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Has the US government abandoned gene patents?

In an unexpected move certain to make queasy biotechnology executives reach for their Pepto Bismol, the United States government issued a brief last Friday that strongly argues against gene patents. The position was explained in an amicus brief filed in a high-profile lawsuit over the validity of patents covering two genes associated with cancer.

“The United States has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter,” the brief, submitted by attorneys for the US Department of Justice, stated.

The biotech industry was already feeling shaky after a New York district court ruled some of the claims in those patents invalid in March (see ‘Breast cancer gene patents judged invalid’). The ruling, which was soon appealed, came as a shock to an industry accustomed to having such cases decided in its favour.

Now, however, it appears that skepticism of gene patents is not limited to the Southern District of New York. The amicus brief filed Friday was formulated after consultations with the US Patent and Trademark Office (USPTO), the National Institutes of Health, the Office of Science and Technology Policy, and other federal organizations. In the brief, the US government argues that isolated DNA which is somehow modified should be patentable. But unmodified DNA should not be patented, according to the brief, because merely isolating a product does not turn it into a man-made invention. Furthermore, arguing that a piece of DNA is useful and that its identification required a significant investment of resources is not sufficient cause to issue a patent, the government stated.

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