`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WOCKHARDT BIO AG
`
`Petitioner
`
`V.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`CASE: Unassigned
`Patent 8,589,182
`
`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
`
`1007
`
`Reardan et al., U.S. Patent No. 8,589,182 (filed Aug. 27, 2012;
`issued Nov. 19, 2013)
`File History for U.S. Patent No. 8,589,182 (filed Aug. 27, 2012;
`issued Nov. 19, 2013)
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Transcript and Slides (“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 (“Preclinical Safety Review”)
`(July 13, 2001)
`
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Briefing Information, Briefing Booklet (“Briefing
`Booklet”) (July 13, 2001)
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Briefing Information, Xyrem Prescription and
`Distribution Process Video and Transcript (“Xyrem Video and
`Transcript”) (July 13, 2001)
`Declaration of Dr. Robert J. Valcuk, Ph.D., R.Ph.
`
`Curriculum Vitae of Dr. Robert J. Valuck, Ph.D., R.Ph.
`
`1008
`
`Shulman, S., “The Broader Message of Accutane,” Am. J. of
`1009
`Public Health, 79:1565-1568 (1989)
`INTENTIONALLY LEFT BLANK
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`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, 21 :3 19-330 (1999)
`“Managing the Risks from Medical Product Use: Creating a
`Risk Management Framework,” Report to the FDA
`Commissioner from the Task Force on Risk Management, U.S.
`Dept. of Health and Human Services, Food and Drug
`Administration ( 1 999)
`
`
`
`Wockhardt Bio AG ’s Exhibit List
`
`Exhibit #
`
`Description
`
`1015
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`66 Fed. Reg. 24391
`File History for U.S. Patent No. 7,668,730 (filed Dec. 17, 2002;
`issued Feb. 23, 2010)
`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
`https://Web.archive.org/Web/20010617210030/http://WwW.fda.g
`ov/ohrms/dockets/ac/cder01.htm (dated June 17, 2001)
`Peripheral and Central Nervous System Drugs Advisory
`Committee, Briefing Information, from FDA Central Website
`(dated July 1, 2001)
`Internet Archive Wayback Machine, Center for Drug Evaluation
`and Research 2001 Meeting Documents, available at
`https://Web.archive.org/Web/2001 1004081740/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=021 196&TABLE1=OB_Rx; and
`http://WWW.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.
`cfm?Appl_No=021 1 96&Product_No=00 1 &table1=OB_Rx
`Rome, E., “It’s a rave new World: Rave culture and illicit drug
`use in the young,” Cleveland Clinic J. ofMed., 68:541-550
`(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-
`1 96_Xyrem_prnt1b1_P 1 .pdf
`INTENTIONALLY LEFT BLANK
`
`INTENTIONALLY LEFT BLANK
`
`INTENTIONALLY LEFT BLANK
`
`FDA’s Center for Drug Evaluation and Research, Advisory
`Committees CDER 2001 Meeting Documents, available at
`http ://WWW.fda.gov/ohrrns/dockets/ac/cder01 .htm#Peripheral%
`20&%20Centra1%20Nervous 1/
`
`
`
`Wockhardt Bio AG ’s Exhibit List
`
`Description
`
`
`
`
`
`Exhibit #
`
`
` 1028
`
`
`
`
`
`Affidavit from the Internet Archive Wayback Machine
`Mitchell, A., et al., “A Pregnancy—Prevention Program in
`Women of Childbearing Age Receiving Isotretinoin,” The New
`England Journal ofMedicine, 333: 101-106 (1995)
`INTENTIONALLY LEFT BLANK
`
`INTENTIONALLY LEFT BLANK
`
`1032
`
`Scrima, L., et al., “Efficacy of Gamma-Hydroxybutyrate Versus
`Placebo in Treating Narcolepsy-Cataplexyz Doub1e—B1ind
`Subjective Measures,” Biol. Psychiatry, 262331-343 (1989)
`
`Date: August 27, 2015
`100 High Street, Suite 2400
`Boston, MA 02110
`(857) 488-4200
`
`Respectfully submitted,
`DUA MORRIS LLP
`
`
`Laura A. Vogel
`Registration No. 55,702
`Attorney for Petitioner
`
`
`
`Wockhardt Bio A G ’s Exhibit List
`
`CERTIFICATION OF SERVICE 137 C.F.R. § 42.6§en
`
`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.
`8,589, I 82
`
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`
`Additional address known to
`
`Petitioner as likely to effect service
`
`Date: August 27, 2015
`
`100 High Street, Suite 2400
`Boston, MA 02110
`(857) 488-4200
`
`Respectfully submitted,
`DUANE MORRIS LLP
`
`
`
`Laura A. Vogel
`Registration No. 55,702
`Attorney for Petitioner