Reversing a longstanding policy, the U.S. federal government has ruled in a legal brief that human and other genes should not be eligible for patents. This could have an enormous impact on medicine and on the biotechnology industry.
It is not yet clear if the new policy will be put into effect by the Patent Office. If it is, it is likely to draw protests from biotechnology companies.
According to the New York Times:
"The issue of gene patents has long been a controversial and emotional one. Opponents say that genes are products of nature, not inventions, and should be the common heritage of mankind. They say that locking up basic genetic information in patents actually impedes medical progress."
The U.S. Patent and Trademark Office has issued thousands of patents on genes over the last few decades, including on about 20 percent of human genes. Biotechnology companies are among the leaders in seeking such patents to create diagnostic tests and drugs that are tailored to individual genes.
Because the genes are isolated from the human body, proponents say they are eligible for patents. However, the U.S. government recently changed its position on this issue and said that genes, whether human or otherwise, should not be eligible for patents because they are a part of nature.
The brief states that simply isolating a gene does not change its nature enough to make it patentable.
Why Continuing to Patent Genes Could be Risky …
It remains to be seen whether the U.S. Patent Office will stop issuing gene patents as a result of the brief, but doing so may be an important step in protecting the future of medicine.
As those who oppose gene patents point out, as a part of nature genes should be left as "the common heritage of mankind," as the New York Times put it. When private corporations begin to control this gene pool, it puts limits on who can and can't develop emerging treatments.
For instance, epigenetic therapy, which is essentially the curing of disease by epigenetic manipulation, involves changing the instructions to your cells -- reactivating desirable genes and deactivating undesirable ones to prevent and treat disease. This emerging field, now in its infancy, may represent the future of medicine, which is why biotechnology companies are scrambling to patent as many genes as they can.
The government's new position actually came as the result of two gene patents -- for BRCA1 (breast cancer gene 1) and BRCA2 (breast cancer gene 2) -- held by Myriad Genetics and the University of Utah Research Foundation. Myriad performs an analysis on these genes to help determine women's risk of breast and ovarian cancers -- a test that costs over $3,000 a pop.
A lawsuit was filed to challenge the patents and the judge ruled they were in fact invalid. As the Times reported, this prompted the government to review their stance on the issue.
Will This Change the Future of GM Seed Patents?
Monsanto has become the world leader in genetic modification of seeds and has won 674 biotechnology patents, far more than any other company. But Monsanto is not only patenting their own GM (genetically modified) seeds. They have also succeeded in slapping patents on a large number of common crop seeds, in essence patenting life forms for the first time -- without a single vote of the people or Congress.
By doing this, Monsanto has become the sole owner of many of the very seeds necessary to support the world's food supply … an incredibly powerful position that no for-profit company should ever hold.
Farmers are now increasingly forced to use GM seeds simply because there are so few alternative sources of seeds remaining. The effect of this is that we're losing renewable agriculture -- the age-old practice of saving and replanting seeds from one harvest to the next.
As mentioned in The Ecologist, one solution to this growing problem would be to make patenting seeds, plants, and genes illegal. As it stands now, each GM seed is patented and sold under exclusive rights. Therefore, farmers must purchase the GM seeds anew each year, because saving seeds is considered to be patent infringement. Anyone who does save GM seeds must pay a license fee to actually re-sow them!
This, of course, results in higher prices and reduced product options.
Unfortunately, the new briefing is not likely to apply to patents for GM seeds because they involve man-made manipulations of DNA, and therefore are not considered a part of nature. It may, however, put a stop to placing patents on genes that are not modified, only isolated, which is a step in the right direction.
At the very least, however, let's hope the course that GM seed patents are taking -- and threatening to hand over control of the food supply to a handful of giant corporations -- may make regulators think twice about continuing to allow patents on natural genes as well …
No one should "own" portions of the human (or any animal or plant) genome aside, perhaps, from their original creator … and no matter what your beliefs on that topic may be, I think we can all agree that the biotechnology companies currently scrambling to buy up these patents are NOT it.