What's the use? Law and authority in patenting human genetic material.

Abstract

Most analyses of the relationship between intellectual property and genetics have focused on important but relatively discrete policy debates about when or whether genetic information should be patented. This article aims to delve beneath the surface of such debates to unearth and interrogate unarticulated themes and assumptions that implicitly reconstruct existing understandings of personhood, citizenship, and authority in terms of genetic discourses. Where the domains of science and the market intersect in patent law, genetic identity and property intertwine, each informing and to a degree becoming a function of the other. As experts in the natural and social sciences construct human identity at the molecular level, venture capital is making deals with these same professionals to manage and transform that identity into marketable products subject to patent rights. Genes are thus becoming sources both of identity and of property, concepts basic to historical constructions of American citizenship Contemporary discourses of genetics and rights may be currently reshaping understandings of citizenship to the extent that the legal identity of the individual is implicated in and constructed through a relationship to her genetic material. The first step toward understanding and analyzing the nature of this relationship is to explore how genetic material itself is identified and defined within the domain of legal discourse. Intellectual property law provides a primary site for this exploration because, more than most other areas of the law, it deals explicitly with defining the nature and legal status of human genetic material. This article explores the patenting of human genetic material as a site where science, the market, and law "situate the self" in the genome in a manner that simultaneously renders it a subject of commerce. As an entry point to this still large area of study, I choose the relatively circumscribed arena presented by the rather heated debates that emerged in 1999 and 2000 around the proposed revisions to the "Utility Examination Guidelines" used by the U.S. Patent and Trademark Office (PTO) in evaluating the validity of patent applications. In examining the debates before the PTO, I aim to show how certain claims, supported by particular models of authoritative knowledge, gain recognition from and access to the power of the American legal and regulatory system while others are marginalized and denied. I argue that the PTO, functioning in a quasi-judicial manner, constructs distinctions between issues of policy and administration as a means to circumscribe the debates over patentability of human genetic material. The boundaries it draws, enables the PTO to bracket and dismiss concerns couched dignitary and religious discourses while recognizing and crediting the more technical arguments of scientific and economic experts.