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 SettlementsISSUES 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 ColchicineThe 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 ExclusivityAMENDMENTS: THE MEDICARE PRESCRIPTION DRUG AND MODERNIZATION ACT OF 2003; IMPLEMENTATION; SELECTED ISSUES; Authorized Generics ; Patent Settlements ; Follow-On Biologics ; CONCLUSION; End Notes; INDEX
