`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`MYLAN PHARMACEUTICALS, INC.
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`
`U.S. Patent No. 8,784,789 to Higashiyama
`Issue Date: July 22, 2014
`Title: Aqueous Liquid Preparations and Light-Stabilized Aqueous Liquid
`Preparations
`
`_____________________
`
`Inter Partes Review No.: IPR2016-00626
`
`Petition’s Updated Exhibit List for Inter Partes Review of U.S. Patent No.
`8,784,789
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Petitioner
`Exhibit #
`1001
`
`1002
`
`1003
`1004
`1005
`
`1006
`
`1007
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`1015
`
`Petitioner’s Exhibit List
`
`Description
`Higashiyama, U.S. Patent No. 8,784,789, “Aqueous Liquid
`Preparations and Light-Stabilized Aqueous Liquid Preparations”
`(“the ’789 patent”)
`Higashiyama, U.S. Patent No. 8,877,168 “Aqueous Liquid
`Preparations and Light-Stabilized Aqueous Liquid Preparations”
`(“the ’168 patent”)
`Declaration of Dr. Amiji
`U.S. Patent No. 6,174,914 (“Yanni”)
`Remington: The Science and Practice of Pharmacy 20th Ed.
`(“Hecht”)
`Lloyd V. Allen Jr. et al. “Compounding Ophthalmic Preparations,”
`International Journal of Pharmaceutical Compounding 2(3) (1998)
`(“Allen”)
`Chemical and Pharmaceutical Bulletin 50(2) (“Araki I”)
`Press Release “Tanabe Seiyaku Granted Rights for Bepotastine
`Besilate for Ophtalmic [sic] Use to Senju Seiyaku (Japan)”
`(“Tanabe”)
`PCT International Patent Publication No. WO 01/080858 (“Araki
`II”)
`topical vs oral administration, Clinical and
`Antihistamines:
`Experimental Allergy 26(3):11-17 (1996) (“Davies”)
`“Stability Testing: Photostability Testing of New Drug Substances
`and Products” (“ICH Guideline”)
`“Formulation
`of
`a Stable Parenteral Product; Clonidine
`Hydrochloride Injection,” PDA Journal of Pharmaceutical Science
`& Technology 56(6):320-325 (1998) (“Kostecka”)
`Photoreactivity of LY277359 Maleate, a 5- Hydroxytryptamine3
`(5-HT3) Receptor Antagonist,
`in Solution, Pharmaceutical
`Research 8(10):1215-1222 (1991) (“Mosher”)
`Reserved
`Press Release “Regarding Extended Indication for Selective
`Histamine H1 Receptor Antagonist/Anti-Allergic Agent Talion®
`Tablets 5 and Talion® Tablets 10 in Treating Pruritus/Itching
`Accompanying Urticaria and Other Skin Diseases” (“Talion Press
`Release”)
`
`1
`
`
`
`1016
`
`1017
`1018
`1019
`1020
`1021
`1022
`1023
`1024
`1025
`1026
`1027
`1028
`1029
`1030
`1031
`1032
`1033
`1034
`1035
`1036
`
`Remington’s Pharmaceutical Sciences, pp. 1410-1419 (1980)
`(“Remington”).
`European Patent Publication No. EP 0 949 260 (“Kita”)
`CV of Dr. Amiji
`Declaration of Higashiyama of Nov. 6, 2007
`Supplemental Amendment of Nov. 13, 2007
`Final Office Action of Feb. 8, 2008
`Declaration of Higashiyama of Dec. 22, 2008
`Amendment of Jan. 5, 2009
`Office Action of May 8, 2009
`Office Action of April 9, 2010
`Final Office Action of Dec. 20, 2010
`Declaration of Higashiyama of Sept., 11, 2012
`Supplemental Amendment of Sept. 14, 2012
`Office Action of Aug. 30, 2013
`Amendment of May 30, 2014
`Notice of Allowance of June 12, 2014
`Amendment of April 24, 2012
`Final Office Action of Apr. 30, 2014
`Reserved
`Confidential Settlement and License Agreement
`Joint Stipulation of Dismissal and Order
`
`2
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