By Dr. Mae-Wan Ho
Institute of Science in Society
It took more than a decade to expose this legal monstrosity; all patents on DNA sequences natural or synthetic should be banned on the ground that they usurp the ‘laws of nature’ embodied in the DNA coding mechanisms that have evolved through billions of years of evolution.
US Government rejects gene patents
The US federal government dropped a bombshell on 29 October 2010 when it reversed a longstanding policy. It said that patents should not be granted for genomic DNA as it is a product of nature even when isolated from the organism . However, recombinant DNA, or new combinations for DNA for making genetically modified organisms, or gene therapy, or ‘synthetic life’ (see  Synthetic Life? Not By a Long Shot, I-SiS 47) remain patentable.
The opinion was expressed in the amicus (friend of the court) brief from the Justice Department in response to the ongoing legal battle over US patents for the breast and ovarian cancer-predisposing genes BRCA1 and BRCA1.
“The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth…
“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.
Is this a major reversal of policy?
“It’s major when the United States, in a filing, reverses decades of policies on an issue that everyone has been focused on for so long,” said Edward Reines, a patent attorney who represents biotechnology companies.
Dr. James P. Evans, a professor of genetics and medicine at the University of North Carolina and head of a government advisory task force on gene patents, referred to the government’s brief “a bit of a landmark, kind of a line in the sand.” He pointed out that although gene patents had been issued for decades, the patentability of genes had never been examined in court.
As of 2010 approximately 40 000 US patents exist that relate to an estimated 2,000 human genes, or about 20 percent of the human genome . Patents have been issued for isolated genes, methods of using the isolated genes, and methods to diagnose a disease based on an association between a gene and a disease.
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