Roxane Laboratories, Inc. et al. vs Jazz Pharmaceuticals Inc.

Notice of Refund

Refund Request

Decision Denying Institution of Covered Business Method Patent Review

Ex 3001

UPDATED MANDATORY NOTICE

107 Mandatory Notice

Patent Owner Updated Mandatory Notices

Patent Owner Exhibit List

Patent Owner Preliminary Response

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

FDA, Import Alert 66-60, Detention Without Physical Examination of Certain Steroid Alternatives (May 11, 1992)

CDC, Gamma Hydroxy Butyrate Use, 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 and 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 ROX1004

Wayback Machine, Archive of the URL corresponding to ROX1005

Wayback Machine, Archive of the URL corresponding to ROX1006

Power of Attorney

Related Matters

Power of Attorney

Notice of Filing Date Accorded to Petition

Petition

Roxane and Par Exhibit List

Power of Attorney

Power of Attorney

U.S. Patent No. 7,765,107

File History for U.S. Patent No. 7,765,107

Advisory Committee Transcript and Slides Part 1

Advisory Committee Transcript and Slides Part 2

Advisory Committee Transcript and Slides Part 3

Advisory Committee Transcript and Slides Part 4

Preliminary Clinical Safety Review

Briefing Booklet Part 1

Briefing Booklet Part 2

Xyrem Video Transcript

Xyrem Video Part 1

Xyrem Video Part 2

Xyrem Video Part 3

Xyrem Video Part 4

Xyrem Video Part 5

Xyrem Video Part 6

Xyrem Video Part 7

Xyrem Video Part 8

Xyrem Video Part 9

Xyrem Video Part 10

Xyrem Video Part 11

Xyrem Video Part 12

Xyrem Video Part 13

Xyrem Video Part 14

Declaration of Dr. Valuck

Dr. Valuck CV

Shulman

Spurgeon

Honigfeld 1996

Burleson 1982

Zeldis

Report to the FDA Commissioner from the Task Force on Risk Management

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

2001 FDA Advisory Committee's Meeting Documents by Center

Center for Drug Evaluation and Research 2001 Meeting Documents June 17 2001

Briefing Information July 1 2001

2001 Meeting Documents October 4 2001

Xyrem OB Entries

Rome

NDA 21-196 Approved Labeling

Roxane Complaint

Par Complaint Part 1

Par Complaint Part 2

Par Complaint Part 3

Par Complaint Part 4

Advisory Committees CDER 2001 Meeting Documents

Wayback Machine Affidavit

Mitchell

Moradi

Lilly

Scrima