Intellectual property
WIPO-WTO colloquium papers
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.
Promoting Access to Medical Technologies and Innovation, 2nd Edition
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.
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.
The Making of the TRIPS Agreement
A comprehensive account of the establishment of the World Trade Organization focusing on those who shaped its creation as well as those who have influenced its evolution. The book examines trade negotiations the WTO’s dispute settlement role the presence of coalitions and groupings within the WTO the process of joining the organization and many other topics including what lies ahead for the organization.
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.
¿Pueden las cadenas de bloques revolucionar el comercio internacional?
El progreso tecnológico siempre ha condicionado el comercio. En los últimos años muchos observadores han saludado la aparición de una nueva tecnología las cadenas de bloques como el nuevo factor que transformará de manera radical el panorama comercial. ¿Pueden las cadenas de bloques revolucionar el comercio internacional? El objetivo de la presente publicación es desmitificar el fenómeno de las cadenas de bloques aportando una explicación básica de esta tecnología. En el documento se analiza la importancia que tiene esta tecnología para el comercio internacional indicando cómo se utiliza en la actualidad y cómo podría llegar a utilizarse en diversas esferas abarcadas por las normas de la OMC. Del análisis se desprende en qué medida podría la adopción de esta tecnología afectar al comercio transfronterizo de mercancías y servicios y a los derechos de propiedad intelectual. El documento examina las posibilidades que ofrecen las cadenas de bloques para reducir los costes del comercio y mejorar la transparencia en las cadenas de suministro así como las oportunidades que brinda a los pequeños productores y las pequeñas empresas. Por último el documento repasa los distintos retos que es necesario superar para que la tecnología pueda utilizarse a gran escala e incidir de manera significativa en el comercio internacional.
Can blockchain revolutionize international trade?
Trade has always been shaped by technological innovation. In recent times a new technology Blockchain has been greeted by many as the next big game-changer. Can Blockchain revolutionize international trade? This publication seeks to demystify the Blockchain phenomenon by providing a basic explanation of the technology. It analyses the relevance of this technology for international trade by reviewing how it is currently used or can be used in the various areas covered by WTO rules. In doing so it provides an insight into the extent to which this technology could affect cross-border trade in goods and services and intellectual property rights. It discusses the potential of Blockchain for reducing trade costs and enhancing supply chain transparency as well as the opportunities it provides for small-scale producers and companies. Finally it reviews various challenges that must be addressed before the technology can be used on a wide scale and have a significant impact on international trade.
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. It 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 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 and related non-WTO treaties. The new edition covers the public health revision of the Agreement that entered into force in 2017 and provides updates on other recent developments.
TRIPS Agreement
The establishment of the WTO’s TRIPS (trade-related aspects of intellectual property rights) Agreement in 1995 changed the face of international intellectual property (IP) law and policy-making. TRIPS negotiators recognized that shortcomings and inconsistencies in IP protection can distort trade and impede its benefits. The TRIPS Agreement helps ease trade tensions about IP issues while leaving WTO members ample space to pursue diverse domestic policies. This brochure produced to mark the WTO’s 20th anniversary looks into the use of IP rights covered by the Agreement.
La chaîne de blocs peut-elle révolutionner le commerce international ?
Le commerce a toujours été façonné par l’innovation technologique. Ces derniers temps une nouvelle technologie la chaîne de blocs a été accueillie par beaucoup comme le prochain grand facteur de changement. La chaîne de blocs peut-elle révolutionner le commerce international ? Cette publication tente de démythifier le phénomène de la chaîne de blocs en fournissant une explication de base de cette technologie. Elle analyse sa pertinence pour le commerce international en examinant comment elle est actuellement utilisée ou peut être utilisée dans les différents domaines couverts par l’OMC. Ce faisant elle donne une idée de la mesure dans laquelle cette technologie pourrait affecter le commerce transfrontières des biens et des services et les droits de propriété intellectuelle. Elle examine le potentiel de la chaîne de blocs de réduire les coûts du commerce et d’améliorer la transparence de la chaîne d’approvisionnement et les possibilités qu’elle offre aux petits producteurs et aux petites entreprises. Enfin elle passe en revue les divers défis qui doivent être relevés pour que cette technologie puisse être utilisée à grande échelle et ait un impact important sur le commerce international.
Competition policy and intellectual property in today's global economy
The fast-evolving relationship between the promotion of welfare-enhancing competition and the balanced protection of intellectual property (IP) rights has attracted the attention of policymakers analysts and scholars. This interest is inevitable in an environment that lays ever greater emphasis on the management of knowledge and innovation and on mechanisms to ensure that the public derives the expected social and economic benefits from this innovation and the spread of knowledge. This book looks at the positive linkage between IP and competition in jurisdictions around the world surveying developments and policy issues from an international and comparative perspective. It includes analysis of key doctrinal and policy issues by leading academics and practitioners from around the globe and a cutting-edge survey of related developments across both developed and developing economies. It also situates current policy developments at the national level in the context of multilateral developments at WIPO WTO and elsewhere.
Trade in Knowledge
Technological change has transformed the ways knowledge is developed and shared internationally. Accordingly in the quarter-century since the WTO was established and since its Agreement on Trade-Related Aspects of Intellectual Property Rights came into force both the knowledge dimension of trade and the functioning of the IP system have been radically transformed. The need to understand and respond to this change has placed knowledge at the centre of policy debates about economic and social development. Recognizing the need for modern analytical tools to support policymakers and analysts this publication draws together contributions from a diverse range of scholars and analysts. Together they offer a fresh understanding of what it means to trade in knowledge in today’s technological and commercial environment. The publication offers insights into the prospects for knowledge-based development and ideas for updated systems of governance that promote the creation and sharing of the benefits of knowledge.
Promouvoir l'accès aux technologies médicales et l'innovation, deuxième édition
Extrait mis à jour : une approche intégrée englobant santé commerce et propriété intellectuelle pour répondre à la pandémie de COVID-19 30 août 2021. La pandémie de COVID-19 constitue une crise de santé publique mondiale extraordinaire. Elle a rendu nécessaire l’intensification de la coopération au niveau planétaire. Dès le début elle a soulevé des questions à l’intersection entre la politique de santé publique la politique commerciale ainsi que le cadre et la gestion de l’innovation y compris pour ce qui est des droits de propriété intellectuelle. La deuxième édition de l’étude conjointe de l’OMS de l’OMPI et de l’OMC intitulée « Promouvoir l’accès aux technologies médicales et l’innovation : Intersections entre la santé publique et la propriété intellectuelle et le commerce » publiée en 2020 contenait un encart spécial présentant les défis posés par la pandémie de COVID-19 par rapport au cadre intégré de politiques en matière de santé de commerce et de PI établi dans l’étude. Cette mise à jour révise les renseignements figurant dans cet encart à la lumière de la situation au 30 août 2021
Promover el acceso a las tecnologías y la innovación en medicina, segunda edición
Texto actualizado: Un enfoque integrado de la salud el comercio y la propiedad intelectual para hacer frente a la COVID-19 30 de agosto de 2021. La enfermedad por coronavirus de 2019 (COVID-19) ha generado una crisis mundial de salud pública extraordinaria. La pandemia ha creado una necesidad acuciante de intensificar la cooperación a nivel mundial y ha planteado interrogantes en la encrucijada entre las políticas de salud pública las políticas comerciales y el marco para la innovación y la manera de gestionarla incluidas las cuestiones relacionadas con los derechos de propiedad intelectual. La segunda edición de la publicación conjunta de la OMS la OMPI y la OMC titulada Promover el acceso a las tecnologías y la innovación en medicina: Intersecciones entre la salud pública la propiedad intelectual y el comercio publicada en 2020 incluía un suplemento especial en que se presentaban los desafíos planteados por la pandemia de COVID-19 en relación con los marcos de política integrados de salud comercio y propiedad intelectual descritos en el estudio. En la presente actualización se revisa la información contenida en ese suplemento a la luz de acontecimientos más recientes al 30 de agosto de 2021.
Promoting Access to Medical Technologies and Innovation, 2nd edition
Updated extract: integrated health trade and IP approach to respond to the COVID-19 pandemic 30 August 2021. The coronavirus disease 2019 (COVID-19) pandemic constitutes an extraordinary global public health crisis. It has created a pressing need for intensified global cooperation. The pandemic has from its outset raised issues at the crossroads of public health policy trade policy and the framework for and management of innovation including those relating to intellectual property rights. The second edition of the joint WHO WIPO and WTO publication “Promoting Access to Medical Technologies and Innovation: Intersections between public health intellectual property and trade” published in 2020 included a special insert mapping the challenges posed by the COVID-19 pandemic in relation to the integrated health trade and IP policy framework set out in the study. This update revises the information contained in that insert in the light of more recent developments as of 30 August 2021.
An Integrated Health, Trade and IP Approach to Respond to the COVID-19 Pandemic
The coronavirus disease 2019 (COVID-19) pandemic constitutes an extraordinary global public health crisis. It has created a pressing need for intensified global cooperation. The pandemic has from its outset raised issues at the crossroads of public health policy trade policy and the framework for and management of innovation including those relating to intellectual property rights. The second edition of the joint WHO WIPO and WTO publication “Promoting Access to Medical Technologies and Innovation: Intersections between public health intellectual property and trade” published in 2020 included a special insert mapping the challenges posed by the COVID-19 pandemic in relation to the integrated health trade and IP policy framework set out in the study. This update revises the information contained in the last version launched in October 2021 in the light of more recent developments as of 17 May 2023.
Une approche intégrée de la santé, du commerce et de la PI pour faire face à la pandémie de COVID-19
La pandémie de maladie à coronavirus 2019 (COVID 19) constitue une crise de santé publique mondiale extraordinaire. Elle a rendu nécessaire l'intensification de la coopération au niveau planétaire. Dès le début elle a soulevé des questions à l'intersection entre la politique de santé publique la politique commerciale ainsi que le cadre et la gestion de l'innovation y compris pour ce qui est des droits de propriété intellectuelle. La deuxième édition de l'étude conjointe de l'OMS de l'OMPI et de l'OMC intitulée "Promouvoir l'accès aux technologies médicales et l'innovation: Intersections entre la santé publique et la propriété intellectuelle et le commerce" publiée en 2020 contenait un encart spécial présentant les défis posés par la pandémie de COVID 19 par rapport au cadre intégré de politiques en matière de santé de commerce et de PI établi dans l'étude. Cette mise à jour révise les renseignements figurant dans la dernière version lancée en octobre 2021 à la lumière de la situation au 17 mai 2023.
Un enfoque integrado de la salud, el comercio y la propiedad intelectual para hacer frente a la pandemia de COVID-19
La pandemia de enfermedad por coronavirus de 2019 (COVID-19) ha generado una crisis mundial de salud pública extraordinaria. Ha creado una necesidad acuciante de intensificar la cooperación a nivel mundial y desde un principio ha planteado cuestiones que conciernen a la vez a las políticas de salud pública a las políticas comerciales y al marco y la gestión de la innovación incluidas las cuestiones relacionadas con los derechos de propiedad intelectual. La segunda edición de la publicación conjunta de la OMS la OMPI y la OMC titulada Promover el acceso a las tecnologías y la innovación en medicina: intersecciones entre la salud pública la propiedad intelectual y el comercio publicada en 2020 incluía un suplemento especial en que se presentaban los desafíos planteados por la pandemia de COVID-19 en relación con los marcos de política integrados de salud comercio y propiedad intelectual descritos en el estudio. En la presente actualización se revisa la información contenida en la última versión publicada en octubre de 2021 a la luz de los acontecimientos más recientes al 17 de mayo de 2023.
Copyright and related rights
Part II of the TRIPS Agreement sets out the substantive standards for the protection of IP that WTO members should follow. This chapter outlines the provisions of Section 1 of Part II (running from Article 9 to Article 14) which sets out the protection that members must make available in the area of copyright and related rights – specifically for literary and artistic works performances phonograms (or sound recordings) and broadcasts.
Some memories of the unique TRIPS negotiations
The invitation to contribute to this book was certainly a pleasant surprise. The question for me was what I should write about: I had not been one of the negotiators and the chapter on the TRIPS negotiations from the perspective of the GATT Secretariat is dealt with by Adrian Otten who was the Secretary of the TRIPS Negotiating Group. Several suggestions were made by my co-authors and upon reflection I decided to contribute with just a short compilation of some memories in respect of a diverse set of aspects whether trade-related or not.
Why we managed to succeed in TRIPS
There have been many books and articles written about the TRIPS Agreement. Most go into great detail over the costs and benefits of the various provisions of the Agreement. As one of the negotiators of the Agreement I will not attempt to debate such an analysis. Rather this chapter will provide brief personal reflections of my experiences during the negotiations which have had a significant impact on the rest of my career as a Canadian diplomat focusing on trade issues.
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.
A world of opportunities and challenges
Research published by the European Parliament in 2017 claimed that Blockchain could “change our lives” (Boucher 2017). What the various blockchain applications that are being developed in areas as diverse as trade finance trade facilitation trade in services intellectual property and government procurement show is that Blockchain has the potential to impact both the traders and the government agencies involved in international trade significantly. Opportunities are multifaceted but will only be realized if several key challenges are addressed.
Remerciements
Mes sincères remerciements vont à ma collègue Kenza Le Mentec pour ses précieux conseils. Mme Le Mentec m’a initiée au sujet et elle a apporté de précieuses contributions en particulier pour les sections techniques décrivant la technologie et pour la section sur la facilitation des échanges. Cette publication n’aurait pas été possible sans son soutien.
Conclusion
Research published by the European Parliament in 2017 claimed that Blockchain could “change our lives” (Boucher 2017). What the various blockchain applications that are being developed in areas as diverse as trade finance trade facilitation trade in services intellectual property and government procurement show is that Blockchain has the potential to impact both the traders and the government agencies involved in international trade significantly. Opportunities are multifaceted but will only be realized if several key challenges are addressed.
The policy context for action on innovation and access
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.
Medical technologies: the fundamentals
Against the background of the global burden of disease (GBD) and global health risks this chapter outlines the fundamental imperative for collaboration. It demonstrates the need for a coordinated approach taking into account health intellectual property (IP) and trade variables to ensure coherent decision-making in the area of public health at the international regional and domestic levels.
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.
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.
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).
La chaîne de blocs peut-elle révolutionner le commerce international ?
Les gros titres annonçant que la chaîne de blocs peut révolutionner différents domaines du commerce international du financement du commerce aux procédures douanières en passant par la propriété intellectuelle sont légion. Le caractère transparent décentralisé et immuable de la chaîne de blocs a éveillé l’intérêt des acteurs privés – et des gouvernements – qui veulent explorer le potentiel de cette technologie afin d’améliorer l’efficacité des processus commerciaux et une multitude de preuves de concept et de projets pilotes utilisant la chaîne de blocs ont été menés dans quasiment tous les domaines du commerce international.
Conclusión
El mundo tal como lo conocemos ha sido definido por las innovaciones tecnológicas. Muchas personas han acogido la aparición de una nueva tecnología la cadena de bloques (una tecnología de registro distribuido) a la que consideran el próximo gran factor de cambio con entusiasmo y optimismo. La cadena de bloques que permite compartir registros digitales y datos de manera segura transparente e inalterable sin necesidad de depender de un único tercero de confianza promete avances interesantes. Esta tecnología podría permitir a los particulares y a las empresas de todo el mundo efectuar transacciones de manera más eficiente más barata y más rápida preservando al mismo tiempo un elevado nivel de seguridad. Al simplificar y digitalizar procesos en los que participan múltiples partes interesadas y que hasta ahora dependían en gran medida del papel reduciendo así los costes de procesamiento verificación seguimiento coordinación y transporte podría tener repercusiones importantes en la forma en que se realizan las operaciones comerciales ya se trate de transacciones comerciales transfronterizas financieras o físicas. Podría reducir el fraude mejorar la gestión de los derechos de propiedad intelectual mejorar la rastreabilidad y la confianza en las cadenas de valor y brindar nuevas oportunidades a las pequeñas empresas.
Current TRIPS issues
This chapter provides a general overview of the ongoing work in the TRIPS Council and other WTO bodies on other aspects of TRIPS and public policy as of the time of writing focusing on the issues which have been the most prominent
Dispute settlement in TRIPS: A two-edged sword
In the Uruguay Round of multilateral trade negotiations under the GATT the negotiations on the TRIPS Agreement were not alone in making a slow start. IPRs were a radically new subject matter for the GATT. There was both uncertainty as to just what could be considered trade-related aspects of IPRs and disagreement over the appropriateness of trying to incorporate them into a negotiation about goods. The constructive ambiguity of the mandate – necessary to achieve consensus at Punta del Este – led to strong disagreement over what did or did not fall within it. This disagreement continued throughout most of the negotiations and was only attenuated towards the end.
Negotiating for Hong Kong
Hong Kong’s overall approach to the TRIPS negotiations was made clear to the other participants from an early stage: Hong Kong held itself out as the exemplar of free trade with a mature respected legal system providing comprehensive protection across the range of IP to right holders.
Executive summary
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.
Introduction
Le monde est en constante évolution porté par les innovations technologiques qui influent sur notre façon de vivre et de faire des affaires. L’histoire de l’économie mondiale est intimement liée aux progrès technologiques. L’invention de la machine à vapeur a conduit à la mécanisation de la production la découverte de l’électricité a permis la production de masse et grâce à l’essor d’Internet il est devenu possible de coordonner à distance les différentes étapes de la production ce qui a entraîné la fragmentation de la production et l’apparition des chaînes de valeur mondiales.
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.
Patents
This chapter explains the provisions of Section 5 of Part II of the TRIPS Agreement entitled ‘Patents’. Section 5 which contains eight articles from Article 27 to Article 34 sets out the obligations of members with respect to standards concerning the availability scope and use of patents. Starting with a general explanation of terms this chapter goes on to explain each specific provision in this Section of the TRIPS Agreement.
Preface
At the heart of the World Trade Organization (WTO) is a set of rules that regulate trade between nations: a body of agreements which have been negotiated and signed by governments of most of the world’s trading nations with the aim of promoting transparency predictability and nondiscrimination 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 as an international intergovernmental organization in administering the provisions of these 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.
Patents: An Indian perspective
In this chapter I share my recollections as a representative of India from 1989–90 in the TRIPS negotiations focusing on India’s defensive interests with respect to the patent provisions of the TRIPS Agreement. I also include some relevant background information as well as some recollections of my interaction with other parties to the TRIPS negotiations.
The TRIPS negotiations: An overview
As a former official within the Secretariat of the GATT/WTO with responsibility for TRIPS matters my aim in this chapter is to set the scene for the contributions to this book of the negotiators themselves by outlining the origins and various stages of the negotiations that led to the TRIPS Agreement. I will also make some general observations on the negotiations in particular on how it proved possible to negotiate an agreement as substantial as the TRIPS Agreement and on why the WTO has been finding it difficult to achieve results comparable to those of the Uruguay Round of multilateral trade negotiations. I will of course do this from the perspective of a former Secretariat official; other chapters will add additional perspectives. I should add that I left the WTO Secretariat in 2008.
Trademarks
This chapter explains the provisions of Section 2 of Part II of the TRIPS Agreement entitled ‘Trademarks’. This Section contains seven articles from Article 15 to Article 21 and deals with the protection that members have to make available for trademarks.
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.
TRIPS and public health
Public health has been one of the most extensively discussed aspects of the TRIPS Agreement both in terms of the treaty text itself and its implementation at the domestic level. Its significance is borne out by a proclamation at the ministerial level the 2001 Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) and by the ensuing amendment of the Agreement itself the first amendment of any WTO multilateral trade agreement undertaken specifically to provide the most vulnerable countries with an additional secure legal pathway to gain access to affordable generic medicines.
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.
¿Pueden las cadenas de bloques revolucionar el comercio internacional?
Son muchos los titulares en los que se sostiene que la cadena de bloques puede revolucionar diversas esferas del comercio internacional desde la financiación del comercio hasta los procedimientos aduaneros y la propiedad intelectual. El carácter transparente descentralizado e inalterable de la cadena de bloques ha despertado el interés de los agentes privados -y de los Gobiernos- en explorar las posibilidades que ofrece esta tecnología para mejorar la eficiencia de los procesos comerciales por lo que ya se han realizado multitud de estudios de viabilidad y proyectos piloto utilizando la cadena de bloques en prácticamente todos los ámbitos del comercio internacional.
Guide to transparency under TRIPS
This Appendix provides a practical guide to the transparency mechanisms established under the TRIPS Agreement concerning how countries choose to implement provisions of the Agreement. These mechanisms help the TRIPS Council to monitor the operation of the Agreement and to promote understanding of members’ intellectual property (IP) policies and legal systems. This Appendix focuses only on the practical use of these mechanisms: the relevant chapters of this book should be consulted for their full background and context.
An integrated health, trade and IP approach to respond to the COVID-19 pandemic
The coronavirus disease 2019 (COVID-19) pandemic constitutes an extraordinary global public health crisis. It has created a pressing need for intensified global cooperation. The pandemic has from its outset raised issues at the crossroads of public health policy trade policy and the framework for and the management of innovation including those relating to intellectual property (IP) rights.
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.
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.
Foreword
As we mark the 20th anniversary of the WTO it seems appropriate that we should put a spotlight on the TRIPS Agreement which also turns 20 this year. When the TRIPS Agreement came into being in 1995 it introduced substantive and comprehensive disciplines on intellectual property rights (IPRs) into the multilateral trading system.
Medical technologies: the innovation dimension
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: the access dimension
Chapter III explained the role of intellectual property (IP) and other policy measures in health innovation; this chapter provides a detailed description of the access dimension and the concepts laws and policies underlying it as well as data on availability and access to health technologies and methodological approaches to their measurement. It also offers an overview of the main determinants of access related to health systems IP and trade policy.
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.
Negotiating for Argentina
To prepare a chapter that presents the experiences of a negotiator of the TRIPS Agreement as close as possible to reality is not an easy task. This is because the Agreement is complex as it covers many subjects related to IP and is made up of a set of rules with varied degrees of specificity and detail. Approaching this task 25 years after the negotiations has introduced complications and involuntary distortions that have made this task even more difficult.
Dispute prevention and settlement
Chapters II to VIII have dealt with members’ commitments as regards the substantive standards for protection of IPRs under domestic laws as well as their enforcement through their domestic legal systems. An important feature of the TRIPS Agreement is that disputes between members about compliance by member governments with these TRIPS obligations are subject to the dispute settlement system of the WTO. The TRIPS provisions on dispute settlement are contained in Part V of the TRIPS Agreement entitled ‘Dispute Prevention and Settlement’.
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.
Guide to TRIPS documents
The TRIPS Agreement 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. In addition the TRIPS Council has itself established a series of reporting processes concerning specific aspects of members’ IP systems. 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 LDC members for whom these provisions do not yet apply).
Foreword
International cooperation on public health is inherently multi-dimensional with a focus on building effective health systems. It is dynamic and responsive to the demands of countries around the globe. Towards this goal the World Health Organization (WHO) the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO) have been working closely together for almost two decades to support global endeavours to improve health outcomes.
Acknowledgements
Preparation of the Handbook was a collective endeavour by the WTO Intellectual Property Government Procurement and Competition Division drawing on years of practical feedback from technical assistance and training programmes prepared and delivered by the Division in particular the material prepared for the first version of the TRIPS module of WTO eTraining. The former director of the Division Mr Adrian Otten substantively reviewed and enhanced earlier versions of this material.
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.
Conclusion
Le monde tel que nous le connaissons aujourd’hui a été façonné par les innovations technologiques. Une nouvelle technologie la chaîne de blocs – technologie de registres distribués – a été accueillie par beaucoup avec enthousiasme et optimisme comme le prochain grand facteur de changement. La chaîne de blocs qui permet de diffuser des données et des informations numériques de manière sûre transparente et immuable sans avoir à recourir à un tiers de confiance unique est une technologie particulièrement prometteuse. Elle pourrait permettre aux individus et aux entreprises du monde entier d’effectuer des transactions de manière plus efficace plus économique et plus rapide tout en conservant un haut niveau de sécurité. Elle pourrait avoir un impact considérable sur la façon de réaliser les opérations commerciales qu’il s’agisse des transactions financières ou des transactions commerciales transfrontières physiques en réduisant les coûts de traitement de vérification de suivi de coordination et de transport grâce à la simplification et à la numérisation des processus qui impliquent de multiples parties prenantes et qui étaient jusqu’à présent fortement tributaires du papier. Elle pourrait réduire la fraude permettre une meilleure administration des droits de propriété intellectuelle renforcer la traçabilité et la confiance dans les chaînes de valeur et offrir de nouvelles possibilités aux petites entreprises.
Copyright: A Nordic perspective
During the Uruguay Round of multilateral trade negotiations I worked at the Finnish Ministry of Education and Culture where my main responsibilities included copyright law and policy. I participated in coordination of the Nordic countries (Finland Iceland Norway and Sweden) in the capitals and represented the Nordic countries in the later stages of the TRIPS negotiations in Geneva. During the same period I was also actively involved in WIPO’s work on copyright and the protection of layout-designs of integrated circuits and also contributed to the intergovernmental work under various other international and European fora such as the International Convention for the Protection of Performers Producers of Phonograms and Broadcasting Organizations (Rome Convention). Since January 1995 I have served at the WTO Secretariat IP Division.
Introduction to the TRIPS Agreement
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 VIII then discuss each of these categories their essential principles and their administration and enforcement in more detail.
Copyright: An Indian perspective
My unexpected participation in the TRIPS negotiations as my country’s sole negotiator on copyright remains one of the unforgettable experiences of a 38-year civil service career.
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.