ABSTRACT

The World Trade Organization (WTO) was founded on the principles of multilateralism and has come to epitomise the globalised economy of the twenty-first century. During the course of trade negotiations, intellectual property (IP) rights were made part of the multilateral trading system, and the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement became a covered agreement of the WTO. The Agreement grants international IP rights protection for IP rights holders across the globe. The rights identified and granted protection in the TRIPS Agreement extends to pharmaceutical patents. Flexibilities were introduced in the TRIPS Agreement, aimed at providing the developing countries with the option to adopt suitable measures to address access to patent-protected pharmaceutical products. The flexibilities include the grant of compulsory licences, exceptions to the exclusive right conferred by patent, allowing for parallel imports and defining the criteria of patentability to achieve the goal of public health. While the flexibilities are available to all developing countries, only a few have fully utilised or implemented the flexibilities into their patent legislation. The introductory chapter presents an overview of globalisation of IP rights in the multilateral trading system, the emergence of knowledge as capital and the problem of access to affordable medicines in developing countries and least developed countries (LDCs), thereby setting the tone for the study to follow.