Access to Medicine Versus Test Data Exclusivity Safeguarding Flexibi

This book explores the concept of test data exclusivity protection for pharmaceuticals. Focusing on Art 39(3) of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and relevant provisions in selected free trade ag

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Owais H. Shaikh

Access to Medicine Versus Test Data Exclusivity Safeguarding Flexibilities Under International Law

Munich Studies on Innovation and Competition Volume 4

Series Editors Josef Drexl, Germany Reto M. Hilty, Germany

More information about this series at http://www.springer.com/series/13275

Owais H. Shaikh

Access to Medicine Versus Test Data Exclusivity Safeguarding Flexibilities Under International Law

Owais H. Shaikh Max Planck Institute for Competition and Innovation Munich, Germany

ISSN 2199-7462 ISSN 2199-7470 (electronic) Munich Studies on Innovation and Competition ISBN 978-3-662-49654-1 ISBN 978-3-662-49655-8 (eBook) DOI 10.1007/978-3-662-49655-8 Library of Congress Control Number: 2016945571 © Springer-Verlag Berlin Heidelberg 2016 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper This Springer imprint is published by Springer Nature The registered company is Springer-Verlag GmbH Berlin Heidelberg

Acknowledgments

I would like to thank my supervisor Prof. Dr. Josef Drexl, the Director of the Max Planck Institute for Innovation and Competition (MPI), for his continuous mentorship, which started early during my LL.M at the Munich Intellectual Property Law Center (MIPLC). His constant support and advice had been most invaluable in the successful completion of my doctoral thesis. Dr. Henning Große Ruse-Khan, now at the University of Cambridge, acted as the MPI internal advisor on my thesis, but his role and influence on my thinking and personality has been beyond academics. I also profited from the knowledge and experience of Prof. Dr. Dr. h. c. Annette Kur both during my LL.M and the PhD. Dr. Sylvie Nerisson, Prof. Andrea Wechsler, and Karin Hasse always endured my repeated request for administrative support with a broad smile. The same is true for the administrative staff at the MPI, especially Petra Schwarz and Gabriele Zinczuk. Dr. Ashish Bharadwaj, now at O.P. Jindal Global University, played a key role in developin