Paper No. ____
`Filed: August 29, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________
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`FAMY CARE LIMITED
`Petitioner
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`v.
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`ALLERGAN, INC.
`Patent Owner.
`_____________________
`
`Case IPR 2017-00566
`Patent 8,648,048
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`PETITIONER’S UPDATED EXHIBIT LIST
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`Filed: August 29, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`FAMY CARE LIMITED
`Petitioner
`
`v.
`
`ALLERGAN, INC.
`Patent Owner.
`_____________________
`
`Case IPR 2017-00566
`Patent 8,648,048
`
`————————————————
`PETITIONER’S UPDATED EXHIBIT LIST
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`Paper No. ____
`Filed: August 29, 2017
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`Description
`Exhibit
`1001 U.S. Patent No. 8,648,048 B2 to Acheampong et al. (“the ’048 patent)
`1002 Declaration of Dr. Peter Kador
`1003 Declaration of Dr. Michael A. Lemp
`1004
`File history of U.S. Patent No. 8,648,048 to Acheampong et al., filed
`August 14, 2013 (“’048 patent FH”)
`
`1005
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`File history of U.S. Patent Application No. 10/927,857 to Acheampong
`et al., filed August 27, 2004 (“’857 application FH”)
`
`1006 U.S. Patent No. 5,474,979 to Ding et al., filed May 17, 1994 (“Ding
`’979”)
`
`1007 K. Sall et al., Two Multicenter, Randomized Studies of the Efficacy and
`Safety of Cyclosporine Ophthalmic Emulsion in Moderate to Severe Dry
`Eye Disease, 107 OPHTHALMOLOGY 631 (2000) (“Sall”)
`
`1008 A. Acheampong 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 2 LACRIMAL
`GLAND, TEAR FILM, & DRY EYE SYNDROMES 1001 (David A. Sullivan et
`al. eds., 1998) (“Acheampong”)
`
`1009 U.S. Patent No. 5,578,586 to Glonek et al., filed February 4, 1994
`(“Glonek”)
`
`1010 U.S. Patent No. 5,981,607 to Ding et al., filed January 20, 1998 (“Ding
`’607”)
`
`1011 R. Kaswan, Intraocular Penetration of Topically Applied Cyclosporine,
`20 TRANSPL. PROC. 650 (1988) (“Kaswan”)
`
`1012 K. Kunert et al., Analysis of Topical Cyclosporine Treatment of Patients
`with Dry Eye Syndrome, 118 ARCH OPHTHALMOL 1489 (2000)
`(“Kunert”)
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`Paper No. ____
`Filed: August 29, 2017
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`1013
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`PHYSICIANS’ DESK REFERENCE FOR OPHTHALMOLOGY 13-18 (Medical
`Economics Co., 27th ed. 1999) (“Ophthalmic PDR”)
`
`1014 K. Turner et al., Interleukin-6 Levels in the Conjunctival Epithelium of
`Patients with Dry Eye Disease Treated with Cyclosporine Ophthalmic
`Emulsion, 19 CORNEA 492 (2000) (“Turner”)
`
`1015 D. Stevenson et al., Efficacy and Safety of Cyclosporin A Ophthalmic
`Emulsion in the Treatment of Moderate-to-Severe Dry Eye Disease, 107
`OPHTHALMOLOGY 967 (2000) (“Stevenson”)
`1016 REMINGTON’S 20TH EDITION: THE SCIENCE AND PRACTICE OF
`PHARMACY (A. Gennaro ed. 2003) (“Remington”)
`
`1017
`
`E. Goto et al., Low-Concentration Homogenized Castor Oil Eye Drops
`for Noninflamed Obstructive Meibomian Gland Dysfunction, 109
`OPHTHALMOLOGY 2030 (2002) (“Goto”)
`
`1018 A. Kanpolat et al., Penetration of Cyclosporin A into the Rabbit Cornea
`and Aqueous Humor after Topical Drop and Collagen Shield
`Administration, 20 CLAO J. 119 (1994) (“Kanpolat”)
`
`1019 C. Vieira et al., Effect of Ricinoleic Acid in Acute and Subchronic
`Experimental Models of Inflammation, 9 MEDIATORS INFLAMMATION
`223 (2000) (“Vieira”)
`
`1020 R. Murphy, The Once and Future Treatment of Dry Eye, REVIEW OF
`OPTOMETRY ONLINE (Feb. 15, 2000) (“Murphy”)
`
`1021 D. Small 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. OCULAR
`PHARMACOLOGY & THERAPEUTICS 411 (2002) (“Small”)
`
`1022
`
`STEDMAN’S MEDICAL DICTIONARY 944, 1300, 1548, 1634, 1821 (27th
`ed. 2000) (“Stedman’s”)
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`1023 Allergan, Inc.’s Complaint for Patent Infringement, Allergan, Inc. v.
`Famy Care Ltd., No. 2:16-cv-401 (E.D. Tex. Apr. 12, 2016)
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`Paper No. ____
`Filed: August 29, 2017
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`1024 APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE
`EVALUATIONS (34th ed. 2014) (Excerpts)
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`1025
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`1026
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`Intentionally Blank
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`7/30/2003 Allergan Correspondence to FDA regarding RESTASIS™
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`1027 RESTASIS Orange Book Listing (dated Jan. 12, 2015)
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`1028 U.S. Patent No. 6,635,654 B1 to Chang et al., filed January 9, 2003
`(“the ’654 patent”)
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`1029 U.S. Patent No. 6,984,628 B2 to Bakhit et al., filed July 15, 2003 (“the
`’628 patent”)
`
`1030
`
`S. Pflugfelder et al., The Diagnosis and Management of Dry Eye, 19
`CORNEA 644 (2000) (“Pflugfelder”)
`
`1031 Mylan Pharm., Inc. v. Allergan, Inc., IPR2016-01131, Paper No. 8
`(P.T.A.B. Dec. 8, 2016)
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`1032 Curriculum Vitae of Dr. Peter Kador
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`1033 Curriculum Vitae of Dr. Michael A. Lemp
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`1034 Affidavit of Peter J. Curtin in Support of Motion for Pro Hac Vice
`Admission Pursuant to 37 C.F.R. § 42.10(c)
`
`1035
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`1036
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`1037
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`Settlement Document 1
`(CONFIDENTIAL – FILED AS BOARD ONLY)
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`Settlement Document 2
`(CONFIDENTIAL – FILED AS BOARD ONLY)
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`Settlement Document 3
`(CONFIDENTIAL – FILED AS BOARD ONLY)
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`Paper No. ____
`Filed: August 29, 2017
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`Respectfully submitted,
`
`/Deanne M. Mazzochi/
`
`Deanne M. Mazzochi (Reg. No. 50,158)
`Peter J. Curtin (pro hac vice)
`John D. Polivick (Reg. No. 57,926)
`dmazzochi@rmmslegal.com
`pcurtin@rmmslegal.com
`jpolivick@rmmslegal.com
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325
`
`Attorneys for Petitioner,
`Famy Care Limited
`
`
`
`
`Dated: August 29, 2017
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`Paper No. ____
`Filed: August 29, 2017
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on August 29, 2017, the
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`foregoing document is being served by E-mail agreement of the parties to the
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`following counsel of record for the Patent Owner:
`
`Dorothy P. Whelan
`Michael J. Kane
`FISH & RICHARDSON P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN
`whelan@fr.com
`kane@fr.com
`Counsel for Allergan, Inc.
`
`Respectfully submitted,
`
`/Deanne M. Mazzochi/
`Deanne M. Mazzochi (Reg. No. 50,158)
`dmazzochi@rmmslegal.com
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325
`
`
`
`
`Dated: August 29, 2017
`
`
`
`
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