Intellectual property
Intellectual Property Provisions in Regional Trade Agreements
This is a revision and update of "Intellectual Property Provisions in Regional Trade Agreements" by Valdés and Runyowa (2012). This paper adjusts the methodology applied to assess the intellectual property (IP) provisions contained in regional trade agreements (RTAs) and the aggregation of such provisions into groups; it also updates the RTAs surveyed from 194 in November 2010 to 245 in February 2014. New information contained in this revision relates to three IP-related investment and non-violation provisions in RTAs. The methodological revisions and new information result in changes to the assessment of the IP content of certain RTAs while the update reveals a growing and increasingly complex network of RTAs with IP content. This revision also provides new insights into possible improvements to the methodological toolkit for analysing IP in RTAs. The paper assembles detailed information about the IP provisions contained in active RTAs notified to the WTO. The goal was to expand beyond the more commonly studied RTAs to review the full array of agreements notified to the WTO and thus to enable consideration of the implications of this diverse range of norm-setting activity for the multilateral system. Mapping of the IP content in RTAs involving parties from all regions and levels of development is necessary to better understand crosscutting trends in RTAs and how all the parts of the international IP framework influence each other. The methodology followed involved surveying each RTA in the sample to determine whether it made reference to any of 32 different IP-related provisions. Two of the three IP-related provisions new to this revision and update are investment-related IP provisions while the other concerns dispute settlement for non-violation claims. The relevant provisions are discussed in detail and summary statistics used to identify patterns over time and by continent level of economic development and selected traders. The number of IP provisions in each RTA is then used to classify agreements according to their level of IP content. The first significant identified trend is the acceleration in the conclusion of RTAs with IP provisions after the creation of the WTO and the entry into force of the WTO TRIPS Agreement. A significant proportion of those RTAs contain some type of IP provision but the number and type of those provisions vary widely across agreements. A majority of the RTAs surveyed include general IP provisions while a smaller proportion contains explicit provisions on specific fields of IP law such as geographical indications patents trademarks and copyright. The inclusion of even more detailed provisions elaborating on specific areas of IP law is less common. As a result the actual IP content of RTAs differs greatly across the sample with slightly less than half of these agreements found to havesubstantive IP standards that can be classified as moderate or high. The RTAs containing a high level of IP provisions are characterized by a hub-and-spoke architecture in which the wording and structure of IP provisions converged around the RTAs of specific countries or blocs. The largest systems are grouped around the EFTA the European Union and the United States. The hub-and-spoke architecture seems to have encouraged the convergence of domestic IP regimes among the respective RTA signatories. The mechanics of this potentially crucial process and its economic implications require further investigation.
WIPO-WTO colloquium papers 2014
The WIPO-WTO Colloquium Papers is a peer-reviewed academic journal published jointly by the World Intellectual Property Organization and the World Trade Organization each year since 2010. Providing a uniquely representative and diverse showcase for emerging IP scholarship from across the globe the journal aims to stimulate analysis and debate on intellectual property (IP) issues particularly of interest to developing countries. And it offers an avenue for the dissemination of a broader and more geographically diverse and representative range of scholarship than is common in much of the academic literature on IP law and policy.
WIPO-WTO colloquium papers 2013
The WIPO-WTO Colloquium Papers is a peer-reviewed academic journal published jointly by the World Intellectual Property Organization and the World Trade Organization each year since 2010. Providing a uniquely representative and diverse showcase for emerging IP scholarship from across the globe the journal aims to stimulate analysis and debate on intellectual property (IP) issues particularly of interest to developing countries. And it offers an avenue for the dissemination of a broader and more geographically diverse and representative range of scholarship than is common in much of the academic literature on IP law and policy.
The global burden of disease and global health risks
The development of effective strategies to improve global health and react to changes in the global burden of disease (GBD) requires an understanding of the GBD and of GBD-related trends coupled with an understanding of major health risks. These are introduced in this section.
Public health and medical technologies: The imperative for international cooperation
Health is a fundamental and universal human right. The attainment by all peoples of the highest possible level of health is the foundational objective of the WHO.
Foreword by the Directors-General
Public health has been a priority for global action for many years. The right of everyone to the enjoyment of the highest attainable standard of physical and mental health is a universal human right just as the burden of disease is shared by all humanity.
Access to medical technologies: The context
This chapter offers an overview of the main determinants of access related to health systems intellectual property (IP) and trade policy. Many other very important socio-economic factors determine access to medical technologies – factors such as health financing the importance of a qualified health care workforce poverty and cultural issues – and lack of access is rarely due entirely to a single determinant but these are not addressed in this study as they are not part of the interface between health IP and trade.
The current R&D landscape
This section reviews the challenges faced by today’s pharmaceutical industry against the background of its evolution outlined in the previous section.
Sharing of influenza viruses and access to vaccines and other benefits
A highly significant development in itself given its central role in preparing for a potential pandemic the PIP Framework also serves to illustrate many of the points made in earlier sections of this chapter relating to the role of public-sector institutions and networks capacity-building in medical innovation sharing of benefits of the fruits of innovation and dealing with IP in a public health context.
Health systems-related determinants of access
There are different determinants of access and any lack of access to medicines or other medical technologies is rarely due entirely to a single determinant. The following sections discuss the main determinants of access that are linked to health IP and trade.
Public health policy
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 described comprises 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 rules on trade in services government procurement and regional and bilateral free trade agreements (FTAs). In addition it outlines the human rights dimension of access to medicines.
Traditional knowledge and traditional medicine
Traditional medicine has long been used as a mainstay of health care for many populations. This section reviews a number of issues concerning traditional medical systems with respect to IP regulatory systems and trade.
Overcoming market failure: The challenge of neglected diseases
There is a particular problem in incentivizing medical R&D for diseases that disproportionately affect poor people in developing countries as the market mechanisms such as intellectual property rights (IPRs) do not work in this case. A key factor is the limited purchasing power of both governments and patients in the countries where such diseases predominate; unlike for other diseases there is no positive spillover from drug development targeted at more affluent markets. These diseases are called neglected diseases and this section deals with the challenges of medical innovation in this area.
Promoting Access to Medical Technologies and Innovation
Promoting Access to Medical Technologies and Innovation examines the interplay between public health trade and intellectual property and how these policy domains affect medical innovation and access to medical technologies. Co-published by the World Health Organization the World Intellectual Property Organization and the WTO the study draws together the three Secretariats respective areas of expertise.
Intellectual property, trade and other policy dimensions
This section provides an overview of elements and legal and policy instruments relating to the IP and international trade system which are relevant to medical innovation and access to medical technologies at the international level.
Economics of innovation and access to medical technologies
The past decade has seen more systematic efforts to use the tools of economic analysis to support discussions on health policy particularly in developing economies. The WHO Commission on Macroeconomics and Health (WHO 2001a) was a major milestone along this road. The present study does not attempt to advance economic analysis and the theoretical understanding of the economics of technology innovation and access issues. Rather it recognizes the growing importance of economic concepts in policy debate and it briefly reviews the main economic concepts and the current body of literature dealing with the IP aspects of these issues.
Intellectual Property Provisions in Regional Trade Agreements
This paper assembles detailed information about the intellectual property (IP) provisions contained in 194 active regional trade agreements (RTAs) that had been notified to the WTO by November 2010. IP provisions in RTAs have been the subject of much study and commentary. However much of this work has focused on a relatively limited number of RTAs with a concentration on parties with narrow geographical and economic profiles. The goal of the current study was to expand beyond the more commonly studied RTAs to make an initial review of the full array of RTAs notified to the WTO and in that way to lay the groundwork for a more comprehensive overview that would enable consideration of the broader system implications of this more diverse range of norm-setting activity. This was tackled by conducting a comprehensive mapping of the IP content in a larger number of RTAs involving parties from all regions and across different levels of development. This broad approach is necessary to better understand cross-cutting trends in RTAs and how all the parts of the international IP framework influence each other. The methodology followed involved surveying each RTA in the sample to determine whether it made reference to any of 30 different IP-related provisions. The relevant provisions are discussed in detail and summary statistics used to identify patterns over time and by continent level of economic development and selected traders. The number of IP provisions in each RTA is then used to classify agreements according to their level of IP content. The first significant identified trend is the acceleration in the conclusion of RTAs with IP provisions after the creation of the WTO and the entry into force of the WTO TRIPS Agreement. A significant proportion of those RTAs contain some type of IP provision but the number and type of those provisions vary widely across agreements. More than two-thirds of the RTAs surveyed include provisions on border measures or statements of general commitment to IP protection or cooperation. A smaller proportion contains explicit provisions on specific fields of IP law such as geographical indications patents trademarks and copyright. The inclusion of even more detailed provisions elaborating on specific areas of IP law is less common. As a result the actual IP content of RTAs differs greatly across the sample with about 40% of these agreements found to have negligible substantive IP standards. A significant number of RTAs containing more detailed IP provisions are characterized by a hub-andspoke architecture in which the wording and structure of IP provisions converged around the RTAs of specific countries or blocs. The largest systems are grouped around the EFTA the European Union and the United States with countries like Chile Japan and Mexico constituting other hubs. The huband- spoke architecture seems to have encouraged the convergence of domestic IP regimes among the respective RTA signatories. The mechanics of this potentially crucial process and its economic implications require further investigation. The analytical methodology followed in this paper also needs additional development to take better advantage of the information gathered together in the course of this study and other data.
WIPO-WTO colloquium papers 2012
The WIPO-WTO Colloquium Papers is a peer-reviewed academic journal published jointly by the World Intellectual Property Organization and the World Trade Organization each year since 2010. Providing a uniquely representative and diverse showcase for emerging IP scholarship from across the globe the journal aims to stimulate analysis and debate on intellectual property (IP) issues particularly of interest to developing countries. And it offers an avenue for the dissemination of a broader and more geographically diverse and representative range of scholarship than is common in much of the academic literature on IP law and policy.
Preface
At the heart of the World Trade Organization (WTO) as an international organization is a set of rules that regulate trade between nations: a body of agreements which have been negotiated and signed by governments of the majority of the world's trading nations with the aim of promoting transparency predictability and non-discrimination in trading relations. These agreements covering trade in goods trade in services and trade-related aspects of intellectual property rights help to define and inform the multiple roles of the WTO in administering the trade agreements providing a forum for trade negotiations handling trade disputes monitoring national trade policies providing technical assistance and capacity building for developing countries and cooperating with other international organizations. Understanding these agreements and their practical policy and legal contexts therefore provides significant insights into the WTO as an institution its activities and international role its partnerships with other organizations and the way in which WTO Member governments identify and pursue their national interests through this intergovernmental forum.
Appendix 2: Guide to TRIPS notifications
TRIPS includes a set of transparency mechanisms which require Members to furnish extensive information about their IP laws and policies and details about how IPRs are administered and enforced in their territories; these laws are also reviewed in detail in the TRIPS Council. The operation of these transparency mechanisms in the years since 1995 has yielded a uniquely comprehensive and systematic body of information that now covers some 130 jurisdictions (essentially all WTO Members other than LDCs for whom these provisions do not yet apply).
Appendix 1: Guide to TRIPS notifications
The TRIPS Agreement gives effect to a principle of transparency founded on a system of notifications about how countries choose to implement TRIPS provisions. These notifications built up since 1996 now amount to a useful collection of factual information about national IP systems as well as specific details on key issues such as incentives for transfer of technology and contact points within national systems. These notifications help the Council for TRIPS to monitor the operation of the Agreement and to promote understanding of Members’ IP policies.
A Handbook on the WTO TRIPS Agreement
This handbook describes the historical and legal background to the TRIPS Agreement its role in the World Trade Organization (WTO) and its institutional framework and reviews the following areas: general provisions and basic principles; copyright and related rights; trademarks; geographical indications; patents; industrial designs layout-designs undisclosed information and anti-competitive practices; enforcement of intellectual property rights; dispute settlement in the context of the TRIPS Agreement; TRIPS and public health; and current TRIPS issues. It contains a guide to TRIPS notifications by WTO Members and describes how to access and make use of the official documentation relating to the TRIPS Agreement and connected issues. Furthermore it includes the legal texts of the TRIPS Agreement and the relevant provisions of the WIPO conventions referred to in it as well as subsequent relevant WTO instruments.
Dispute prevention and settlement
This chapter provides an overview of the TRIPS Agreement. It first explains the historical and legal background of the Agreement and its place in the World Trade Organization (WTO). It then turns to the general provisions and basic principles as well as other provisions and institutional arrangements that apply to all the categories of intellectual property rights (IPRs) covered by TRIPS. Chapters II to VII then discuss each of these categories in more detail.
A Handbook on the WTO TRIPS Agreement
This handbook describes the historical and legal background to the TRIPS Agreement its role in the WTO and its institutional framework and reviews the following areas: general provisions and basic principles; copyright and related rights; trademarks; geographical indications; patents; industrial designs layout-designs undisclosed information and anti-competitive practices; enforcement of IPRs; dispute settlement in the context of the TRIPS Agreement; TRIPS and public health; and current TRIPS issues. It contains a guide to TRIPS notifications by WTO members and describes how to access and make use of the official documentation relating to the TRIPS Agreement and related issues. Furthermore it includes the legal texts of the TRIPS Agreement and the relevant provisions of the WIPO conventions referred to in it as well as subsequent relevant WTO instruments.
WIPO-WTO colloquium papers 2011
The WIPO-WTO Colloquium Papers is a peer-reviewed academic journal published jointly by the World Intellectual Property Organization and the World Trade Organization each year since 2010. Providing a uniquely representative and diverse showcase for emerging IP scholarship from across the globe the journal aims to stimulate analysis and debate on intellectual property (IP) issues particularly of interest to developing countries. And it offers an avenue for the dissemination of a broader and more geographically diverse and representative range of scholarship than is common in much of the academic literature on IP law and policy.
WIPO-WTO colloquium papers 2010
The WIPO-WTO Colloquium Papers is a peer-reviewed academic journal published jointly by the World Intellectual Property Organization and the World Trade Organization each year since 2010. Providing a uniquely representative and diverse showcase for emerging IP scholarship from across the globe the journal aims to stimulate analysis and debate on intellectual property (IP) issues particularly of interest to developing countries. And it offers an avenue for the dissemination of a broader and more geographically diverse and representative range of scholarship than is common in much of the academic literature on IP law and policy.
China - Measures Affecting the Protection and Enforcement of Intellectual Property Rights
On 10 April 2007 the United States requested consultations with China concerning certain measures pertaining to the protection and enforcement of intellectual property rights in China.
European Communities - Protection of Trademarks and Geographical Indications for Agricultural Products and Foodstuffs
On 1 June 1999 the US requested consultations with the EC in respect of the alleged lack of protection of trademarks and geographical indications (GIs) for agricultural products and foodstuffs in the EC. The US contended that EC Regulation 2081/92 as amended does not provide national treatment with respect to geographical indications and does not provide sufficient protection to pre-existing trademarks that are similar or identical to a geographical indication. The US considered this situation to be inconsistent with the EC’s obligations under the TRIPS Agreement including but not necessarily limited to Articles 3 16 24 63 and 65 of the TRIPS Agreement...
European Communities - Protection of Trademarks and Geographical Indications for Agricultural Products and Foodstuffs
On 1 June 1999 the US requested consultations with the EC in respect of the alleged lack of protection of trademarks and geographical indications (GIs) for agricultural products and foodstuffs in the EC. The US contended that EC Regulation 2081/92 as amended does not provide national treatment with respect to geographical indications and does not provide sufficient protection to pre-existing trademarks that are similar or identical to a geographical indication. The US considered this situation to be inconsistent with the EC’s obligations under the TRIPS Agreement including but not necessarily limited to Articles 3 16 24 63 and 65 of the TRIPS Agreement...
United States - Section 211 Omnibus Appropriations Act of 1998
On 8 July 1999 the European Communities requested consultations with the United States in respect of Section 211 of the US Omnibus Appropriations Act. The EC and its member States alleged as follows: - Section 211 which was signed into law on 21 October 1998 did not allow the registration or renewal in the United States of a trademark if it was previously abandoned by a trademark owner whose business and assets have been confiscated under Cuban law. - This law provided that no US court shall recognize or enforce any assertion of such rights. - Section 211 US Omnibus Appropriations Act was not in conformity with the US’ obligations under the TRIPS Agreement notably its Article 2 in conjunction with the Paris Convention Article 3 Article 4 Articles 15 to 21 Article 41 Article 42 and Article 62