On Monday a federal judge struck down patents held on two human genes linked to breast and ovarian cancer. If the decision is upheld it could call into question the patents of thousands of other human genes, potentially reshaping the law of intellectual property and bioethics.
The genes at the center of the dispute have mutations that are associated with cancer. The American Civil Liberties Union alongside the Public Patent Foundation at the Benjamin Cardozo School of Law filed suit, along with individual patients and medical organizations to challenge the patents. They argued that the genes, as products of nature, fell outside of those things that can be patented. The patents, they said, stifle research, innovation, and limit testing operations. While the law prohibits direct patenting of the DNA in human bodies, genetics companies had gotten around precedent by arguing that the work of isolating the DNA from the body transforms it, thereby making it patentable. Indeed, it is an argument persuasive enough to grant hundreds of similar patents and appeared to have the blessing of the Supreme Court which upheld patents on certain living organisms in 1980.
The effect of the decision, if it is upheld, cannot be understated. Currently about 20 percent of human genes are already patented, fueling a multi-billion dollar industry. No one is really sure of what the fallout would mean. Some argue it would be devastating to medical research, as the practice of medicine has become more personalized due in large part to the growing availability of genetic testing. Others see this as a potential boom for research institutions who so far have been hamstrung from research geared toward curing disease, rather than maintaining it, due in large part to the intellectual property restrictions on certain suspicious genomes.
Those who fought the patents were as much challenging the monopoly genetics companies created, not so much with the gene patent as the ability to create diagnostic tests for those specific genes. So in some respects this can be seen as a victory for making genetic testing even more available and affordable, a point repeated by the Plaintiffs in the case. That said, it is hard to deny the fact that genetic research is expensive, and upholding this decision could, in the short term, scare private dollars away from developmental research. Both sides seem to agree that the result will be to push more and more developmental research into public universities, which, given the nature of the subject, maybe where the work should have stayed all along.
photo courtesy of ynse via Flickr