`Filed: November 21, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC. and AKORN 1NC.,1
`Petitioners,
`
`V.
`
`ALLERGAN, 1NC.,
`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 IPR20 1 7-005 76 and IPR2017-00594, IPR20 1 7-005 78 and IPR2017-00596,
`IPR2017-00579 and IPR2017-00598,
`IPR20 1 7-005 83
`and IPR2017-00599,
`
`IPR20 1 7-005 85 and IPR2017-00600, and IPR20 1 7-005 86 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
`
`
`Exhibit
`
`No.
`
`1001
`
`Description
`
`The Patent (US. 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)
`
`1002
`
`Declaration of Dr. Mansoor Amiji
`
`1003
`Curriculum Vitae of Dr. Mansoor Amiji
`
`1004
`
`1005
`
`File History (US. 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 US. Patent Application No. 10/927,857, filed on
`August 27, 2010 to Acheampong et al.
`
`1006
`
`US. 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 ofcyclosporine to rabbit, dog, and
`human eyes, 2 LACRIMAL GLAND, TEAR FILM, AND DRY EYE
`SYNDROMES 1001 (1998)
`
`1009
`
`US. Patent No. 5,578,586 to Glonek et al., filed February 4, 1994
`
`1010
`US. 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)
`
`
`
`
`
`
`
`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
`
`Turner, K., et al., Interleukin-6 Levels in the Conjunctival
`Epithelium ofPatients 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 ofModerate-to-Severe
`1015
`Dry Eye Disease 107 OPHTHALMOL. 967 (2000)
`
`Remington’s 20th Edition: The Science and Practice of Pharmacy
`1016 (A. Gennaro ed. 2003)
`
`
`
`
`
`1017
`
`1018
`
`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. 1 19 (1994)
`
`Vieira, A., et al., Effect ofricinoleic acid in acute and subchronic
`experimental models of inflammation, 9 MED. INFLAMM. 223
`1019
`(2000)
`
`1020
`
`Murphy, R., The Once and Future Treatment ofDry Eye, REVIEW
`OF OPTOMETRY 1 (2000)
`
`1021
`
`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. 00. 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
`
`1 024
`
`Approved Drug Products with Therapeutic Equivalence
`Evaluations (34th Ed.) (2014) (Excerpts)
`
`File history of US. Patent No. 8,629,111 to Acheampong et al.
`1025
`(Exhibit Number Reserved in IPR2016-01 128, -01 129, -01 13 0,
`(IPR2016-
`01127)
`&-01131)
`
`
`& -01 13 1)
`
`1025
`(IPR2016-
`01132)
`
`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,
`
`
`
`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
`
`1027
`
`1028
`
`1029
`
`1030
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-2000-7626
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L- 1 998-5709
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L- 1 998-5707
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`1031 Management, Notebook Number L-2000-7726
`
`
`
`1032
`
`Orange Book 29th Edition (2009) (excerpts)
`
`1033
`
`Mayssa Attar Professional Linkedin Profile
`
`-3-
`
`
`
`1038
`
`1038
`
`1039
`
`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.
`
`1040
`Bloch, Ph.D.
`
`1041
`
`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
`
`
`
`
`
`1034
`
`1035
`
`1036
`
`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.,
`1037
`M.S.Sc.
`
`Facts About Dry Eye, NATIONAL EYE INSTITUTE OFFICE OF SCIENCE
`COMMUNICATIONS, PUBLIC LIAISON, AND EDUCATION, 2013,
`https://nei.nih.g0V/health/dryeye/dryeye (accessed June 26,
`2017)
`
`1045
`
`1046
`
`Niederkorn, et al., Desiccating Stress Induces T Cell-Mediated
`degren ’s Syndrome-Like Lacrimal Keratoconjunctivitis, 176 J.
`IMMUNOL. 3950 (2006)
`
`-4-
`
`
`
`
`
`1047
`
`1048
`
`Garralt, 8., Dry Eye Syndrome Preferred Practice Pattern,
`AMERICAN ACADEMY OF OPHTHALMOLOGY (2013)
`
`Garralt, 8., Dry Eye Syndrome Preferred Practice Pattern Limited
`Revision, AMERICAN ACADEMY OF OPHTHALMOLOGY (2011)
`
`Eadie, S., et al., Kerato-Conjunctivitis Sicca Treated With
`1054 Cortisone andACTH, 39 BRIT. J. OPHTHAL. 90 (1955)
`
`
`
`1055
`
`Gaulhofer, W. K., The Effect of Cortisone on Sjo'gren ’s Syndrome,
`CXLIX, ACTA MEDICA SCANDINAVICA (1954)
`
`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-a11eViate-dry-eye.htm1 (accessed
`June 26, 2017)
`
`1049
`
`Allergan Granted Marketing Authorization by the FDA for
`TrueTearn", the First Intranasal Neurostimulating Device
`Proven to Temporarily Increase Tear Production,
`https://www.a11ergan.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 ://ophtha1mologytimes.modernmedicinecorn/ophthalmology
`times/news/novel- neurostimulator-device-uses-nasal-cavities-
`
`1050
`
`105 1
`
`stimulate-tears?page=0,1 (accessed June 26, 2017)
`
`1052
`
`1053
`
`Marsh, P. and Pflugfelder S., Topical Nonpreserved
`Methylprednisolone Therapyfor Keratoconjunctivitis Sicca in
`Sjo'rgen 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)
`
`
`
`
`
`
`
`1056
`
`Rolando, M., et al., Topical Non-Preserved Diclofenac Therapyfor
`Keratoconjunctivitis Sicca, 506 ADV. EXP. MED. BIO.
`(LACRIMAL GLAND, TEAR FILM & DRY EYE SYNDROMES 3) 1237
`(2002)
`
`1057
`
`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
`1058
`the Consensus Panel, 17 THER. DRUG MONIT. 642 (1995)
`
`
`
`1059
`
`Foulks, G.N., et al., 2007 Report of the International Dry Eye
`Workshop (DEWS) 5 OCULAR SURF. 65 (2007)
`
`1060
`
`Avunduk, et al., The Comparison ofEfficacies of Topical
`Corticosteroids and Nonsteroidal Anti-inflammatory Drops on
`Dry Eye Patients: A Clinical and Immunocytochemical Study,
`136 AM. J. OPHTHAL.593 (2003)
`
`1061
`
`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-
`1062 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.g0V/scripts/cder/daf
`/index.cfm?event=overview.process&App1N0=050790
`(accessed June 20, 2017)
`
`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.corn/news-releases/a11ergan-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.htm1# (accessed June 20, 2017)
`
`
`
`1067 FDA Label for Restasis MultiDoseTM
`
`
`
`1068 Allergan Form 10-K for the year ended December 31, 1993
`
`1069
`
`Patent and Exclusivityfor: N05 0790, ORANGE BOOK,
`https://WWW.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm
`?Product_No=001&App1_No=050790&App1_type=N (accessed
`June 21, 2017)
`
`1070
`
`Kymionis, G.D., et al., Treatment ofchronic dry eye: focus on
`cyclosporine, 2 CLIN. OPTHALMOL., 829 (2008)
`
`Chronic Dry Eye Disease, https://WWW.restasis.com/What-Is-
`1071 Chronic-Dry-Eye-Disease (accessed June 21 , 2017)
`
`
`
`
`
`1072
`
`Allergan Form 10-K for the year ended December 31, 2002
`
`1 073
`
`1074
`
`Keratoconjunctivitis Sicca, MERCK MANUAL,
`http ://Www.merckmanua1s.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, 6 J. OPHTHALMIC VIS. RES.
`1075 192 (2011)
`
`
`
`1076
`
`Xiidra, https://www.xiidra.corn/ (accessed June 22, 2017)
`
`
`
`
`
`1077
`
`1078
`
`1079
`
`1080
`
`1081
`
`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 nodfor 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, 20 1 7)
`
`Dry eyes, MAYO CLINIC, http://Www.mayoc1inic.org/diseases-
`conditions/dry-eyes/basics/treatment/con-20024129 (accessed
`June 22, 2017)
`
`Scleral Lenses, CONTACT LENS MANUFACTURERS ASSOCIATION,
`http://WWW.contact1enses.org/sclera1.htm (accessed June 22,
`2017)
`
`Jedlicka, J., Scleral Contact Lenses, ALLABOUTVISION.COM,
`http://WWW.a11aboutvision.com/contacts/scleral-lenses.htm
`(accessed June 22, 2017)
`
`Merck & Co., Inc. V. Teva Pharms. USA, Inc., 395 F.3d 1364,
`1082
`1376-77 (Fed. Cir. 2005)
`
`1083
`
`New Patents Could Sustain Allergan Restasis Franchise Until
`2024, SEEKING ALPHA,
`http ://seekinga1pha.corn/article/ 1 945 5 5 1-neW-patents-cou1d-
`sustain-allergan-restasis-franchise-unti1—2024 (accessed June 22,
`20 17)
`
`1084
`
`FDA Label for Lacrisert®
`
`
`
`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)
`
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`
`1086
`
`Narayanan, 8., Which Drop for Dry Eye?, REV. OPTOM., 2009,
`https://Www.reVieW0foptometry.com/article/Which-drop-for-
`dry-eye (accessed June 20, 2017)
`
`-8-
`
`
`
`
`
`1087
`
`1088
`
`Schachet, J., The Golden Age ofDry Eye Management, REVIEW OF
`OPTOMETRY, 2008, https://Www.reVieW0foptometry.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)
`
`1089
`
`1090
`
`1091
`
`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 , 20 1 7)
`
`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/articlehtm (accessed June 23, 2017)
`
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`
`
`
`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, 9 J. OPHTHALMIC VIs. RES. 240 (2014)
`
`Dry Eye Syndrome, E MEDICINE HEALTH,
`http://WWW.emedicinehea1th.com/dry_eye_syndrome-
`health/article_em.htm (accessed June 23, 2017)
`
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`
`1096
`
`PubMed Abstract: Mrukwa-Kominek, et al., Effect ofanti-
`inflammatory therapy on the treatment ofdry eye syndrome, 109
`KLIN OCZNA 79 (2007)
`
`-9-
`
`
`
`
`
`1097
`
`1098
`
`Adler, R., Dry Eye Treatment: Getting ReliefFrom Dry Eyes,
`ALLABOUTVISION.COM, http://WWW.a11aboutvision.com/
`conditions/dryeye.htm (accessed June 23, 2017)
`
`Ramsey, L., How Allergan wentfiom a tiny Los Angeles eye care
`company to the biggest takeover target of201 5, BUSINESS
`INSIDER, 2015, http://WWW.businessinsider.com/allergan-
`history-since-1948-founding-2015-1 1 (accessed June 22, 2017)
`
`Allergan Product Information,
`https://WWW.a11erganoptometry.com/ Product-Information/
`(accessed June 23, 2017)
`
`1099
`
`
`
`1100
`
`1101
`
`1102
`
`1103
`
`1104
`
`Allergan Third Quarter 2016 Earnings Call Transcript
`
`Allergan Second Quarter 2016 Earnings Call Transcript
`
`Allergan Form 10-K for the year ended December 31, 2005
`
`Allergan Form 10-K for the year ended December 31, 2014
`
`Allergan Third Quarter 2015 Earnings Call Transcript
`
`1105
`Allergan Third Quarter 2013 Earnings Call Transcript
`
`1106
`
`1107
`
`1108
`
`1109
`
`1110
`
`Allergan Fourth Quarter 2007 Earnings Call Transcript
`
`Allergan First Quarter 2009 Earnings Call Transcript
`
`Allergan Third Quarter 2009 Earnings Call Transcript
`
`Weintraub, A., Allergan: Smoothing the Wrinkles,
`BLOOMBERG.COM, 2006,
`https://WWW.bloomberg.com/news/articles/2006-02-08/a11ergan-
`smoothing-the-wrinkles (accessed June 21, 2017)
`
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`http ://Www.pm1ive.com/pharma_news/restasis_ad_among_most
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`
`-10-
`
`
`
`
`
`1111
`
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`of Chronis Dry Eye, CISION PR NEWSWIRE, 2016,
`http://Www.prnewswire.com/news-releases/actress-marisa—
`tomei-p artners-With-allergan-to -raise-awareness-of— chronic-dry-
`eye-3 003 01221 .html# (accessed on June 22, 2017)
`
`1112
`
`Allergan Form 10-K for the year ended December 31, 2011
`
`Bihari, M., Understanding Your Health Plan Drug Formulary,
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`drug-formulary- 1 73 8897 (accessed June 22, 2017)
`
`1113
`
`1114
`
`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
`
`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)
`
`1116
`
`
`
`1117
`
`My Tears, My Rewards® Program Terms and Conditions,
`https://WWW.restasis.com/TermsOste/TermsAndConditions5
`(accessed June 22, 2017)
`
`1118
`
`List of testimony of Ivan T. Hofrnann
`
`1119
`
`PROTECTIVE ORDER MATERIAL — Allergan, 2012 US. Eye
`Care Sales & Marketing Plan: RESTASIS® Professional
`(AGN_RESl 123159)
`
`PROTECTIVE ORDER MATERIAL — Allergan, 2006 US. Eye
`Care Sales & Marketing Plan: 2006 Optometric Business Plan
`(AGN_RESl 147478)
`
`1120
`
`1121
`
`PROTECTIVE ORDER MATERIAL — Allergan, 2016 US. Eye
`Care Sales & Marketing Plan: Lifitegrast Plan and MDPF
`Overview (AGN_RESO614120)
`
`-11-
`
`
`
`
`
`1122
`
`Reserved
`
`1123
`
`1124
`
`PROTECTIVE ORDER MATERIAL — Allergan, 2004 US.
`Managed Healthcare/Institutional/Government: Managed
`Healthcare RESTASIS® 2004 Strategies, “Paving the Way
`Through Managed Care” (AGN_RESl 120941)
`
`PROTECTIVE ORDER MATERIAL — Allergan, RESTASIS®
`DTC Update, August 4, 2010 (AGN_RESl 148612)
`
`PROTECTIVE ORDER MATERIAL — Natexis Bleichroeder Inc.,
`1125
`Allergan, Inc., First Call Note (AGN_RES0734285)
`
`
`
`1126
`
`1127
`
`1128
`
`1129
`
`1130
`
`1131
`
`PROTECTIVE ORDER MATERIAL — Bilal Ghazi 2007
`
`Marketing Plan (AGN_RES 1 124168)
`
`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_RESl 146945)
`
`PROTECTIVE ORDER MATERIAL — Allergan, 2008 U.S. Eye
`Care Sales & Marketing Plan: Optometric Strategies Overview
`(AGN_RESl 147652)
`
`PROTECTIVE ORDER MATERIAL — Allergan, 2016 Dry Eye
`Business Plan (AGN_RES1 154033)
`
`PROTECTIVE ORDER MATERIAL — Allergan, 2008 U.S. Eye
`Care Sales & Marketing Plan: All Roads Lead to RESTASIS®
`(AGN_RES 1 1 53 653)
`
`Schuurhuis, G. J., et al., The polyoxyethylene castor oil Cremophor
`EL modifies multidrug resistance, 62 MOT. J. CANCER, 591
`(1990)
`
`1132
`
`1133
`
`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-
`
`
`
`Declaration of Shannon M. Bloodworth in support of Petitioner’s
`1138
`Motion for Pro Hac Vice Admission
`
`1139
`
`1140
`
`1141
`
`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
`1142
`
`
`
`
`
`1135
`
`July 6, 2017 Email Regarding Patent Owner’s Sur-reply
`
`1136
`
`1137
`
`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
`
`1143
`
`Transcript of Telephonic Hearing Held Tuesday, 26 September
`2017, in IPR2016-01127; IPR2016-01128; IPR2016-01129;
`
`IPR2016- 01130; IPR2016-01131 and IPR2016-01132
`
`1144
`
`1145
`
`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.g0V/_uploads/site_files/Office-of—Technology-Research-
`and-Patents-FAQs.pdf (accessed October 13, 2017) downloaded
`from EX1 15 7
`
`-13-
`
`
`
`1147
`
`Sovereign immunity protects patent owners fiom what some see as
`PTAB 's kangaroo court, says tribe lawyer, IAM-MEDIA.COM,
`http://WWW.iam-media.corn/Blog/Detail.aspx?g=e6d0e73 7-
`a215-484e-989f—a7c79 1c901ef (accessed October 13, 2017)
`
`1148
`
`Allergan Partners With Indian Tribe to Protect Drug Patent
`Update, FOX BUSINESS,
`http://Www.foxbusiness.corn/features/20 1 7/09/0 8/allergan-
`partners-With-indian-tribe-to-protect-drug-patents-3rd-
`update.html (accessed October 13, 2017)
`
`-- 3rd
`
`1149
`
`Health-Care Alliances Letter to Congress, October 10, 2017
`
`Waxman hits out at Allergan patent deal with Mohawk tribe,
`FINANCIAL TIMES, https://WWW.ft.corn/content/81bd8930-abb8-
`1 1e7-aab9-abaa44b1e130?mhq5j=e7 (accessed October 13,
`2017)
`
`1150
`
`
`
`
`
`1146
`
`Allergan ’s patent transaction with St. Regis Mohawks could
`presage more arbitrage patent transactions, IPWATCHDOG,
`http://WWW.ipwatchdog.corn/2017/09/18/allergans-patent-
`transaction-With-st-regis-mohawks-could-presage-more-
`arbitrage-patent-transactions/id=87970 (accessed October 13,
`2017)
`
`1151
`
`Plaintiff’ s Production of Documents in Response to Court’s
`October 6, 2017 Order, Case No. 2:15-cV-01455-WCB, D1.
`
`510, Filed 10/10/17
`
`1152
`
`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-
`1 0/AAM%20White%20Paper%20Renting%20Tribal%201mmu
`nity%20to%20Evade%201PR%20ReVieW%20of%20Pharmaceu
`tical%20Patents.pdf (accessed October 13, 2017 from
`https://WWW.accessiblemeds.orgO
`
`-14-
`
`
`
`
`
`1153
`
`1154
`
`1155
`
`1156
`
`1157
`
`1158
`
`1159
`
`Allergan pays Mohawk Tribe to protect patents fiom challenges,
`REUTERS, https://WWW.reuters.corn/article/us-allergan-patents-
`mohaWk/allergan-pays-mohaWk-tribe-to-protect-patents-from-
`challenges-idUSKCNlBJ2DK (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.corn/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
`1 3 , 20 1 7)
`
`Allergan and Saint Regis Mohawk Tribe Announce Agreements
`Regarding RESTASIS® Patents, https://WWW.srmt-
`nsn. gov/news/20 1 7/allergan- and-saint-regis-mohaWk-tribe-
`announce-agreements-regarding-restasis-patents (accessed
`October 13, 2017)
`
`FlowRider Surfi Ltd. v. Pac. SurfDesigns, 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
`1160
`183289 (E.D. Pa. Jan. 14, 2016)
`
`1161
`
`SourceOne Global Partners, LLC v. KGK Synergize, Inc., No. 08-
`C-7403, 2009 WL 1346250 (ND. 111. May 13, 2009)
`
`-15-
`
`
`
`
`
`1162
`
`1163
`
`1164
`
`1165
`
`Diné Citizens Against Ruining Our Env ’t. v. US. Office ofSurface
`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,
`20 17)
`
`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
`
`
`
`Brief for the Federal Respondent, Oil States Energy Services, LLC,
`v. Greene ’s Energy Group, LLC, et al., No. 16-712, October
`20 17.
`
`1167
`
`1168
`
`1169
`
`Transcript of Telephonic Hearing Held Monday, 05 March 2018, in
`IPR2016-01127; IPR2016-01128; IPR2016-01129; IPR2016-
`
`01130; IPR2016-01131 and IPR2016-01132
`
`Wright et al., Federal Practice & Proc. Juris. § 3914.10 n. 71 (2d
`ed.) (excerpts)
`
`1170
`
`Wright et al., Federal Practice & Proc. Juris. § 3914.18 (2d ed.)
`
`1171
`H.R. REP. 112-98, 45-48 (2011) (excerpts)
`
`1172
`
`Judgment, Allergan, Inc., and The Saint Regis Mohawk Tribe v.
`Teva Pharmaceuticals USA, Inc., Akorn, Inc., Mylan
`Pharmaceuticals Inc., and Mylan Inc., No. 2018-1 130 (CAFC —
`November 13, 2018)
`
`-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 1172 on this 21 day of
`
`November 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: IPR1335 1-00081P1@fr.com
`Email: IPR1335 1-00081P2@fr.com
`Email: IPR1335 1-00081P3@fr.com
`Email: IPR1335 1-00081P4@fr.com
`Email: IPR1335 1-00081P5@fr.com
`Email: IPR1335 1-00081P6@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: jdepump_o@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.
`
`Respectfully submitted,
`
`Dated: November 21, 2018
`
`/ Steve Parmelee /
`
`Steven W. Parmelee, Lead Counsel
`
`Reg. No. 31,990
`
`-18-
`
`