ABSTRACT
This introduction presents an overview of the key concepts discussed in the subsequent chapters of this book. The book aims to contribute to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. It shows that international intellectual property law provides a sufficient scope for countries to exercise flexibilities and align national laws and regulations with domestic needs and priorities. The book focuses on the complex and emerging issues of biologics – a relatively novel and highly complex class of medicinal products promising unprecedented health benefits. It traces the evolution of test data exclusivity for pharmaceutical products in national laws implemented primarily through free trade agreements. The book discusses the meaning and functions of compulsory licensing for patents, the requirements under the Trade-Related Aspects of Intellectual Property Rights Agreement, and trends of its application in relation to pharmaceutical products.
