Intellectual property

This chapter deals with the provisions of the TRIPS Agreement that set out standards for protection of undisclosed information, including test data (Article 39 of Section 7 in Part II of the Agreement) and measures for the control of anti-competitive practices in licences (Article 40 of Part II of the TRIPS Agreement). It also deals with the suppression of unfair competition, a matter which is specifically referred to in Articles 22 (relating to protection of geographical indications) and 39 (relating to protection of undisclosed information), and also arises through the reference in Article 2 of the TRIPS Agreement to the Paris Convention: Article 10bis of that convention sets out general standards for the suppression of unfair competition. As for all sections of Part II, these sections have to be read together with the relevant provisions of pre-existing treaties in the area of international IP law, which are incorporated by reference into the TRIPS Agreement. Reference will be made to these treaties in the sections below. This chapter will also have to be read in conjunction with other relevant provisions of the TRIPS Agreement explained in other chapters (such as concerning non-discrimination, enforcement of IP rights and the administration of IP). Wherever appropriate, cross-references are made to other chapters.

The purpose of this chapter is to introduce the key features of the provisions of Part III, Sections 1 to 5, of the TRIPS Agreement entitled ‘Enforcement of Intellectual Property Rights’. This Part of the Agreement elaborates in 21 articles the enforcement procedures that members have to make available to permit prompt and effective action against infringements of IPRs covered by the TRIPS Agreement.

COVID-19, caused by SARS-Cov-2, was declared to be a pandemic by the World Health Organization on 11 March 2020. Since then, the issue of the relationship between patent protection and the development of and access to medical treatments and technologies – a longstanding and enduringly important public policy issue – has become central to the debate on the linkages between IP, innovation, access, and public health between stakeholders with divergent interests.

This chapter outlines the policy framework for public health, intellectual property (IP), international trade and competition, focusing on how they intersect, with particular emphasis on medical technologies. The framework comprises the human rights dimension of access to medicines; the policy, economic and legal features of IP and innovation systems; regulation of medical products; competition policy; and relevant trade policy measures, including import tariffs, non-tariff measures, rules on trade in services, government procurement, and regional and bilateral free trade agreements (FTAs). In addition, it discusses the economics of innovation and access to medical technologies and outlines the interface between genetic resources, traditional knowledge and traditional medicine, IP and trade.

Public health is inherently a global challenge and thus assumes high priority for international cooperation. The World Health Organization (WHO) is the directing and coordinating authority for health, but the interaction between health issues and other policy domains – human rights, development policy, intellectual property (IP) and international trade – creates a strong rationale for cooperation and coordination between the WHO and other international organizations, in particular the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO). This study and its updated and reviewed second edition have emerged from an ongoing programme of trilateral cooperation among these agencies. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies. The need for cooperation and coherence at the international level has intensified over the past decades, as successive multilateral decisions have confirmed.

Chapter II has described the main elements of the policy framework for innovation and access. This chapter considers how this policy framework applies to innovation in medical technologies. It reviews the factors that have spurred innovation in medical technologies in the past, identifies how current models of R&D are evolving, and charts the role of established and new participants in the innovation process, including in the context of neglected diseases, emerging pathogens with pandemic potential and antibacterial treatments. It also covers the role of IP, particularly patents, in the R&D system.

Medical technologies – medicines, vaccines and medical devices – are essential for public health. Access to essential medicines and the lack of research to address neglected diseases have been a major concern for many years. To promote innovation and to ensure equitable access to all vital medical technologies, policy-makers need a clear understanding of the innovation processes that lead to new technologies and of the ways in which these technologies are disseminated in health systems. This study seeks to reinforce the understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and of how they affect medical innovation and access to medical technologies. This collaborative effort by the World Health Organization, the World Intellectual Property Organization and the World Trade Organization draws together the three Secretariats’ respective areas of expertise. The study is intended to inform ongoing technical cooperation activities undertaken by the three organizations and to support policy discussions. It has been prepared to serve the needs of policy-makers, as well as lawmakers, government officials, delegates to international organizations, non-governmental organizations and researchers. The second edition comprehensively reviews the existing material and captures new developments in key areas since the initial launch of the study in 2013. Among the new topics covered by the study are antimicrobial resistance and cuttingedge health technologies. The second edition provides updated data on health, innovation trends in the pharmaceutical sector, and trade and tariffs. It includes an updated overview of access to medical technologies globally and key provisions in free trade agreements, and takes account of developments in IP legislation and jurisprudence.

This publication is the product of extensive collaboration between the WHO, WIPO and WTO Secretariats, led by the Department of Public Health, Innovation and Intellectual Property in the WHO, the Global Challenges Division in WIPO and the Intellectual Property, Government Procurement and Competition Division in the WTO.