`_____________________
`
`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 Updated Exhibit List for Inter Partes Review of U.S. Patent No.
`8,877,168
`
`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
`
`i
`
`Petitioner
`Exhibit #
`1001
`
`1002
`
`1003
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`
`
`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
`Confidential Settlement and License Agreement
`Joint Stipulation of Dismissal and Order
`
`1015
`
`1016
`
`1017
`
`1018
`1019
`1020
`1021
`1022
`1023
`1024
`1025
`1026
`1027
`1028
`1029
`1030
`1031
`1032
`1033
`1034
`
`1035
`1036
`
`ii
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
