31 William Mitchell Law Review 1057 (2004-2005)
This comment surveys the costs of deoxyribonucleic acid (DNA) diagnostic tests and argues in favor of non-exclusive licensing as a means to provide broad access to affordable DNA diagnostic testing. Part II provides background information on genetic testing, patenting genes as applied to genetic testing, the Bayh-Dole Act, and technology transfer. In addition, Part II summarizes academic commentary regarding the implications of exclusive licensing for biotechnology. Scholars propose a number of solutions, including expanding the experimental use exception. Part III details proposed rulemaking for DNA diagnostics. Part IV reviews anecdotal examples of genetic testing for breast cancer, hereditary hemochromatosis, and Canavan Disease. These genetic testing examples include survey evidence from clinical laboratorians. The survey and anecdotal evidence indicates that patents may increase prices and reduce access to genetic testing. This note contends that, although only a partial solution, Licensing Genomic Inventions addresses genetic tests developed with NIH funding. This comment also discusses improvements to the draft language. Part V concludes that exclusive licensing increases the prices of and decreases access to diagnostic genetic tests. Licensing Genomic Inventions means to address the patent system’s undesirable effects on the delivery of public health.
"Note: Exclusive Licensing of DNA Diagnostics: Is There a Negative Effect on Quantity and Quality of Healthcare Delivery that Compels NIH Rulemaking?,"
William Mitchell Law Review: Vol. 31
, Article 10.
Available at: http://open.mitchellhamline.edu/wmlr/vol31/iss3/10