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 IPR2015-00545
`Patent 8,589,182
`_____________________
`
`AMNEAL PHARMACEUTICALS LLC and
`PAR PHARMACEUTICAL, INC.’S 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
`_____________________
`
`AMNEAL PHARMACEUTICALS LLC and
`PAR PHARMACEUTICAL, INC.
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`CASE IPR2015-00545
`Patent 8,589,182
`_____________________
`
`AMNEAL PHARMACEUTICALS LLC and
`PAR PHARMACEUTICAL, INC.’S 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
`
`
`
`Amneal Pharmaceuticals LLC and
` Par Pharmaceutical, Inc. Exhibit List
`
`
`
`Exhibit #
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`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)
`
`Lilly et al., U.S. Patent Appl. Pub. No. 2004/0176985 (filed
`Mar. 18, 2004; published Sep. 9, 2004) (“Lilly”)
`
`Honigfeld, G., “Effects of the Clozapine National Registry
`System on Incidence of Deaths Related to Agranulocytosis,”
`Psychiatric Services, 47:52-56 (1996)
`
`
`
`Amneal Pharmaceuticals LLC and
` Par Pharmaceutical, Inc. Exhibit List
`
`Exhibit #
`
`Description
`
`1012
`
`1013
`
`1014
`
`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)
`
`1015
`
`66 Fed. Reg. 24391
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`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)
`
`
`
`Amneal Pharmaceuticals LLC and
` Par Pharmaceutical, Inc. Exhibit List
`
`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
`
`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/
`
`1028
`
`Affidavit from the Internet Archive Wayback Machine
`
`1029
`
`1030
`
`1031
`
`1032
`
`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)
`
`
`
`
`
`
`AAmneal Phharmaceutiicals LLC
`and
`List
` Par
`
`
`Pharmaceeutical, Incc. Exhibit
`
`
`
`Exhhibit #
`
`
`
`Descrription
`
`TXi
`
`
`
`
`
`
`Talk Aboutt Sleep, “AAn Intervieww with Orpphan Mediical about
`
`
`
`
`
`Xyrem®,” aavailable aat http://wwww.talkabooutsleep.coom/an-
`
`
`nterview-wwith-orphann-medical--about-xyreem/ (“Talkk About
`
`
`
`
`Sleep”) (Feeb. 12, 200
`1)
`
`nS
`
`
`
`
`
`
`Honigfeld, G., et al., ““Reducingg Clozapinee-Related MMorbidity
`
`
`
`
`
`
`
`nnd Mortaliity: 5 Yearrs of Experrience withh the Clozaaril Nationaal
`
`-7 (“Honiggfeld”)
`
`
`
`Registry,” JJ. Clin. Pssych. 59 (suuppl. 3): 3
`1998)
`
`Ha
`
`R(
`
`
`
`. 28, 1998;;
`
`Elsayed et aal., U.S. Paatent No. 66,045,501 ((filed Aug
`
`
`
`
`
`
`
`sssued Apr. 4, 2000) ((“Elsayed””)
`
`
`
`Ei
`
`,
`
`4, 2001)
`
`
`
`
`UU.S. Provissional Appll. No. 60/3332,807 (fi
`led Nov. 1
`
`
`
`
`
`
`Jaazz Pharmmaceuticals Form 10-KK, (Annuall Report) ffor the
`
`
`
`pperiod endinng Decembber 31, 20
`14
`
`
`
`
`
`Complaint ffor Patent Infringemeent, Jazz PPharmaceutticals, Inc.
`
`
`
`
`
`v. Par Pharmmaceuticalls, Inc., 2:113-cv-078884 (Decemmber 27,
`013)
`
`
`
`
`
`DDeclarationn of Barry GGilman
`
`Cv2
`
`
`
`10033
`
`
`
`10034
`
`
`
`10035
`
`
`
`10036
`
`
`
`10037
`
`
`
`10038
`
`
`
`10039
`
`
`
`10040
`
` Hac Vice
`
`
`
`Declarationn of Stevenn A. Maddoox In Suppport of Pro
`
`
`
`DM
`
`
`
`
`Motion
`
`
`
`Respectfuully Submi
`
`tted,
`
`
`
`
`Dennies VVarughese
`
`Registratiion No. 61
`,868
`
`
`Attorney ffor Petitionner
`
`STERNEE, KESSLERR, GOLDSTEEIN & FOX PP.L.L.C.
`
`
`
`Date: Juuly 28, 20115
`
`
`
`
`
`
`
`1100 NNew York AAvenue, N..W.
`
`
`
`Washinngton, D.C. 20005-39934
`71-2600
`(202) 3
`
`
`
`and
`
`
`
`AAmneal Phharmaceutiicals LLC
`List
` Par
`
`
`Pharmaceeutical, Incc. Exhibit
`
`
`
`e)) R. § 42.6(eE (37 C.F.RSERVICETION OF SCERRTIFICAT
`
`
`
`
`
`
`
`
`
`
`
`TThe underrsigned heereby cerrtifies thatt the aboove-captionned "Ammneal
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Par Pharmmaceutical,, Inc.’s Exxhibit Listt," along wwith
`
`
`
`
`
`Pharmaaceuticals
`
`LLC and
`
`
`
`Exhibitt 1040, weere served
`
`
`
`
`
`in their enntirety on JJuly 28, 20015, upon
`
`
`
`
`
`
`
`the followwing
`
`
`
`parties via electroonic mail:
`
`
`
`to F. Domminic Cerrit
`
`51 Maddison Avennue
`
`
`
`
`Evangeeline Shih
`
`Frank CC. Calvosa
`URQUHART
`
`QUINN EEMANUEL
`T &
`
`SULLIVAAN LLP
`
`
`
`22nd Flloor
`
`
`New Yoork, NY 100010
`nemanuel.
`
`nickcerrrito@quin
`com
`
`
`
`evangellineshih@qquinnemannuel.com
`
`
`
`frankcaalvosa@quinnemanueel.com
`
`
`John VV. Biernackki
`
`
`
`JONES
`DAY
`Point
`North
`
`
`901 Laakeside Avvenue
`
`
`Clevelland, OH 444114
`
`
`
`
`
`jvbiernnacki@jonnesday.comm
`
`
`
`
`
`STERN
`
`
`
`Respeectfully subbmitted,
`
`
`
`NE, KESSLEER, GOLDSTTEIN & FOXX P.L.L.C.
`
`
`
`
`
`
`
`Denniies Varughhese
`. 61,868
`
`Registtration No
`
`
`Attornney for Pettitioner
`
`15 Date: Juuly 28, 201
`
`
`
`
`
`
`
`
`1100 NNew York AAvenue, N..W.
`
`
`
`Washinngton, D.C. 20005-39934
`71-2600
`(202) 3
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