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Papers by E. Richard Gold

PART 2 CASE STUDIES Brazil 5. Property rights, biocultural resources and two tragedies: Some less... more PART 2 CASE STUDIES Brazil 5. Property rights, biocultural resources and two tragedies: Some lessons from Brazil 113 Edson Beas Rodrigues Jr Kenya 6. Old wine in new skin: Traditional knowledge and customary law under the evolving normative environment in Kenya 183 Kent Nnadozie India 7. Sustaining the indigenous knowledge commons 207 Ashok Kumbamu

Science Translational Medicine, Jul 3, 2013

The U.S. Supreme Court’s decision in the Myriad Genetics case will promote translation of genetic... more The U.S. Supreme Court’s decision in the Myriad Genetics case will promote translation of genetics-based diagnostics while preserving patent protection for other biomedical products.

A book focusing on transnational perspectives on BRCA would certainly be incomplete without a cha... more A book focusing on transnational perspectives on BRCA would certainly be incomplete without a chapter on the international uproar regarding patents on the BRCA gene sequences and testing methods. BRCA 'gene patents' have been the focus of intense controversy for decades and-more recently-the subject of court battles in the US and Australia. Most conspicuously, the US Supreme Court handed down its ruling on whether human genes are patentable subject matter on 13 June, 2013 (AMP v. Myriad [2013]). General patentability criteria are globally uniform and technology-neutral (requiring that the invention is new, involves an inventive step and is capable of industrial application). 2 National patent systems show considerable variation, however, in how each criterion is applied, either through patent legislation or as developed through case law. As with any other field of technology, biological materials are, in principle, capable of fulfilling these criteria. In all jurisdictions, however, a question of threshold must be addressed before these patentability criteria are applied. This question concerns whether or not the invention constitutes patentable subject matter. Although not traditionally viewed as satisfying this threshold requirement, many kinds of living matter are now considered to be eligible, and as a consequence patents have intruded on the field of human genetics as well. This intrusion has not gone unnoticed and has led to a 'policy storm' (Gold and Carbone 2010) surrounding the desirability of human gene patents since the late 1980s. At the centre of this storm is Myriad Genetics Inc (hereinafter Myriad). Myriad is a biotech spin-off from the Center for Genetic Epidemiology at the University of Utah. It is not the only owner of patents related to human genes, mutations and diagnostic methods with respect to the BRCA1 and BRCA2 genes. However, it has been singled out in the policy storm largely because of the way in which it chose to use its patent rights. Myriad accumulated sufficient patent rights to create a service monopoly in the US, but it did not achieve that level of dominance in any other jurisdiction. It also made a number of commercialization decisions that did not sit well within the research community (Baldwin and Cook-Deegan 2013, Gold and Carbone 2010, Parthasarathy 2007).

the renewal, indeed the strengthening, of the postwar multilateral order." 17 Minister Freeland r... more the renewal, indeed the strengthening, of the postwar multilateral order." 17 Minister Freeland recognizes that the United States, at this time, might not always be a partner, and this requires Canada to continue working "with other likeminded people and countries who share our aims." 18

The Development Agenda 2 adopted on September 28, 2007, presents WIPO with a formidable challenge... more The Development Agenda 2 adopted on September 28, 2007, presents WIPO with a formidable challenge of how to implement it. This challenge does not simply arise from the breadth and aspirations of the document, but from the critical stance that the Agenda demands that WIPO takes on the very lifeblood of the organization: that sometimes less, not more, intellectual property (IP) is best. Any paradigm shift, as represented by the Development Agenda, is daunting and would challenge any large institution attempting to manage it. It took much effort for the World Bank, for example, to transform its initial objective of infrastructure reconstruction in Europe into developing country economic growth and, more recently, from debt management to sustainable development and poverty reduction. This paper suggests, however, that steering change at WIPO is an order of magnitude more challenging than the World Bank's transformation. This is so for three reasons: 1) WIPO is not in a position to manage the cultural change required by the Development Agenda; 2) WIPO's principal strength is in administering technical intellectual property treaties rather than in norm development; and 3) WIPO Members have a tendency to say one thing internationally but do the opposite nationally. Given this, WIPO should not be entrusted with implementing its own Agenda. Instead, it should restrict its role to finding and funding outside organizations to do the transformative work required to implement the Development Agenda.

The San Diego law review, 1995

specializing in technology law and has S.J.D. and LL.M. degrees from the University of Michigan L... more specializing in technology law and has S.J.D. and LL.M. degrees from the University of Michigan Law School. The author gratefully acknowledges the financial assistance of the Social Sciences and Humanities Research Council of Canada, the Mackenzie King Foundation, and the University of Michigan with respect to the research and preparation of this Article. The author wishes to thank Tory Tory DesLauriers & Binnington for the use of their facilities in writing this Article. This Article was written in partial fulfillment of the requirements for the grant of S.J.D. at the University of Michigan Law School. The author particularly wishes to thank David Foulds, who graciously provided editorial and research assistance and undertook the arduous task of extracting this Article from the author's thesis. 1. W.E. BURGHARDT Du Bors, THE SOULS OF BLACK FOLKS 126 (Penguin Books 1982) (1903). I. THE NATURE OF PROPERTY DISCOURSE Researchers and those arguing on their behalf commonly express their assertions of control over human biological materials in terms of property law. 13 Property, whether in the form of common-law property, a patent right, or a trade secret, offers researchers a significant degree of control over the subsequent use of their discoveries and the ability to substantially profit from these discoveries. Property law is, however, imbued with certain attributes that make its application to discoveries in distributed on the basis of one's ability to pay. This point is raised simply to point out that in many countries, including Canada, health care is viewed as a merit good. Id 11. MICHAEL WALZER, SPHERES OF JUSTICE 86-91 (1983). The right to health care has been recognized internationally, in human rights instruments, see, e.g., Organization of American States: Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights, Nov. 14, 1988, 28 l.L.M. 161, 164 (stating that everyone has a right to health, including primary health care), and through the provision of state health care in most western countries, see, e.g., MILTON I. ROEMER, NATIONAL HEALTH SYSTEMS OF THE WORLD: THE COUNTRIES (1991) (referring to Germany,

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, Jan 6, 2002

Brief of Amici Curiae ("friend of the court") submitted by certain academics in law, me... more Brief of Amici Curiae ("friend of the court") submitted by certain academics in law, medicine, health policy, and clinical genetics in support of petitioners on petition for a Writ of Certiorari (No. 11-725)

Intellectual Property and Emerging Technologies

The Human Genome Project (HGP) and follow-on collaborative studies have provided scientists with ... more The Human Genome Project (HGP) and follow-on collaborative studies have provided scientists with a vast amount of information about the human genome. Despite this, and despite an increasing focus on genomewide analysis, there are still significant gaps in our understanding of how the human organism functions as a whole and how life choices and environmental factors interact with our pre-programmed genetic constituents. These are important questions, for which answers are vital if we want to create a healthier world for future generations. Biobanks are widely recognized as vital research tools in this quest. They contribute by providing collections of human tissue linked with genetic information and other health information that permit researchers to pinpoint disease targets and perfect drug development. There is a wide diversity in types and forms of biobank, ranging from small-scale disease-specific collections through to more recently established large-scale population resources.

The opinions expressed and arguments employed herein do not necessarily reflect the official view... more The opinions expressed and arguments employed herein do not necessarily reflect the official views of the OECD or of the governments of its Member countries.

info:eu-repo/semantics/publishe

Frontiers in Drug Discovery

Among the lessons learned from the COVID-19 pandemic is the need to develop antiviral drugs poise... more Among the lessons learned from the COVID-19 pandemic is the need to develop antiviral drugs poised to treat the next pandemic. Unfortunately, traditional drug development economic models, centered principally on patents, are ineffective to induce private sector investment due to unpredictable timing and cause of the next pandemic. As a result, illustrated by the COVID-19 pandemic, it is the public and philanthropic sectors sectors that overwhelmingly fund the development of innovative vaccines and therapies. To meet the need for proactive antiviral medicines in advance of the next pandemic, new models of drug development are needed. Open science partnerships (OSPs) show promise in this regard. Rather than rely principally on patents and private investment, OSPs combine a variety of academic, philanthropic, governmental, and private sector incentives to share knowledge and develop and test antiviral drugs. Private sector investments are, within an OSP, not only leveraged against inve...

This fascinating study describes efforts to define and protect traditional knowledge and the asso... more This fascinating study describes efforts to define and protect traditional knowledge and the associated issues of access to genetic resources, from the negotiation of the Convention on Biological Diversity to The Declaration on the Rights of Indigenous Peoples and the Nagoya Protocol. Drawing on the expertise of local specialists from around the globe, the chapters judiciously mix theory and empirical evidence to provide a deep and convincing understanding of traditional knowledge, innovation, access to genetic resources, and benefit sharing.

Opening keynote for the National Data Services Framework Summit 2019.

Launched in 2009, GPS: Where Genomics, Public Policy and Society Meet is a series hosted by Genom... more Launched in 2009, GPS: Where Genomics, Public Policy and Society Meet is a series hosted by Genome Canada to facilitate a dialogue between federal policymakers and researchers exploring issues at the interface of genomics and its ethical, environmental, economic, legal and social aspects (or GE 3 LS). Overarching themes for the series and specific topics are selected on the basis of their importance and timeliness, as well as the "ripeness" of the underlying scholarship. Accordingly, the first series focused on "Genetic Information," whereas in year two, attention has shifted to "Translational Genomics." At the core of these exchanges is the development of policy briefs that explore options to balance the promotion of science and technology while respecting the many other considerations that affect the cultural, social or economic well-being of our society. Co-authors of the briefs are leaders in their field and are commissioned by Genome Canada to synthesize and translate current academic scholarship and policy documentation into a range of policy options. The briefs also benefit from valuable input provided by invited commentators and a group of expert participants and other stakeholders convened at half-day events in Ottawa. Briefs are not intended to reflect the authors' personal views, nor those of Genome Canada. Rather than advocating a unique recommendation, briefs attempt to establish a broader evidence base that can inform various policymaking needs at a time when emerging genomic technologies across the life sciences stand to have a profound impact on Canada.

SSRN Electronic Journal, 2011

Developing countries; Intellectual property; United States The puzzle of global IP politics The f... more Developing countries; Intellectual property; United States The puzzle of global IP politics The field of global intellectual property (IP) politics is booming. Still seen as esoteric in the mid-1990s, the number of new publications is now rapidly growing. Tellingly, at the 2011 Annual Convention of the International Studies Association, as many as 23 papers presented looked at the global governance of IP. 1 In exploring power struggles underlying the global IP regime, political scientists have built on two of the legal experts' legacies. 2 The first is a propensity to define the dependent variable in terms of legal standards for IP protection. This focus is exemplified by the few studies that aim at explaining anything other than legal standards, such as preferences, behaviours, practices, principles or worldviews related to IP. 3 Concentrating on a single dependant variable, however, is not necessarily a scientific sin. Arguably, a focus on only one dependent variable but eclecticism in the search for significant independent variables is a fruitful strategy to advance a research program. The second of the IP lawyers' legacies is a strong tendency to picture IP debates as binary oppositions. Political stances are located on a unidimensional continuum opposing the advocates of stronger IP protection with the supporters of weaker protection. The reference point used to define the meaning of the terms "strong" and "weak" evolve as new narratives are constructed to explain the past and to encapsulate aspirations for the future. 4 At present, the division between "strong" and "weak" seems to be embodied by the Agreement on Trade-Related Aspects of Intellectual Property (TRIPs), which several OECD countries and businesses see as weak and outdated while many developing countries and nongovernmental organisations (NGOs) consider overly strong and unfair. The reality of political debates is obviously more complex than simplistic dichotomies. For analytical purposes, however, binary oppositions are useful heuristic devices to apprehend empirical realities.

Science Translational Medicine, Jul 3, 2013

The San Diego law review, 1995

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, Jan 6, 2002

Intellectual Property and Emerging Technologies

info:eu-repo/semantics/publishe

Frontiers in Drug Discovery

Opening keynote for the National Data Services Framework Summit 2019.

SSRN Electronic Journal, 2011

Regulation and Governance, 2019

While policymakers often make bold claims on the positive impact of intellectual property (IP) ri... more While policymakers often make bold claims on the positive impact of intellectual property (IP) rights on both developed and developing country economies, the empirical literature is more ambiguous. IP rights have both incentive and inhibitory effects that are difficult to isolate in the abstract and dependent on economic context. To unravel these contradictory effects, this article introduces an index that evaluates the strength of IP protection in 124 developing countries for the years 1995 to 2011. We illustrate the value of this index to economics study and show evidence that is consistent with IP leading to increased growth. Our results are further consistent with two causal pathways highlighted in the literature: that IP leads to greater levels of technology transfer and increased domestic inventive activity. Yet, other aspects of our study fit uneasily with this simple story. We find, for example, evidence suggesting that increased levels of growth lead to greater levels of IP protection, contradictory evidence in the literature linking IP with growth, a lack of evidence that increased levels of IP protection lead to actual use of the IP system and problems with what IP indexes measure. Because of this, we suggest another – and so far undertheorized – explanation of the links between IP and growth: that IP may have few direct effects on growth and that any causality is due to belief rather than actual deployment of IP.

European Journal of International Relations, Jan 1, 2010

While the WTO secretariat, key delegations, several NGOs, and industry publicly present the 30 Au... more While the WTO secretariat, key delegations, several NGOs, and industry publicly present the 30 August 2003 WTO Decision as an attempt to reconcile intellectual property with access to medicines, our research shows otherwise. We draw on qualitative analyses of 54 interviews and a lexicometric analysis of press releases to show that their enthusiastic public statements contrast deeply with their internal, cynical beliefs. Most of these actors not only consider the WTO Decision to be fundamentally flawed but claim to have known this prior to its adoption. We argue that a procedural norm of consensus-seeking impeded traditional bargaining over this sensitive issue and that distrust among participants hindered truth-seeking deliberation. Caught between strategic and communicative actions, state and non state actors found themselves trapped in their own rhetoric of reconciling intellectual property with access to medicines. They realized that the appearance of a solution, rather than a functional solution, provided the only realistic outcome to a fruitless and publicly damaging continuation of debate. From a theoretical perspective, this case study sheds a new light on the gray zone between rational choice theory and constructivism, where both discourse and strategies matter. From an empirical perspective, it illustrates the risk of seeking consensus within international regimes when the procedural norm of consensus coexists with a high level of distrust.

"Why some developing countries adopt US-style IP rules that go beyond those required by the TRIPs... more "Why some developing countries adopt US-style IP rules that go beyond those required by the TRIPs agreement.? With this paper, we contribute to the disentanglement of this puzzling situation in two manners. First, we explore one often neglected reason for the adoption of US-style rules, i.e. the socialization of decision-makers in the adopting country through interaction with experts in US IP law. Second, we rely on a more systematic conceptualization and measurement of variables than has been adopted in many previous studies. Overall, we bring forward strong quantitative evidence that socialization is a significant force in the export and import of IP rules.
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This article focuses on the intersection of health and one of the main drivers of the global econ... more This article focuses on the intersection of health and one of the main drivers of the global economy, intellectual property. It is widely recognized that IP is an inter-sectoral issue with linkages to many other important public policy areas, such as health, agriculture, the environment, and education. In inter-sectoral issues such as IP, there is discussion on the need for governments around the world to achieve policy coherence not only across their various departments, but also between their domestic and international positions in important fora.
To appreciate better the complexity of achieving policy coherence, this article first gives a multi-disciplinary view of policy coherence and then provides the Canadian context for the debate. Next, it describes three examples at the border of public health and intellectual property in Canada and internationally: (1) health innovation and access to medicines in developing countries; (2) traditional knowledge (medicinal); and (3) pandemic influenza preparedness. Finally, the article discuses international experiences with a variety of mechanisms for achieving policy coherence in IP and health, including the practice of advisory groups, multi-stakeholder dialogue, inter-departmental coordination mechanisms, broad delegations for international meetings, and white papers. From this review, a few observa-tions can be made. First, effective coordination requires two main factors: leadership and a permanent institution that can build trust. While inter-ministerial coordination is a widely used process for policy coherence, it is not always successful. Indeed, the lack of leadership in inter-ministerial coordination has strongly constrained policy coherence.

Why do some countries adopt exogenous rules into their domestic law when those rules contravene t... more Why do some countries adopt exogenous rules into their domestic law when those rules contravene their specific interests? We draw on the policy-diffusion literature to identify four causal mechanisms that we hypothesize explain the adoption of such rules. While existing literature treats these mechanisms as independent, we argue that each works in combination with the others to facilitate legal transplantation. While one mechanism—coercion—tends to initiate the transplantation process, it fades over time and three others largely supplant it: contractualization, socialization, and regulatory competition. These mechanisms act in a mutually supportive manner. We test our claims via a quantitative analysis of legal transplants in the field of intellectual property (IP) that incorporates an original index of IP protection in 121 developing countries over 14 years. This article concludes with a plea for theoretical eclecticism, acknowledging multi-causality and context-conditionality. Any comprehensive explanation of legal transplantation must include the identification of mutual reinforcement between causal mechanisms, rather than simply rank their relative contributions.

This article synthesizes the results of two analyses, one at a macro and the second at the micro ... more This article synthesizes the results of two analyses, one at a macro and the second at the micro level, to shed new light on the process of international socialization. More particularly, the first analysis examines the seeming adoption of intellectual property norms at the state level while the second looks at the internalization of similar norms at the individual decision-maker level. Both pay special attention to foreign education and capacity building courses as carriers of US norms to developing countries. By triangulating the results of these analyses, we gain a more precise picture of international socialization processes than analyses centred at only one level. It becomes possible to distinguish between socialization types (acculturation or persuasion) and idea types (causal or normative beliefs).

Any give by Canada on patents will be costly not only to its health care system, but also to its ... more Any give by Canada on patents will be costly not only to its health care system, but also to its innovators.

Vulnerable: The Policy, Law and Ethics of COVID-19, 2020

This chapter addresses intersections among international trade law, intellectual property rights,... more This chapter addresses intersections among international trade law, intellectual property rights, and domestic innovation policies to prevent , detect, and treat pandemics. Structural issues with Canada's innovation system affected preparedness for this pandemic and, unless remedied, will impede responses to future crises. In this chapter , we suggest aligning domestic and international policy measures to nuance Canada's approach to intellectual property and accelerate Canada's global contributions through open science. Résumé Commerce international, propriété intellectuelle et politique d'innovation : les leçons d'une pandémie Ce chapitre traite des recoupements entre le droit commercial international , les droits de propriété intellectuelle et les politiques natio-nales d'innovation pour prévenir, détecter et traiter les pandémies. Les problèmes structurels du système d'innovation canadien ont affecté la préparation à cette pandémie et, s'ils ne sont pas corrigés,