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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ARGENTUM PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`CIPLA LTD.
`Patent Owner
`
`
`Patent No. 8,168,620
`Issue Date: May 1, 2012
`Title: COMBINATION OF AZELASTINE AND STEROIDS
`_______________
`
`Inter Partes Review No. IPR2017-00807
`
`
`PETITIONER’S EXHIBIT LIST AS OF APRIL 10, 2018
`
`

`

`Pursuant to 37 C.F.R. § 42.63(e), Petitioner ARGENTUM
`
`PHARMACEUTICALS LLC presents a complete list of Petitioner’s exhibits,
`
`along with Exhibits 1172 and 1173 filed by Petitioner on April 10, 2018, and
`
`Exhibit 1171 filed by Patent Owner on April 10, 2018.
`
`TABLE OF EXHIBITS
`
`Ex #
`
`Exhibit
`
`Filed
`
`1001 U.S. Patent No. 8,168,620 (“’620 patent”)
`1002 Prosecution History of U.S. Patent No. 8,168,620
`1003 Declaration of Dr. Robert Schleimer
`1004 Declaration of Dr. Maureen Donovan
`1005 Meda Pharms. Inc. v. Apotex Inc., 14-cv-1453 (D. Del. May 12,
`2016) (Claim Construction Memorandum and Order)
`1006 UK Patent Application GB 0213739.6
`1007 U.S. Patent No. 5,164,194 (“Hettche”)
`1008 Physician’s Desk Reference, Astelin® Label, rev.1/99, pp.3147-3148
`(54th ed. 2000) (“Astelin® Label”)
`1009 U.S. Patent No. 4,335,121 (“Phillipps”)
`1010 Flonase® Label (1998)
`1011 European Patent Application No. 0780127 (“Cramer”)
`1012 PCT Publication No. WO 98/48839 to Segal (“Segal”)
`1013 British Pharmaceutical Codex (1973)
`1014 U.S. Patent Publication No. 20040136918 (“Garrett”)
`1015 Falser, N., et al., “Comparative efficacy and safety of azelastine and
`levocabastine nasal sprays in patients with seasonal allergic rhinitis.”
`ARZNEIMITTELFORSCHUNG, 51(5):387-93 (2001)
`
`X
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`X
`X
`X
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`X
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`X
`X
`X
`X
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`2
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`

`

`1016 Kusters, S., et al., “Effects of Antihistamines on Leukotriene and
`Cytokine Release from Dispersed Nasal Polyp Cells.” ARZNEIM-
`FORSCH/DRUG RES., 52(2): 97-102 (Feb. 2002)
`1017 Stellato, C., et al., An in vitro Comparison of Commonly Used
`Topical Glucocorticoid Preparations, J. ALLERGY CLIN. IMMUNOL.,
`Vol. 104, No. 3, Part 1,623-629 (Sept. 1999)
`1018 Johnson, M., Development of fluticasone propionate and comparison
`with other inhaled corticosteroids, J. Allergy Clin. Immunol., Vol.
`101, No. 4, Part 2, S434-S439 (1998)
`1019 Dykewicz, Mark S., et al., “Diagnosis and management of rhinitis:
`complete guidelines of the joint task force on practice parameters in
`allergy, asthma and immunology,” ANNALS OF ALLERGY, ASTHMA &
`IMMUNOLOGY, Vol. 81, 478-518 (1998)
`1020 Stoloff, R., et al., “Combination Therapy with Inhaled Long-Acting
`ß2-Agonists and Inhaled Corticosteroids: A Paradigm Shift in
`Asthma Management,” PHARMACOTHERAPY, Vol. 22, No. 2, 212-226
`(Feb. 2002)
`1021 Berger, W. E. et al., “Double-blind trials of azelastine nasal spray
`monotherapy versus combination therapy with loratadine tablets and
`beclomethasone nasal spray in patients with seasonal allergic
`rhinitis,” ANNALS OF ALLERGY, ASTHMA & IMMUNOLOGY, Vol. 82,
`535-541 (1999)
`1022 Cauwenberge, P. et al., “Consensus statement on the treatment of
`allergic rhinitis,” ALLERGY, Vol. 55: 116-134 (2000)
`1023 Spector, S., “Ideal Pharmacology for Allergic Rhinitis,” J. ALLERGY
`CLIN. IMMUNOL., Vol. 103, No. 3, Part 2, S386-87 (1999)
`1024 Bousquet et al., Management of Allergic Rhinitis and Its Impact on
`Asthma, JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, Vol.
`108, No. 5 (2001)
`1025 Markham, A., et al., “Inhaled Salmeterol-Fluticasone Propionate
`Combination, A Review of its Use in Persistent Asthma,” DRUGS
`60(5) 1207-1233 (Nov. 2000)
`
`1026
`1027 Ansel, et al., Pharmaceutical Dosage Forms and Drug Delivery
`Systems, ch. 7 (6th ed. 1995)
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`3
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`

`
`1028
`
`1029
`1030 Advair Diskus Prescribing Information (2000)
`1031 Juniper, E., "First-line Treatment of Seasonal (Ragweed)
`Rhinoconjunctivitis)," Canadian Medical Association Journal, Vol.
`156, No. 8, April 1997, 1123-31.
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`1032
`1033 Wade & Weller, HANDBOOK OF PHARMACEUTICAL EXCIPIENTS
`(1994)
`1034 Ratner, P., et al., “A Comparison of the Efficacy of Fluticasone
`Propionate Aqueous Nasal Spray and Loratadine, Alone and in
`Combination, for the Treatment of Seasonal Allergic Rhinitis,”
`JOURNAL OF FAMILY PRACTICE, Vol. 47, No. 2, 118-125 (Aug. 1998)
`1035 Drouin, M., et al. “Adding Loratadine to Topical Nasal Steroid
`Therapy Improves Moderately Severe Seasonal Allergic
`Rhinoconjunctivitis.” ADVANCES IN THERAPY, 12(6): 340-349; 1995.
`1036 Simpson, R., Budesonide and terfenadine, separately and in
`combination, in the treatment of hay fever, ANNALS OF ALLERGY,
`Vol. 73 497-502 (Dec. 1994)
`
`1037
`1038 Brooks, C. et al. “Spectrum of Seasonal Allergic Rhinitis Symptom
`Relief with Topical Corticoid and Oral Antihistamine Given Singly
`or in Combination.” AM. J. RHINOL., Vol. 10, 193-196 (1996)
`1039 Juniper, E F., et al., “Comparison of beclomethasone dipropionate
`aqueous nasal spray, astemizone, and the combination in the
`prophylactic treatment of ragweed pollen-induced
`rhinoconjunctivitis,” JOURNAL OF ALLERGY AND CLINICAL
`IMMUNOLOGY, Vol. 83, No. 3, Cover page, Publications page, 627-
`633 (Mar. 1989)
`1040 Benincasa, C. & Lloyd, R.S., “Evaluation of Fluticasone Propionate
`Aqueous Nasal Spray Taken Alone and in Combination with
`Cetirizine in the Prophylactic Treatment of Seasonal Allergic
`Rhinitis,” DRUG INVEST., Vol. 8, Issue 4, 225-233 (1994)
`1041 Galant, S. and Wilkinson, R., “Clinical Prescribing of Allergic
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`
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`4
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`

`

`Rhinitis Medication in the Preschool and Young School-Age Child.”
`BIODRUGS, 15(7): 453-463; 2001
`1042 Schleimer, R., “Glucocorticosteroids: Their Mechanisms of Action
`and Use in Allergic Diseases,” ALLERGY PRINCIPLES & PRACTICE,
`pp.638-660 (1998)
`
`1043
`
`1044
`1045 Ratner, Paul H., et al., “Combination therapy with azelastine
`hydrochloride nasal spray and fluticasone propionate nasal spray in
`the treatment of patients with seasonal allergic rhinitis,” ANNALS OF
`ALLERGY, ASTHMA & IMMUNOLOGY, VOL. 100, 74-81 (2008)
`1046 IMITREX Prescribing Information (2013)
`1047 NASACORT AQ Prescribing Information (2013)
`1048 Rabago, David, et al., “Efficacy of daily hypertonic saline nasal
`irrigation among patients with sinusitis: A randomized controlled
`trial,” The Journal of Family Practice, Vol. 51, No. 12, 1049-1055
`(2002)
`1049 Budavari, S., et al. (Ed), “Edetate Disodium,” The Merck Index,
`Eleventh Edition, 550 (1989)
`1050 Ratner, Paul H., et al., “A double-blind, controlled trial to assess the
`safety and efficacy of azelastine nasal spray in seasonal allergic
`rhinitis,” Journal of Allergy and Clinical Immunology, Vol. 94, No.
`5, 818-825 (1994)
`1051 Curriculum Vitae of Dr. Robert Schleimer
`1052 Curriculum Vitae of Dr. Maureen Donovan
`1053 Patent Certification for U.S. Patent No. 5,164,194 - Astelin® Nasal
`Spray (2000)
`1054 “Avicel® RC-591 Microcrystalline Cellulose and
`Carboxymethylcellulose Sodium, NF, BP,” FMC Corporation (1994)
`1055 Dr. Accetta Patient Record (1998)
`1056 U.S Patent No. 6,417,206, Antitussive Antihistaminic Decongestant
`Compositions July 9, 2002
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`5
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`

`

`1057 Business Wire, "Meda: Strategic Acquisition of MedPointe Inc
`Completed," August 22, 2007, newsroom.mylan.com/2016-08-05-
`Mylan-Completes-Acquisition-of-Meda. (Accessed January 17,
`2018).
`1058 Center for Drug Evaluation and Research, "Cross Discipline Team
`Leader Review: Application Number 202236Orig1s000."
`1059 GlaxoSmithKline, "GSK Consumer Healthcare Launches FLONASE
`Sensimist Allergy Relief Nationwide," February 8, 2017,
`http://us.gsk.com/en-us/media/press-releases/2017/gsk-consumer-
`healthcare-launches-flonase-sensimist-allergy-relief-nationwide/
`(Accessed January 10, 2018).
`1060 Meda AB, "Meda has Settled the U.S. Astelin Patent Litigation with
`Apotex," April 21, 2008, https://globenewswire.com/news-
`release/2008/04/21/56156/0/en/Meda-has-settled-the-U-S-Astelin-
`patent-litigation-with-Apotex.html (accessed January 1, 2018).
`1061 "Generic Astelin," http://allergies.emedtv.com/astelin/generic-
`astelin.html, (accessed January 17, 2018).
`1062 Food and Drug Administration Orange Book, "Cetirizine &
`Levocetirizine".
`1063 Food and Drug Administration Orange Book, "Fexofenadine".
`
`1064 Food and Drug Administration Orange Book, "Loratadine &
`Desloratadine".
`1065 Durie, Daralyn J. & Mark A. Lemley, "A Realistic Approach to the
`Obviousness of Inventions," William & Mary Law Review, 50(3),
`pp. 989-1020; 2008.
`1066 Meda, "Annual Report 2015."
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`1067 Meda, "Annual Report 2014."
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`1068 Meda, "Annual Report 2013."
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`1069 Congress of the United States Congressional Budget Office,
`"Prescription Drug Pricing in the Private Sector," January 2007.
`1070 Food and Drug Administration Orange Book, "Beclomethasone".
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`6
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`

`

`1071 Sur, Denise K. & Stephanie Scandale, "Treatment of Allergic
`Rhinitis," American Family Physician, 81 (12): pp. 1440-1446;
`2010.
`1072 Brozek, Jan L. et al., "Allergic Rhinitis and its Impact on Asthma
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`2011.
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`1077 DiMasi, Joseph A. et al., "Innovation in the Pharmaceutical Industry:
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`2016.
`1078 Center for Drug Evaluation and Research, "Summary Application
`Review: Application Number 22-203," October 15, 2008.
`1079 Meda, "Annual Report 2009."
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`1080 Drug Topics, "2010 top 200 Generic Drugs by Total Prescriptions,"
`June 2011.
`1081 Voet, Martin A., "Putting it All Together: Product Life-Cycle
`Management," The Generic Challenge, 2nd ed. Boca Raton:
`BrownWalker Press, Ch. 7 pp. 147-166; 2008.
`1082 Shadowen, Steve D. et al., "Anticompetitive Product Changes in the
`Pharmaceutical Industry," Rutgers Law Journal, 31(1-2); 2009.
`1083 Food and Drug Administration, "Dymista NDA Approval," May 1,
`2012.
`1084 Carrier, Michael A. & Steve D. Shadowen, "Product Hopping: A
`New Framework," Notre Dame Law Review, 92(1): pp. 1-81; 2016.
`1085 Herper, Matthew, "Inside the Secret World of Drug Company
`Rebates," Forbes, May 10, 2012,
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`7
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`

`https://www.forbes.com/sites/matthewherper/2012/05/10/why-
`astrazeneca-gives-insurers-60-discounts-on-nexiums-list-
`price/#41d1b60e2b25 (accessed February 8, 2018).
`1086 Congress of the United States Congressional Budget Office,
`"Prescription Drug Pricing in the Private Sector," January 2007.
`1087 Scherer, F.M., "The Pharmaceutical Industry - Prices and Progress,"
`The New England Journal of Medicine, 351(9): pp.927-932; 2004.
`1088 Congress of the United States Congressional Budget Office, "How
`Increased Competition from Generic Drugs has Affected Prices and
`Returns in the Pharmaceutical Industry," July 1998.
`1089 Danzon, Patricia M., "Pharmacy Benefit Management: Are
`Reporting Requirements Pro- or Anticompetitive?" International
`Journal of the Economics of Business, 22(2): pp.245-261; 2015.
`1090 Academy of Managed Care Pharmacy, "Concepts in Managed Care
`Pharmacy," April 2012.
`1091 Danzon, Patricia M. & Mark V. Pauly, "Health Insurance and the
`Growth in Pharmaceutical Expenditures," Journal of Law and
`Economics, 45: pp. 587-613; 2002.
`1092 ABA Section of Antitrust Law, Pharmaceutical Industry Antitrust
`Handbook, Chicago: ABA Publishing; 2009.
`1093 Congress of the United States Congressional Budget Office,
`"Promotional Spending for Prescription Drugs," December 2009.
`1094 Scherer, F.M. & David Ross, Industrial Market Structure and
`Economic Performance, Boston: Houghton Mifflin Company, Ch. 16
`pp. 571-611; 1990.
`1095 John Lu, Yite et al., "Promotiona nd market Share in the Proton
`Pimp Inhibitor Market: A Case Study," Journal of Pharmaceutical
`Marketing & Management, 17(3/4): pp. 39-59; 2006.
`1096 Yi, John C. et al., "An Exploratory Study to Improve Sales
`Operations When Selling Multiple Prescription Drugs," California
`Journal of Operations Management, 9(1): 43-57; 2011.
`1097 Patwardhan, Avinash R., "Physicians-Pharmaceutical Sales
`Representatives Interactions and Conflict of Interest: Challenges and
`Solutions," The Journal of Health Care Organization, 53: pp. 1-5;
`2016.
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`8
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`1098 Fugh-Berman, Adriane & Shahram Ahari, "Following the Script:
`How Drug Reps Make Friends and Influence Doctors," PLoS
`Medicine, 4(4): 621-625; 2007.
`1099 Elliott, Carl, "The Drug Pushers," The Atlantic, April 2006,
`https://www.theatlantic.com/magazine/archive/2006/04/the-drug-
`pushers/304714/ (Accessed Feburary 21, 2018).
`1100 Allan, G. Michael et al., "Physician Awareness of Drug Cost: A
`Systematic Review," PLoS Medicine, 4(9): pp. 1486-1496; 2007.
`1101 Shrank, William H. et al., "Physicians' Perceptions of Relecant
`Prescription Drug Costs: Do Costs to the Individual Patient or to the
`Population Matter Most?" The American Journal of Managed Care,
`12(9): 545-551; 2006.
`1102 Shelley, Suzanne, "Copay Programs' Increased Value to
`Manufacturers is Matched by Rising Criticism," Pharmaceutical
`Commerce, January 15, 2014,
`http://pharmaceuticalcommerce.com/brand-marketing-
`communications/copay-programs-increased-value-to-manufacturers-
`is-matched-by-rising-criticism/ (Accessed October 27, 2017).
`1103 Apotex Corp., "Apotex Corp. A Global Leader Focused on
`Excellence," Pharmacy Times, July 11, 2014 (Accessed January 25,
`2018).
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`the Launch of the Generic Version of Xyzal," Perrigo, November 29,
`2010 (Accessed January 19, 2018).
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`allergy-sufferers?tsid=5 (Accessed January 30, 2018).
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`Nasonex," Apotex Corp, March 24, 2016,
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`center/2016/03/24/apotex-launches-first-generic-version-of-mercks-
`nasonex (Accessed January 11, 2018).
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`Regulator," Nature News, May 18, 2012,
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`9
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`

`regulator-1.10668 (Accessed February 13, 2018).
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`1109 Food and Drug Administration, "Claritin-D Drug Approval".
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`1110 Food and Drug Administration, "Nasalide Drug Approval".
`
`1111 Food and Drug Administration Orange Book, "Traimcinolone".
`
`1112 NDC Director - Ticanase.xlsx
`
`1113 Food and Drug Administration Orange Book, "Fluticasone
`Propionate".
`1114 Food and Drug Administration Orange Book, "Olopatadine".
`
`1115 Food and Drug Administration Orange Book, "Budesonide".
`
`1116 Food and Drug Administration Orange Book, "Mometasone".
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`1117 Mahr, Krista & Zeba Siddiqui, "As Combination Drugs Engulf India,
`an American Pharmaceutical Giant Profits," Reuters, December 15,
`2015, https://www.reuters.com/investigates/special-report/india-
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`(CDSCO), May 2012.
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`and Clinical Research, 5(3): pp. 25-29; 2012.
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`Medicines in India: Key Issues Which Call for Action," Indian
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`1123 Food and Drug Administration Orange Book, "Patent Listing:
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`Success," Landslide; 2017.
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`Practical Tutorial," Methods Mol Biol., 823: 391-408, 2012.
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`22, 2018).
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`11
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`1135 "India Pharma Inc.: Capitalizing on India's Growth Potential,"
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`1139 Curriculum Vitae of John C. Staines, Jr.
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`1140 Declaration of John C. Staines, Jr.
`
`1141 Deposition Transcript of Dr. Alexander Dominic D’Addio, February
`21, 2018
`1142 Deposition Transcript of Dr. Warner W. Carr, February 7, 2018
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`1143 Deposition Transcript of Dr. Hugh David Charles Smyth, January
`31, 2018
`1144 Second Declaration of Dr. Robert Schleimer
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`1145 Second Declaration of Dr. Maureen Donovan (filed under seal)
`
`1146 Dell and Colliopoulos, “Avicel® RC/CL, Microcrystalline Cellulose
`and Carboxymethylcellulose Sodium, NF, BP,” (2001) pp. 1-27
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`macroglobulin into human nasal airways,” Clinical and Experimental
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`1148 Han et al., “A Multicenter Randomized Double-Blind 2-Week
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`1149 Nairn J.G., “Solutions, Emulsions, Suspensions and Extracts,”
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`12
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`19th ed., 1995, pages 1495-1523
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`
`1151 Schmidt et al., “The New Topical Steroid Ciclesonide is Effective in
`the Treatment of Allergic Rhinitis,” J Clin Pharmacol 1999; 39:
`1062-1069
`1152 U.S. Patent No. 3,636,200 (“Zentner”)
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`1153 U.S. Patent No. 5,196,436 (“Smith”)
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`1154 U.S. Patent No. 5,658,919 (“Ratnaraj”)
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`1155 U.S. Patent No. 6,565,832 (“Haslwanter”)
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`1156 PCT Publication No. WO01/28563 (“Nagano”)
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`1157 Patent Assignment by and between VIATRIS and MedPointe,
`executed August 16, 2002
`1158 E-mail correspondence between Adam LaRock and Michael R.
`Houston, February 20, 2018 to March 5, 2018
`1159 Berger et al., “Efficacy of azelastine nasal spray in patients with an
`unsatisfactory response to loratadine,” Annals of Allergy, Asthma &
`Immunology, Vol. 91, August 2003, pages 205- 211
`1160 Corren et al., “Effectiveness of Azelastine Nasal Spray Compared
`with Oral Cetirizine in Patients with Seasonal Allergic Rhinitis,”
`Clinical Therapeutics, Vol. 27, No. 5, May 2005, pages 543-553
`1161 LaForce et al., “Efficacy of azelastine nasal spray in seasonal allergic
`rhinitis patients who remain symptomatic after treatment with
`fexofenadine,” Annals of Allergy, Asthma & Immunology, Vol. 93,
`August 2004, pages 154-159
`1162 Berger et al., “Impact of azelastine nasal spray on symptoms and
`quality of life compared with cetirizine oral tablets in patients with
`seasonal allergic rhinitis, “Annals of Allergy, Asthma &
`Immunology, Vol., 97, September 2006, pages 375-381
`1163 Updated Curriculum Vitae of Dr. Robert Schleimer
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`1164 McNeely et al., “Intranasal Azelastine - A Review of its Efficacy in
`the Management of Allergic Rhinitis,” Drugs 1998 Jul; 56 (1): pages
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`91-114
`1165 Second Declaration of Dr. Maureen Donovan (redacted version)
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`1166 U.S. Patent No. 8,933,060 (“Lulla”)
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`1167 U.S. Patent No. 8,304,405 (“Lulla”)
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`1168 Kublik et al, “Nasal delivery systems and their effect on deposition
`and absorption,” Advanced Drug Delivery Reviews 29 (1998) pages
`157–177
`1169 Supplemental Declaration of John C. Staines, Jr.
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`1170 Supplemental Declaration of Dr. Robert Schleimer
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`1171 Errata to Staines Declaration of March 6, 2018 (Exhibit 1140)
`
`1172 Email correspondence from Michael Houston to Adam LaRock
`dated December 27, 2017
`1173 Email correspondence from Adam LaRock to Michael Houston
`dated January 4, 2018
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`Dated: April 10, 2018
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`By: /Michael R. Houston/
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`Michael R. Houston
`Reg. No. 58,486
`Counsel for Petitioner
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing
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`PETITIONER’S EXHIBIT LIST AS OF APRIL 10, 2018 and Exhibits 1172-
`
`1173 were served on April 10, 2018 on Counsel for Patent Owner via electronic
`
`mail to the following:
`
`
`
`dvarughe-PTAB@skgf.com
` dsterlin-PTAB@skgf.com
` alarock-PTAB@skgf.com
` ueverett-PTAB@skgf.com
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`Dated: April 10, 2018
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`By: /Michael R. Houston/
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`Michael R. Houston
`Reg. No. 58,486
`Counsel for Petitioner
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