`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WOCKHARDT BIO AG
`
`Petitioner
`
`V.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`CASE: Unassigned
`Patent 7,668,730
`
`WOCKHARDT BIO AG’S EXHIBIT LIST
`
`Mail Stop “PA TENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`
`P.O. Box 1450
`
`Alexandria, VA 223 13 -1450
`
`
`
`
`
`Wockhardt Bio AG’s Exhibit List
`
`Exhibit #
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`Reardan, et al., U.S. Patent No. 7,668,730 (filed Dec. 17, 2002;
`issued Feb. 23, 2010)
`
`File History for U.S. Patent No. 7,668,730 (filed Dec. 17, 2002;
`issued Feb. 23, 2010)
`
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Transcript and Slides (July 13, 2001)
`
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Briefing Information, Division of
`Neuropharmacological Drug Products Preliminary Clinical
`Safety Review of NDA 21-196 (July 13, 2001)
`
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Briefing Information, Briefing Booklet (July 13,
`2001)
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Briefing Information, Xyrem Video and Transcript
`
`1007
`
`Declaration of Dr. Robert J. Valcuk, Ph.D., R.Ph.
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`Curriculum Vitae of Dr. Robert J. Valuck, Ph.D., R.Ph.
`
`Shulman, S., “The Broader Message of Accutane,” Am. J. of
`Public Health, 79:1565—1568 (1989)
`Spurgeon, D., “Advent of Mail—Order Pharmacy Causes Concern
`Among Some Pharmacists,” Can. Med. Assoc. J., 152:1485—1486
`(1995)
`Honigfeld, G., “Effects of the Clozapine National Registry
`System on Incidence of Deaths Related to Agranulocytosis,”
`Psychiatric Services, 47:52-56 (1996)
`Burleson, K., “Review of computer applications in institutional
`pharmacy-—1975-1981,” Am. J. Hosp. Pharm. , 39:53-70 (1982)
`Zeldis, J ., et al., “S.T.E.P.S.TM: A comprehensive Program for
`Controlling and Monitoring Access to Thalidomide,” Clirz.
`Therapeutics, 212319-330 (1999)
`“Managing the Risks from Medical Product Use: Creating a Risk
`Management Framework,” Report to the FDA Commissioner
`
`1015
`
`66 Fed. Reg. 24391
`
`
`
`Wockhardt Bio AG’s Exhibit List
`
`Exhibit #
`
`Description
`
`1016
`
`INTENTIONALLY LEFT BLANK
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`FDA Center for Drug Evaluation and Research, 2001 FDA
`Advisory Committee’s Meeting Documents by Center, available
`at http://WWW.fda.gov/ohrms/dockets/ac/01docsbc.htm
`
`Internet Archive Wayback Machine, Center for Drug Evaluation
`and Research 2001 Meeting Documents, available at
`https2//Web.archive.org/Web/20010617210030/http://wWW.fda.go
`V/ohrms/dockets/ac/cder0l .htm (dated June 17, 2001)
`
`Internet Archive Wayback Machine, FDA Peripheral & Central
`Nervous System Drugs Advisory Committee, Briefing
`Information for Xyrem NDA 21-196, available at
`https://web.archive.org/web/20010701233052/http://WWW.fda.go
`v/ohrms/dockets/ac/01/briefing/3754b1.htm (dated July 1, 2001)
`
`Internet Archive Wayback Machine, Center for Drug Evaluation
`and Research 2001 Meeting Documents, available at
`https://Web.archive.org/web/20011004081740/http://wwW.fda.g
`ov/ohrms/dockets/ac/cder01.htm (dated Oct. 4, 2001)
`Orange Book Entries for Xyrem®, available at
`http://WWw.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cf
`m?Appl_No=021 l96&TABLE1=OB_RX; and
`http://WWW.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.
`cfm?Appl No=02l l96&Product No=001&tablel=OB RX
`Rome, E., “It’s a rave new World: Rave culture and illicit drug
`use in the young,” Cleveland Clinic J. ofMed, 682541-550
`(2001)
`
`FDA Center for Drug Evaluation and Research, NDA 21-196,
`Approved Labeling, available at
`http://WWW.accessdata.fda.gov/drugsatfda_docs/nda/2002/21—
`l96_Xyrem_prntlbl Pl .pdf
`
`1024
`
`INTENTIONALLY LEFT BLANK
`
`1025
`
`INTENTIONALLY LEFT BLANK
`
`1026
`
`INTENTIONALLY LEFT BLANK
`
`
`
`Wockhardt Bio AG ’s Exhibit List
`
`Exhibit #
`
`Description
`
`1027
`
`FDA’s Center for Drug Evaluation and Research, Advisory
`Committees CDER 2001 Meeting Documents, available at
`http ://wWw.fda. gov/ohrms/dockets/ac/cder01 .htm#Peripheral%
`20&%20Central%20Nervous 1/
`
`1028
`
`Affidavit from the Internet Archive Wayback Machine
`
`1029
`
`Mitchell, A., “A Pregnancy-Prevention Program in Women of
`Childbearing Age Receiving Isotretinoin,” The New England
`Journal 0fMedicine, 333: 101-106 (1995)
`
`
`1030
`
`INTENTIONALLY LEFT BLANK
`
`1031
`
`1032
`
`I INTENTIONALLY LEFT BLANK
`
`
`Scrima, L., et al., “Efficacy of Gamma—HydroXybutyrate versus
`Placebo in Treating Narcolepsy-Cataplexy: Double-Blind
`Subjective Measures,” Biol. Psychiatry, 26:331-343 (1989).
`
`Respectfully submitted,
`DU EMORRIS LP
`
`
`
`
`aura A. Vogel
`Registration No. 55,702
`Attorney for Petitioner
`
`Date: August 27, 2015
`100 High Street, Suite 2400
`Boston, MA 02110
`(857) 488-4200
`
`
`
`
`
`CERTIFICATION OF SERVICE (37 C.F.R. § 42.6gen
`
`The undersigned hereby certifies that the aboVe—captioned “Wockhardt Bio
`
`AG’s Exhibit List” was served in its entirety on August 27, 2015, upon the
`
`following parties Via electronic mail:
`
`Schwegman Lundberg &
`Woessner/Jazz Pharmaceutical
`
`F. Dominic Cerrito
`Eric C. Stops
`Gabriel P. Brier
`
`P.O. Box 2938
`Minneapolis, MN 55402
`Patent owner ’s correspondence
`address ofrecordfor US. Patent No.
`7,668, 730
`
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`
`Additional address known to
`
`Petitioner as likely to eflect service
`
`Date: August 27, 2015
`
`100 High Street, Suite 2400
`Boston, MA 02110
`(857) 488-4200
`
`Respectfully submitted,
`DUANE MORRIS LLP
`
`5%} M Q X
`
`[
`
`(2
`
`Laura A. Vogel
`Registration No. 55,702
`Attorney for Petitioner