European Opposition to Exclusive Control Over Predictive Breast Cancer Testing and the Inherent Implications for United States Patent Law and Public Policy: A Case Study of the Myriad Genetics' BRCA Patent Controversy
Seton Hall University - School of Law
Food & Drug Law Journal, Vol. 59, No. 1, 2004
Between 1980 and 2001, the United States Patent and Trademark Office awarded over 8,000 patents on genes and genetic material, including at least 1,500 claiming sequences of human genetic material. Controversy over gene patents has arisen due to a variety of issues, including their relatively recent arrival into the patent realm, their grant of exclusivity over specific sequences of human genes, and their effect on research and diagnosis. These issues ultimately reflect both legal factors, dealing directly with the application of patent laws, and policy factors, implicating problems of access, cost, and quality in both the patient realm and the research setting. Because many gene patents either directly claim or include genes and/or the corresponding proteins that are essential to genetic diagnosis, a grant of exclusivity may hinder both healthcare and the advancement of scientific technology. There is currently an unparalleled legal challenge underway in the European Union regarding a number of human gene patents held by a United States corporation for sequences of two genes, BRCA1 and BRCA2, mutations in which indicate a predisposition to breast cancer. Specifically, the most recent opposition challenges the patent as not fulfilling relevant provisions in the European patent law, as well as impeding heath care and scientific discovery. This Article addresses the European controversy over the BRCA1 gene patent and offers potential mechanisms to resolve similar legal and policy concerns in the United States.
Number of Pages in PDF File: 23
Keywords: intellectual property law, breast cancer, patent, European Patent Office, opposition, health care, research
JEL Classification: O34, K19, K33
Date posted: April 24, 2006
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