Intellectual Property Rights in Pharmaceutical Test Data : Origins, Globalisation and Impact

Adam Buick

ISBN 10: 3031294351 / ISBN 13: 9783031294358

Published by Springer International Publishing, 2023

About this Item

Druck auf Anfrage Neuware - Printed after ordering - This book considers the intellectual property protection of clinical test data that has been submitted to governments, in particular through test data exclusivity rights. It focuses on how these intellectual property rights first emerged in the early 1980s, how they have globalised over the past four decades, and what impact they have had upon access to medicine. This book makes a number of significant and original contributions to the literature around the protection of submitted test data. First, the book draws upon the theory of regulatory globalisation to provide an explanation of how intellectual property rights in submitted pharmaceutical test data have become nearly ubiquitous in the legal systems of most major economies. Second, through a comprehensive analysis and synthesis of provisions on the protection of submitted test data in free trade agreements, as well as a comparison of a range of national approaches to the protection of submitted test data, it reveals the broader global regulatory pattern that has given rise to these intellectual property rights. Third, by analysing data on drug approvals in the US, it provides an empirical insight into the impact of test data exclusivity in national pharmaceutical markets. Fourth, the book covers a number of developments regarding test data exclusivity that have occurred as a result of responses to the COVID-19 pandemic, both at the national level as well as at the World Trade Organisation (WTO). This book will appeal to academics researching the intersection of intellectual property and the life sciences, civil society activists working to promote access to medicines, and students (particularly those at the post-graduate level) studying the relationship between intellectual property and medicine.

Seller Inventory # 9783031294358

Bibliographic Details

• Title: Intellectual Property Rights in Pharmaceutical Test Data : Origins, Globalisation and Impact
• Publisher: Springer International Publishing
• Publication Date: 2023
• Language: English
• ISBN 10: 3031294351
• ISBN 13: 9783031294358
• Binding: Buch
• Condition: Neu
• Dimensions: 241W x 160H x 19D millimeters 241 millimeters width by 160 millimeters height by 19 millimeters depth
• Weight: 535 grams

About this title

Synopsis

This book considers the intellectual property protection of clinical test data that has been submitted to governments, in particular through test data exclusivity rights. It focuses on how these intellectual property rights first emerged in the early 1980s, how they have globalised over the past four decades, and what impact they have had upon access to medicine.  

This book makes a number of significant and original contributions to the literature around the protection of submitted test data. First, the book draws upon the theory of regulatory globalisation to provide an explanation of how intellectual property rights in submitted pharmaceutical test data have become nearly ubiquitous in the legal systems of most major economies. Second, through a comprehensive analysis and synthesis of provisions on the protection of submitted test data in free trade agreements, as well as a comparison of a range of national approaches to the protection of submitted test data, it reveals the broader global regulatory pattern that has given rise to these intellectual property rights. Third, by analysing data on drug approvals in the US, it provides an empirical insight into the impact of test data exclusivity in national pharmaceutical markets. Fourth, the book covers a number of developments regarding test data exclusivity that have occurred as a result of responses to the COVID-19 pandemic, both at the national level as well as at the World Trade Organisation (WTO). 

This book will appeal to academics researching the intersection of intellectual property and the life sciences, civil society activists working to promote access to medicines, and students (particularly those at the post-graduate level) studying the relationship between intellectual property and medicine.

About the Author

Adam Buick is a lecturer in law at Ulster University. He has previously taught at Nottingham Trent University, the University of Leeds and the University of Bradford. Adam Buick holds a PhD from the University of Leeds, as well as an LLM from Trinity College Dublin and an LLB from Queen's University Belfast.