Pharmaceutical Test Data Exclusivity: A Multi-Jurisdictional Survey [CRC] (eBook)

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.