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Pharmaceutical Test Data Exclusivity

A Multi-Jurisdictional Survey

Specificaties
Gebonden, 176 blz. | Engels
Kluwer Law International | 1e druk, 2022
ISBN13: 9789403501062
Rubricering
Hoofdrubriek : Juridisch
Kluwer Law International 1e druk, 2022 9789403501062
Onderdeel van serie AIPPI Law Series
Verwachte levertijd ongeveer 15 werkdagen

Samenvatting

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.

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.

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.

Specificaties

ISBN13:9789403501062
Taal:Engels
Bindwijze:gebonden
Aantal pagina's:176
Druk:1
Verschijningsdatum:15-9-2022
ISSN:

Inhoudsopgave

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 arion-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

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