`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`U.S. Patent No. 8,633,162 to Acheampong et al.
`
`Declaration of Dr. Mansoor Amiji
`
`Curriculum Vitae of Dr. Mansoor Amiji
`
`File history of U.S. Patent No. 8, 633,162 to Acheampong et al.
`
`File history of U.S. Patent Application No. 10/927,857, filed on
`August 27, 2010 to Acheampong et al.
`
`U.S. Patent No. 5,474,979 to Ding et al., filed May 17, 1994
`
`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)
`
`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, 2 LACRIMAL GLAND, TEAR FILM, AND DRY EYE
`SYNDROMES 1001 (1998)
`
`U.S. Patent No. 5,578,586 to Glonek et al., filed February 4, 1994
`
`U.S. Patent No. 5,981,607 to Ding et al., filed January 20, 1998
`
`R. Kaswan, Intraocular Penetration of Topically Applied
`Cyclosporine 20 TRANSPL. PROC. 650 (1988)
`
`
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`K. Kunert et al., Analysis of Topical Cyclosporine Treatment of
`Patients with Dry Eye Syndrome 118 ARCH OPHTHALMOL
`1489 (2000)
`
`Physicians’ Desk Reference for Ophthalmic Medicines, 1999
`
`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)
`
`D. Stevenson et al. Efficacy and Safety of Cyclosporin A
`Ophthalmic Emulsion in the Treatment of Moderate-to-
`Severe Dry Eye Disease 107 OPHTHALMOL. 967 (2000)
`
`REMINGTON’S 20TH EDITION: THE SCIENCE AND PRACTICE OF
`PHARMACY (A. Gennaro ed. 2003)
`
`E. Goto et al. Low-Concentration Homogenized Castor Oil Eye
`Drops for Noninflamed Obstructive Meibomian Gland
`Dysfunction 109 OPHTHALMOL. 2030 (2002)
`
`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)
`
`A. Vieira et al., Effect of ricinoleic acid in acute and subchronic
`experimental models of inflammation, 9 MED. INFLAMM. 223
`(2000)
`
`R. Murphy, The Once and Future Treatment of Dry Eye, REVIEW
`OF OPTOMETRY 1 (2000)
`
`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. OC. PHARM. THERAP. 411 (2002)
`
`STEDMAN’S MEDICAL DICTIONARY 27TH EDITION (M.B. Pugh ed.
`2000)
`
`Complaint; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc.,
`Teva Pharmaceutical Industries Ltd., Apotex, Inc., Apotex
`Corp., Akorn, Inc., Mylan Pharmaceuticals Inc., and Mylan
`Inc., No. 2:15-cv-01455
`
`Approved Drug Products with Therapeutic Equivalence
`Evaluations (34th Ed.) (2014) (Excerpts)
`
`Declaration of Dr. Walter Chambliss
`
`Curriculum Vitae of Dr. Walter Chambliss
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026