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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________
`
`MICRO LABS LIMITED AND MICRO LABS USA INC.
`Petitioners,
`
`v.
`
`SANTEN PHARMACEUTICAL CO., LTD. AND ASAHI GLASS CO., LTD.
`Patent Owners.
`_____________
`
`Inter Partes Review No. IPR2017-01434
`U.S. Patent No. 5,886,035
`
`_____________
`
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`
`

`

`In accordance with the Patent Trial and Appeal Board’s November 29, 2017 Order (Paper
`
`No. 11), pp. 5–6, n.1, n.2, Petitioners submit two new exhibits, Ex. 1029 and Ex. 1030.
`
`The content of Exhibit 1029 is the same as Ex. 1006 (“Ueno”), except for the addition of
`
`two new declarations at the end in compliance with 37 C.F.R. §§ 1.68 and 42.63(b). One
`
`declaration is sworn by the same person who submitted the original certification, Hannah
`
`Mendoza, the project manager for the translation. The second declaration is sworn by a member
`
`of the translation team personally attesting to the accuracy of the translation, Frank McGee.
`
`The content of Exhibit 1030 is the same as Ex. 1007 (“Bezuglov 1982”), except for the
`
`addition of two new declarations at the end in compliance with 37 C.F.R. §§ 1.68 and 42.63(b).
`
`One declaration is sworn by the same person who submitted the original certification, Sarah
`
`Faup (whose last name has since become Hall), the project manager for the translation. The
`
`second declaration is sworn by a member of the translation team personally attesting to the
`
`accuracy of the translation, Keith Blasing.
`
`Petitioners provide an updated exhibit list below:
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`
`Exhibit No.
`
`Document
`
`1001
`
`U.S. Patent No. 5,886,035 to Shirasawa et al. (issued March 23, 1999).
`
`1002
`
`File History of U.S. Patent No. 5,886,035.
`
`1003
`
`1004
`
`EP0639563A2 to Klimko et al. (published February 22, 1995).
`
`EP0471856A1 to Kishi et al. (published February 26, 1992).
`
`1005
`
`U.S. Patent No. 5,292,754 to Kishi et al. (issued March 8, 1994).
`
`1006
`
`JP-A-7070054 to Ueno Japan et al. (published March 14, 1995).
`
`2
`
`
`
`

`

`1007
`
`1008
`
`1009
`
`1010
`
`Bezuglov, V. V. & L. D. Bergelson, “Fluoroprostaglandins—A New Class of
`Biologically Active Analogues of Natural Prostaglandins” in Lipids of
`Biological Membranes (L.D. Bergelson, ed., 1982).
`
`Bezuglov, Vladimir V. “Fluorodeoxy Prostaglandins, Synthesis and
`Perspectives” in Prostaglandins and Cardiovascular Diseases (Takayuki Ozawa
`et al. eds., 1986).
`
`Camras et al. “Reduction of intraocular pressure in normal and glaucomatous
`primate (Aotus trivirgatus) eyes by topically applied PGF2 ,” Curr. Eye Res.
`1:205-209 (1981).
`
`Stjernschantz, J.W. “From PGF2 -Isopropyl Ester to Latanoprost: A Review
`of the Development of Xalatan,” Investig. Ophthal. & Vis. Sci. 42(6):1134-
`1145 (2001).
`
`1011
`
`Nixon, D. “Hyperemia in Glaucoma Patients,” (2008) available online at
`http://www.medscape.org/viewarticle/577054.
`
`1012
`
`PCT/US97/20671 to Klimko et al. (published May 22, 1998).
`
`1013
`
`U.S. Provisional Patent Application No. 60/030,519 to Klimko et al. (made
`accessible as of May 22, 1998).
`
`1014
`
`Alm A 1989 Progress in Clin and Biological Research pg 447-458.
`
`1015
`
`Stjernschantz J 1992 Drugs of the Future 691-704.
`
`1016
`
`1017
`
`1018
`
`1019
`
`Product Details for NDA 020597 (XALATAN) available online at
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Typ
`e=N&Appl_No=020597.
`
`Patent and Exclusivity for: N202514 (ZIOPTAN) available online at
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=0
`01&Appl_No=202514&Appl_type=N.
`
`Lee, P.Y. et al., “The effect of prostaglandin F2 alpha on intraocular pressure in
`normotensive human subjects,” Invest. Ophthalmol. Vis. Sci. Oct.
`29(10):1474–1477 (1988).
`
`Camras, C.B. et al., “Maintained reduction of intraocular pressure by
`prostaglandin F2 alpha-1-isopropyl ester applied in multiple doses in ocular
`hypertensive and glaucoma patients,” Ophthalmology Sep. 96(9):1329–1337
`(1989).
`
`3
`
`
`
`

`

`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`Nilsson, S.F. et al., “Increased uveoscleral outflow as a possible mechanism of
`ocular hypotension caused by prostaglandin F2 alpha-1-isopropylester in the
`cynomolgus monkey,” Exp. Eye Res. May 48(5):707–716 (1989).
`
`Pederson, J.E. et al., “Laser-induced primate glaucoma. I. Progression of
`cupping,” Arch. Ophthalmol. Nov. 102(11):1689-92 (1984).
`
`Radius, R.L. et al., “Laser-induced primate glaucoma. II. Histopathology,”
`Arch. Ophthalmol. Nov. 102(11):1693-8 (1984).
`
`Lee, P.Y. et al., “Pharmacological testing in the laser-induced monkey
`glaucoma model,” Curr. Eye Res. Jul. 4(7):775-81 (1985).
`
`Bito, L.Z. “Species differences in the responses of the eye to irritation and
`trauma: a hypothesis of divergence in ocular defense mechanisms, and the
`choice of experimental animals for eye research,” Exp. Eye Res. Dec.
`39(6):807-29 (1984).
`
`1025
`
`U.S. Patent No. 3,914,265 to Middleton (issued October 21, 1975).
`
`1026
`
`Nelson, N.A. “Prostaglandin Nomenclature,” J. Med. Chem. 17(9):911-918
`(1974).
`
`1027
`
`Declaration of Mitchel deLong, Ph.D
`
`1028
`
`Declaration of Aron D. Rose, M.D.
`
`1029
`
`1030
`
`Exhibit 1006 (JP-A-7070054 to Ueno Japan et al. (published March 14, 1995)
`(“Ueno”)) with affidavits in compliance with 37 C.F.R. §§ 42.63(b) and 1.68,
`as required by the Board in its November 29, 2017 Order (Paper No. 11), pp. 5–
`6, n.1.
`
`Exhibit 1007 (Bezuglov, V. V. & L. D. Bergelson, “Fluoroprostaglandins—A
`New Class of Biologically Active Analogues of Natural Prostaglandins” in
`Lipids of Biological Membranes (L.D. Bergelson, ed., 1982) (“Bezuglov
`1982”)) with affidavits in compliance with 37 C.F.R. §§ 42.63(b) and 1.68, as
`required by the Board in its November 29, 2017 Order (Paper No. 11), p. 6, n.2.
`
`
`
`
`
`
`
`
`
`
`4
`
`
`
`

`

`Dated: December 11, 2017
`
`
`
`
`
`By: /Cedric C.Y. Tan/
` Cedric C.Y. Tan (Reg. No. 56,082)
`Sean M. Weinman (Reg. No. 69,515)
`PILLSBURY WINTHROP
`SHAW PITTMAN LLP
`1200 Seventeenth Street, NW
`Washington, DC 20036
`Tel.: (202) 663-8000
`Fax.: (202) 663-8007
`Email: cedric.tan@pillsburylaw.com
`
`
`5
`
`
`
`

`

`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a true copy of the foregoing Petitioners’ Updated
`
`Exhibit List was served on December 11, 2017, by filing this document through the Patent Trial
`
`and Appeal Board End to End System as well as delivering a copy via electronic mail upon the
`
`following attorneys of record for Patent Owner:
`
`
`
`
`
`
`
`
`
`
`Arlene L. Chow (Reg. No. 47,489)
`arlene.chow@hoganlovells.com
`Eric J. Lobenfeld (pro hac vice)
`eric.lobenfeld@hoganlovells.com
`Ernest Yakob, Ph.D. (Reg. No. 45,893)
`ernest.yakob@hoganlovells.com
`HOGAN LOVELLS US LLP
`875 Third Avenue
`New York, NY 10022
`Tel: (212) 918-3000
`Fax: (212) 918-3100
`
`
` /Cedric C.Y. Tan/
` Cedric C.Y. Tan (Reg. No. 56,082)
`PILLSBURY WINTHROP
`SHAW PITTMAN LLP
`1200 Seventeenth Street, NW
`Washington, DC 20036
`Tel.: (202) 663-8000
`Fax.: (202) 663-8007
`Email: cedric.tan@pillsburylaw.com
`
`
`
`
`
`

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