The lack of widely used tests cannot be blamed on a lack of patents. In recent years, the U.S. Patent and Trademark Office has allowed about 20 percent of human genes to be patented, including those associated with common diseases such as Alzheimer’s, asthma, and colon cancer.
Duke University geneticist Robert Cook-Deegan, who has coauthored several papers on genetic intellectual property, suggests that the science linking these genetic markers to disease is simply too preliminary. “Most of these markers have weak associations with disease,” he says. The diseases also have complex causes, which include many different genes and environmental factors.
All this suggests that the dustup about to unfold in the ACLU vs. Myriad case misses the real issue, which is how to best push forward and clinically validate the thousands of biomarkers now languishing in databases.
I believe that the solution might be a government-led effort to fund and encourage the development of this nascent science, in the form of either a program along the lines of the Human Genome Project or subsidies to encourage companies to take the plunge–a method that has helped revitalize the research, development, and production of vaccines.
The results of this clinical validation project should be available as a public resource that private companies can lease for a period of time if they agree to develop and market a test. They would be required to follow rules allowing others to offer and interpret their test for a reasonable fee.
Myriad’s refusal to license its test is a major reason for the suit against it. So is the $3,000 price tag. A public resource model would also alleviate the unsettling prospect of something as fundamental as human DNA being owned by private entities–an idea that might not even make sense in the future, as the diagnosis of disease points toward a complicated interaction of genes and other factors.
Alternatives to patenting genetic tests will not be part of the ACLU vs. Myriad dispute. But as part of a wider discussion, we should figure out a better way to push the science forward and get creative with solutions to the age-old tension between private ownership and public good.
David Ewing Duncan is the author of Experimental Man: What One Man’s Body Reveals about His Future, Your Health, and Our Toxic World.