PHARMACEUTICAL PATENTS: ISSUES AND CONSIDERATIONS

PHARMACEUTICAL PATENTS: ISSUES AND CONSIDERATIONS

LIBRARY OF CONGRESS CATALOGING-IN-PUBLICATION DATA

CONTENTS

PREFACE

Chapter 1: PHARMACEUTICAL PATENT SETTLEMENTS: ISSUES IN INNOVATION AND COMPETITIVENESS

SUMMARY

INTRODUCTION

PATENT DISPUTES UNDER THE HATCH-WAXMAN ACT

Patent Fundamentals

FDA Approval Procedures

Resolution of Patent Disputes

Generic Exclusivity

FUNDAMENTALS OF REVERSE PAYMENT SETTLEMENTS

ANTITRUST IMPLICATIONS OF REVERSE PAYMENT SETTLEMENTS

General Antitrust Standards

Judicial Approaches to Reverse Payment Settlements

ISSUES AND OBSERVATIONS

End Notes

Chapter 2: THE ROLE OF PATENTS AND REGULATORY EXCLUSIVITIES IN PHARMACEUTICAL INNOVATION

SUMMARY

BACKGROUND

FUNDAMENTALS OF THE PATENT SYSTEM

FUNDAMENTALS OF REGULATORY EXCLUSIVITY

Data Exclusivity Versus Market Exclusivity

New Chemical Entity Exclusivity

New Clinical Study Exclusivity

Orphan Drug Exclusivity

Biologics Exclusivity

Pediatric Exclusivity

Qualified Infectious Disease Products

Generic and Follow-On Exclusivity

INNOVATION POLICY ISSUES

The Term of Regulatory Exclusivities

Regulatory Exclusivity for Colchicine

The MODDERN Cures Act

International Issues

CONCLUSION

End Notes

Chapter 3: PATENT INFRINGEMENT AND EXPERIMENTAL USE UNDER THE HATCH-WAXMAN ACT: CURRENT ISSUES

SUMMARY

BACKGROUND

INTRODUCTION TO THE HATCH-WAXMAN ACT

PATENT INFRINGEMENT DISPUTE RESOLUTION

THE SAFE HARBOR PROVISION

THE PATENT INFRINGEMENT PROVISION

CONGRESSIONAL ISSUES AND OPTIONS

End Notes

Chapter 4: THE HATCH-WAXMAN ACT: OVER A QUARTER CENTURY LATER

SUMMARY

INTRODUCTION

OVERVIEW OF THE ORIGINAL ACT

Accelerated Generic Drug Approval Process

Patent Term Restoration

Data Exclusivity

AMENDMENTS: THE MEDICARE PRESCRIPTION DRUG AND MODERNIZATION ACT OF 2003

IMPLEMENTATION

SELECTED ISSUES

Authorized Generics

Patent Settlements

Follow-On Biologics

CONCLUSION

End Notes

INDEX