UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`WOCKHARDT BIO AG
`Petitioner,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner.
`
`_____________________
`
`Inter Partes Review No.: IPR2015-01813
`Patent 8,589,182
`_____________________
`
`PETITIONER WOCKHARDT BIO AG’S UPDATED 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
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`WOCKHARDT BIO AG
`Petitioner,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner.
`
`_____________________
`
`Inter Partes Review No.: IPR2015-01813
`Patent 8,589,182
`_____________________
`
`PETITIONER WOCKHARDT BIO AG’S UPDATED 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
`
`
`
`
`
`
`Wockhardt Bio AG’s Updated Exhibit List
`
`Exhibit #
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`1008
`1009
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`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.
`Shulman, S., “The Broader Message of Accutane,” Am. J. of
`Public Health, 79:1565-1568 (1989)
`INTENTIONALLY LEFT BLANK
`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.™: A Comprehensive Program for
`Controlling and Monitoring Access to Thalidomide,” Clin.
`Therapeutics, 21:319-330 (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 (1999)
`
`1
`
`
`
`Wockhardt Bio AG’s Updated 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/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=021196&TABLE1=OB_Rx; and
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.
`cfm?Appl_No=021196&Product_No=001&table1=OB_Rx
`Rome, E., “It’s a rave new world: Rave culture and illicit drug
`use in the young,” Cleveland Clinic J. of Med., 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-
`196_Xyrem_prntlbl_P1.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/ohrms/dockets/ac/cder01.htm#Peripheral%
`20&%20Central%20Nervous 1/
`
`2
`
`
`
`Wockhardt Bio AG’s Updated Exhibit List
`
`Exhibit #
`
`Description
`
`1028
`
`1029
`
`1030
`1031
`
`1032
`
`1033
`
`
`
`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 of Medicine, 333:101-106 (1995)
`INTENTIONALLY LEFT BLANK
`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)
`Transcript of Teleconference with the Board held on September
`14, 2015
`
`
`
`
`Date: September 17, 2015
`100 High Street, Suite 2400
`Boston, MA 02110
`(857) 488-4200
`
`
`Respectfully submitted,
`DUANE MORRIS LLP
`
`/Laura A. Vogel/ f
`Laura A. Vogel
`Registration No. 55,702
`Attorney for Petitioner
`
`3
`
`
`
`Wockhardt Bio AG’s Updated Exhibit List
`
`CERTIFICATION OF SERVICE ON PATENT OWNER
`
`
`
`Pursuant to 37 C.F.R. § 42.6 (e), the undersigned hereby certifies that the
`
`above-captioned “Wockhardt Bio AG’s Updated Exhibit List” was served in its
`
`entirety on September 17, 2015, by filing this document through the Patent
`
`Review Processing System, as well as e-mailing a copy to counsel of record for
`
`Patent Owner as follows:
`
`F. Dominic Cerrito
`nickcerrito@quinnemanuel.com
`Evangeline Shih
`evangelineshih@quinnemanuel.com
`Frank C. Calvosa
`frankcalvosa@quinnemanuel.com
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`
`John V. Biernacki
`jvbiernacki@jonesday.com
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114
`
`A courtesy copy of the foregoing was also served via e-mail on counsel of
`
`record for the Petitioner in Case Nos.: IPR2015-00545, IPR2015-00546, and
`
`IPR2015-00547 as follows:
`
`
`
`
`
`
`
`Wockhardt Bio AG’s Updated Exhibit List
`
`Matthew C. Ruedy
`mruedy@meiplaw.com
`Steven Maddox
`smaddox@meiplaw.com
`MADDOX EDWARDS, P.L.L.C.
`1900 K Street NW – Suite 725
`Washington, D.C. 20006
`
`And, upon counsel of record for the Petitioner in Case Nos.: IPR2015-
`
`00548, IPR2015-00551, and IPR2015-00554 as follows:
`
`Aziz Burgy
`aziz.burgy@arentfox.com
`Bradford Frese
`bradford.frese@arentfox.com
`XYREM@arentfox.com
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`
`
`Respectfully submitted,
`DUANE MORRIS LLP
`
`/Laura A. Vogel/ f
`Laura A. Vogel
`Registration No. 55,702
`Attorney for Petitioner
`
`
`
`
`Date: September 17, 2015
`100 High Street, Suite 2400
`Boston, MA 02110
`(857) 488-4200
`
`
`2
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