`
`Paper No. ___
`Filed: March 8, 2018
`
`
`
`
`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).
`
`
`
`
`
`
`
`
`LIST OF EXHIBITS
`
`Description
`
`The Patent (U.S. Patent No. 8,685,930; 8,629,111; 8,642,556;
`8,633,162; 8,648,048; or 9,248,191 to Acheampong et al., in
`IPR2016-01127 – IPR2016-01132, respectively)
`
`Exhibit
`No.
`
`1001
`
`1002
`
`Declaration of Dr. Mansoor Amiji
`
`1003
`
`Curriculum Vitae of Dr. Mansoor Amiji
`
`1004
`
`1005
`
`File History (U.S. Patent No. 8,685,930; 8,629,111; 8,642,556;
`8,633,162; 8,648,048; or 9,248,191 to Acheampong et al., in
`IPR2016-01127 –01132, respectively)
`
`File history of U.S. Patent Application No. 10/927,857, filed on
`August 27, 2010 to Acheampong et al.
`
`1006
`
`U.S. Patent No. 5,474,979 to Ding et al., filed May 17, 1994
`
`1007
`
`1008
`
`Sall, K., et al., Two Multicenter, Randomized Studies of the
`Efficacy and Safety of Cyclosporine Ophthalmic Emulsion in
`Moderate to Severe Dry Eye Disease, 107 OPHTHALMOL. 631
`(2000)
`
`Acheampong, A., 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)
`
`1009
`
`U.S. Patent No. 5,578,586 to Glonek et al., filed February 4, 1994
`
`1010
`
`U.S. Patent No. 5,981,607 to Ding et al., filed January 20, 1998
`
`1011
`
`Kaswan, R., Intraocular Penetration of Topically Applied
`Cyclosporine 20 TRANSPL. PROC. 650 (1988)
`
`
`
`
`
`-1-
`
`
`
`
`
`1012
`
`Kunert, K., et al., Analysis of Topical Cyclosporine Treatment of
`Patients with Dry Eye Syndrome 118 ARCH OPHTHALMOL 1489
`(2000)
`
`1013
`
`Physicians’ Desk Reference for Ophthalmic Medicines (1999)
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`Turner, K., et al., Interleukin-6 Levels in the Conjunctival
`Epithelium of Patients with Dry Eye Disease Treated with
`Cyclosporine Ophthalmic Emulsion 19 CORNEA 492 (2000)
`
`Stevenson, D., et al. Efficacy and Safety of Cyclosporin A
`Ophthalmic Emulsion in the Treatment of Moderate-to-Severe
`Dry Eye Disease 107 OPHTHALMOL. 967 (2000)
`
`Remington’s 20th Edition: The Science and Practice of Pharmacy
`(A. Gennaro ed. 2003)
`
`Goto, E., et al. Low-Concentration Homogenized Castor Oil Eye
`Drops for Noninflamed Obstructive Meibomian Gland
`Dysfunction 109 OPHTHALMOL. 2030 (2002)
`
`Kanpolat, A., 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)
`
`Vieira, A., et al., Effect of ricinoleic acid in acute and subchronic
`experimental models of inflammation, 9 MED. INFLAMM. 223
`(2000)
`
`Murphy, R., The Once and Future Treatment of Dry Eye, REVIEW
`OF OPTOMETRY 1 (2000)
`
`Small, D., 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)
`
`-2-
`
`
`
`
`
`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
`
`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
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-2000-7626
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-1998-5709
`
`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
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`Orange Book 29th Edition (2009) (excerpts)
`
`1033 Mayssa Attar Professional Linkedin Profile
`
`-3-
`
`
`
`
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1038
`
`1039
`
`1040
`
`1041
`
`PROTECTIVE ORDER MATERIAL - Transcript of May 31, 2017
`Deposition of Robert S. Maness, Ph.D.
`
`PROTECTIVE ORDER MATERIAL - Transcript of June 1, 2017
`Deposition of Rhett Schiffman, M.D., M.S.Sc.
`
`PROTECTIVE ORDER MATERIAL - 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.
`
`PROTECTIVE ORDER MATERIAL - Transcript of June 22, 2017
`Deposition of Mayssa Attar, Ph.D.
`
`REDACTED - Transcript of June 22, 2017 Deposition of Mayssa
`Attar, Ph.D.
`
`PROTECTIVE ORDER MATERIAL - Declaration of Andrew F.
`Calman, M.D.
`
`PROTECTIVE ORDER MATERIAL - Declaration of Daniel A.
`Bloch, Ph.D.
`
`PROTECTIVE ORDER MATERIAL - Declaration of Ivan T.
`Hofmann
`
`1042
`
`Curriculum Vitae of Andrew F. Calman, M.D.
`
`1043
`
`Curriculum Vitae of Daniel A. Bloch, Ph.D.
`
`1044
`
`Curriculum Vitae of Ivan T. Hofmann
`
`1045
`
`1046
`
`Facts About Dry Eye, NATIONAL EYE INSTITUTE OFFICE OF SCIENCE
`COMMUNICATIONS, PUBLIC LIAISON, AND EDUCATION, 2013,
`https://nei.nih.gov/health/dryeye/dryeye (accessed June 26,
`2017)
`
`Niederkorn, et al., Desiccating Stress Induces T Cell-Mediated
`Sjögren’s Syndrome-Like Lacrimal Keratoconjunctivitis, 176 J.
`IMMUNOL. 3950 (2006)
`
`-4-
`
`
`
`
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`1055
`
`Garralt, S., Dry Eye Syndrome Preferred Practice Pattern,
`AMERICAN ACADEMY OF OPHTHALMOLOGY (2013)
`
`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,
`https://med.stanford.edu/news/all-news/2015/01/a- real-tear-
`jerker-team-creates-device-to-alleviate-dry-eye.html (accessed
`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 June 26, 2017)
`
`Dalton, M., Novel neurostimulator device uses nasal cavities to
`stimulate tears, OPHTHALMOLOGY TIMES,
`http://ophthalmologytimes.modernmedicine.com/ophthalmology
`times/news/novel- neurostimulator-device-uses-nasal-cavities-
`stimulate-tears?page=0,1 (accessed June 26, 2017)
`
`Marsh, P. and Pflugfelder S., Topical Nonpreserved
`Methylprednisolone Therapy for Keratoconjunctivitis Sicca in
`Sjörgen Syndrome, 106 OPHTHALMOL. 811 (1999)
`
`PubMed Abstract: Sainz de la Maza Serra, et al., Nonpreserved
`Topical Steroids and Punctal Occlusion for Severe
`Keratoconjunctivitis Sicca, 10 ARCH. SOC. ESP. OFTALMOL. 751
`(2000)
`
`Eadie, S., et al., Kerato-Conjunctivitis Sicca Treated With
`Cortisone and ACTH, 39 BRIT. J. OPHTHAL. 90 (1955)
`
`Gaulhofer, W. K., The Effect of Cortisone on Sjögren’s Syndrome,
`CXLIX, ACTA MEDICA SCANDINAVICA (1954)
`
`-5-
`
`
`
`
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`Rolando, M., et al., Topical Non-Preserved Diclofenac Therapy for
`Keratoconjunctivitis Sicca, 506 ADV. EXP. MED. BIO.
`(LACRIMAL GLAND, TEAR FILM & DRY EYE SYNDROMES 3) 1237
`(2002)
`
`Glenn, C., New Thinking Spurs New Products, 1 REV.
`OPHTHALMOL. (FEB. 2003)
`
`Oellerich, et al., Lake Louise Consensus Conference on
`Cyclosporin Monitoring in Organ Transplantation: Report of
`the Consensus Panel, 17 THER. DRUG MONIT. 642 (1995)
`
`Foulks, G.N., et al., 2007 Report of the International Dry Eye
`Workshop (DEWS) 5 OCULAR SURF. 65 (2007)
`
`Avunduk, et al., The Comparison of Efficacies of Topical
`Corticosteroids and Nonsteroidal Anti-inflammatory Drops on
`Dry Eye Patients: A Clinical and Immunocytochemical Study,
`136 AM. J. OPHTHAL.593 (2003)
`
`Lamberts, D.W., Clinical Diseases of the Tear Film, THE CORNEA,
`3rd Ed., (eds. Smolin & Thoft (1994))
`
`Akpek, et al., Ocular Rosacea: Patient Characteristics and Follow-
`up, 104 OPHTHALMOL. 1863 (1997)
`
`1063
`
`Allergan Form 10-K for the year ended December 31, 2015
`
`1064
`
`FDA Approved Drug Products, New Drug Application No. 050790,
`DRUGS@FDA, https://www.accessdata.fda.gov/scripts/cder/daf
`/index.cfm?event=overview.process&ApplNo=050790
`(accessed June 20, 2017)
`
`1065
`
`Allergan Form 10-K for the year ended December 31, 2009
`
`-6-
`
`
`
`
`
`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
`
`1070
`
`1071
`
`Patent and Exclusivity for: N050790, ORANGE BOOK,
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm
`?Product_No=001&Appl_No=050790&Appl_type=N (accessed
`June 21, 2017)
`
`Kymionis, G.D., et al., Treatment of chronic dry eye: focus on
`cyclosporine, 2 CLIN. OPTHALMOL., 829 (2008)
`
`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
`
`1073
`
`1074
`
`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)
`
`1075
`
`Javadi and Feizi, Dry Eye Syndrome, 6 J. OPHTHALMIC VIS. RES.
`192 (2011)
`
`1076
`
`Xiidra, https://www.xiidra.com/ (accessed June 22, 2017)
`
`-7-
`
`
`
`
`
`1077
`
`1078
`
`1079
`
`1080
`
`1081
`
`1082
`
`1083
`
`FDA approves new medication for dry eye disease, FDA NEWS
`RELEASE,
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnounceme
`nts/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/ne
`ws/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)
`
`Jedlicka, J., Scleral Contact Lenses, ALLABOUTVISION.COM,
`http://www.allaboutvision.com/contacts/scleral-lenses.htm
`(accessed June 22, 2017)
`
`Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364,
`1376-77 (Fed. Cir. 2005)
`
`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
`
`Stephenson, M., OTC Drops: Telling the Tears Apart, REV.
`OPHTHALMOL., https://www.reviewofophthalmology.com/
`article/otc-drops-telling-the-tears-apart (accessed June 20, 2017)
`
`Narayanan, S., Which Drop for Dry Eye?, REV. OPTOM., 2009,
`https://www.reviewofoptometry.com/article/which-drop-for-
`dry-eye (accessed June 20, 2017)
`
`-8-
`
`
`
`
`
`1087
`
`1088
`
`1089
`
`1090
`
`1091
`
`1092
`
`1093
`
`1094
`
`1095
`
`1096
`
`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)
`
`Refresh Products, http://www.refreshbrand.com/Products (accessed
`June 23, 2017)
`
`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)
`
`Methylprednisolone (Oral Route), Mayo Clinic,
`http://www.mayoclinic.org/drugs-supplements/
`methylprednisolone-oral-route/description/drg-20075237
`(accessed June 23, 2017)
`
`Hessen, M. and Akpek, E., Dry Eye: an Inflammatory Ocular
`Disease, 9 J. OPHTHALMIC VIS. RES. 240 (2014)
`
`Dry Eye Syndrome, E MEDICINE HEALTH,
`http://www.emedicinehealth.com/dry_eye_syndrome-
`health/article_em.htm (accessed June 23, 2017)
`
`PubMed Abstract: Mrukwa-Kominek, et al., Effect of anti-
`inflammatory therapy on the treatment of dry eye syndrome, 109
`KLIN OCZNA 79 (2007)
`
`-9-
`
`
`
`
`
`1097
`
`1098
`
`1099
`
`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)
`
`Allergan Product Information,
`https://www.allerganoptometry.com/ 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
`
`1108
`
`Allergan Third Quarter 2009 Earnings Call Transcript
`
`1109
`
`1110
`
`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)
`
`Restasis commercial among most memorable as of 2013, PMLIVE,
`http://www.pmlive.com/pharma_news/restasis_ad_among_most
`_memorable_of_2013_531999 (accessed June 21, 2017)
`
`-10-
`
`
`
`
`
`1111
`
`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)
`
`Copayment Tier Definitions, BLUE CROSS AND BLUE SHIELD OF
`NORTH CAROLINA, 2017,
`http://www.bcbsnc.com/content/services/ formulary/rxdef.htm
`(accessed June 22, 2017)
`
`1115
`
`Allergan Fourth Quarter 2015 Earnings Call Transcript
`
`1116
`
`1117
`
`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)
`
`My Tears, My Rewards® Program Terms and Conditions,
`https://www.restasis.com/TermsOfUse/TermsAndConditions5
`(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)
`
`-11-
`
`
`
`
`
`1122
`
`Reserved
`
`1123
`
`1124
`
`1125
`
`1126
`
`1127
`
`1128
`
`1129
`
`1130
`
`1131
`
`1132
`
`1133
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2004 U.S.
`Managed Healthcare/Institutional/Government: Managed
`Healthcare RESTASIS® 2004 Strategies, “Paving the Way
`Through Managed Care” (AGN_RES1120941)
`
`PROTECTIVE ORDER MATERIAL – Allergan, RESTASIS®
`DTC Update, August 4, 2010 (AGN_RES1148612)
`
`PROTECTIVE ORDER MATERIAL – Natexis Bleichroeder Inc.,
`Allergan, Inc., First Call Note (AGN_RES0734285)
`
`PROTECTIVE ORDER MATERIAL – Bilal Ghazi 2007
`Marketing Plan (AGN_RES1124168)
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2007 U.S. Eye
`Care Sales & Marketing Plan (AGN_RES1134471)
`
`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)
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2016 Dry Eye
`Business Plan (AGN_RES1154033)
`
`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, 62 MOT. J. CANCER, 591
`(1990)
`
`Declaration of Anna G. Phillips in support of Petitioner’s Motion
`for Pro Hav Vice Admission
`
`1134
`
`June 5, 2017 Email Regarding Deposition Requests
`
`-12-
`
`
`
`
`
`1135
`
`July 6, 2017 Email Regarding Patent Owner’s Sur-reply
`
`1136
`
`1137
`
`1138
`
`1139
`
`1140
`
`1141
`
`
`1142
`
`1143
`
`1144
`
`1145
`
`July 21, 2017 Email Regarding New Arguments and Evidence in
`Patent Owner’s Sur-reply
`
`Transcript of Telephonic Hearing Held Monday, 11 September
`2017, in IPR2016-01127; IPR2016-01128; IPR2016-01129;
`IPR2016- 01130; IPR2016-01131 and IPR2016-01132
`
`Declaration of Shannon M. Bloodworth in support of Petitioner’s
`Motion for Pro Hac Vice Admission
`
`Declaration of Charles G. Curtis, Jr. in support of Petitioner’s
`Motion for Pro Hac Vice Admission
`
`Declaration of Jennifer A. MacLean in support of Petitioner’s
`Motion for Pro Hac Vice Admission
`
`Declaration of Eric D. Miller in support of Petitioner’s Motion for
`Pro Hac Vice Admission
`
`Declaration of Benjamin S. Sharp in support of Petitioner’s Motion
`for Pro Hac Vice Admission
`
`Transcript of Telephonic Hearing Held Tuesday, 26 September
`2017, in IPR2016-01127; IPR2016-01128; IPR2016-01129;
`IPR2016- 01130; IPR2016-01131 and IPR2016-01132
`
`Partnership Between Drug Giant and Native American Tribe May
`Affect Patent Challenges,
`http://www.npr.org/templates/transcript/transcript.php?storyId=
`552181878 (accessed October 13, 2017)
`
`Frequently Asked Questions about New Research and Technology
`(Patent) Business, https://www.srmt-
`nsn.gov/_uploads/site_files/Office-of-Technology-Research-
`and-Patents-FAQs.pdf (accessed October 13, 2017) downloaded
`from EX1157
`
`-13-
`
`
`
`
`
`1146
`
`1147
`
`
`1148
`
`Allergan’s patent transaction with St. Regis Mohawks could
`presage more arbitrage patent transactions, IPWATCHDOG,
`http://www.ipwatchdog.com/2017/09/18/allergans-patent-
`transaction-with-st-regis-mohawks-could-presage-more-
`arbitrage-patent-transactions/id=87970 (accessed October 13,
`2017)
`
`Sovereign immunity protects patent owners from what some see as
`PTAB's kangaroo court, says tribe lawyer, IAM-MEDIA.COM,
`http://www.iam-media.com/Blog/Detail.aspx?g=e6d0e737-
`a215-484e-989f-a7c791c901ef (accessed October 13, 2017)
`
`Allergan Partners With Indian Tribe to Protect Drug Patents -- 3rd
`Update, FOX BUSINESS,
`http://www.foxbusiness.com/features/2017/09/08/allergan-
`partners-with-indian-tribe-to-protect-drug-patents-3rd-
`update.html (accessed October 13, 2017)
`
`1149
`
`Health-Care Alliances Letter to Congress, October 10, 2017
`
`1150
`
`1151
`
`1152
`
`Waxman hits out at Allergan patent deal with Mohawk tribe,
`FINANCIAL TIMES, https://www.ft.com/content/81bd8930-abb8-
`11e7-aab9-abaa44b1e130?mhq5j=e7 (accessed October 13,
`2017)
`
`Plaintiff’s Production of Documents in Response to Court’s
`October 6, 2017 Order, Case No. 2:15-cv-01455-WCB, D.I.
`510, Filed 10/10/17
`
`Jay, W. M., Santos, J.A., Patent-Assignment Transactions Between
`Brand-Name Drug Companies and Native American Tribes Will
`Undermine a Healthy Patent System and Harm Patients, AAM
`WHITE PAPER, October 12, 2017,
`https://www.accessiblemeds.org/sites/default/files/2017-
`10/AAM%20White%20Paper%20Renting%20Tribal%20Immu
`nity%20to%20Evade%20IPR%20Review%20of%20Pharmaceu
`tical%20Patents.pdf (accessed October 13, 2017 from
`https://www.accessiblemeds.org/)
`
`-14-
`
`
`
`
`
`1153
`
`1154
`
`1155
`
`1156
`
`1157
`
`1158
`
`1159
`
`1160
`
`1161
`
`Allergan pays Mohawk Tribe to protect patents from challenges,
`REUTERS, https://www.reuters.com/article/us-allergan-patents-
`mohawk/allergan-pays-mohawk-tribe-to-protect-patents-from-
`challenges-idUSKCN1BJ2DK (accessed October 13, 2017)
`
`Plaintiff Allergan, Inc.’s Response to Defendants’ Motion for
`Summary Judgment of Non-Infringement, Case No. 2:15-cv-
`01455-WCB, D.I. 460, Filed 8/22/17 (Public Version),
`Excerpted
`
`A Native American Tribe, a Drugmaker and an Unusual Patent
`Plan, BLOOMBERG NEWS,
`https://www.bloomberg.com/news/articles/2017-09-08/allergan-
`makes-deal-with-native-american-tribe-over-drug-patents
`(accessed October 13, 2017)
`
`Brief for the Federal Respondent in Opposition, Oil States Energy
`Services LLC v. Greene’s Energy Group, LLC, No. 16-712
`(U.S. Apr. 28, 2017), downloaded from
`https://www.justice.gov/sites/default/files/briefs/2017/05/01/16-
`712_oil_states_energy_servs._llc_opp.pdf (accessed October
`13, 2017)
`
`Allergan and Saint Regis Mohawk Tribe Announce Agreements
`Regarding RESTASIS® Patents, https://www.srmt-
`nsn.gov/news/2017/allergan-and-saint-regis-mohawk-tribe-
`announce-agreements-regarding-restasis-patents (accessed
`October 13, 2017)
`
`FlowRider Surf, Ltd. v. Pac. Surf Designs, Inc., 2017 WL 2349031
`(S.D. Cal. May 26, 2017)
`
`Gingras v. Rosette, Case No. 5:15-cv-101, 2016 WL 2932163 (D.
`Vt. May 18, 2016)
`
`Commonwealth v. Think Finance, Inc., No. 14-cv-7139, 2016 WL
`183289 (E.D. Pa. Jan. 14, 2016)
`
`SourceOne Global Partners, LLC v. KGK Synergize, Inc., No. 08-
`C-7403, 2009 WL 1346250 (N.D. Ill. May 13, 2009)
`
`-15-
`
`
`
`
`
`1162
`
`1163
`
`1164
`
`1165
`
`Diné Citizens Against Ruining Our Env’t. v. U.S. Office of Surface
`Mining Reclamation & Enf’t, No. 12-cv-1275-AP, 2013 WL
`68701 (D. Colo. Jan. 4, 2013)
`
`Memorandum Opinion and Order, Docket No. 522; Allergan, Inc.,
`and The Saint Regis Mohawk Tribe v. Teva Pharmaceuticals
`USA, Inc., Mylan Inc., Mylan Pharmaceuticals Inc., and Akorn,
`Inc., No. 2:15-cv-01455-WCB (October 16, 2017)
`
`Findings of Fact and Conclusions of Law, Docket No. 523;
`Allergan, Inc., and The Saint Regis Mohawk Tribe v. Teva
`Pharmaceuticals USA, Inc., Mylan Inc., Mylan Pharmaceuticals
`Inc., and Akorn, Inc., No. 2:15-cv-01455-WCB (October 16,
`2017)
`
`Final Judgment, Docket No. 524; Allergan, Inc., and The Saint
`Regis Mohawk Tribe v. Teva Pharmaceuticals USA, Inc., Mylan
`Inc., Mylan Pharmaceuticals Inc., and Akorn, Inc., No. 2:15-cv-
`01455-WCB (October 16, 2017)
`
`1166
`
`October 11, 2017 Email Chain
`
`1167
`
`1168
`
`Brief for the Federal Respondent, Oil States Energy Services, LLC,
`v. Greene’s Energy Group, LLC, et al., No. 16-712, October
`2017.
`
`Transcript of Telephonic Hearing Held Monday, 05 March 2018, 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 1168 on this 8th day of
`
`March 2018, on Allergan, Inc. and the St. Regis Mohawk Tribe as follows:
`
`Dorothy P. Whelan
`Michael Kane
`Susan Morrison Colletti
`Robert M. Oakes
`Jonathan Singer
`Fish & Richardson P.C.
`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
`Email: achan@shorechan.com
`Email: jdepumpo@shorechan.com
`Email: mshore@shorechan.com
`Email: cevans@shorechan.com
`
`Marsha K. Schmidt
`Email: marsha@mkschmidtlaw.com
`
`
`
`-17-
`
`
`
`And on the remaining Petitioners as follows:
`
`
`
`Gary Speier
`Mark Schuman
`Carlson, Caspers, Vandenburgh,
`Lindquist & Schuman, P.A.
`Email: gspeier@carlsoncaspers.com
`Email: mschuman@carlsoncaspers.com
`Attorneys for Teva Pharmaceuticals USA, Inc.
`
`
`
`
`
`Michael Dzwonczyk
`Azadeh Kokabi
`Travis Ribar
`Sughrue Mion, PLLC
`Email: mdzwonczyk@sughrue.com
`Email: akokabi@sughrue.com
`Email: tribar@sughrue.com
`Attorneys for Akorn Inc.
`
`
`
`
`
`Dated: March 8, 2018
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
`Steven W. Parmelee, Lead Counsel
`Reg. No. 31,990
`
`
`
`-18-
`
`