The Supreme Court of the United States is presently considering a very interesting case with serious consequences for Parkinson’s research. They are expected to issue their ruling by the end of June.
This case involves a company based in Utah that has obtained patents on two specific genes and developed specialized tests based on these genes. Presently, Myriad is the only company who is able to test for these genes and the cost of this testing, about $4,000 must be borne by the patient or, more likely, their insurance company. The two genes involved are BRCA1 and BRCA2 which are linked to hereditary breast cancer. However, the tests originally developed actually missed about.10% of the cancer in the mutated genes. So they developed another test, and added $650 to $700 more to the testing process.
There are several other diagnostic genetic testing companies that also hold patents on testing for specific genes – and the profits from these tests are not small. One study by the United Health Group found that over $5 billion a year is spent on genetic testing for about 2,500 conditions in the U.S. One such company is 23andMe, which has the only testing protocol for familial Parkinson’s gene in this country. Anyone who wants to know if they carry this gene must use the kit from 23andMe.
The question the Supreme Court is asking is “are genes patentable?” And, like most cases, there are two sides to this debate. Research is expensive and companies who develop specific tests on specific genes depend of the income generated during the 20 years of the patent’s life to recoup their initial expense and pursue more avenues of research. But if the gene itself is patented, that places the gene out of the reach of other researchers by making it too expensive to obtain and forcing them to go through a complicated process of obtaining permissions. This stand in the way of further research or developing other ways of using it. It interferes with doctors’ ability to conduct clinical research and treat patients. These researcher feel that a gene is a part of nature and nature is not patentable. Patents are issued for inventions, but genes are part of our DNA.
The company holding the patents claims that once a gene is extracted from the chain of DNA, it has been manipulated and therefore is no longer a simple part of nature, that the manipulation separates it from nature and makes it comparable to an invention.
This is a philosophical as well a practical dilemma, with wide ranging implications for the future of medical research and development of tests and treatments. Patents may encourage investors to back certain types of research and protect their investments. On the other side is the question of human dignity: is not human DNA intrinsic to one’s body and therefore part of one’s very nature? Are patents even the right way to even think about developing and financing research along these lines?
The United States Supreme Court is not alone in considering these issues. Australia is also considering the same charges against this company. It may take the Supreme Court longer than June 30th to clarify the issues and render its decision. Whatever the decision, the companies working with genetic testing are probably going to have some changes in their future.