Generic drugs : the pay-for-delay problem / Christina M. Curtin, editor.

Format:

Book

Contributor:

Curtin, Christina M.

Series:

Public health in the 21st century series.

Public health in the 21st century

Language:

English

Subjects (All):

Generic drugs--Prices.

Generic drugs.

Drugs--Prices.

Drugs.

Pharmaceutical industry--United States.

Pharmaceutical industry.

Physical Description:

1 online resource (138 p.)

Edition:

1st ed.

Place of Publication:

New York : Nova Biomedical/Nova Science Publishers, c2011.

Language Note:

English

Summary:

'Pay-for-delay' agreements have arisen as part of patent litigation settlement agreements between brand-name and generic pharmaceutical companies. This title examines the 'pay-for-delay' program and how drug company pay-offs cost consumers billions.

Contents:

Intro

Library of Congress Cataloging-in-Publication Data

Contents

Preface

Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions

Summary

Recommendation

Background

Findings from Pharmaceutical Agreement Filings from FY2004 through FY2009

Study Methodology

How Staff Calculated the Additional Delay in Generic Entry Associated with Agreements that Involved Compensation from the Brand to the Generic

How Staff Calculated the Estimate of 3.5 Billion Annually that Consumers Lose due to Pay-For-Delay Agreements

(1) Consumer savings from generic competition

(2) Likelihood of Settlements with Payment to Delay, and the Length of Delay

(3) Sales Volume of Drugs for which Settlements are Likely

(4) Final Estimate Calculation

Results with Varied Assumptions

End Notes

"Pay-for-Delay" Settlements in the Pharmaceutical Industry: How Congress Can Stop Anticompetitive Conduct, Protect Consumers' Wallets, and Help Pay for Health Care Reform (The 35 Billion Solution)

A Brief History

New FTC Analysis of Empirical Data

Savings to Consumers and the Federal Government

Encouraging Signs

Looking Forward

Appendix: Calculation of Consumer Savings

Consumer Savings from Generic Competition

Likelihood of Settlements with Payment to Delay, and the Length of Delay

Sales Volume of Drugs for which Settlements are Likely

Final Estimate Calculation

Statement of the Federal Trade Commission, before the Subcommittee on Courts and43

Competition Policy, Hearing on "Anticompetitive Pay-for-Delay Settlements in the Pharmaceutical Industry: Why Consumers and the Federal Government are Paying Too Much for Prescription Drugs"

I. The Need for a Legislative Solution.

A. Permissive Court Decisions have Made Pay-for-Delay Settlements Commonplace in Hatch-Waxman Patent Cases

B. The Profitability of Delaying Generic Entry Means that these Agreements will become More Prevalent

C. Pay-For-Delay Settlements Impose Enormous Costs on Consumers and the Health Care System

D. Permissive Legal Treatment of Pay-for-Delay Settlements Undermines the Hatch-Waxman Act

E. Legislation is Likely to be Swifter and More Comprehensive than Litigation

II. The Arguments against Barring Exclusion Payments Are Contradicted by Experience in the Market

III. The Legislative Remedy

Conclusion

Testimony of Heather Bresch, Chief Operating Officer, Mylan, Inc., before the Subcommittee on Courts and Competition Policy, Hearing on "Pay to Delay: Are Patent Settlements that Delay Generic Drug Market Entry Anticompetitive?"

A Brief History of Hatch-Waxman

Authorized Generics

Patent Settlements

Testimony of Bret M. Dickey, Senior Vice President, Compass Lexecon, before the Subcommittee on Courts and Competition Policy, Hearing on "Pay to Delay: Are Patent Settlements that Delay Generic Drug Market Entry Anticompetitive?"

Appendix. An Economic Assessment of Patent Settlements in the Pharmaceutical Industry

Executive Summary

Introduction

I. Competition in the Pharmaceutical Industry

A. Innovation and Patent Protection

B. Generic Competition

C. The Hatch-Waxman Amendments

1. Introduction

2. FDA approval prior to Hatch-Waxman

3. Overview of Hatch-Waxman

4. Patent litigation under Hatch-Waxman

D. Patent Litigation and Settlement Agreements

II. Competitive Effects of Patent Settlements: Short-Run

A. Overview

1. Patent settlements reduce the direct and indirect costs of litigation

2. Patent settlements have the potential to be anticompetitive.

B. Economic Framework

1. Basic Model

2. Litigation costs

3. Risk aversion

4. Information asymmetries

III. Competitive Effects of Reverse Payment Settlements: Short-Run

B. Regulatory and Judicial Enforcement

1. History

2. Current status

C. "Reverse Payment" and "Exclusion Payments" Are Misnomers

D. Basic Economic Model

E. Introducing Real-World Complexities to the Basic Model60

1. Overview

2. Cash payments with litigation costs and/or risk aversion

3. Cash payments with a cash-strapped generic

4. Cash payments with an optimistic generic

5. Cash payments with information asymmetries

6. Collateral business agreements

IV. Long-Run Competitive Effects

V. Policy Implications and Conclusions

Statement of Guy Donatiello, Endo Pharmaceuticals Inc., before the Subcommittee on Courts and Competition Policy, Hearing on "Pay to Delay: Are Patent Settlements that Delay Generic Drug Market Entry Anticompetitive?"

Statement of William P. (Bill) Kennedy, Co-Owner, Nephron Pharmaceuticals Corporation, before the U.S. House of Representatives, Hearing on "H.R. 1706, the Protecting Consumer Access to Generic Drugs Act of 2009"

Company Profile

The Challenge

The Position of Nephron Pharmaceuticals Corporation on H.R. 1706

Nephron's Recommendation for H.R. 1706

Testimony of William Vaughan, Senior Health Analyst, Consumers Union, Non-Profit Publisher of Consumer Reports, before the Subcommittee on Courts and Competition Policy, Hearing on "Pay to Delay: Are Patent Settlements that Delay Generic Drug Market E...

Rapid Entry of Generic Drugs Can Help Dampen High Health Care Costs Now, Assisting Families and Governments in a Difficult Time

High Costs Impact Familie

Costs of Drugs Impact Governments and Taxpayers.

Generics Dramatically Lower Costs

Many Generics about to Enter Market

The Dynamics of Generic Drug Competition Create Powerful Incentives for Brand-Name and Generic Companies to Settle Patent Litigation in A Way that Thwarts the Objectives of the Hatch-Waxman Act

Other Legislative Suggestions to Help Speed Generic Entry

Finding Other Ways to Help Consumers Hold Down Drug Costs While Promoting Drug Innovation

Appendix #1

Best Buy Drug Campaign

Appendix #2

The Hatch-Waxman Act Exacerbates the Incentive to Settle Patent Litigation with Compensation Paid to the Generic Applicant

These Settlements Are Contrary to the Purpose of the Hatch-Waxman Act

Experience Shows that Brand-Name Companies and Generic Applicants Do Not Need to Use Payments for Delay to Settle Patent Litigation

The Courts are Unlikely to Provide Timely Relief to Consumers

Chapter Sources

Index

Blank Page.

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on print version record and CIP data provided by publisher.

ISBN:

1-61122-360-1

OCLC:

761307745