`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`ARGENTUM PHARMACEUTICALS LLC
`
`Petitioner
`
`v.
`
`CIPLA LIMITED
`
`Patent Owner
`
`_____________________
`
`Case No. IPR2017-00807
`
`U.S. Patent No. 8,168,620
`_____________________
`
`CIPLA LTD.'S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`

`

`Cipla's
`Exhibit #
`2001
`2002
`2003
`2004
`2005
`2006
`2007
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Description
`Warner Carr, M.D. Declaration
`Warner Carr, M.D. Curriculum Vitae
`Alexander Dominic D'Addio, Ph.D. Declaration
`Alexander Dominic D'Addio, Ph.D. Curriculum Vitae
`John C. Jarosz Declaration
`John C. Jarosz Curriculum Vitae
`Hugh David Charles Smyth, Ph.D. Declaration
`Hugh David Charles Smyth, Ph.D. Curriculum Vitae
`Complaint for Patent Infringement, December 2, 2014, Meda
`Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and Apotex
`Corp., Case No. 1:14-cv-01453-UNA (D. Del.)
`Complaint for Patent Infringement, September 9, 2016, Meda
`Pharmaceuticals Inc. and Cipla Ltd., v. Perrigo UK Finko Limited
`Partnership, Perrigo Company and Perrigo Pharmaceuticals Co.,
`Case No. 1:16-cv-00794-LPS (D. Del.)
`Expert Report of Robert P. Schleimer, Ph.D., August 19, 2016,
`Meda Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and
`Apotex Corp., Case No. 1:14-cv-01453-LPS (D. Del.)
`Expert Rebuttal Report of Robert P. Schleimer, Ph.D., July 29,
`2016, Meda Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc.
`and Apotex Corp., Case No. 1:14-cv-01453-LPS (D. Del.)
`Expert Reply Report of Robert P. Schleimer, Ph.D., August 19,
`2016, Meda Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc.
`and Apotex Corp., Case No. 1:14-cv-01453-LPS (D. Del.)
`Dr. Maureen Donovan Deposition transcript, October 7, 2016,
`Meda Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and
`Apotex Corp., Case No. 1:14-cv-01453-LPS (D. Del.)
`Expert Report of Maureen D. Donovan, Ph.D., June 30, 2016,
`Meda Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and
`Apotex Corp., Case No. 1:14-cv-01453-LPS (D. Del.)
`
`
`
`- 1 -
`
`

`

`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Description
`Expert Reply Report of Maureen D. Donovan, Ph.D., August 19,
`2016, Meda Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc.
`and Apotex Corp., Case No. 1:14-cv-01453-LPS (D. Del.)
`Publicly Filed Proposed Joint Pretrial Order, November 10, 2016,
`Meda Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and
`Apotex Corp., Case No. 1:14-cv-01453-LPS (D.I.137) (Redactions
`in Original)
`Bench Trial Transcript, Volume A, December 13, 2016, Meda
`Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and Apotex
`Corp., Case No. 1:14-cv-01453-LPS (D. Del.)
`Bench Trial Transcript, Volume B, December 14, 2016, Meda
`Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and Apotex
`Corp., Case No. 1:14-cv-01453-LPS (D. Del.)
`Bench Trial Transcript, Volume C, December 15, 2016, Meda
`Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and Apotex
`Corp., Case No. 1:14-cv-01453-LPS (D. Del.)
`Bench Trial Transcript, Volume D, December 16, 2016, Meda
`Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and Apotex
`Corp., Case No. 1:14-cv-01453-LPS (D. Del.)
`Plaintiffs' Proposed Findings of Fact, January 10, 2017, Meda
`Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and Apotex
`Corp., Case No. 1:14-cv-01453-LPS (D. Del.) (D.I. 155)
`Defendants' Proposed Finding of Facts, January 10, 2017, Meda
`Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and Apotex
`Corp., Case No. 1:14-cv-01453-LPS (D. Del.) (D.I. 156)
`Defendants' Opening Post-Trial Brief, January 24, 2017, Meda
`Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and Apotex
`Corp., Case No. 1:14-cv-01453-LPS (D. Del.) (D.I. 158)
`Dr. Robert Schleimer Deposition transcript, September 29, 2016,
`Meda Pharmaceuticals Inc. and Cipla Ltd., v. Apotex Inc. and
`Apotex Corp., Case No. 1:14-cv-01453-LPS (D. Del.)
`Gennaro, A. R. Remington's Pharmaceutical Sciences (17th ed.,
`1985), Ch. 80: 1455-1477; Ch. 82: 1478-1491; Ch. 84:1492-1517
`
`Cipla's
`Exhibit #
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`
`
`- 2 -
`
`

`

`Cipla's
`Exhibit #
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`2042
`
`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Description
`Accolate Approval Letter and Label, Application Number 20-
`547/S011, Zeneca Pharmaceuticals
`Avomeen Analytical Services Report, June 30, 2016 (PTX0129)
`Expert Report of Dr. Matthew J. Herpin and Corresponding
`Documents (PTX1663)
`Expert Report of Dr. Ramprakash Govindarajan and
`Corresponding Documents (PTX1664)
`Duonase Imitator Product Labels (PTX0026)
`Allegra-D Approval Letter, Application Number 20786, Approved
`December 24, 1997, (PTX0126)
`Intentionally Left Blank
`Physicians' Desk Reference, 54th ed., pp. 1343-1344, 2404-2406,
`2781-2783 (2000)
`Riordan, John. An Introduction to Combinatorial Analysis (1958),
`Ch. 1: 1-18
`Zyrtec-D FDA Label, Approved August 10, 2001
`Argentum Pharmaceuticals, "About,"
`http://www.argentumpharmaceuticals.com/about/ (accessed May
`17, 2017)
`Khan, M., and Reddy, I. Pharmaceutical and Clinical Calculations
`(2nd ed., 2000), pp. 149-167 (PTX0194)
`Flonase® Label 1998, Application Number 20-121/S009,
`November 1998 (PTX0059)
`British Pharmaceutical Codex (1973), "Hypromellose," pp. 232,
`307-308 (PTX0193)
`Howarth, P. H. "A comparison of the anti-inflammatory properties
`of intranasal corticosteroids and antihistamines in allergic rhinitis,"
`Allergy, 62: 6-11; 2000 (PTX0337)
`Nielsen, Lars P. "Review Article, Intranasal Corticosteroids for
`Allergic Rhinitis - Superior Relief?" Am. J. Respir Med., 2(1): 55-
`65; 2001 (PTX0338)
`
`
`
`- 3 -
`
`

`

`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Description
`Shenfield, G. M. "Fixed drug combinations: which ones can be
`recommended?" Current Therapeutics, 27(11): 15-29; 1986 (DTX-
`048)
`Michael, Y., et al. "Characterisation of the aggregation behavior in
`a salmeterol and fluticasone propionate inhalation aerosol system,"
`International Journal of Pharmaceutics, 221: 165-174; 2001
`(PTX0179)
`Hampel, F., et al. "Double-blind, Placebo-Controlled Study of
`Azelastine and Fluticasone in a Single Nasal Spray Delivery
`Device," Annals of Allergy, Asthma, & Immunology, 105: 168-173;
`2010 (PTX0230)
`Weiler, J. M., et al. "Azelastine nasal spray as adjunctive therapy
`to azelastine tablets in the management of seasonal allergic
`rhinitis," Ann. Allergy Asthma Immunol, 79: 327-332; 1997
`(PTX0329)
`Blaiss, M. "Efficacy, Safety, and Patient Preference of Inhaled
`Corticosteroids: A Review of Pertinent Published Data," Allergy
`and Asthma Proc., 22(6): S5-S10; 2001 (PTX0058)
`DataMonitor – "Pipeline and Commercial Insight: Allergic
`Rhinitis," July 2010 (PTX0396)
`2006 Cipla-Meda License Agreement with Quality Agreement
`(PTX1016)
`2011 First Amendment to Cipla-Meda Agreement (PTX0282)
`Physicians' Desk Reference, 54th ed., pp. 2783- 2786 (2000)
`Leung, D., et al. "The Editors' Choice: MP29-02: A Major
`Achievement in the treatment of allergic rhinitis," J. Allergy Clin.
`Immunol., 129(5): 1216; 2012 (PTX0029)
`Allergic Rhinitis - Global Drug Forecast and Market Analysis to
`2024, GlobalData, September 2015 (PTX0397)
`MedPointe Making Medicine Better: Astelin® Day Life CyclePlan,
`November 1, 2002 (PTX1005)
`
`Cipla's
`Exhibit #
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`2051
`
`2052
`
`2053
`
`2054
`
`
`
`- 4 -
`
`

`

`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Description
`MedPointe Product & Process Development Program Priorities
`and Issues - September 9, 2002 (PTX0143)
`Astelin® Nasal Spray Life Cycle Management Projects
`(Preliminary Plan) (PTX1006)
`2006.02.06 Email from Paul Edick to Dennis Fuge re: Pfeiffer Bi
`Dose Nasal Spray System (PTX0149)
`2006.03.21 Email and attachment from Kalidas Kale to Alex
`D'Addio re: Astelin – Flonase Combination Product Feasibility
`Assessment Plan (PTX0151)
`Dang, Phuong Grace, et al. U.S. Patent No. 8,071,073 (Filed
`November 22, 2005; Issued December 6, 2011)
`Dang, Phuong Grace, et al. U.S. Patent No. 8,518,919 (Filed
`November 10, 2011; Issued August 27, 2013)
`MedPointe Laboratory Notebook No. 1044 - Excerpts (PTX0142)
`IMS data for U.S. allergic rhinitis products, 01.2012-04.2016
`(PTX0929)
`Intentionally Left Blank
`2011.11.02 Email and attachment from Ashwini Dumaswala to
`Bryan Roecklein re: 2012 Dymista® Strategic Plan (PTX1118)
`"All Products - Apotex Products: United States,"
`http://www.apotex.com/us/en/products/
`search.asp?qt=AII&qs=&t=AII%20Products (accessed June 22,
`2016) (PTX0420)
`Dymista® Prescribing Information 2015 (PTX0024)
`Drug Approval Package: Dymista®, Application Number 202236,
`Meda Pharmaceuticals, Inc., Approved May 1, 2012 (PTX0392)
`Meda AB Interim Report, Jan.-Sept. 2012 (PTX0393)
`"At a Glance" Cipla, http://www.cipla.com/en/corporate-
`information/at-a-glance.html (accessed June 28, 2016) (PTX0379)
`Duonase Nasal Spray – Prescribing Information (PTX0134)
`
`Cipla's
`Exhibit #
`2055
`
`2056
`
`2057
`
`2058
`
`2059
`
`2060
`
`2061
`
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`2070
`
`
`
`- 5 -
`
`

`

`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Description
`Cipla Website, "Respiratory," http://www.cipla.com/en/our-
`businesses/strategic-business-units/respiratory.html (accessed June
`28, 2016) (PTX0380)
`IMS data for Duonase competitor products, 2005-2016 (PTX0816)
`Dymista® briefing document (PTX1654)
`2014.11.14 Email and attachment from Stuart Loeschto Betsy
`Orrison re: Dymista® US Marketing Plan 2015 (PTX0271)
`Dymista® Competitor Benchmarking Presentation 2012
`(PTX0926)
`Meda – 2016 Dymista® Brand Plan (PTX0406)
`FDA.gov, "Prescription to Over-the-Counter (OTC) Switch List,"
`http:/www.fda.gov/AboutFDA/CentersOffices/OfficeofMedical
`ProductsandTobacco/CDER/ucm106378.htm (accessed June 28,
`2016) (PTX0407)
`Johnson & Johnson Press Release, "RHINOCORT® Allergy Spray
`Now Available Over The Counter Nationally," February 8, 2016,
`http://www.jnj.com/news/all/RHINOCORT-Allergy-Spray-Now-
`Available-Over-The-Counter-Nationally (accessed June 30, 2016)
`(PTX0408)
`2011.11.02 Email and attachment from Ashwini Dumaswala to
`Bryan Roecklein re: 2012 Dymista® Strategy Plan (PTX0267)
`MEDA Presentation re: staffing, timelines for expansion, price
`comparisons (2001) (PTX0871)
`FDA.gov, "First-Time Generic Drug Approvals - March 2016,"
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDru
`gsareDevelopedandApproved/DrugsandBiologicApprovalReports/
`ANDAGenericDrugApproval (accessed June 28, 2016)
`(PTX0424)
`Renavatio Presentation & Meda Presentation - Dymista® Phase I
`Exploratory Research (PTX0426)
`
`Cipla's
`Exhibit #
`
`2071
`
`2072
`2073
`
`2074
`
`2075
`
`2076
`
`2077
`
`2078
`
`2079
`
`2080
`
`2081
`
`2082
`
`
`
`- 6 -
`
`

`

`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Description
`Transmittal of advertisements and promotional labeling to the U.S.
`Food and Drug Administration for Dymista®, June 17, 2015
`(PTX0914)
`Transmittal of advertisements and promotional labeling to the U.S.
`Food and Drug Administration for Dymista®, June 16, 2015
`(PTX0916)
`Transmittal of advertisements and promotional labeling to the U.S.
`Food and Drug Administration for Dymista®, November 26, 2012
`(PTX0917)
`Transmittal of advertisements and promotional labeling to the U.S.
`Food and Drug Administration for Dymista®, June 29, 2015
`(PTX0915)
`Cipla Duonase Marketing Presentation (PTX0315)
`Meda/Cipla Powerpoint – Complete Picture (PTX0412)
`"The Difference Between AR and Sinusitis," Drs. Miller & Alt,
`December 2, 2015, http://healthcare.utah.edu/the-
`scopelshows.php?shows=O_hf3tm0mc (accessed June 28, 2016)
`(PTX0429)
`Family Allergy & Asthma Care of Montana Website, "If one is
`good, 2 are better…A new nasal spray containing 2 medications!",
`March 11, 2013, http://www. familyallergyasthmacare.
`com/2013103/if- one-is-good-2-are-better -a-new-nasal-spray-
`containing-2-medications/ (accessed June 28, 2016) (PTX0430)
`Bousquet, Jean, et al. "Allergic Rhinitis," Dymista®: in a class of
`its own for treatment of AR - Key Opinion, http:/
`/keyopinions.info/downloads/dymista-class-treatment-allergic-
`rhinitis/ (accessed June 28, 2016) (PTX0431)
`Samuelson, Paul A., and Nordhaus, William D. (Eds.). Economics
`(19th ed., 2010), p. 49 (PTX0415)
`Dymista® Marketing Plan 2016 (PTX0438)
`Dymista® Formulary Coverage Powerpoint 2014 (PTX0892)
`
`Cipla's
`Exhibit #
`
`2083
`
`2084
`
`2085
`
`2086
`
`2087
`2088
`
`2089
`
`2090
`
`2091
`
`2092
`
`2093
`2094
`
`
`
`- 7 -
`
`

`

`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Description
`Meda Memorandum re: CVS Caremark Formulary Decisions 2015
`(PTX0447)
`Bagwell, K. "The Economic Analysis of Advertising," Handbook
`of Industrial Organization (2007), eds. M. Armstrong and R.
`Porter, vol. 3, pp. 1703-1706 (PTX0432)
`Ching, A. and Ishihara, M. "Measuring the Informative and
`Persuasive Roles of Detailing on Prescribing Decisions," April 27,
`2010, Working Paper (PTX0433)
`Berndt, Ernst R. "The U.S. Pharmaceutical Industry: Why Major
`Growth In Times of Cost Containment?" Health Affairs, 20(2):
`110-111; 2001 (PTX0434)
`Bloomberg Website, "Pharmaceutical Company Overview of
`Mylan Specialty L.P.,"
`http://www.bloomberg.com/research/stocks/private/snapshot.asp?p
`rivcapld=3346320 (accessed May 19, 2017)
`Newsroom Website, "Mylan Completes Acquisition of Meda,"
`http://newsroom.mylan.com/2016-08-05-Mylan-Completes-
`Acquisition-of-Meda (accessed May 19, 2017)
`Apotex Press Release, "Apotex Launches First Generic Version of
`Merck's Nasonex®," March 24, 2016,
`http://www.apotex.com/global/about/press/20160324.asp
`(accessed June 28, 2016) (PTX0409)
`Intentionally Left Blank
`The United States Pharmacopeia: 24 National Formulary 19
`(1999), pp. 2107-2130 (PTX0188)
`Lieberman, H. A., et al. (Eds.). Pharmaceutical Dosage Forms
`(2nd ed., 1996), Ch. 4: 149-181 (PTX0177)
`Shin Etsu Pharmacoat USP Hypromellose Brochure (2005)
`(PTX0186)
`Intentionally Left Blank
`Gennaro, A. R., et al. (Eds.). Remington: The Science and Practice
`of Pharmacy (20th ed., 2000), Ch. 22: 316-334 (PTX0184)
`
`Cipla's
`Exhibit #
`2095
`
`2096
`
`2097
`
`2098
`
`2099
`
`2100
`
`2101
`
`2102
`
`2103
`
`2104
`
`2105
`
`2106
`
`2107
`
`
`
`- 8 -
`
`

`

`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Description
`
`Intentionally Left Blank
`Intentionally Left Blank
`Kibbe, A. H. (Ed.). "Hydroxypropyl Methylcellulose," in
`Handbook of Pharmaceutical Excipients (3rd ed., 2000), pp. 252-
`255 (PTX0198)
`Michael, Y., et al. "The physico-chemical properties of salmeterol
`and fluticasone propionate in different solvent environments,"
`International Journal of Pharmaceutics, 200: 279-288; 2000
`(PTX0180)
`Allen, Jr., L.V. (Ed.). The Art, Science, and Technology of
`Pharmaceutical Compounding (1998), Ch. 20: 219-238
`(PTX0167)
`Lieberman, H. A., et al. (Eds.). Pharmaceutical Dosage Forms
`(2nd ed., 1996), vol. 2, Ch. 5: 183-241 (PTX0192)
`Meda Highlights of Prescribing Information 2015 (PTX0154)
`Intentionally Left Blank
`Intentionally Left Blank
`Intentionally Left Blank
`Intentionally Left Blank
`Intentionally Left Blank
`MedPointe Product & Process Development, Program Priorities
`and Issues - November 18, 2002, "Commercial Product Technical
`Support" (PTX0144)
`2006.02.06 Email from Richard Spivey to Alex D'Addio re:
`Pfeiffer Bi Dose Nasal Spray System (PTX0150)
`2003.11.11 Email and attachment from Mary Lehr to Gul Balwani
`(PTX0255)
`IMS data for Indian allergic rhinitis nasal spray products,
`December 2010-December 2014 (PTX0823)
`IMS data for Indian allergic rhinitis nasal sprays products, March
`2013 – March 2017
`
`Cipla's
`Exhibit #
`2108
`2109
`
`2110
`
`2111
`
`2112
`
`2113
`
`2114
`2115
`2116
`2117
`2118
`2119
`
`2120
`
`2121
`
`2122
`
`2123
`
`2124
`
`
`
`- 9 -
`
`

`

`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Description
`
`Intentionally Left Blank
`IMS data for Duonase competitor products, 2005-2017
`2017.03.21 Email from Mike Houston to Adam LaRock re
`IPR2017-00807
`Intentionally Left Blank
`FDA, Center for Drug Evaluation and Research, "Allergic
`Rhinitis: Clinical Development Programs for Drug Products,"
`Guidance for Industry, 2000 (PTX0025)
`Hitti, Miranda. "FDA Oks Generic Version of Flonase," WebMD,
`http://www.webmd.com/allergies/news/20060222/fdaoksgenericve
`rsionofflonase (accessed May 26, 2017)
`"What is a Tiered Formulary and What Does it Mean for Me?,"
`Medicare News and Updates,
`https://blog.medicaremadeclear.com/blog/bid/78229/WhatisaTiere
`dFormularyandWhatDoesitMeanforMe (accessed May 26, 2017)
`IMS data for U.S. allergic rhinitis products, May 2011 - April
`2017
`Bousquet, J., et al. “Management of Allergic Rhinitis and Its
`Impact on Asthma,” Journal of Allergy and Clinical Immunology,
`108(5); excerpt; 2001. (ARIA Contributors) (PTX0326)
`Memorandum Opinion, May 12, 2016, Meda Pharmaceuticals Inc.
`and Cipla Ltd., v. Apotex Inc. and Apotex Corp., Case No. 1:14-
`cv-01453-LPS (D. Del.) (D.I. 114)
`Wade, A., and Weller, P. (Eds.). Handbook of Pharmaceutical
`Excipients (2nd ed., 1994), p. 154
`Talbot, Andrew, et al. "Mucociliary Clearance and Buffered
`Hyperonic Saline Solution," Laryngoscope, 107(4): 500-503; 1997
`Intentionally Left Blank
`DataMonitor – "Commercial and Stakeholder Perspectives:
`Allergic Rhinitis," September 2004 (PTX0098)
`
`Cipla's
`Exhibit #
`2125
`2126
`
`2127
`
`2128
`
`2129
`
`2130
`
`2131
`
`2132
`
`2133
`
`2134
`
`2135
`
`2136
`
`2137
`
`2138
`
`
`
`- 10 -
`
`

`

`Cipla's
`Exhibit #
`2139
`
`2140
`2141
`
`2142
`2143
`2144
`
`2145
`2146
`2147
`2148
`2149
`2150
`2151
`
`2152
`
`2153
`
`2154
`
`2155
`2156
`
`2157
`
`2158
`2159
`2160
`2161
`
`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Description
`Affidavit in Support of Motion for Pro Hac Vice Admission of
`Uma N. Everett
`Declaration of Adam C. LaRock
`Physicians' Desk Reference, 54th ed., pp. 535-536, 1344-1346
`(2000) (Served)
`Declaration of Nikhil Chopra, September 19, 2017 (Served)
`Declaration of Patsy Jeffery, September 19, 2017 (Served)
`Physicians' Desk Reference, 56th ed., pp. 2758-2760 (2002)
`(Served)
`U.S. Patent 6,599,914
`U.S. Utility 09/841,506
`Second Carr Declaration
`Second D’Addio Declaration
`Second Jarosz Declaration
`Second Smyth Declaration (CONFIDENTIAL)
`Cipla Duonase Manufacturing Guide (PTX0153)
`(CONFIDENTIAL)
`Cipla Duonase Manufacturing Guide (PTX0135)
`(CONFIDENTIAL)
`Meda Investigation report: Dymista 6.4 g Nasal Spray Stability
`results (PTX0141) (CONFIDENTIAL)
`Meda NDA excerpt 3.2.P.3 Manufacture [Dymista (azelastine
`hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50
`mcg] (PTX0138) (CONFIDENTIAL)
`Cipla Duonase Stability Testing Form (CONFIDENTIAL)
`Kibbe, A.H., Antimicrobial preservative Index, in Handbook of
`Pharmaceutical Excipients (3rd ed., 2000), pp.646-647
`Hayashi, H. and Hashimoto, S., “Anti-infammatory actions of new
`antihistamines,” Clinical and Experimental Allergy 29: 1593-1596
`(1999)
`Deposition Transcript for Schleimer
`Deposition Transcript for Maureen Donovan
`Amended Default Protective Order
`Barnes, P.J., “Clinical outcome of adding long-acting β-agonists to
`inhaled corticosteroids” Respiratory Medicine 95: S12-S16 (2001)
`
`
`
`- 11 -
`
`

`

`Cipla's
`Exhibit #
`2162
`
`2163
`2164
`
`2165
`
`2166
`2167
`
`2168
`2169
`2170
`
`2171
`2172
`2173
`
`2174
`
`2175
`
`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Description
`Andy, C. and Thering, A., “ How effective are nasal steroids
`combined with nonsedating antihistimines for seasonal allergies?”
`J. Fam. Pract. 7: 616 (2002)
`MMIT Dymista Formulary Information
`September 7, 2007 Letter from Philantha Bowen to Michael
`Bernhard regarding IND 77363 (PTX0110)
`May 19, 2008 Letter from Philantha Bowen to Richard Fosko
`regarding IND 77363 (PTX0114)
`Intentionally Left Blank
`Sherman, W., “Uses and Abuses of Antihistimine Drugs” The
`Bulletin (1951)
`John C. Jarosz Curriculum Vitae
`Clarinex Product Label (2001)
`Storms, W. et al., “Allergic rhinitis: The patient’s perspective”
`Journal of Allergy and Clinical Immunology (1997)
`Cipla Duonase Manufacturing Guide (PTX0153) (PUBLIC)
`Cipla Duonase Manufacturing Guide (PTX0135) (PUBLIC)
`Meda Investigation report: Dymista 6.4 g Nasal Spray Stability
`results (PTX0141) (PUBLIC)
`Meda NDA excerpt 3.2.P.3 Manufacture [Dymista (azelastine
`hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50
`mcg] (PTX0138) (PUBLIC)
`Cipla Duonase Stability Testing Form (PUBLIC)
`
`
`- 12 -
`
`
`
`
`
`

`

`Cipla's Updated Exhibit List
`IPR2017-00807
`
`Cipla’s
`Exhibit #
`2176
`2177
`2178
`2179
`2180
`2181
`2182
`
`
`
`Description
`Second Smyth Declaration (PUBLIC)
`Exhibit from Second Donovan Deposition
`Second Deposition Transcript for Maureen Donovan
`Second Deposition Transcript for Robert Schleimer
`Deposition Transcript for John Staines, Jr.
`Reserved
`Joint Stipulation to Limit Petition Under 37 CFR 42.71
`
`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`
`
`Dennies Varughese
`
`Date: May 11, 2018
`Registration No. 61,868
`
`
`
`
`
`
`1100 New York Avenue, N.W. Attorney for Patent Owner
`Washington, D.C.20005-3934
`
`(202) 371-2600
`
`
`
`- 13 -
`
`

`

`
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. §§ 42.6(e))
`
`The undersigned hereby certifies that the above-captioned CIPLA LTD'S
`
`UPDATED EXHIBIT LIST along with Exhibit 2182, were served in their
`
`entirety on May 11, 2018, upon the following parties via electronic mail:
`
`Michael R. Houston: mhouston@foley.com
`Joseph P. Meara: jmeara@foley.com
`James P. McParland: jmcparland@foley.com
`Andrew R. Cheslock: acheslock@foley.com
`Tyler C. Liu: TLiu@agpharm.com
`ARG-dymista@foley.com
`
`FOLEY & LARDNER LLP
`321 North Clark Street
`Suite 2800
`Chicago, IL 60654
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
` Dennies Varughese
`Date: May 11, 2018
` Registration No. 61,868
`
`
`
`
`
`1100 New York Avenue, N.W. Attorney for Patent Owner
`Washington, D.C.20005-3934
`
`(202) 371-2600
`
`
`
`
`
`
`
`
`
`