`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`APOTEX CORP.
`APOTEX, INC.
`Petitioner
`
`v.
`
`ALLERGAN, INC.
`Patent Owner
`_____________________
`
`Case IPR: Unassigned
`U. S. Patent No. 8,642,556
`_____________________
`
`APOTEX'S 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
`
`

`

`Petition for Inter Partes Review of USPN 8,642,556
`
`Description
`
`APOTEX
`Exhibit #
`1001 Acheampong, A., et al., "Methods of Providing Therapeutic Effects
`Using Cyclosporin Components," U.S. Patent No. 8,642,556 (filed on
`August 14, 2013; issued on February 4, 2014)
`1002 Ding, S., et al., "Emulsion Eye Drop For Alleviation of Dry Eye
`Related Symptoms in Dry Eye Patients and/or Contact Lens Wearers,"
`U.S. Patent No. 5,981,607 (filed on January 20, 1998; issued on
`November 9, 1999)
`1003 Ding, S., et al. "Nonirritating Emulsions For Sensitive Tissue," U.S.
`Patent No. 5,474,979 (filed on May 17, 1994; issued December 12,
`1995)
`Sall, K., et al., "Two Multicenter, Randomized Studies of the Efficacy
`and Safety of Cyclosporine Ophthalmic Emulsion in Moderate to
`Severe Dry Eye Disease," Ophthalmology 107: 631-639 (2000)
`1005 Declaration of Erning Xia, Ph.D.
`Curriculum Vitae of Erning Xia, Ph.D.
`1006
`1007 Declaration of Christopher N. Ta, Ph.D.
`Curriculum Vitae of Christopher N. Ta, Ph.D.
`1008
`Coles, W.H. and Jaros, P.A., "Dynamics of ocular surface pH," Brit. J.
`1009
`Ophthalmol. 68: 549-552 (1984)
`1010 Declaration of Harry C. Boghigian
`Curriculum Vitae of Harry C. Boghigian
`1011
`1012
`"Ophthalmic Drug Products for Over-the-Counter Human Use; Final
`Monograph," Federal Register 53: 7076-93 (1988), available at
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Development
`Resources/Over-
`theCounterOTCDrugs/StatusofOTCRulemakings/ucm071941.htm, last
`accessed March 24, 2015
`"CTFA Becomes the Personal Care Products Council," available at
`http://www.personalcarecouncil.org/ctfa-becomes-personal-care-
`products-council (last accessed Jan. 29, 2015)
`Freeman, J.M., "The Punctum Plug: Evaluation of a New Treatment for
`the Dry Eye," Transactions American Academy of Ophthalmology and
`Otolaryngology 79: 874-879 (1975)
`1015 Kunert, K., et al., "Analysis of Topical Cyclosporine Treatment of
`Patients With Dry Eye Syndrome," Arch Ophthalmol 118: 1489-1496
`(2000)
`
`1004
`
`1013
`
`1014
`
`
`
`- 1 -
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`

`

`Petition for Inter Partes Review of USPN 8,642,556
`
`Description
`
`APOTEX
`Exhibit #
`1016
`
`Turner, K., et al., "Interleukin-6 Levels in the Conjunctival Epithelium
`of Patients with Dry Eye Disease Treated with Cyclosporine Opthalmic
`Emulsion," Cornea 19: 492-496 (2000)
`1017 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,"
`in Lacrimal Gland, Tear Film, And Dry Eye Syndromes 2 - Basic
`Science and Clinical Relevance,Plenum Press, New York New York,
`Chapter 144, pp. 1001-1004 (1998)
`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," Journal of Ocular
`Pharmacology and Therapeutics 18: 411-418 (2002)
`1019 USPN 8,642,556 complete File History
`1020 Murphy, R., "The Once and Future Treatment Of Dry Eye," Review of
`Optometry January 2000 Cover Focus, available at
`http://legacy.revoptom.com/archive/FEATURES/ro0200f6.htm
`6 (last accessed October 21, 2014)
`Inatomi, T., et al., "Expression of Secretory Mucin Genes by Human
`Conjunctival Epithelia," Invest Ophthalmol 37: 1684-1692 (1996)
`Solomon, A., et al., "Doxycycline Inhibition of Interleukin-1 in the
`Corneal Epithelium," Invest Ophthalmol Vis Sci 41: 2544-2557 (2000)
`Stevenson, D., et al., "Efficacy and Safety of Cyclosporin A
`Ophthalmic Emulsion in the Treatment of Moderate-to-Severe Dry Eye
`Disease," Ophthalmology 107: 967-974 (2000)
`Personal Care Production Council available at
`http://www.personalcarecouncil.org/ (last accessed Jan. 29, 2015)
`1025 Allergan Dry Eye Product Portfolio Fact Sheet, downloaded from
`http://www.allergan.com/assets/pdf/dry_eye_product_portfolio_fact_sh
`eet.pdf, last accessed January 26, 2015
`"Certain Steroid Preparations for Ophthalmic and/or Otic Use," in
`Federal Register 41: 34340-34342 (1976)
`Chidambaram, N. and Burgess, D.J., "Effect of Nonionic Surfactant on
`Transport of Surface-Active and Non-Surface-Active Model Drugs and
`Emulsion Stability in Triphasic Systems," AAP Pharmsci 2: 1-11
`(2000)
`
`1018
`
`1021
`
`1022
`
`1023
`
`1024
`
`1026
`
`1027
`
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`

`

`Petition for Inter Partes Review of USPN 8,642,556
`
`Description
`
`APOTEX
`Exhibit #
`1028
`
`1030
`
`1032
`
`Pflugfelder, S.C., et al., "The Diagnosis and Management of Dry Eye-A
`Twenty-five-Year Review," Cornea 19: 644-649 (2000)
`1029 Albietz, J.M., "Dry eye: An Update On Clinical Diagnosis,
`Management and Promising New Treatments," Clin & Exp. Optometry
`84: 4-18 (2001)
` Liu, K., et al., "Synthetic Approaches to the 2010 New Drugs,"
`Bioorganic & Medicinal Chemistry 20: 1155-1174 (2012)
`1031 Glonek, T., et al., "Dry Eye Treatment Process And Solution," U.S.
`Patent No. 5,578,586 (filed on February 4, 1994; issued on November
`26, 1996)
`Rowe, E.L., "Effect of Emulsifer Concentration and Type on the
`Particle Size Distribution of Emulsions," Journal of Pharmaceutical
`Science 54: 260-264 (1965)
`1033 Goto, E. et al., "Low-concentration Homogenized Castor Oil Eye
`Drops for Noninflamed Obstructive Meibomian Gland Dysfunction,"
`Ophthalmology 109: 2030-2035 (2002)
` Certain Ophthalmic Combination Drugs Containing a Steroid and
`Anti-Infective(s) for Human Use; Drug Efficacy Study Implementation;
`Amendment," Federal Register 47: 21296-21301 (1982)
`1035 Yeh, S. et al., "Apoptosis of Ocular Surface Cells in Experimentally
`Induced Dry Eye," Invest. Ophthalmology & Visual Sci. 44:124-129
`(2003)
`Lemp, M.A., "Report of the National Eye Institute/Industry Workshop
`on Clinical Trials in Dry Eyes," CLAO 21: 221-232 (1995)
`1037 Gilbard, J.P., "Dry Eye, Blepharitis, and Chronic Eye Irritation: Divide
`and Conquer," J. Ophthalmic Nurs. Technol. 18: 109-115 (1999)
`1038 Napper, G. et al., "Ocular therapeutics," Clin. & Exp. Optometry 86:
`414-415 (2003)
`1039 Allergan, Inc. 2002 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, (last accessed Jan. 16,
`2015 )
`Taban, M. et al., "Update on Punctal Plugs," Comp. Ophthalmology
`Update 7: 205-2012 (2006)
`Chanana, G., and Sheth, B., "Particle Size Reduction of Emulsions by
`Formulation Design-II: Effect of Oil and Surfactant Concentration,"
`PDA J. Pharm. Sci. & Tech., 49: 71-76 (1995)
`
`1034
`
`1036
`
`1040
`
`1041
`
`
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`- 3 -
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`

`

`Petition for Inter Partes Review of USPN 8,642,556
`
`Description
`
`APOTEX
`Exhibit #
`1042
`
`1043
`
`Chung, H. et al., "Oil components modulate physical characteristics
`and function of the natural oil emulsions as drug or gene delivery
`system," J. Controlled Release 71:339- 350 (2001)
`RESTASIS® Approved Label, downloaded from the Allergan website
`https://www.restasisprofessional.com/RestasisProfessional/FullPrescrib
`ingInformation, last accessed January 28, 2015
`1044 American Academy of Ophthalmology Cornea/External Disease Panel.
`Preferred Practice Pattern® Guidelines. Dry Eye Syndrome. San
`Francisco, CA: American Academy of Ophthalmology (2013),
`available at: www.aao.org/ppp (last accessed December 31, 2014)
`1045 De Paiva, C.S., and Pflugfelder, S.C., "Rationale for Anti-Inflammatory
`Therapy in Dry Eye Syndrome," Arq. Bras. Oftalmol. 71: 89-95 (2008)
`1046 Autry, J.C., "Mix It Up: When to Call a Compounding Pharmacist,"
`Review of Optometry 149: 30-37 (July 15, 2012)
`1047 Mann, E., "Drugs Used in the Treatment of Dry Eye Syndrome, Anti-
`Inflammatory Drugs and Topical Anti-Allergy Drugs," Continuing
`Education & Training pp. 30-40 (2007)
`1048 Allergan, Inc. 2001 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January
`1, 2015
`1049 Allergan, Inc. 2003 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January
`1, 2015
`1050 Allergan, Inc. 2004 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January
`1, 2015
`1051 Allergan, Inc. 2005 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January
`1, 2015
`1052 Allergan, Inc. 2006 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January
`1, 2015
`
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`- 4 -
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`

`

`Petition for Inter Partes Review of USPN 8,642,556
`
`1060
`
`APOTEX
`Description
`Exhibit #
`1053 Allergan, Inc. 2009 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January
`1, 2015
`1054 Allergan, Inc. 2010 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January
`1, 2015
`1055 Allergan, Inc. 2011 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January
`1, 2015
`1056 Allergan, Inc. 2012 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January
`1, 2015
`1057 Allergan, Inc. 2013 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January
`1, 2015
`1058 Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations, patent and exclusivity data for RESTASIS®, downloaded
`from FDA website
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?A
`ppl_No=050790&Product_No=001&table1=OB_Rx, last accessed
`January 12, 2015
`1059 Maïssa, C., et al., " Effect of Castor Oil Emulsion Eyedrops on Tear
`Film Composition and Stability," Contact Lens & Anterior Eye 33: 76-
`82 (2010)
`Systane Lubricant Eye Drops information at Systane.com, Systane
`Products, Systane Balance Lubricant Eye Drops, downloaded from
`Alcon website http://www.systane.com/Systane-Balance-Lubricant-
`Eye-Drops.aspx, last accessed April 21, 2015
`Learn more about Systane Gel Drops at Systane.com, Systane Products,
`Systane Gel Drops, downloaded from Alcon website
`http://www.systane.com/Gel-Drops.aspx, last accessed April 21, 2015
`Systane® Lubricant Eye Gel, Systane Products, Systane Lubricant Eye
`Gel, downloaded from Alcon website http://www.systane.com/Systane-
`Lubricant-Eye-Gel.aspx, last visited April 21, 2015
`
`1061
`
`1062
`
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`

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`Petition for Inter Partes Review of USPN 8,642,556
`
`Description
`
`1064
`
`1065
`
`APOTEX
`Exhibit #
`1063 Dry Eye Drop Symptom relief product information at Systane.com,
`Systane Products, Systane Ultra Lubricant Eye Drops, downloaded
`from Alcon website http://www.systane.com/Dry-Eye-Drop.aspx, last
`visited April 21, 2015
`LACRISERT® (hydroxypropyl cellulose ophthalmic insert) Approved
`Label, downloaded from the FDA website
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018771s017
`lbl.pdf, last accessed April 14, 2015
`Bausch and Lomb "Dry Eye Products," downloaded from Bausch and
`Lomb website http://www.bausch.com/our-products/dry-eye-
`products/dry-eye-products, last accessed April 14, 2015
`1066 Drugs@FDA: FDA Approved Drug Products, LACRISERT®,
`downloaded from the FDA website
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fusea
`ction=Search.DrugDetails, last accessed April 16, 2015
`1067 Drugs@FDA: FDA Approved Drug Products, RESTASIS®,
`downloaded from the FDA website
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/temptn.cfm, last
`accessed April 14, 2015
`
`Respectfully submitted,
`
` /Eldora L. Ellison/
`Eldora L. Ellison, Ph.D. (Reg. No. 39,967)
`Lead Attorney for Petitioner Apotex Corp. and
`Apotex, Inc.
`
`Date: June 4, 2015
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`1936347.1
`
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`
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`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`
`The undersigned hereby certifies that the above-captioned "Apotex's Exhibit
`
`List" and Exhibits 1001-1067, were served in their entirety on June 4, 2015, upon
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`the following party via FEDEX®:
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`Allergan, Inc.
`
`
`2525 Dupont Drive, T2-7H
`
`
`Irvine, CA 92612-1599
`
`Patent owner's correspondence address
`of record for U.S. Patent No. 8,642,556
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`Jonathan Singer
`FISH & RICHARDSON
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`singer@fr.com
`Address known to the petitioner
`as likely to effect service
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
` /Eldora L. Ellison/
` Eldora L. Ellison, Ph.D. (Reg. No. 39,967)
`Date: June 4, 2015
` Lead Attorney for Petitioner Apotex Corp. and
`
`
`
`
`
` Apotex, Inc.
`
`
`
`
`
`1100 New York Avenue, N.W.
`Washington, D.C. 20005 - 3934
`(202) 371-2600
`
`
`
`
`