History of a gene patent: tracing the development and application of commercial BRCA testing

B Williams-Jones - Health LJ, 2002 - HeinOnline
Health LJ, 2002HeinOnline
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 …
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 context 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
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