|U.S. may end DNA patents; Biotech Industry on notice|
|By Staff and Wire Reports|
|Sunday, 31 October 2010 09:45|
The US government, in a move that may signal a reversal of its position in a dispute central to the biotechnology industry, has filed a court brief saying that isolated DNA cannot be patented. The federal government said on Friday that human and other genes should not be eligible for patents because they are part of nature. This news could have a huge impact on medicine and on the biotechnology industry.
Reversing a longstanding policy, the federal government said on Friday that human and other genes should not be eligible for patents because they are part of nature. The new position could have a huge impact on medicine and on the biotechnology industry.
At this point, according to several published reports, is not clear if the position in the legal brief will be put into effect by the Patent Office.
''The chemical structure of native human genes is a product of nature, and is no less a product of nature when that structure is 'isolated' from its natural environment than are cotton fibres that have been separated from cotton seeds or coal that has been extracted from the earth,'' the Justice Department said in the friend-of-the-court brief filed on Friday.
The news is very likely to draw protests from biotech companies which will insist that these patents are vital to the development of diagnostic tests, drugs and other personalized medicine drugs which are tailored for individual patients based on their own genes.
Edward Reines, a patent attorney who represents biotechnology companies told the New York Times: “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."
In its brief, the government said it now believed that the mere isolation of a gene, without further alteration or manipulation, does not change its nature.
“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,” the brief said.
As Bloomber Reports, Myriad makes a test for detecting breast cancer. Medical groups say its tight control over use of the genes has discouraged scientists from exploring other options for breast cancer screening.
Rejecting Myriad's patents ''would lead to the invalidity of thousands of biotechnology patents, and effectively unravel the foundation of the entire biotechnology industry'', the company said in a court filing in December. ''Numerous therapeutic drugs and diagnostic tests in development would be jeopardised.''
The brief was filed in connection with a case involving two human genes linked to breast and ovarian cancer.
Government lawyers also claimed the reversal would not severely impact the biotechnology industry, arguing the new position would not affect man-made manipulations of DNA, such as genetically modified crops or gene therapies.