History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing
![handle is hein.journals/hthlj10 and id is 129 raw text is: History of a Gene Patent: Tracing the Development
and Application of Commercial BRCA Testing
Bryn Williams-Jones*
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 context of the international race to
discover and patent the BRCA genes. The paper then focuses on Myriad's devel-
opment 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
. Bryn Williams-Jones, Ph.D., Centre for Family Research & Homerton College, University of Cam-
bridge (Contact: Centre for Family Research, Faculty of Social and Political Sciences, Free School Lane,
University of Cambridge, Cambridge, United Kingdom, CB2 3RF, bryn@genethics.ca). This paper is
based on a chapter from the author's dissertation, Genetic TestingforSale: Implications of Commercial
BRCA Testing in Canada (Ph.D. Dissertation, University of British Columbia 2002) [unpublished]. The
author would like to thank Michael Burgess, Timothy Caulfield, Janice Graham, and Patricia Baird for
their enthusiastic supervision, support, and critical commentary; and Lori Sheremeta, Shobita
Parthasarathy, Patricia Kaufert, Doug Horsman, Karen Panabaker, and Mary McCullum for help with
background information about the law, politics, and science of providing genetic testing for hereditary
breast cancer. Many of the ideas here have benefited from discussions with the Genetics and Ethics
Research Group at the Centre for Applied Ethics, University of British Columbia. This research was
supported by fellowships from the Canadian Health Services Research Foundation, the Social Sciences
and Humanities Research Council of Canada, the Qu6bec Fonds pour la Formation de Chercheurs et
I'Aide A la Recherche, and the Centre for Applied Ethics at the University of British Columbia.](ViewImageLocal?handle=hein.journals/hthlj10&div=9&collection=journals&method=preview&ext=.png&size=3)
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History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing
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