Academic journal article Health Law Journal

History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing

Academic journal article Health Law Journal

History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing

Article excerpt

1. Introduction

The patenting and commercialization of human genetic material raises a host of complex social, ethical, and policy issues, such as the potential for discrimination or stigmatization in access to health care services or employment, the exploitation of minority or indigenous communities in DNA prospecting, and the implications for ongoing biomedical research and access to health care services. But in order to conduct a comprehensive analysis of even one of these issues, it is crucial to first develop a detailed understanding of the particular history and context that have shaped the issue. The objective of this paper is to provide such a description of one particular case, namely the patenting by Myriad Genetics of the two genes (BRCA1 and BRCA2) associated with hereditary breast and ovarian cancer. Following a brief discussion of the aetiology of hereditary breast and ovarian cancer, the founding of Myriad Genetics and its transformation into a biopharmaceutical company is examined as part of the larger conte xt of the international race to discover and patent the BRCA genes. The paper then focuses on Myriad's development and control of public and commercial BRCA testing in the United States, their recent moves to enforce the patents and establish markets in Europe and Canada, and the mounting Canadian and international opposition to Myriad's commercialization and control of BRCA testing.

The Myriad case is a harbinger of an increasing number of instances where gene patents provide companies with monopolies on the development, marketing, and provision of genetic tests and therapeutics. Not surprisingly, this case has become a focal point in Canada and Europe for debates about the social and ethical implications of DNA patenting and the commercialization of genetic tests. There have been legal challenges of the BRCA patents in Europe, legislation to require compulsory licensing of diagnostic tests introduced in France, and in Canada an almost nationwide rejection of Myriad's monopoly rights to BRCA testing. There is clearly a need for sustained and comprehensive social, ethical, and policy analysis of the issues arising from this and similar cases. These issues will only touched on in this paper, as the primary task is to show how a rich description of a specific exemplar--the Myriad case--is essential groundwork for conducting a comprehensive social, ethical, and policy analysis of the commer cialization of new genetic technologies.

2. Biotechnology and Gene Patenting

By the early 1990s, enormous amounts of public and private funds were being invested in genetics research and biotechnology development. (1) The U.S. public expenditure on the Human Genome Project is estimated at greater than US$3 billion. The U.S. biotechnology industry invested US$11 billion in R&D in 1999 (2) and US$15.6 billion in 2001. (3) In Canada in 1998, federal biotechnology funding reached C$314 million, of which million was devoted to R&D; (4) Canadian industry invested C$341 million while not-for-profit institutes invested C$115 million. (5) With the creation of Genome Canada in February 2000, the federal government continued its support of biotechnology research by investing a further C$300 million specifically towards genomics R&D. (6) Similar funding initiatives have been launched in the United Kingdom (7) and other European and Asian nations.

While the potential health benefits to be derived from biotechnology were clearly a motivating factor for the substantial public investments, this goal was closely parallelled (if not exceeded) by the conviction that developing a strong biotechnology industry is essential for stimulating economic growth and building a 'knowledge-based economy.' (8) Public financial investments in biotechnology were thus also supported by government policies and regulations to facilitate technology transfer and commercialization. (9)

The 1980 U. …

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