BRCA1 and BRCA2 are genes that encode breast cancer susceptibility proteins. These proteins act in DNA repair as well as destruction of irreparable DNA in breast tissue, in effect working to stop cells from becoming cancerous. It is estimated that the risk of breast cancer for the average woman is approximately 12 percent, but for women with mutated copies of BRCA1, that number jumps to as high as 85 percent.
BRCA2 mutations are associated with a similar, but not as extreme increase in breast cancer risk. Furthermore, BRCA1 and BRCA2 mutations also lead to an increased risk of ovarian and other cancers. Tests for these mutations are therefore extremely useful for educating women on their risks, allowing them to make better choices regarding their future medical decision making.
Such a test does exist; it is called BRAC (Be Ready Against Cancer) Analysis and was developed by and is supplied by Myriad Genetics, a biotech company based in Salt Lake City. According to their Web site, "Myriad Genetics' strategy is to understand the role of genes in human disease and then use that information to develop and commercialize products that assess a person's risk of developing disease later in life and guide treatment decisions based on an individual's genetic makeup and specific cause of disease." Myriad currently holds patents on the BRCA1 and BRCA2 genes, and is the only company that can provide testing for these genes.
It may come as a surprise that a company can patent a gene—in fact, approximately 20 percent of the human genome is currently patented by some company or another. While patent law stipulates that one cannot patent nature, it is possible to patent a genetic sequence once it has been purified, isolated or perhaps modified because then it can be considered "man-made." Why do companies patent genes? To make money, of course. By patenting a gene such as BRCA, companies like Myriad can supply testing at prices unchecked by competition, because there is no competition.
Last year, the American Civil Liberties Union sued Myriad and the patent office in federal court, claiming that these patents were illegal and unconstitutional. On March 29 of this year, Judge Robert Sweet of the Southern District Court of New York gave his ruling, siding with the plaintiffs. His ruling was based upon the fact that an isolated or purified gene is not substantially different from that gene in its natural state, and therefore is not man-made and not eligible to be patented. Of course, there will be appeals—from now until who knows when—but this decision was a shocker and brings forward many important questions about the costs and benefits of allowing genes to be patented.
To stay with the Myriad BRCA example: If Judge Sweet's ruling were to hold, other companies could begin working with the BRCA genes and it would not be very hard nor costly to develop a test for mutations in this gene. These companies could now compete with Myriad and drive the cost way down, greatly reducing Myriad's profitability.
Before I continue, let me make it known that I think this sort of genetic testing is absolutely a good thing, and although whether or not a person chooses to learn their genes and in turn get a good idea about their future is a whole other issue, people should have that choice. I believe that research and availability of these types of tests will greatly improve health and health care. So why not take down these patents and allow these types of testing to become more affordable?
Myriad and other companies that hold gene patents put a lot of money into the research for these genes. It's a high risk, high reward game. They patent genes that seem promising, then pour millions of dollars into research in the chance that some day they will be able to use that gene for profit. Without the potential of reward, why incur the monetary risk? We would like to think that drug companies would design their miracles out of altruism, but that is not happening any time soon. In short, the promise of monetary reward fuels innovation. Now of course the issue isn't completely cut and dry; a lot of research is not done by private companies, but through public funds. However the research and development arms of private companies are an important source of scientific innovation.
So as I see things, the issue of whether or not to allow gene patents is a question of give and take. On one hand, allowing companies to patent genes will give them the inspiration to try to work on the next generation of tests and cures, while keeping the current tests locked up and expensive. On the other hand, prohibiting gene patenting makes the already discovered tests more affordable and widespread, but may hinder the undertaking of future discoveries. So how do we get the best of both worlds?
Now I am not going to even begin to feign an understanding of patent laws, but as I understand it from a few minutes with the Internet, one of these patents lasts approximately 20 years. So why not draw a compromise? Allow a company such as Myriad to have the sole ability to work with a gene and profit from its use for five years. That should be enough to make the research worthwhile, and then allow other companies to do "generic" testing, decreasing cost and increasing availability.
This issue will not be resolved any time soon, but it seems that there are legitimate pros and cons to both sides. Rather than attempting, as we so often do in American politics, to choose the lesser of two evils, we should work to find a point in the middle that can allow for the increased availability of lifesaving scientific advances as well as provide an environment in which innovation and new discoveries can be made.