Last week, the U.S. Department of Justice filed an amicus brief which argued that naturally-occurring DNA sequences can’t be patented:
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….
“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….
But 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.
However, the government suggested such a change would have limited impact on the biotechnology industry because man-made manipulations of DNA, like methods to create genetically modified crops or gene therapies, could still be patented.
This is a good thing. First, the patent seeker really hasn’t contributed much at all:
To me, the really galling thing is that Myriad didn’t discover these genes, publicly funded research did. The goal of that research is not to enrich patent holders, but to improve human health for society as a whole. The patent drives up diagnosis costs by preventing anyone else from entering the diagnosis market: the $3,000 it costs to screen for these genes is a little over half of the price of resequencing** an entire bacterial genome at high coverage (and the latter cost includes labor, amortization of machines, etc.–the bacterial genome cost is priced as a business would).
Actually, that’s an overestimate of the price of a bacterial genome–it will cost, in a couple of months, around $700 for a very high quality de novo genome. But I digress. The key point is that, with sequencing costs dropping, it would be trivial to patent, and thereby exclude from the wider scientific community, gene sequences from a variety of microorganisms.
These patents also provide monopoly protection for a diagnostic process that is trivial to conduct:
The real problem here is that many hospitals and most doctors are not doing simple molecular biology techniques, commonly done in high school laboratories, as part of standard practice (i.e., PCR, invented in 1986, and sequencing). One could make and sell kits for this to provide standardized reagents, but the profit margins would be much lower.
Oh, I see.
Well done, DOJ.