`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC., and
`ROXANE LABORATORIES, INC.
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`CASE IPR: Unassigned
`Patent 7,668,730
`_____________________
`
`
`
`
`
`PAR PHARMACEUTICAL, INC., AND ROXANE LABORATORIES,
`INC.’S EXHIBIT LIST (COVERED BUSINESS METHOD PATENT
`REVIEW OF U.S. PATENT NO. 7,668,730 )
`
`
`
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Covered Business Method Patent Review of USPN 7,668,730
`Par and Roxane Exhibit List
`
`
`
`Par
`Exhibit #
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`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
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Briefing Information, Division of
`Neuropharmacological Drug Products Preliminary Clinical
`Safety Review of NDA 21-196
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Briefing Information, Briefing Booklet
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Briefing Information, Xyrem Video and Transcript
`Declaration of Dr. Robert J. Valcuk, Ph.D., R.Ph. (“Valuck
`Dec.”)
`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.™: A comprehensive Program for
`Controlling and Monitoring Access to Thalidomide,” Clin.
`Therapeutics, 21:319-330 (1999)
`
`
`
`2
`
`
`
`Covered Business Method Patent Review of USPN 7,668,730
`Par and Roxane Exhibit List
`
`Par
`Exhibit #
`
`Description
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`“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)
`66 Fed. Reg. 24391
`
`INTENTIONALLY LEFT BLANK
`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)
`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.g
`ov/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=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)
`
`
`
`3
`
`
`
`Covered Business Method Patent Review of USPN 7,668,730
`Par and Roxane Exhibit List
`
`Par
`Exhibit #
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`Description
`
`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
`
`Complaint, Jazz Pharms., Inc. v. Roxane Labs., Inc., 2:11-cv-
`02523 (D.N.J. May 5, 2011)
`
`Complaint, Jazz Pharms., Inc. v. Par Pharm., Inc., 2:13-cv-
`07884 (D.N.J. Dec. 27, 2013)
`
`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
`
`1030
`
`1031
`
`1032
`
`Mitchell, A., “A Pregnancy-Prevention Program in Women of
`Childbearing Age Receiving Isotretinoin,” The New England
`Journal of Medicine, 333:101-106 (1995)
`
`Moradi et al., U.S. Patent Appl. Pub. No. 2004/0019794 (filed
`Jul. 29, 2002; published Jan. 29, 2004)
`
`Lilly et al., U.S. Patent Appl. Pub. No. 2003/0093295 (filed Jan.
`31, 2002; published May 15, 2003)
`Scrima, L., et al., “Efficacy of Gamma-Hydroxybutyrate versus
`Placebo in Treating Narcolepsy-Cataplexy: Double-Blind
`Subjective Measures,” Biol. Psychiatry, 26:331-343 (1989).
`
`
`
`
`
`
`
`4
`
`
`
`Covered Business Method Patent Review of USPN 7,668, 730
`Par and Roxane Exhibit List
`
`Respectfully Submitted,
`
`fisg
`
`Aziz Burgy
`Registration No. 51,514
`Attorney for Petitioner
`
`Date: July 8, 2014
`ARENT Fox LLP
`
`1717 K Street, NW
`Washington, DC 20036
`202.857.6000
`
`
`
`Covered Business Method Patent Review of USPN 7,668, 730
`Par and Roxane Exhibit List
`
`CERTIFICATION OF SERVICE 137 C.F.R. §§ 42.6194, 42.1051an
`
`The undersigned hereby certifies that the above—captioned ”Par Pharmaceutical,
`
`Inc., and Roxane Laboratories, Inc’s Exhibit List," along with Exhibits PAR1001
`
`- 1032, were served in their entirety on July 9, 2014, upon the following parties
`
`Via Express mail:
`
`Schwegman Lundberg &
`Woessner/Jazz Pharmaceutical
`
`F. Dominic Cerrito
`Eric C. Stops
`Gabriel P. Brier
`
`PO. Box 293 8
`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 efi’ect service
`
`Respectfully submitted,
`
`ARENT Fox LLP
`
`Aziz Burgy
`Registration No. 51,514
`Attorney for Petitioner
`
`’72! 7‘!
`Date:
`ARENT Fox LLP
`
`-/
`
`7
`
`1717 K Street, NW
`Washington, DC 20036
`202.857.6000
`
`