`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`MYLAN PHARMACEUTICALS, INC.
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`
`U.S. Patent No. 8,877,168 to Higashiyama
`Issue Date: November 4, 2014
`Title: Aqueous Liquid Preparations and Light-Stabilized Aqueous Liquid
`Preparations
`
`_____________________
`
`Inter Partes Review No.: IPR2016-01163
`
`Petitioner’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 8,877,168
`
`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. Mansoor M. Amiji
`Yanni et al., U.S. Patent No. 6,174,914 “Method of Inhibiting
`Cytokine Release from Human Ocular Cells” (“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”)
`Tetsuya Araki et al., “Photochemical Behavior of Sitafloxacin,
`Fluoroquinolone Antibiotic, in an Aqueous Solution,” Chemical
`and Pharmaceutical Bulletin 50(2) 229-234 (2002) (“Araki I”)
`Press Release “Tanabe Seiyaku Granted Rights for Bepotastine
`Besilate for Ophtalmic [sic] Use to Senju Seiyaku (Japan)”
`(“Tanabe”)
`Masanori Araki et al., PCT International Patent Publication No.
`WO 01/080858 “Stable Liquid Preparation” (“Araki II”)
`R.J. Davies et al., Antihistamines:
`topical vs. oral administration,
`Clinical and Experimental Allergy 26(3):11-17 (1996) (“Davies”)
`“Stability Testing: Photostability Testing of New Drug Substances
`and Products,” ICH Harmonized Tripartite Guideline (1996) (“ICH
`Guideline”)
`Dolores Kostecka et al., “Formulation of a Stable Parenteral
`Product; Clonidine Hydrochloride Injection,” PDA Journal of
`Pharmaceutical Science & Technology 56(6):320-325 (1998)
`(“Kostecka”)
`Gerold L. Mosher et al., “Photoreactivity of LY277359 Maleate, a
`5- Hydroxytryptamine3
`(5-HT3) Receptor Antagonist,
`in
`Solution,” Pharmaceutical Research 8(10):1215-1222 (1991)
`(“Mosher”)
`Reserved
`
`vi
`
`Petitioner
`Exhibit #
`1001
`
`1002
`
`1003
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`
`
`1015
`
`1016
`
`1017
`
`1018
`1019
`1020
`1021
`1022
`1023
`1024
`1025
`1026
`1027
`1028
`1029
`1030
`1031
`1032
`1033
`1034
`
`Petition for Inter Partes Review of USPN 8,877,168
`
`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”)
`Remington’s Pharmaceutical Sciences 16th Ed., pp. 1403-1419
`(1980) (“Remington”).
`Jun-ichiro Kita et al., European Patent Publication No. EP 0 949
`260 “Acid-Addition Salts of Optically Active Piperidine
`Compound and Process for Producing the Same” (“Kita”)
`CV of Dr. Mansoor M. Amiji
`Declaration of Higashiyama Under 37 CFR § 1.132 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
`Examiner Interview Summary of August 11, 2018 in ’678
`application
`
`vii
`
`
`
`CERTIFICATION OF SERVICE ON PATENT OWNER
`
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4) and 42.105, the undersigned
`
`certifies that on the 8th day of June 2016, a complete copy of the foregoing Petition
`
`for Inter Partes Review of U.S. Patent No. 8,877,168, Power of Attorney, Exhibit
`
`List, and all supporting exhibits were served via UPS® to the Patent Owner by
`
`serving the correspondence address of record for the ’168 patent:
`
`WENDEROTH, LIND & PONACK, L.L.P.
`1030 15th Street, N.W.,
`Suite 400 East
`Washington DC 20005-1503
`
`Courtesy copies of the foregoing were also served via UPS® on counsel of
`
`record for the Patent Owner in Bausch & Lomb Inc. et al. v. Micro Labs Ltd. et al.,
`
`No. 15-cv-03113-NLH-JS (D.N.J.) as follows:
`
`Melissa A. Chuderewicz
`PEPPER HAMILTON
`301 Carnegie Center
`Suite 400
`Princeton, New Jersey 08543-5276
`T: (609) 951-4118
`F: (609) 452-1147
`chuderem@pepperlaw.com
`
`Bryan C. Diner
`Justin J. Hasford
`FINNEGAN, HENDERSON, FARABOW, GARRETT &
`DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`T: (202) 408-4000
`F: (202) 408-4400
`
`
`
`bryan.diner@finnegan.com
`justin.hasford@finnegan.com
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Lance Soderstrom
`Reg. No. 65405
`Alston & Bird LLP
`90 Park Avenue, 15th Floor
`New York, New York 10016-1387
`lance.soderstrom@alston.com
`
`H. James Abe
`Reg. No. 61182
`Alston & Bird LLP
`333 South Hope Street, 16th Floor
`Los Angeles, CA 90071
`james.abe@alston.com
`
`Joseph M. Janusz
`Reg. No. 70396
`Alston & Bird LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28205
`joe.janusz@alston.com
`
`Attorneys for Petitioner
`Mylan Pharmaceuticals, Inc.