Skip to content
You are not logged in |Login  
     
Limit search to available items
Record:   Prev Next
Resources
More Information
Bestseller
BestsellerE-book

Title Pharmaceutical Patents: Issues and Considerations.

Publication Info. [Place of publication not identified] : Nova Science Publishers, Inc. : Nova Science Publishers, Inc., 2013.

Item Status

Description 1 online resource.
Physical Medium polychrome
Description text file
Series Laws and legislation
Pharmacology-research, safety testing, and regulation
Laws and legislation series.
Pharmacology-research, safety testing, and regulation series.
Contents 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.
Bibliography Includes bibliographical references and index.
Local Note eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America
Language Text in English.
Subject United States. Drug Price Competition and Patent Term Restoration Act of 1984.
Drug Price Competition and Patent Term Restoration Act of 1984 (United States)
Pharmacy -- Law and legislation -- United States.
Pharmacy -- Law and legislation.
United States.
Drugs -- Law and legislation -- United States.
Drugs -- Law and legislation.
Patent laws and legislation -- United States.
Patent laws and legislation.
Pharmaceutical industry -- United States.
Pharmaceutical industry.
United States.
Genre/Form Electronic books.
Subject Medication.
Other Form: Print version: Pharmaceutical Patents: Issues and Considerations. [Place of publication not identified] : Nova Science Publishers, Inc. : Nova Science Publishers, Inc., 2013 1626187584 9781626187580 (OCoLC)838416768
ISBN 9781626187597 (electronic book)
1626187592 (electronic book)
9781626187580
1626187584