The federal government has taken a new position on the patentability of human genes: genes are products of nature that should not be eligible for a patent. This new position was announced in a friend-of-the-court brief filed by the Department of Justice on 29 October 2010. The legal arguments laid out in the brief do support the ability to patent “man-made transformation or manipulation of the raw materials of the genome.” However, for a DNA-based product to qualify for a patent, the patent-seeker must do “something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.”
The government’s brief was filed as part of a lawsuit that questions whether or not two human genes that are linked to breast and ovarian cancer should be allowed to be patented. Myriad Genetics currently holds the patents for these genes. The plaintiffs in the case claim that patients should not have to pay more than $3,000 for a test to detect mutations in the BRCA1 and BRCA2 genes since the test relies upon naturally occurring products (i.e. DNA sequences). A lower court judge ruled in March that the patents were invalid. Myriad Genetics has appealed the decision.
It is unclear if the United States Patent Office will change its policy regarding patents on genetic products. The agency has issued thousands of patents for genes of humans and other species.
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