Amneal Pharmaceuticals, LLC et al. vs Jazz Pharmaceuticals, Inc.

Notice of Refund

Petitioner's Request for Refund of Fees

Decision - Denying Institution of Covered Business Method Patent Review

Finance Definition, Merriam-Webster.com

Patent Owner Exhibit List

Patent Owner Preliminary Response

PR Newswire, FDA Issues GHB Warning, (Nov. 8, 1990)

FDA, Import Alert, Detention Without Physical Examination of Certain Steroid Alternatives (May 11, 1992)

CDC, GHB Use New York and Texas, 1995-1996, MMWR 46(13), 281-83 (Apr. 4, 1997)

NIDA, NIDA Community Drug Alert Bulletin, Club Drugs (Dec. 1999)

ONDCP, Gamma Hydroxybutyrate (Nov. 2002)

Date Rape Drugs, Hearing Before the Subcomm. on Oversight and Investigations of the H. Comm. on Commerce, 106th Cong., 58-66 (Mar. 11, 1999)

SAMHSA, Advisory GHB, A Club Drug to Watch (Nov. 2002)

NDIC, Information Bulletin, GHB Analogs (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, secs 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)

Patent Quality Improvement Act of 2013, S. 866, 113th Cong. sec. 2(2) (2013)

Stopping the Offensive Use of Patents Act, H.R. 2766, 113th Cong. sec 2(a)(2) (2013)

Wayback Machine, Archive of the URL corresponding to AMN1004

Wayback Machine, Archive of the URL corresponding to AMN1005

Wayback Machine, Archive of the URL corresponding to AMN1006

Notice of Filing Date Accorded to Petition

Power of Attorney

Power of Attorney

Patent Owner Mandatory Notices

Petition for Covered Business Method Patent Review of U.S. Patent No. 7,895,059

Power of Attorney

Power of Attorney

Power of Attorney

Petitioner's Exhibit List

U.S. Patent No. 7,895,059

File History for U.S. Patent No. 7,895,059 - Part 1

File History for U.S. Patent No. 7,895,059 - Part 2

FDA Advisory Committee, Transcript and Slides - Part 1

FDA Advisory Committee, Transcript and Slides - Part 2

FDA Advisory Committee, Transcript and Slides - Part 3

FDA Advisory Committee, Transcript and Slides - Part 4

FDA Advisory Committee Preliminary Clinical Safety Review

FDA Advisory Committee Briefing Booklet - Part 1

FDA Advisory Committee Briefing Booklet - Part 2

FDA Advisory Committee Xyrem Video Transcript

FDA Advisory Committee Xyrem Video - Part 1

FDA Advisory Committee Xyrem Video - Part 2

FDA Advisory Committee Xyrem Video - Part 3

FDA Advisory Committee Xyrem Video - Part 4

FDA Advisory Committee Xyrem Video - Part 5

FDA Advisory Committee Xyrem Video - Part 6

FDA Advisory Committee Xyrem Video - Part 7

FDA Advisory Committee Xyrem Video - Part 8

FDA Advisory Committee Xyrem Video - Part 9

FDA Advisory Committee Xyrem Video - Part 10

FDA Advisory Committee Xyrem Video - Part 11

FDA Advisory Committee Xyrem Video - Part 12

FDA Advisory Committee Xyrem Video - Part 13

FDA Advisory Committee Xyrem Video - Part 14

Robert J. Valuck Declaration

Curriculum Vitae of Dr. Robert J. Valuck, Ph.D., R.Ph.

Shulman, The Broader Message of Accutane

Spurgeon, Advent of Mail-Order Pharmacy Causes Concern Among Some Pharmacists

Honigfeld, Effects of the Clozapine National Registry System on Incidence of Deaths Related to Agranulocytosis

Burleson, Review of computer applications in institutional pharmacy

Zeldis, A comprehensive Program for Controlling and Monitoring Access to Thalidomide

Managing the Risks from Medical Product Use

66 Fed. Reg. 24391

File History for U.S. Patent No. 7,668,730 - Part 1

File History for U.S. Patent No. 7,668,730 - Part 2

File History for U.S. Patent No. 7,668,730 - Part 3

File History for U.S. Patent No. 7,668,730 - Part 4

File History for U.S. Patent No. 7,668,730 - Part 5

FDA Advisory Committee Meeting Documents by Center

FDA Advisory Committee Internet Archive Wayback Machine

FDA Advisory Committee Briefing Information for Xyrem

Advisory Committee Meeting October 4, 2001

Orange Book Entries for Xyrem

Rome, Rave culture and illicit drug use in the young

FDA Approved Labeling

Amneal Complaint

Roxane Complaint

Par Pharmaceuticals Complaint - Part 1

Par Pharmaceutical Complaint - Part 2

Par Pharmaceutical Complaint - Part 3

Par Pharmaceutical Complaint - Part 4

Advisory Committees CDER 2001 Meeting Documents

Affidavit from the Internet Archive Wayback Machine

Mitchell, A Pregnancy-Prevention Program in Women of Childbearing Age Receiving Isotretinoin

U.S. Patent Publication 2004/0019794

U.S. Patent Publication 2003/0093295

Scrima, The Effects of y-Hydroxybutyrate on the Sleep of Narcolepsy Patients