Coalition For Affordable Drugs VI LLC vs Celgene Corporation

Notice of Appeal

Denying Patent Owner's Request for Rehearing

Patent Owner Rehearing Request

Patent Owner Rehearing Request (copy of Nov 25, 2016)

Final Written Decision

Record of Oral Hearing

Patent Owner Demonstratives

Petitioner's Demonstrative Exhibits 1 of 2

Petitioner's Demonstrative Exhibits 2 of 2

Petitioner's Reply in Support of Motion to Exclude Patent Owner's Evidence

Patent Owner Reply Motion to Exclude

Petitioner's Opposition to Patent Owner's Sur-Reply

Order - re Oral Hearing

Patent Owner Opposition to Petitioner's Motion to Exclude

Petitioner's Response to Patent Owner's Motion to Exclude Evidence

Petitioner's Updated Exhibit List as of June 30, 2016

2016.05.25 Electronic Correspondence with PTAB

Patent Owner Motion to Strike

Patent Owner Exhibit List

Exhibit 2112

Order - Conduct of the Proceedings

Patent Owner Exhibit List

Patent Owner Motion to Exclude Evidence

Petitioner's Motion to Exclude Patent Owner's Evidence

Exhibit 2111

Petitioner's Request for Oral Argument

Patent Owner Request for Oral Argument

Notice of Joint Stipulation to Modify Trial Due Date 4

Patent Owner Objections

Petitioner's Reply to Patent Owner's Response

Petitioner's Motion to Seal

Petitioner's Updated Exhibit List

Managing the teratogenic risk of thalidomide and lenalidomide - an industry perspective

2013 Rho Chi Lecture - Writing the Headlines of Tomorrow

DiPiro Transcript Volume 1 and 2 (PROTECTED)

DiPiro Transcript Volume 1 and 2 (PUBLIC)

Frau Transcript Volume 1 and 2 (PROTECTED)

Frau Transcript Volume 1 and 2 (PUBLIC)

STEPS - A Comprehensive Program for Controlling and Monitoring Access to Thalidomide

Dr. Frau Deposition Excerpt

Dr. Frau Deposition Excerpt

Dr. Frau Deposition Excerpt Part 1 of 2

Dr. Frau Deposition Excerpt Part 2 of 2

Dr. Frau Deposition Excerpt Part 1 of 2

Dr. Frau Deposition Excerpt Part 2 of 2

Dr. Frau Deposition Excerpt

Notice of Joint Stipulation to Change Due Date 2

Decision Pro Hac Vice Motion

Petitioner's Reply In Support of Motion to Submit Supplemental Information

Petitioner's Notice of Deposition of Dr. Lourdes M. Frau

Petitioner's Notice of Deposition of Joseph T. DiPiro

Petitioner's Motion for Pro Hac Vice Admission of Sadaf Abdullah

Petitioner's Updated Exhibit List

Declaration of Sadaf Abdullah

Patent Owner Opposition to Motion to Submit Supplemental Information

CONFIDENTIAL Declaration of Lourdes M. Frau, M.D., FAAP, FISPE

REDACTED Declaration of Lourdes M. Frau, M.D., FAAP, FISPE

CONFIDENTIAL Declaration of Joseph T. DiPiro, Pharm.D.

REDACTED Declaration of Joseph T. DiPiro, Pharm.D.

Patent Owner Exhibit List

Motion to Seal and for Entry of Protective Order

Patent Owner Response

Intentionally Left Blank

Chart of Cited Prior Art prepared by CFAD expert Dr. Jeffrey Fudin

Listing of Cited Prior Art prepared by CFAD expert Dr. Jeffrey Fudin

Talsma, J. - New Clozapine REMS program changes monitoring, dispensing requirements (2015)

CONFIDENTIAL Declaration of Lourdes M. Frau, M.D., FAAP, FISPE

REDACTED Declaration of Lourdes M. Frau, M.D., FAAP, FISPE

CONFIDENTIAL Declaration of Joseph T. DiPiro, Pharm.D.

REDACTED Declaration of Joseph T. DiPiro, Pharm.D.

January 7 and 8 2016 Deposition of Dr. Jeffery Fudin Volumes 1 and 2

Drugs at FDA, FDA Approved Drug Products - Vasotec

Marwick, C. - Thalidomide Back--Under Strict Control (1997)

Vanchieri, C. - Preparing for Thalidomide Comeback (1997)

Monmaney, T. - Thalidomide reemerges as potential wonder drug Medicine, A Notorious Cause of Birth Defects, It Is Now being Tested for Use Against Leprosy, Aids and Cancer (1998)

Young, C.R. - Management of the Adverse Effects of Clozapine (1998)

Website Bio of Dr. Allen A. Mitchell, M.D., Director Slone Epidemiology Center, Boston University

Expunged

CONFIDENTIAL Declaration of John Freeman, Corporate VP, Head of Global Drug Safety and Risk Management, Celgene Corporation

REDACTED Declaration of John Freeman, Corporate VP, Head of Global Drug Safety and Risk Management, Celgene Corporation

Leonard, M. - Thalidomide returns, as do fears (1997)

Allen, W. - The Return of Thalidomide, Are we Ready to Forget Images Like This and Give the Drug Another Chance (1997)

Drugs at FDA, FDA Approved Drug Products - Depakene

Physicians Desk Reference - Depakote (1998)

Practice Parameter, Management Issues for Women with Epilepsy (Summary Statement) (1998)

Yerby, M. - Contraception, pregnancy and lactation in women with epilepsy (1996)

Canger, R. - Malformations in Offspring of Women with Epilepsy, A Prospective Study (1999)

Lipton, R. - Prevalence and Burden of Migraine in the United States, Data From the American Migraine Study II (2001)

Drugs at FDA, FDA Approved Drug Products - Indocin

Norton - Teratogen Update, Fetal Effects of Indomethacin Administration During Pregnancy (1997)

Achiron, - In Utero Congestive Heart Failure Due to Material Indomethacin Treatment for Polyhydramnios and Premature Labour in a Fetus with Antenatal Closure of the Foramen Ovale (1996)

Pomeranz - Acute renal failure in the neonate induced by the administration of indomethacin as a tocolytic agent (1996)

Physicians Desk Reference - Indocin (1998)

Lawrence - Estimates of the Prevalence of Arthritis and Selected Musculoskeletal Disorders in the United States (1998)

Barr - Teratogen Update, Angiotensin-Converting Enzyme Inhibitors (1994)

Physicians Desk Reference - Vasotec (1998)

Physicians Desk Reference - Cozaar (1998)

Burt - Prevalence of Hypertension in the US Adult Population (1995)

Siegel - Trends in Antihypertensive Drug Use in the United States (1997)

Drugs at FDA FDA Approved Drug Products - Coumadin

Raivio - Fetal Risks Due to Warfarin Therapy During Pregnancy (1977)

Baillie - The Congenital warfarin syndrome, a case report (1980)

Astedt - Antenatal Drugs Affecting Vitamin K Status of the Fetus and the Newborn (1995)

Physicians Desk Reference - Coumadin (1998)

21 C.F.R. Section 201 (Subpart B) (April 1, 1998)

Transcript of the FDA Forty-Seventh Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee Sept. 4, 1997

Transcript of the FDA Forty-Seventh Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee Sept. 5, 1997

Drugs at FDA, FDA Approved Drug Products - Cozaar

Ault - Thalidomide comes close to US approval (1997)

Miller - Teratogen Update, Thalidomide, A Review, With a Focus on Ocular Findings and New Potential Uses (1999)

Institute for Alternative Futures, Optimal Futures for Risk Evaluation and Mitigation Strategies (REMS) Workshop Report (2010)

THALOMID Package Insert (July 1998)

S.T.E.P.S. Physician Registration Card

S.T.E.P.S. Instructions for Physicians

S.T.E.P.S. Dear Dr. Letter

S.T.E.P.S. Pharmacy Registration Card

S.T.E.P.S. Dear Pharmacist Letter

S.T.E.P.S. Patient Registration Form

CONFIDENTIAL Commercial Outsourcing Services Agreement between Alternate Site Distributors Inc. and Celgene Corporation, Inc. (1997)

Drugs at FDA, FDA Approved Drug Products - Depakote

Selected portions of the CDC online history of the National Center on Birth Defects and Developmental Disabilities

Physicians Desk Reference - Depakene (1998)

Motion to Submit Supplemental Information

Petitioner's Updated Exhibit List

IDS, Application No. 12 966,261

Federal Register Volume 62, Number 53

IDS, Application No. 12 966,240

Petitioner's Updated Mandatory Notice

Petitioner's Updated Mandatory Notice

Petitioners' ADR Statement

Order

Order Motions for Pro Hac Vice Admission of Andrew S. Chalson and Paul J. Skiermont

Paul Skiermont Pro Hac Vice Motion

Petitioner Updated Exhibit List

Paul Skiermont Declaration

Power of Attorney

Patent Owner Updated Mandatory Notices

Patent Owner Exhibit List

Patent Owner Unopposed Motion for Pro Hac Vice Admission of Andrew S. Chalson

Declaration of Andrew S. Chalson in Support of Patent Owner Unopposed Pro Hac Vice Motion

Notice of Joint Stipulation to Modify Due Dates 1 and 2

Notice of Deposition of Jeffrey Fudin

Patent Owner Objections

Decision - Instituting Inter Partes Review - 37 CFR 42.108

Scheduling Order

Expunged

Decision - Denying Sanctions Motion - 37 C.F.R. 42.12

DECISION Motion to Withdraw Exhibit

Order Conduct of the Proceeding

Patent Owner Reply to Sanctions Motion

Petitioner's Unopposed Motion to Withdraw Wu Declaration

Sanctions Opposition_IPR2015_01092

Petitioner's Current Exhibit List

FDA Orange Book Listings for '501 Patent

FDA Orange Book Listings for '720 Patents

Revlimid Pricing 2015

Thalomid Pricing 2015

Pomalyst Pricing 2015

Celgene v. Barr Complaint

Celgene v. Natco Original Complaint

Celgene v. Lannett Complaint

Barr Stipulated Agreement of Dismissal

Bricklayers v. Celgene Antitrust complaint

Celgene Motion to Bifurcate and Stay REMS Patents

Order granting Celgene motion to bifurcation and Stay of Rems (Natco)

Thalomid OB Patents

Revlimid OB Patents

Pomalyst OB Patents

FTC innovation report_October 2003

Evergreening (Dwivedi)

FTC Staff Study January 2010 pay for delay costs billions

FTC Statement May 2015

CEPR Study_Cost of Pharma IPR exemption

Wu Declaration

Recent review house subcomittee hearing

AIA House subcomittee hearing 112th Cong. 29 (2011)

Neumann Shepard's Report

CV Juan Wu Aug2015

Diether et al JF 2009

Political and Regulatory Timeline Exhibit

Excerpts from Reg SHO final rule

Karpoff and Lou 2010 JF

Fang et al JF 2015 forthcoming

Boeher and Wu

Boehmer Jones and Zhang

Massa Zhang and Zhang RFS 2015 forthcoming

Massa Zhang and Zhang WP

He_Tian

Dechow JFE

Akbas WP

Engelberg

Diether

Lamont Testimony

Patent Owner Exhibit List

Patent Owner Preliminary Response

Patent Owner Motion for Sanctions

Thalomid June 2014 Package Insert

Dr. V. Pannikar, WHO - The Return of Thalidomide, New Uses and Renewed Concerns

Revlimid February 2015 Package Insert

Pomalyst April 2015 Package Insert

FDA website - About the FDA (2014)

May 2006 Thalomid FDA approval letter

December 2005 Revlimid FDA approval letter

February 2013 Pomalyst FDA approval letter

Koren, G., et al - Drugs in Pregnancy (1998)

Celgene January 2005 Form 8-K

Kirn, T. - Mandatory FDA restrictions on the way for isotretinoin, voluntary programs deemed ineffective (2005)

PR Newswire Isotretinoin Makers Reach Agreement with Celgene on S.T.E.P.S. Risk Management Patents

The Wayback Machine - Frequently Asked Questions

The Wayback Machine, Search Results for http//rarediseases.info.nih.gov/ord/

The Wayback Machine - Office of Rare Diseases

FDA Orphan Drug Designations and Approvals for Thalidomide

FDA Orphan Drug Designations and Approvals for Lenalidomide

FDA Orphan Drug Designations and Approvals for Pomalidomide

Celgene December 2014 Form 10-K

PR Newswire, - NORD Honors Celgene Corporation for Development of THALOMID(R) (thalidomide) (1999)

Uhl, Kathleen, et al. - Thalidomide Use in the US, Experience with Pregnancy Testing in the S.T.E.P.S. Programme (2006)

Center for Drug Evaluation and Research, FDA - Transcript 47th Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee (1997)

FDA, Transcript, Thalidomide, Potential Benefits and Risk Open Public Scientific Workshop (1997)

FDA, Transcript, Thalidomide, Potential Benefits and Risk Open Public Scientific Workshop (1997)

Warren, R. - TVAC Position On The Return Of Thalidomide, Living In A World with THALIDOMIDE, A New Reality (1998)

Delaware Department of State, Division of Corporations, Coalition for Affordable Drugs

Delaware Department of State - Division of Corporations, Coalition for Affordable Drugs VI LLC - Entity Details

The Wall Street Journal, New Hedge Fund Strategy - Dispute the Patent, Short the Stock (2015)

Business Insider - Hedge Fund Manager Kyle Bass Is Going After Big Pharma And Its BS Patents (2015)

Hayman Capital Management, L.P. June 2015 Form ADV Part 2A Brochure

The Wall Street Journal - Innovate or Else - Kyle Bass Strikes Again and Challenges Shire Patents (2015)

Dallas Observer - Dallas Erich Spangenberg is Very Proud to be Americas Biggest Patent Troll (2013)

January 2014 Spangenberg/IPNav email threatening IPRs

January 2014 Spangenberg/IPNav threatened 501 patent IPR petition

January 2014 Spangenberg/IPNav threatened 501 patent IPR declaration

January 2014 Spangenberg/IPNav threatened 720 patent obviousness IPR petition

January 2014 Spangenberg/IPNav threatened 720 patent obviousness IPR declaration

January 2014 Spangenberg/IPNav threatened 720 patent anticipation IPR petition

January 2014 Spangenberg/IPNav threatened 720 patent anticipation IPR declaration

January 2014 Spangenberg/IPNav patent family tree

July 2014 IRDP email threatening IPRs

July 2014 IRDP threatened 501 patent IPR petition

July 2014 IRDP threatened 501 patent IPR declaration

July 2014 IRDP threatened 720 patent obviousness IPR petition

July 2014 IRDP threatened 720 patent obviousness IPR declaration

July 2014 IRDP threatened 720 patent anticipation IPR petition

July 2014 IRDP threatened 720 patent anticipation IPR declaration

July 2014 IRDP patent family tree

Law360 - Shire Drugs Are Next Targets of Hedge Fund AIA Reviews (2015)

Hayman Capital Management, L.P. - Statement of J. Kyle Bass Chief Investment Officer, Hayman Capital Management, L.P. (2015)

Reuters - U.S. hedge fund plans to take on big pharma over patents (2015)

Pharma, The Catalyst - What They Are Saying, Close Patent Loopholes That Threaten Innovation for Patients (2015)

IP Watchdog - Senator Coons - Patents Are about the American Dream (2015)

Petitioner's Updated Mandatory Notice

Power of Attorney

Power of Attorney

Order - Authorizing Patent Owner's Motion for Sanctions - 37 CFR 42.12

Related Matters

Notice of FIling Date Accorded to Petition

Petition For Inter Partes Review of U.S. Patent No. 6,045,501

Power of Attorney

U.S. Patent No. 6,045,501

Fudin Declaration

Sloane

U.S. Patent No. 6,045,501 Prosecution History

Powell

Mitchell

Dishman

CDC

Honigfeld

Bastani

Yang

Gardner

Federal Register

Fudin CV

NIH

FDA Thalomid Approval Letters

NIH Press Release

Mann