Gene Patents
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CURRENT OPINION
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Gene Patents
Perspectives from the Clinical Laboratory Karen P. Mann Department of Pathology, Emory University School of Medicine, Atlanta, Georgia, USA
Abstract
Patents involving human genes, human genetic material, and genotype-phenotype correlations are a reality and are increasingly having a negative effect on the clinical molecular diagnostic laboratory and on patient care. Specifically, gene patents and exclusive licensing of diagnostic testing has a detrimental effect on the quality of laboratory testing, the cost of testing, turnaround time, coordination of care, patient access to testing and the ability to confirm testing at a separate laboratory. In this article, gene patents are discussed from the perspective of a medical director of a molecular diagnostics laboratory, and the effect of such patents on clinical laboratory practice is examined.
1. Introduction The patenting of human genes is a hot topic in the media and in the clinical laboratory. Last year, the Association for Molecular Pathology and a long list of plaintiffs – including other professional organizations, oncologists, patients, genetic counselors, and researchers – joined the American Civil Liberties Union in a lawsuit charging that patents on two human genes associated with an increased risk of breast and ovarian cancer, BRCA1 and BRCA2, are unconstitutional and should be invalidated.[1,2] The recent decision by Judge Sweet in favor of the plaintiffs has been heralded as the end of gene patenting.[3] Given that Myriad Genetics, Inc., is appealing this decision, and given the likelihood that this will ultimately be decided in the US Supreme Court, this celebration is premature. Although I am hopeful that this first step heralds the end of the practice of gene patents, the future of these patents is unknown. It is my sincere wish that the issues I discuss in this article will cease to be pertinent in the future, but, for the meantime, these issues continue to face the clinical laboratory. In this article, I discuss how intellectual property affects how I practice medicine, including the effect of patents on test menus, turnaround times, the choice of laboratories for referral testing, coordination of care, and laboratory finance. In short, I want you to feel my pain. This article represents my personal perspective on the patenting of genes/genotype-phenotype correlation, as used in diagnostic testing and developed during my years as a practi-
cing pathologist and laboratory medical director in academic healthcare. I am not a lawyer; I do not work in the private practice/commercial sector; and I am not an entrepreneur.
2. Philosophy versus the Real World The practice of patenting human genes and non-gene DNA sequences can be looked at both philosophically and practically. Philosophically, I feel that genes are products of nature and, therefore, should not be patentable. In addition, I feel that clinical laboratories should be allowed to offer standardof-care medic
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