`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ARGENTUM PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`ALCON RESEARCH, LTD.
`Patent Owner
`
`
`Patent No. 8,268,299
`Issue Date: September 18, 2012
`Title: SELF PRESERVED AQUEOUS PHARMACEUTICAL COMPOSITIONS
`
`
`
`Inter Partes Review No. IPR2017-01053
`
`
`
`PETITIONER’S EXHIBIT LIST AS OF MAY 1, 2018
`
`
`
`
`
`
`
`
`
`
`
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`
`
`
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`
`
`
`
`
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`Pursuant to 37 C.F.R. § 42.63(e), Petitioner ARGENTUM
`
`PHARMACEUTICALS LLC presents a complete list of Petitioner’s exhibits,
`
`including Exhibits 1041-1095 and 1098-1112, filed on May 1, 2018.
`
`
`Exhibit
`#
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`1009
`
`1010
`1011
`
`
`
`TABLE OF EXHIBITS
`
`Description
`
`Filed Served
`
`Kabra et al., U.S. Patent No. 8,268,299, “Self
`Preserved Aqueous Pharmaceutical Compositions”
`(filed September 20, 2007; issued September 18, 2012)
`Declaration of Dr. Erning Xia
`
`Xia et al., WO 2005/097067, “Zinc Preservative
`Composition and Method of Use” (filed March 24, 2005;
`Chowhan et al., U.S. Patent No. 6,143,799, “Use of
`Borate-Polyol Complexes in Ophthalmic Compositions”
`(filed July 2, 1998; issued November 7, 2000)
`Gadd et al., “Microorganisms and Heavy Metal Toxicity,”
`Microbial Ecology, 4:303-317 (1978)
`FDA Approved Drug Label “TRAVATAN® (travoprost
`ophthalmic solution) 0.004% Sterile” (2001)
`Schneider et al., U.S. Patent No. 6,011, 062, “Storage-Stable
`Prostaglandin Compositions” (Filed February 9, 1999; issued
`January 4, 2000)
`File history of U.S. Patent No. 8,268,299
`Joint Claim Construction Statement dated
`7/18/2014 in Alcon Research, Ltd. v. Mylan
`Pharmaceuticals, Inc. C.A. No. 1:13-cv-01332-
`File history of U.S. Patent No. 8,323,630
`File history of U.S. Patent No. 8,388,941
`
`X
`
`X
`
`X
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`X
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`X
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`X
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`X
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`X
`X
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`X
`X
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`X
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`X
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`X
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`X
`
`X
`
`X
`
`X
`
`X
`X
`
`X
`X
`
`
`-i-
`
`
`
`
`
`Exhibit
`#
`1012
`
`1013
`
`1014
`
`1015
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`Description
`
`Filed Served
`
`Sheftel, “Indirect Food Additives and Polymers:
`Migration and Toxicology,” p. 422 (2000)
`The European Agency for the Evaluation of Medicinal
`Products, Veterinary Medicines Evaluation Unit, “Polyoxyl
`Castor Oil, Polyoxyl Hydrogenated Castor Oil Summary
`“Antimicrobial Effectiveness Testing,” in The United
`States Pharmacopeia 26 (2002): The National Formulary
`22, pp. 2002-2004
`Curriculum Vitae of Erning Xia, Ph.D.
`FORM 6-K, SECURITIES AND EXCHANGE
`COMMISSION, For
`The Merck Index, An Encyclopedia of Chemicals, Drugs, and
`Biologicals, 11th Ed., (1989), Merck Research Laboratories,
`3484.
`Reserved
`
`Kabara and Orth “Chapter 1, Principles for Product
`Preservation”, Preservative-Free and Self-Preserving
`Cosmetics and Drugs, Principles and Practice, (1997) Marcel
`Patent Owner Alcon Research, Ltd.’s Response, IPR2013-
`00428, Paper 30.
`
`Declaration of Dr. Yvonne Buys.
`
`Declaration of Dr. Richard P. Parrish, Ex. 2020, IPR2013-
`00428.
`
`X
`
`X
`
`X
`
`X
`X
`
`X
`
`
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`X
`
`X
`
`
`
`X
`
`X
`
`X
`
`X
`
`1023 Curriculum Vitae of Dr. Yvonne Buys, M.D.
`
`1024 Kass et al., The Ocular Hypertension Treatment Study: A
`Randomized Trial Determines that Topical Ocular Hypotensive
`Medication Delays or Prevents the Onset of Primary Open-
`
`X
`
`X
`
`X
`
`X
`
`
`-ii-
`
`
`
`
`
`Exhibit
`#
`1025 Mizoue et al., Travoprost with sofZia® preservative system
`lowered intraocular pressure of Japanese normal tension
`glaucoma with minimal side effects, CLIN. OPHTH. 347-354
`1026 Bagnis et al., Antiglaucoma drugs: The role of preservative-
`free formulations, Saudi J. of Ophth. 389-394 (2011).
`
`Description
`
`Filed Served
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
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`X
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`X
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`X
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`X
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`X
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`X
`
`X
`
`X
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`X
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`X
`
`X
`
`X
`
`X
`
`X
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`Save big on your TRAVATAN Z® Solution prescription, June
`24, 2008,
`http://web.archive.org/web/20080624220702/http://www.travat
`Save big on your TRAVATAN Z® Solution prescription, April
`1, 2009,
`http://web.archive.org/web/20090401152511/http://www.travat
`Save up to $20 on your next four prescriptions with this card,
`March 27, 2010,
`http://web.archive.org/web/20100327064125/http://www.travat
`Pay no more than $25 for each 30-day supply of TRAVATAN
`Z® Solution through December 2011, May 6, 2011,
`http://web.archive.org/web/20110506025033/http://www.travat
`Pay no more than $25 for each 30-day supply of TRAVATAN
`Z® Solution through March 2013, February 10, 2012,
`http://web.archive.org/web/20120210013546/http://www.travat
`X
`Save up to $1,300 on your Alcon Medication Refills, Pay as
`little as $25 for each 30-day supply of prescribed eyedrops from
`Alcon through December 2013, June 29, 2013,
`1033 OPENINGS™ Patient Support Program, March 29, 2014,
`http://web.archive.org/web/20140329091929/http://www.mygla
`ucomasupport.com/openings-patient-support-program.shtml?
`1034 Openings® Patient Support Program from Alcon, October 31,
`2015,
`http://web.archive.org/web/20151031211128/http://www.mygla
`1035 OPENINGS® Patient Support Program, March 12, 2016,
`http://web.archive.org/web/20160312083239/http://www.mygla
`ucomasupport.com/get-support.shtml?
`1036 OPENINGS® Savings Card, February 22, 2017,
`https://www.myglaucomasupport.com/openings-program-
`savings-card.shtml
`
`
`-iii-
`
`
`
`Filed Served
`
`
`
`Exhibit
`#
`1037 Declaration of Dr. Henry Grabowski, Ex. 2007, IPR2013-
`00428.
`
`Description
`
`1039
`
`1038 The Merck Index, An Encyclopedia of Chemicals, Drugs, and
`Biologicals, 13th Ed., (2001), Merck Research Laboratories,
`5769, 8797, 9842.
`“Antimicrobial Effectiveness Testing,” in The United States
`Pharmacopeia 27 (2004): The National Formulary 22, pp. 2148-
`2150
`1040 The Merck Index, An Encyclopedia of Chemicals, Drugs, and
`Biologicals, 11th Ed., (1989), Merck Research Laboratories,
`5629, 8680, 9684.
`1041 Alcon Systane® Free Liquid Gel Label.
`1042 Alcon Systane® Free Liquid Gel Brochure.
`1043
`Stone et al., “Microbiology Assessment of a Multi -Dose
`Preservative Free Tear Product,” Investigative Ophthalmology
`& Visual Science, May 2005, Vo1.46.
`1044 Rosenthal et al., “Preservative Efficacy Of A New Lubricant
`Eye Drop Without Traditional Preservatives,” Investigative
`Ophthalmology & Visual Science, May 2006, Vol.47.
`1045 Deposition Transcript of SOUMYAJIT MAJUMDAR, April
`13, 2018.
`1046 Monopost package insert
`
`X
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`
`
`
`
`
`
`X
`X
`X
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`X
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`X
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`X
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`X
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`X
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`X
`
`X
`
`X
`X
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`1047 Alasbali et al., “Discrepancy between Results and Abstract
`Conclusions in Industry- vs Nonindustry-funded Studies
`Comparing Topical Prostaglandins,” American Journal of
`Ophthalmology, 2009;147: 33–38.
`1048 Deposition Transcript of GEORGE G. ZHANEL, April 10,
`2018.
`1049 Kuppens et al., “Effect of timolol with and without preservative
`X
`on the basal tear turnover in glaucoma,” British Journal of
`Ophthalmology 1995; 79: 339-342.
`
`X
`
`
`-iv-
`
`
`
`Filed Served
`
`Description
`
`
`
`Exhibit
`#
`1050 Birt et al., “Prostaglandin Efficacy and Safety Study
`Undertaken by Race (The PRESSURE Study),” J Glaucoma
`2010;19: 460–467.
`FDA Approval Letter for New Indication August 31, 2010 -
`Travatan.
`1052 Novartis SEC Form 6-K - April 8, 2011.
`
`1051
`
`1053
`
`FDA Orange Book -Tafluprost.
`
`1054
`
`1059
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`Fung et al., “An evidence-based review of unoprostone
`isopropyl ophthalmic solution 0.15% for glaucoma: place in
`therapy,” Clinical Ophthalmology 2014:8 543–554.
`1055 Medscape Ophthalmology, “Lowering IOP With Medical
`Therapy in Patients With Glaucoma: Concomitant
`Treatment of Glaucoma,” 2008, Accessed at
`https://www.medscape.org/viewarticle/580534_3
`1056 Liebmann et al., “Current Therapeutic Options and Treatments
`in Development for the Management of Primary Open-
`Angle Glaucoma,” Am J Manag Care, 2017 Sep; 23(15
`Suppl):S279-S292.
`1057 MPR, “Glaucoma Treatments,” August 2017, Accessed at
`https://www.empr.com/glaucoma-
`treatments/printarticle/180363/
`1058 Byrne, “Clinicians: prostaglandins are the clear choice for first-
`line glaucoma therapy,” Primary Care Optometry News, April
`2004.
`“Percentage of the glaucoma prescription market in the United
`X
`States as of 2015, by product type,” Statista , 2018, Accessed at
`https://www.statista.com/statistics/566520/us-glaucoma-rx-
`market-distribution-by-product-type/
`1060 Bryan, Garnier & Co, “Nicox Independent Research Update,”
`January 2018.
`
`X
`
`
`-v-
`
`
`
`Description
`
`Filed Served
`
`
`
`Exhibit
`#
`1061
`
`Southwell, “July 2016 Corporate Presentation,” Inotek
`Pharmaceuticals, Cantor Fitzgerald 2nd Annual Health Care
`Conference.
`1062 Durie et al., “A Realistic Approach to the Obviousness of
`Inventions,” William & Mary Law Review (2008), Vol. 50,
`Issue 3
`1063 McDuff, “Thinking Economically About Commercial
`Success,” Landslide, March/April 2017, pp. 37- 40.
`
`1064 Alcon SEC Form 20-F 2009
`
`1067
`
`1065 Voet, M.A., “The Generic Challenge: Understanding Patents,
`FDA & Pharmaceutical Life-Cycle Management,” 2nd Edition
`(2008), pp. 147-166.
`1066 Grabowski et al., “Brand Loyalty, Entry, and Price Competition
`X
`in Pharmaceuticals After the 1984 Drug Act,” Journal of Law
`& Economics, Vol. XXXV (1992), pp. 331-350.
`Shadowen et al., “Anticompetitive Product Changes in the
`Pharmaceutical Industry,” Rutgers Law Journal (2009), Vol.
`41, Nos. 1 & 2.
`1068 Carrier et al., “Product Hopping: A New Framework,” Notre
`Dame Law Review (2016), Vol. 92, Issue 1, pp. 167-230.
`1069 Danzon et al., “Health Insurance and the Growth in
`X
`Pharmaceutical Expenditures,” Journal of Law and Economics,
`vol. XLV( October 2002), pp. 587-613.
`1070 Rizzo, J.A., “Advertising and Competition in the Ethical
`X
`Pharmaceutical Industry: The Case of Antihypertensive Drugs,”
`Journal of Law and Economics, vol. XLII (April 1999), pp. 89-
`115.
`1071 Elliott, C. “The Drug Pushers,” The Atlantic Monthly (April
`2006), pp. 2-13.
`
`X
`
`1072 ABA Section of Antitrust Law, Pharmaceutical Industry
`Antitrust Handbook, Chicago: ABA Publishing; 2009.
`
`X
`
`
`-vi-
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`
`
`Description
`
`Filed Served
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`X
`
`X
`
`X
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`X
`
`X
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`X
`
`X
`
`X
`
`
`
`Exhibit
`#
`1073
`
`1078
`
`FEDERAL TRADE COMMISSION BRIEF AS AMICUS
`CURIAE, Mylan v. Warner Chilcott Public Limited, Civil
`Action No. 12-3824
`1074 Ragusa, “Pharmaceutical Product Switching: Antitrust
`Pitfalls,” Portfolio Media (2016), Accessed at
`http://www.law360.com/articles/403075/print?section=competi
`tion
`1075 Alcon SEC Form 20-F 2010
`X
`1076 Congress of the United States Congressional Budget Office,
`X
`"Prescription Drug Pricing in the Private Sector," January 2007.
`1077 Herper, Matthew, "Inside the Secret World of Drug Company
`X
`Rebates," Forbes, May 10, 2012,
`https://www.forbes.com/sites/matthewherper/2012/05/10/why-
`astrazeneca-gives-insurers-60-discounts-on-nexiums-list-
`price/#41d1b60e2b25 (accessed February 8, 2018).
`Saha et al., “Generic Competition in the US Pharmaceutical
`Industry,” Int. J. of the Economics of Business, Vol. 13, No. 1,
`February 2006, pp. 15–38.
`1079 Grabowski et al., “Recent trends in brand-name and generic
`drug competition,” Journal of Medical Economics (2013), 1–8.
`
`1080
`
`Frank et al., “Pricing, Patent Loss and the Market for
`X
`Pharmaceuticals,” Southern Economic Journal; Oct 1992; 59, 2;
`165-179.
`1081 Melton et al., “Current Therapy in Ocular Disease,” Review of
`Optometry (May 2011).
`
`X
`
`1082 Lipman, M. “Law360's Product-Hopping Cheat Sheet For
`2015,” Portfolio Media (March 2015).
`Fugh-Berman, Adriane & Shahram Ahari, "Following the
`Script: How Drug Reps Make Friends and Influence Doctors,"
`PLoS Medicine, 4(4): 621-625; 2007.
`
`1083
`
`X
`
`X
`
`
`-vii-
`
`
`
`
`
`Exhibit
`#
`1084
`
`Description
`
`1085
`
`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.
`Paimela et al., “The preservative polyquaternium-1 increases
`cytoxicity and NFkappaB linked inflammation in human
`corneal epithelial cells,” Molecular Vision 2012; 18:1189-1196
`1086 Aitken et al., “Prescription Drug Spending Trends In The
`United States: Looking Beyond The Turning Point,” Health
`Affairs, 28, no.1 (2009):w151-w160
`1087 Castanheira et al., “The Unexpected Consequences of
`Asymmetric Competition. An Application to the
`Pharmaceutical Industry,” May 2017, accessible at
`https://editorialexpress.com/cgi-
`bin/conference/download.cgi?db_name=jei2017&paper_id=21
`1088 Morton et al., “Enabling Competition in Pharmaceutical
`Markets,” Hutchins Center Working Paper #30 (May 2017).
`
`1090
`
`1089 Berndt et al., “Pricing and reimbursement in U.S.
`Pharmaceutical Markets,” NBER Working Paper No. 16297
`(August 2010), accessible at
`http://www.nber.org/papers/w16297
`Federal Trade Commission Report, “Pharmacy Benefit
`Managers: Ownership of Mail-Order Pharmacies,” August
`2005.
`1091 Whitson et al., “Ocular Surface Tolerability of Prostaglandin
`Analogs in Patients with Glaucoma or Ocular Hypertension,”
`JOURNAL OF OCULAR PHARMACOLOGY AND
`THERAPEUTICS, Volume 26, Number 3, 2010.
`Second Declaration of Dr. Yvonne Buys.
`
`1092
`
`1093
`
`Second Declaration of Dr. Erning Xia
`
`1094 Declaration of John C. Staines, Jr.
`
`
`-viii-
`
`Filed Served
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
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`X
`
`X
`
`X
`
`X
`
`X
`
`
`
`
`
`Exhibit
`#
`1095 U.S. Patent Application Publication Number 2006/0229219 to
`Yu et al.
`Intentionally left blank
`
`Description
`
`1096
`
`1097
`
`Intentionally left blank
`
`1098 Decision in ASTRAZENECA AB et al. v. APOTEX CORP. et
`al, US Federal Circuit Court of Appeals, 2014-1221, April 7,
`2015.
`1099 Dawber et al., “Potentiometric and Polarimetric Studies of the
`Reaction of Boric Acid and Tetrahydroxyborate Ion with
`Polyhydroxy Compounds,” J. Chem. SOC., Faraday Trans. I,
`1982, 78, 2521-2528
`Sharma et al., “Effect of complexing reagents on the ionization
`constant of boric acid and its relation to isotopic exchange
`separation factor,” Indian Journal of Chemistry, Vol. 30A,
`January 1991, pp. 66-69
`Sharp, D.W.A (Ed.), “The Penguin Dictionary of Chemistry,”
`2nd Edition (1990), p. 138.
`
`1100
`
`1101
`
`1102 Kanzaki et al., “Inhibitory Effect of Magnesium and Zinc on
`Crystallization Kinetics of Hydroxyapatite (0001) Face,” J.
`Phys. Chem. B 2000, 104, 4189-4194
`Schneider, U.S. Patent No. 5,631,287 titled STORAGE-
`STABLE PROSTAGLANDIN COMPOSITIONS, filed
`December 22, 1994; issued May 20, 1997.
`Patent Term Calculation for U.S. Patent No. 6,143,799
`
`1103
`
`1104
`
`1105
`
`Patent Term Calculation for U.S. Patent No. 6,011,062
`
`
`-ix-
`
`Filed Served
`
`X
`
`X
`
`
`
`
`
`X
`
`X
`
`
`
`
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`
`
`
`
`Exhibit
`#
`1106
`
`Description
`
`Filed Served
`
`Patent Term Calculation for U.S. Patent No. 5,631,287
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`1107 Connors, K.A., “Thermodynamics of Pharmaceutical Systems:
`An Introduction for Students of Pharmacy,” 2002, Chapter 10:
`“Solubility,” pages 116-134.
`1108 The Merck Index, An Encyclopedia of Chemicals, Drugs, and
`Biologicals, 12th Ed. (1996), Merck Research Laboratories,
`1733,1735.
`1109 Blachford, U.S. Patent No. 4,316,852 titled MANUFACTURE
`OF METALLIC SOAPS, filed March 13, 1980; issued
`February 23, 1982.
`SYSTANE ® FREE, the Minimal Blur Liquid Gel, May 28,
`2006,
`http://www.systane.com/professional/SYSTANE_Free.asp
`1111 Unique Preserving Action of SYSTANE® FREE, May 28,
`2006,
`http://www.systane.com/professional/Unique_Preserving.asp
`1112 Declaration of Milycia Rodriguez
`
`1110
`
`
`
`
`-x-
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`Dated: May 1, 2018 By: /Joseph P. Meara/
`
`Joseph P. Meara
`Reg. No. 44,932
`Counsel for Petitioner
`
`Michael R. Houston
`Reg. No. 58,486
`Counsel for Petitioner
`
`
`
`
`
`
`
`
`CERTIFICATION OF SERVICE
`
`
`The undersigned hereby certifies that a copy of the foregoing PETITIONER’S
`
`EXHIBIT LIST AS OF May 1, 2018 and Exhibits 1041-1095 and 1098-1112 were
`
`served on May 1, 2018 on Counsel for Patent Owner via electronic mail to the
`
`following addresses:
`
`dkrinsky@wc.com
`
`csuarez@wc.com
`
`TravZ-IPR@wc.com
`
`
`
`
`Dated: May 1, 2018
`By: /Joseph P. Meara/
`Joseph P. Meara
`Reg. No. 44,932
`Counsel for Petitioner
`
`
`
`
`
`
`
`
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