Pharmaceutical Test Data Exclusivity: A Multi-Jurisdictional Survey

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; exclusivity is available on a jurisdiction-by-jurisdiction basis. This book, the only one of its kind, provides expert guidance, chapter by chapter, on test data exclusivity rights for pharmaceutical products in twenty-two major markets worldwide.

For each jurisdiction, in addition to explaining the available regulatory data protection - including both substantive and formal requirements for approvals and testing, protection of undisclosed data, confidentiality, and enforcement in practice - local experts 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.

This book originated from a project conducted by the Pharma Committee of the International Association for the Protection of Intellectual Property (AIPPI), the world's leading non-profit association dedicated to the development, expansion, and improvement of international and regional treaties and agreements and national laws relating to intellectual property. Many committee members and observers are authors of chapters in this book. An unmatched starting point for innovator pharmaceutical companies and their advisers to evaluate data exclusivity rules and oppor