`Par and Amneal Exhibit List
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`AMNEAL PHARMACEUTICALS, LLC and
`PAR PHARMACEUTICAL, INC
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`CASE IPR: Unassigned
`Patent 7,668,730
`_____________________
`
`PAR PHARMACEUTICAL, INC., AND
`AMNEAL PHARMACEUTICALS, LLC’S EXHIBIT LIST
`(PETITION FOR INTER PARTES 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
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`Par
`Exhibit #
`
`Inter Partes Review of USPN 7,668,730
`Par and Amneal Exhibit List
`
`Description
`
`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`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
`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)
`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)
`
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`2
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`
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`Inter Partes Review of USPN 7,668,730
`Par and Amneal Exhibit List
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`Par
`Exhibit #
`
`Description
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`1014
`
`1015
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`1016
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`1017
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`1018
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`1019
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`1020
`
`1021
`
`1022
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`“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)
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`3
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`Par
`Exhibit #
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`1023
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`1024
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`1025
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`1026
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`1027
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`Inter Partes Review of USPN 7,668,730
`Par and Amneal Exhibit List
`
`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
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`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/
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`1028
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`Affidavit from the Internet Archive Wayback Machine
`
`1029
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`1030
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`1031
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`1032
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`1033
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`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).
`Talk About Sleep, “An Interview with Orphan Medical,”
`available at http://www.talkaboutsleep.com/an-interview-with-
`orphan-medical-about-xyrem/ (last visited Dec. 15, 2014) (Feb.
`12, 2001)
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`4
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`Par
`Exhibit #
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`1034
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`1035
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`1036
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`1037
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`1038
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`1039
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`Inter Partes Review of USPN 7,668,730
`Par and Amneal Exhibit List
`
`Description
`
`Honigfeld, G., et al., “Reducing Clozapine-Related Morbidity
`and Mortality: 5 Years of Experience with the Clozaril National
`Registry,” Journal of Clinical Psychiatry 59 (suppl. 3): 3-7
`(1998)
`Elsayed et al., U.S. Patent No. 6,045,501 (filed Aug. 28, 1998;
`issued Apr. 4, 2000)
`Lilly et al., U.S. Patent Application No. 2004/0176985 A1 (filed
`Mar. 18, 2004 and claiming priority to U.S. Patent Application
`No. 10/062,251, filed Jan. 31, 2002; published Sep. 9, 2004)
`(“Lilly”)
`U.S. Provisional Patent Application Ser. No. 60/332,807 (“’807
`application) filed November 14, 2001.
`INTENTIONALLY LEFT BLANK
`January 13, 2014 Email from A. Burgy to G. Brier, re: Jazz v.
`Par, Civil Action No. 13-7884
`
`
`Respectfully Submitted,
`
`
`
`
`Aziz Burgy
`Registration No. 51,514
`Attorney for Petitioner
`
`
`
`
`
`Date: January 8, 2015
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`
`
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`5
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`Inter Partes Review of USPN 7,668,730
`Par and Amneal Exhibit List
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`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`
`The undersigned hereby certifies that the above-captioned "Par Pharmaceutical,
`
`Inc., and Amneal Pharmacuticals, LLC’s Exhibit List," along with Exhibits
`
`PAR1001 - 1039, were served in their entirety on January 8, 2015, upon the
`
`F. Dominic Cerrito
`Eric C. Stops
`Gabriel P. Brier
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`
`Richard G. Greco
`RICHARD G. GRECO PC
`90 State Street, Suite 700
`Albany, New York 12207
`
`
`John V. Biernacki
`Jones Day
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114
`
`Additional address known to
`Petitioner as likely to effect service
`
`
`following parties via Express mail:
`
`Schwegman Lundberg &
`Woessner/Jazz Pharmaceutical
`P.O. Box 2938
`Minneapolis, MN 55402
`
`Patent owner’s correspondence
`address of record for U.S. Patent No.
`7,668,730
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`Inter Partes Review of USPN 7,668,730
`Par and Amneal Exhibit List
`
`Respectfully submitted,
`
`
`ARENT FOX LLP
`Aziz Burgy
`Registration No. 51,514
`Attorney for Petitioner
`
`
`
`
`
`Date: January 8, 2015
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000