A bill submitted before Congress in late March—the Genomic Research and Diagnostic Accessibility Act of 2002—would exempt from patent infringement medical practitioners (and their respective hospitals and HMOs) who perform genetic diagnostic tests based on patented gene sequences. It would also exempt researchers who use patented genetic sequences for noncommercial purposes and would require the publication of genetic sequences within 30 days of patent filing in cases in which federal funds have been used to develop the invention. The biotech industry argues that such legislation, which would effectively eradicate market exclusivity, would damage the genetic diagnostic market, inhibiting the progress of diagnostic healthcare products.
If passed, the legislation would almost certainly drive down the price of genetic testing without an immediate impact on the development of new tests—in the short term. Genetic labs have demonstrated the ability to quickly develop genetic tests using basic molecular techniques following the publication of gene sequences without the incentive of patents. For example, the genetic test for hereditary hemochromatosis, which causes severe organ damage due to iron overload, was offered by labs several months after the publication of the gene and its common mutations.
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