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.
“We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA,” the brief said. “The district court’s judgment in this case, however, prompted the United States to reevaluate the relationship between such patents and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature.”
What happens next? It’s unclear how this will affect day-to-day operations at the USPTO, but the New York Times, which broke the news late Friday, notes that no lawyers from the patent office are listed on the brief – a possible sign that the position has few fans at the USPTO, which has granted thousands of gene patents over the years.
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