UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR2015-005541
`Patent 7,668,730
`_____________________
`
`PETITIONERS’ EXHIBIT LIST
`(REPLY TO PATENT OWNER’S RESPONSE)
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`1 Case IPR2015-01818 has also been joined with this proceeding.
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR2015-005541
`Patent 7,668,730
`_____________________
`
`PETITIONERS’ EXHIBIT LIST
`(REPLY TO PATENT OWNER’S RESPONSE)
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`1 Case IPR2015-01818 has also been joined with this proceeding.
`
`
`
`IPR2015-00554 (Patent No. 7,668,730)
`Petitioners’ Exhibit List
`
`PAR
`Exhibit #
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`Reardan et al., U.S. Patent No. 7,895,059 (filed Feb. 11, 2010;
`issued Feb. 22, 2011)
`
`File History for U.S. Patent No. 7,895,059 (filed Feb. 11, 2010;
`issued Feb. 22, 2011)
`
`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. Valuck, 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)
`
`2
`
`
`
`IPR2015-00554 (Patent No. 7,668,730)
`Petitioners’ Exhibit List
`
`PAR
`Exhibit #
`
`Description
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`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)
`
`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)
`
`3
`
`
`
`IPR2015-00554 (Patent No. 7,668,730)
`Petitioners’ Exhibit List
`
`PAR
`Exhibit #
`
`Description
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`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
`
`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
`
`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)
`
`4
`
`
`
`IPR2015-00554 (Patent No. 7,668,730)
`Petitioners’ Exhibit List
`
`PAR
`Exhibit #
`
`Description
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`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)
`
`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)
`
`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
`
`Declaration of Barry Gilman
`
`Jazz Pharmaceuticals SEC Form 10-K (February 24, 2015)
`
`INTENTIONALLY LEFT BLANK
`
`INTENTIONALLY LEFT BLANK
`
`5
`
`
`
`IPR2015-00554 (Patent No. 7,668,730)
`Petitioners’ Exhibit List
`
`PAR
`Exhibit #
`
`Description
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`INTENTIONALLY LEFT BLANK
`
`Expert Questions Answered by Bryan Bergeron, Expert EV
`(2011)
`
`INTENTIONALLY LEFT BLANK
`
`File History Excerpt, U.S. Patent No. 7,668,730, Appeal Brief
`(filed July 18, 2007)
`
`File History Excerpt, U.S. Patent No. 7,668,730, Specification
`
`Webster’s Third New International Dictionary Excerpt
`
`Webster’s II New College Dictionary Excerpt
`
`Roget’s II The New Thesaurus 3d Edition Excerpt
`
`INTENTIONALLY LEFT BLANK
`
`Deposition Transcript of Bryan Bergeron, Vol. 1 (Jan. 21, 2016)
`
`Deposition Transcript of Bryan Bergeron, Vol. 2 (Jan. 22, 2016)
`
`Deposition Transcript of Joseph DiPiro, Day 1 (Feb. 3, 2016)
`
`Deposition Transcript of Joseph DiPiro, Day 2 (Feb. 4, 2016)
`
`FDA Guidance for Industry (December 1999)
`
`Third Affidavit of Christopher Butler (Internet Wayback
`Machine)
`
`6
`
`
`
`Date: February 19, 2016
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`
`IPR2015-00554 (Patent No. 7,668,730)
`Petitioners’ Exhibit List
`
`Respectfully submitted,
`
`Bradford C. Frese
`Registration No. 69,772
`Attorney for Petitioner Par Pharmaceutical,
`Inc.
`
`7
`
`
`
`IPR2015-00554 (Patent No. 7,668,730)
`Petitioners’ Exhibit List
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e))
`
`The undersigned hereby certifies that the above-captioned Petitioners’ Exhibit
`
`List, along with Exhibits 1045, 1047-1051, and 1053-1058, were served in their
`
`entirety on February 19, 2016, upon the following parties via electronic mail.
`
`F. Dominic Cerrito
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`nickcerrito@quinnemanuel.com
`
`John V. Biernacki
`Jones Day
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114
`jvbiernacki@jonesday.com
`
`known
`addresses
`Additional
`Petitioner as likely to effect service
`
`to
`
`Date: February 19, 2016
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`
`Respectfully submitted,
`
`Bradford C. Frese
`Registration No. 69,772
`Attorney for Petitioner Par
`Pharmaceutical, Inc.
`
`8
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