077
`
`1078
`
`1079
`
`1080
`
`FDA approves new medication for dry eye disease, FDA News
`Release,
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnounce
`ments/ucm510720.htm, accessed June 22, 2017
`
`Bailey, G., Shire gets FDA nod for Xiidra (lifitegrast) for dry eye,
`OPTOMETRY TIMES OPTOMETRY ALCON,
`http://optometrytimes.modernmedicine.com/optometrytimes/n
`ews/shire-gets-fda-nod-xiidra-lifitegrast-dry-eye, accessed
`June 22, 2017
`
`Dry eyes, Mayo Clinic, http://www.mayoclinic.org/diseases-
`conditions/dry-eyes/basics/treatment/con-20024129, accessed
`June 22, 2017
`
`Scleral Lenses, Contact Lens Manufacturers Association,
`http://www.contactlenses.org/scleral.htm, accessed June 22,
`2017
`
`-9-
`
`

`

`
`
`1081
`
`Jedlicka, J., Scleral Contact Lenses, AllAboutVision.com,
`http://www.allaboutvision.com/contacts/scleral-lenses.htm,
`accessed June 22, 2017
`
`1082
`
`Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1376-
`77 (Fed. Cir. 2005)
`
`1083
`
`New Patents Could Sustain Allergan Restasis Franchise Until 2024,
`SEEKING ALPHA, http://seekingalpha.com/article/1945551-
`new-patents-could-sustain-allergan-restasis-franchise-until-
`2024, accessed June 22, 2017
`
`1084
`
`FDA Label for Lacrisert®
`
`1085
`
`1086
`
`1087
`
`Stephenson, M., OTC Drops: Telling the Tears Apart, REVIEW OF
`OPHTHALMOLOGY, https://www.reviewofophthalmology.com/
`article/otc-drops-telling-the-tears-apart, accessed June 20,
`2017
`
`Narayanan, S., Which Drop for Dry Eye?, REVIEW OF OPTOMETRY,
`2009, https://www.reviewofoptometry.com/article/which-
`drop-for-dry-eye, accessed June 20, 2017
`
`Schachet, J., The Golden Age of Dry Eye Management, REVIEW OF
`OPTOMETRY, 2008,
`https://www.reviewofoptometry.com/ce/the-golden-age-of-
`dry-eye-management, accessed June 20, 2017
`
`1088
`
`Refresh Products, http://www.refreshbrand.com/Products, accessed
`June 23, 2017
`
`-10-
`
`

`

`
`
`1089
`
`1090
`
`1091
`
`1092
`
`Alrex (loteprednol etabonate ophthalmic suspension) 0.2%, Bausch
`+ Lomb, http://www.bausch.com/ecp/our-products/rx-
`pharmaceuticals/rx-pharmaceuticals/alrex-loteprednol-
`etabonate-ophthalmic-suspension-02, accessed June 23, 2017
`
`Lotemax (loteprednol etabonate ophthalmic suspension) 0.5%,
`Bausch + Lomb, http://www.bausch.com/ecp/our-
`products/rx-pharmaceuticals/rx-pharmaceuticals/lotemax-ecp,
`accessed June 23, 2017
`
`Fluorometholone Suspension – Ophthalmic, MedicineNet.com,
`http://www.medicinenet.com/fluorometholone-
`ophthalmic_suspension/article.htm, accessed June 23, 2017
`
`Rimexolone Suspension – Ophthalmic, MedicineNet.com,
`http://www.medicinenet.com/rimexolone-
`ophthalmic/article.htm, accessed June 23, 2017
`
`1093 Methylprednisolone (Oral Route), Mayo Clinic,
`http://www.mayoclinic.org/drugs-supplements/
`methylprednisolone-oral-route/description/drg-20075237,
`accessed June 23, 2017
`
`1094
`
`Hessen, M. and Akpek, E., Dry Eye: an Inflammatory Ocular
`Disease, J. OPHTHALMIC VIS. RES. 9(2):240-250, 2014,
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4181208/,
`accessed June 23, 2017
`
`1095
`
`Dry Eye Syndrome, E Medicine Health,
`http://www.emedicinehealth.com/dry_eye_syndrome-
`health/article_em.htm, accessed June 23, 2017
`
`-11-
`
`

`

`
`
`1096 Mrukwa-Kominek et al., Effect of anti-inflammatory therapy on the
`treatment of dry eye syndrome, KLIN OCZNA 109(1-3):79-84,
`2007, Abstract, https://www.ncbi.nlm.nih.gov/pubmed/
`17687921, accessed June 23, 2017
`
`1097
`
`1098
`
`Adler, R., Dry Eye Treatment: Getting Relief From Dry Eyes,
`AllAboutVision.com, http://www.allaboutvision.com/
`conditions/dryeye.htm, accessed June 23, 2017
`
`Ramsey, L., How Allergan went from a tiny Los Angeles eye care
`company to the biggest takeover target of 2015, Business
`Insider, 2015, http://www.businessinsider.com/allergan-
`history-since-1948-founding-2015-11, accessed June 22, 2017
`
`1099
`
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`Product-Information/, accessed June 23, 2017
`
`1100
`
`Allergan Third Quarter 2016 Earnings Call Transcript
`
`1101
`
`Allergan Second Quarter 2016 Earnings Call Transcript
`
`1102
`
`Allergan Form 10-K for the year ended December 31, 2005
`
`1103
`
`Allergan Form 10-K for the year ended December 31, 2014
`
`1104
`
`Allergan Third Quarter 2015 Earnings Call Transcript
`
`1105
`
`Allergan Third Quarter 2013 Earnings Call Transcript
`
`1106
`
`Allergan Fourth Quarter 2007 Earnings Call Transcript
`
`1107
`
`Allergan First Quarter 2009 Earnings Call Transcript
`
`-12-
`
`

`

`
`
`1108
`
`Allergan Third Quarter 2009 Earnings Call Transcript
`
`1109 Weintraub, A., Allergan: Smoothing the Wrinkles, Bloomberg.com,
`2006, https://www.bloomberg.com/news/articles/2006-02-
`08/allergan-smoothing-the-wrinkles, accessed June 21, 2017
`
`1110
`
`1111
`
`Restasis commercial among most memorable as of 2013, PMLiVE,
`http://www.pmlive.com/pharma_news/restasis_ad_among_m
`ost_memorable_of_2013_531999, accessed June 21, 2017
`
`Actress Marisa Tomei Partners with Allergan to Raise Awareness of
`Chronis Dry Eye, CISION PR NEWSWIRE, 2016,
`http://www.prnewswire.com/news-releases/actress-marisa-
`tomei-partners-with-allergan-to-raise-awareness-of-chronic-
`dry-eye-300301221.html#, accessed on June 22, 2017
`
`1112
`
`Allergan Form 10-K for the year ended December 31, 2011
`
`1113
`
`1114
`
`Bihari, M., Understanding Your Health Plan Drug Formulary,
`https://www.verywell.com/understanding-your-health-plan-
`drug-formulary-1738897, accessed June 22, 2017
`
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`Carolina, 2017, http://www.bcbsnc.com/content/services/
`formulary/rxdef.htm, accessed June 22, 2017
`
`1115
`
`Allergan Fourth Quarter 2015 Earnings Call Transcript
`
`1116
`
`The My Tears, My Rewards® Program Gives You Instant Savings
`on Every Prescription Plus Ongoing Support With Treatment,
`https://www.restasis.com/Savings-and-Support/Program-
`Benefits, accessed June 22, 2017
`
`-13-
`
`

`

`
`
`1117
`
`My Tears, My Rewards® Program Terms and Conditions,
`https://www.restasis.com/TermsOfUse/TermsAndConditions
`5, accessed June 22, 2017
`
`1118
`
`List of testimony of Ivan T. Hofmann
`
`1119
`
`1120
`
`1121
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2012 U.S. Eye
`Care Sales & Marketing Plan: RESTASIS® Professional
`(AGN_RES1123159)
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2006 U.S. Eye
`Care Sales & Marketing Plan: 2006 Optometric Business Plan
`(AGN_RES1147478)
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2016 U.S. Eye
`Care Sales & Marketing Plan: Lifitegrast Plan and MDPF
`Overview (AGN_RES0614120)
`
`1122
`
`Reserved
`
`1123
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2004 U.S.
`Managed Healthcare/Institutional/Government: Managed
`Healthcare RESTASIS® 2004 Strategies, “Paving the Way
`Through Managed Care” (AGN_RES1120941)
`
`1124
`
`PROTECTIVE ORDER MATERIAL – Allergan, RESTASIS®
`DTC Update, August 4, 2010 (AGN_RES1148612)
`
`1125
`
`Natexis Bleichroeder Inc., Allergan, Inc., First Call Note
`(AGN_RES0734285)
`
`1126
`
`PROTECTIVE ORDER MATERIAL – Bilal Ghazi 2007 Marketing
`Plan (AGN_RES1124168)
`
`-14-
`
`

`

`
`
`1127
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2007 U.S. Eye
`Care Sales & Marketing Plan (AGN_RES1134471)
`
`1128
`
`1129
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2009 U.S. Eye
`Care Sales & Marketing Plan: Strategic
`Communications/Phase IV (AGN_RES1146945)
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2008 U.S. Eye
`Care Sales & Marketing Plan: Optometric Strategies
`Overview (AGN_RES1147652)
`
`1130
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2016 Dry Eye
`Business Plan (AGN_RES1154033)
`
`1131
`
`1132
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2008 U.S. Eye
`Care Sales & Marketing Plan: All Roads Lead to RESTASIS®
`(AGN_RES1153653)
`
`Schuurhuis, G.J. et al., The polyoxyethylene castor oil Cremophor
`EL modifies multidrug resistance, BR. J. CANCER, 62:591-594
`(1990)
`
`1133
`
`Declaration of Anna G. Phillips in support of Petitioner’s Motion
`for Pro Hac Vice Admission
`
`1134
`
`June 5, 2017 Email Regarding Deposition Requests
`
`1135
`
`July 6, 2017 Email Regarding Patent Owner’s Sur-reply
`
`1136
`
`July 21, 2017 Email Regarding New Arguments and Evidence in
`Patent Owner’s Sur-reply
`
`-15-
`
`

`

`
`
`1137
`
`Transcript of Telephonic Hearing Held Monday, 11 September 2017,
`in IPR2016-01127; IPR2016-01128; IPR2016-01129;
`IPR2016-01130; IPR2016-01131 and IPR2016-01132
`
`1138
`
`Declaration of Shannon M. Bloodworth in support of Petitioner’s
`Motion for Pro Hac Vice Admission
`
`1139
`
`Declaration of Charles G. Curtis, Jr. in support of Petitioner’s
`Motion for Pro Hac Vice Admission
`
`1140
`
`Declaration of Jennifer A. MacLean in support of Petitioner’s
`Motion for Pro Hac Vice Admission
`
`1141
`
`Declaration of Eric D. Miller in support of Petitioner’s Motion for
`Pro Hac Vice Admission
`
`1142
`
`Declaration of Benjamin S. Sharp in support of Petitioner’s Motion
`for Pro Hac Vice Admission
`
`1143
`
`PROTECTIVE ORDER MATERIAL – Transcript of Telephonic
`Conference Call Held Tuesday, 26 September 2017, in
`IPR2016-01127; IPR2016-01128; IPR2016-01129; IPR2016-
`01130; IPR2016-01131 and IPR2016-01132
`
`
`
`-16-
`
`

`

`CERTIFICATE OF SERVICE
`
`
`
`This is to certify that I caused to be served true and correct copies of the
`
`foregoing Petitioners’ Updated Exhibit List and Exhibit 1143 on this 28th day of
`
`September, 2017, on Allergan and the St. Regis Mohawk Tribe as follows:
`
`Dorothy P. Whelan
`Michael Kane
`Susan Morrison Colletti
`Robert M. Oakes
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: IPR13351-0008IP1@fr.com
`Email: IPR13351-0008IP2@fr.com
`Email: IPR13351-0008IP3@fr.com
`Email: IPR13351-0008IP4@fr.com
`Email: IPR13351-0008IP5@fr.com
`Email: IPR13351-0008IP6@fr.com
`Email: PTABInbound@fr.com
`
`Alfonso Chan
`Joseph DePumpo
`Michael W. Shore
`Christopher L. Evans
`Shore Chan DePumpo LLP
`901 Main Street, Suite 3300
`Dallas, TX 75201
`Email: achan@shorechan.com
`Email: jdepumpo@shorechan.com
`Email: mshore@shorechan.com
`Email: cevans@shorechan.com
`
`-17-
`
`
`
`
`
`
`

`

`
`
`And on the remaining Petitioners as follows:
`
`
`Gary Speier
`Mark Schuman
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST & SCHUMAN, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Email: gspeier@carlsoncaspers.com
`Email: mschuman@carlsoncaspers.com
`Attorneys for Teva Pharmaceuticals USA, Inc.
`
`Michael Dzwonczyk
`Azadeh Kokabi
`Travis Ribar
`SUGHRUE MION, PLLC
`2100 Pennsylvania Ave., NW
`Washington, DC 20037
`Email: mdzwonczyk@sughrue.com
`Email: akokabi@sughrue.com
`Email: tribar@sughrue.com
`Attorneys for Akorn Inc.
`
`
`
`Dated: September 28, 2017
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
`
`
`
`
`
`-18-
`
`

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