E. Richard Gold

Myriad Genetics: In the eye of the policy storm

From the late 1980s, a storm surrounding the wisdom, ethics, and economics of human gene patents has been brewing. The various winds of concern in this storm touched on the impact of gene patents on basic and clinical research, on health care delivery, and on the ability of public health care systems to provide equal access when faced with costly patented genetic diagnostic tests. Myriad Genetics, Inc., along with its subsidiary, Myriad Genetic Laboratories, Inc., a small Utah-based biotechnology company, found itself unwittingly in the eye of this storm after a series of decisions it made regarding the commercialization of a hereditary breast cancer diagnostic test. This case study examine the background to Myriads decisions, the context in which these decisions were made and the policy, research and business response to them.

Are Patents Impeding Medical Care and Innovation

This months debate examines whether the current patent system is crucial for stimulating health research or whether it is stifling biomedical research and impeding medical care.

Genetic testing, ethical concerns, and the role of patent law

This article examines the changing debate over gene patenting and the possible connection between patent law and the ethical and policy concerns associated with the use of genetic testing technologies (e.g. the premature implementation and inappropriate marketing of genetic tests). Arguably, patent law helps to form the market forces that lead to these concerns. It is suggested that existing safeguards fail to control these concerns because of, for example, a lack of provider knowledge and an absence of an adequate regulatory framework. While patent law can be associated with a number of ethical and policy concerns, the article also suggests that patent law may have a positive role in reducing them. Patent law provides policy makers and the public with a focal point – the patent holder – upon which to attach accountability for ethical and legal conduct. The article concludes by inviting policy makers to consider the ways in which patent law could be modified in order to optimize its constructive influence.

Consensus-seeking, distrust and rhetorical entrapment: The WTO decision on access to medicines

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.

Needed: models of biotechnology intellectual property

Although never uncontroversial, intellectual property rights in biotechnological innovation are once more the focus of intense debate. The debate has yet to reach any result, largely because of several important errors in the way that various disciplines approach it. These errors include making assumptions without empirical basis and conflating various intellectual property regimes. What is needed is a transdisciplinary integrated method to correct these errors. Such a method can be implemented through the construction of alternative models of intellectual property protection designed to balance the various social, ethical and economic constraints that affect biotechnology.

Patent landscaping for life sciences innovation: toward consistent and transparent practices

As industry, governments and academia increasingly rely on patent landscapes to map scientific and technological trends, an interdisciplinary workshop provides recommendations for developing consistent and transparent landscaping practices.

The European Biotech Directive: Past as Prologue

The directive on the legal protection of biotechnological inventions (the Biotech Directive) represents the end of a decade-long dialogue on how best to encourage biotechnology innovation in Europe while addressing ethical concerns. The Biotech Directive represents an interesting compromise between Parliament, Commission, and Council based on divergent policy concerns, treaty limitations, and international trade rules. In this article, the authors explore the meaning and implication of the Biotech Directive by examining its contentious history, its provisions, and its jurisdictional foundations. Drawing on this base, the authors examine questions left unanswered by the Biotech Directive and analyse how the Biotech Directive fits in with existing international law.

Genomics knowledge and equity: a global public goods perspective of the patent system

Genomics, the comprehensive examination of an organisms entire set of genes and their interactions, will have a major impact on the way disease is diagnosed, prevented and treated in the new millennium. Despite the tremendous potential it holds for improving global health, genomics challenges policy-makers to ensure that its benefits are harnessed equitably across populations and nations. The classification of genomics as a global public good and the inequity encountered in the development and application of genomics knowledge are outlined in this paper, We examine the effect of the current patent system on the distribution of costs and benefits relating to genomics knowledge between countries of different economic strength. The global public goods concept provides a normative economic rationale for the modification of certain aspects of the current patent system and for the creation of complementary mechanisms to respond to the health needs of low-income and middle-income countries.

DNA patents and diagnostics: not a pretty picture

Restrictive licensing practices on DNA patents are stymieing clinical access and research on genetic diagnostic testing. Diagnostic companies, university tech transfer offices and their respective associations need to pay more attention.

Moving the gene patent debate forward

A framework for achieving compromise between industry and civil society.