Paper No. __
`Filed: October 21, 2014
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`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 CBM2014-00151
`Patent 7,668,730
`________________
`
`JAZZ PHARMACEUTICALS, INC.’S EXHIBIT LIST AS OF
`October 21, 2014 PURSUANT TO 37 C.F.R. § 42.63(e)
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`Filed: October 21, 2014
`
`
`
`
`
`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 CBM2014-00151
`Patent 7,668,730
`________________
`
`JAZZ PHARMACEUTICALS, INC.’S EXHIBIT LIST AS OF
`October 21, 2014 PURSUANT TO 37 C.F.R. § 42.63(e)
`
`
`
`
`
`
`
`
`
`
`
`Case CBM2014-00151
`Patent 7,668,730
`Patent Owner’s Exhibit List
`
`
`DESCRIPTION
`PR Newswire, “FDA Issues GHB Warning,” (Nov. 8, 1990)
`U.S. Food & Drug Administration, “Import Alert 66-60,
`Detention Without Physical Examination of Certain Steroid
`Alternatives” (May 11, 1992)
`Centers for Disease Control, “Gamma Hydroxy Butyrate Use –
`New York and Texas, 1995-1996,” MMWR 46(13); 281-83
`(Apr. 4, 1997)
`National Institute on Drug Abuse, “NIDA Community Drug
`Alert Bulletin – Club Drugs” (Dec. 1999)
`Office of National Drug Control Policy, “Gamma
`Hydroxybutyrate (GHB)” (Nov. 2002)
`Date Rape Drugs, Hearing Before the Subcomm. on Oversight
`& Investigations of the H. Comm. on Commerce, 106th Cong.,
`58-66 (Mar. 11, 1999) (statement of Terrance W. Woodworth,
`Deputy Director, Office of Diversion Control, Drug
`Enforcement Administration)
`Substance Abuse and Mental Health Services Administration,
`“Advisory – GHB: A Club Drug to Watch” (Nov. 2002)
`National Drug Intelligence Center, “Information Bulletin: GHB
`Analogs: GBL, BD, GHV, and GVL” (Aug. 2002)
`Controlled and Uncontrolled Substances Used to Commit Date
`Rape, Hearing Before the Subcomm. on Crime of the H. Comm.
`on the Judiciary, 105th Cong. (July 30, 1998)
`Date Rape Drugs, Hearing Before the Subcomm. on Oversight
`& Investigations of the H. Comm. on Commerce, 106th Cong.
`(Mar. 11, 1999)
`Hillory J. Farias and Samantha Reid Date-Rape Drug
`Prohibition Act of 2000, Pub. L. No. 106-172, §§ 2(5)-(6), 114
`Stat. 7, 7-8 (Feb. 18, 2000)
`146 Cong. Rec. H55-62 (daily ed. Jan. 31, 2000)
`Letter from Dr. Robert Temple, Director, ODE I, to Dr. Dayton
`T. Reardan, Orphan Medical, Inc. (July 17, 2002)
`Letter from Dr. Russell Katz, Director, Division of Neurology
`Products, ODE I, to Dr. Dayton T. Reardan, Orphan Medical,
`Inc. (Nov. 18, 2005)
`
`
`
`EXHIBIT NO.
`Exhibit 2001
`Exhibit 2002
`
`Exhibit 2003
`
`Exhibit 2004
`
`Exhibit 2005
`
`Exhibit 2006
`
`Exhibit 2007
`
`Exhibit 2008
`
`Exhibit 2009
`
`Exhibit 2010
`
`Exhibit 2011
`
`Exhibit 2012
`Exhibit 2013
`
`Exhibit 2014
`
`
`
`
`
`Case CBM2014-00151
`Patent 7,668,730
`Patent Owner’s Exhibit List
`
`
`EXHIBIT NO.
`Exhibit 2015
`
`Exhibit 2016
`
`Exhibit 2017
`
`Exhibit 2018
`
`Exhibit 2019
`
`DESCRIPTION
`Patent Quality Improvement Act of 2013, S. 866, 113th Cong.
`§2(2) (2013)
`Stopping the Offensive Use of Patents Act, H.R. 2766, 113th
`Cong. § 2(a)(2) (2013)
`Wayback Machine, Archive of the URL corresponding to
`PAR1004
`(http://www.fda.gov/ohrms/dockets/ac/01/briefing/3754b1_02_s
`ection%203.pdf)
`Wayback Machine, Archive of the URL corresponding to
`PAR1005
`(http://www.fda.gov/ohrms/dockets/ac/01/briefing/3754b1_01_1
`-orphan-medical.pdf)
`Wayback Machine, Archive of the URL corresponding to
`PAR1006
`(http://www.fda.gov/ohrms/dockets/ac/01/briefing/3754b1_01_3
`-orphan-medical%20xyrem.MPG)
`
`
`Date: October 21, 2014
`
`
`
`
`Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito
` Reg. No. 38,100
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7450
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`
`John V. Biernacki
`Reg. No. 40,511
`JONES DAY
`North Point
`901 Lakeside Avenue
`
`
`
`Case CBM2014-00151
`Patent 7,668,730
`Patent Owner’s Exhibit List
`
`
`Cleveland, Ohio 44114
`General Tel: (216) 586-3939
`Direct Tel: (216) 586-7747
`Fax: (216) 579-0212
`jvbiernacki@jonesday.com
`
`Attorneys for Jazz Pharmaceuticals, Inc.
`
`
`
`
`
`
`
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`
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`
`
`
`
`
`
`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 CBM2014-00151
`Patent 7,668,730
`________________
`
`CERTIFICATE OF SERVICE
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certify that JAZZ
`
`PHARMACEUTICALS, INC.’S EXHIBIT LIST AS OF October 21, 2014 was
`
`served on October 21, 2014 by filing this document through the Patent Review
`
`Processing System, as well as e-mailing copies to aziz.burgy@arentfox.com,
`
`Bradford.frese@arentfox.com and XYREM@arentfox.com.
`
` Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito
` Reg. No. 38,100
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7450
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`
`John V. Biernacki
`Reg. No. 40,511
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, Ohio 44114
`General Tel: (216) 586-3939
`Direct Tel: (216) 586-7747
`Fax: (216) 579-0212
`jvbiernacki@jonesday.com
`Attorneys for Jazz Pharmaceuticals, Inc.
`
`Date: October 21, 2014
`
`
`
`
`
`
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