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Pharmaceutical Test Data Exclusivity: A Multi-Jurisdictional Survey

Pharmaceutical Test Data Exclusivity: A Multi-Jurisdictional Survey

Author: John C. Todaro; Martin Bensadon; Brigitte Carion-Taravella
Publisher: Kluwer Law International
ISBN: 9789403501062
Published In: August 2022
Format: Hardback
Jurisdiction: International ? Disclaimer:
Countri(es) stated herein are used as reference only

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Description
Contents

Details

About this book:

Pharmaceutical Test Data Exclusivity is designed to provide expert guidance, chapter by chapter, on test data exclusivity rights for innovative pharmaceutical products in twenty-two major markets worldwide. Data exclusivity gives pharmaceutical companies a limited period of time in which clinical test data are exclusive to the innovator. Internationally, however, aside from prohibition against unfair commercial use, there are no specifics as to how these data are protected. This book will be the starting point for innovator pharmaceutical companies and their advisers to evaluate data exclusivity rules and opportunities around the world.

What’s in this book:

This book originated from a project conducted by the Pharma Committee of the International Association for the Protection of Intellectual Property (AIPPI). In addition to explaining the available regulatory data protection in each jurisdiction, contributors of chapters in this book, who are local experts, committee members and observers, provide detailed information and guidance on the degree to which test data exclusivity may be achieved in such areas of pharmaceutical research as the following:

–       infectious disease products;

–       paediatrics products;

–       chemical and biological products;

–       agricultural products;

–       animal health products;

–       orphan drugs; and

–       new chemical entities.

How this will help you:

As an unmatched starting point for innovator pharmaceutical companies and their advisers to evaluate data exclusivity rules and opportunities around the world, this book will be an invaluable resource for IP professionals, governments, non-governmental organizations, and international organizations to promote and share IP laws and practices. By providing detailed information on the cutting-edge issues of IP and proposing an adequate balanced position to frame the issues, this book will be a valuable resource for pharmaceutical innovators on the various data exclusivity provisions available for innovative drug products in the listed countries.

Editors:

John C. Todaro, Martin Bensadon & Brigitte Carion-Taravella
List of Contributors

List of Abbreviations

Foreword

Luiz Henrique do Amaral, President of AIPPI

Introduction

John C. Todaro, Martin Bensadon, Brigitte Carion-Taravella

Argentina

Martín Bensadon, Eugenio Hoss

Australia

Nicholas Tyacke, Eliza Saunders, Sarah McKenzie

Brazil

Ana Claudia Mamede Carneiro, Roberto Faria de Sant’Anna Junior

Canada

Charles Boulakia, Santosh Chari, Anita Nador

Chile

Ignacio Gillmore, José Santos Ossa, Camila Suarez Alcántara

China

Amy Feng, Alex Guan

Colombia

Ximena Castellanos

European Union

Mathilde Rauline, Muriel Morel-Pécheux, Maurane Cadinot, Nicolás Vincent Ruiz, Brigitte Carion-Taravella

India

Vidisha Garg

Israel

David Gilat

Japan

Takeshi S. Komatani, Takashi Fujita, Osamu Yamamoto, Yoshinori Shimizu, Masaru Nakajima

Republic of Korea

Yoon Suk Shin

Mexico

Carolina Ponce

Peru

Carlos Fernández-Dávila Winkler, Julisa Quiliche Chávez, Nicolle Pérez Mercado

Russia

Renat Krasnoperov

Kingdom of Saudi Arabia

Namir B. Sioufi

South Africa

Dirk Hanekom

Switzerland

Simon Holzer

Taiwan

Kevin C.W. Feng

Turkey

Ezgi Baklaci Gülkokar

United Arab Emirates

Namir B. Sioufi

United Kingdom

Daniel Lim

United States

Michael K. Stern