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What’s the Point in Patenting Genes?

Whatever the outcome of the ACLU vs. Myriad case, a new effort is needed to turn genetic testing into a useful diagnostic tool.

Earlier this month, the American Civil Liberties Union (ACLU) filed a lawsuit that challenges the right of Myriad Genetics to patent a genetic test for breast cancer. The suit revives the question, should human DNA be owned?

For years, patent officials around the world have wrestled with how to apply existing patent law to the discovery of genes that promise to be powerful predictors of disease. The legal question has been, are these discoveries natural entities that cannot be patented, or can a diagnostic test involving a particular gene be considered intellectual property?

Currently, the U.S. Patent and Trademark Office has it both ways. It does not allow anyone to patent my own specific BRCA1 gene, but it allowed Myriad to patent the sequence of the gene with mutations that indicate breast cancer–which can then be compared with another patient’s version of the gene to see if she carries the mutation pattern.

Now the ACLU, joined by a broad coalition of plaintiffs, including physicians, patient groups, and scientific associations, argues that this was a mistake and should be overturned.

“The government should not be granting private entities control over something as personal and basic to who we are as our genes,” said Anthony Romero, executive director of the ACLU, in a statement. “Moreover, granting patents that limit scientific research, learning, and the free flow of information violates the First Amendment.”

Supporters of Myriad’s patent counter that without intellectual property, companies will not spend the money that it takes to validate genetic tests for disease, which can cost millions of dollars.

Both positions, however, ignore the reality that using genetics to diagnose different diseases remains a scientifically immature technology. Just last month, the New England Journal of Medicinenoted that thousands of DNA markers have been discovered and associated with ailments such as diabetes and heart disease, but these markers have yet to be clinically tested to see if they are real predictors of disease.

So far, Myriad’s BRCA1 test is one of only a handful that have been clinically validated for determining a risk factor for a common disease, in part because the company spent years gathering data to support the usefulness of the test and convincing doctors to use it.

Most other DNA-based diagnostic tests have a fairly narrow application. For example, one such test is used in conjunction with the drug Herceptin for breast cancer (which only works for women who overexpress the HER2 gene). Other DNA tests are used to identify rare genetic disorders such as Tay-Sachs and Huntington’s disease. Even the Myriad test identifies a rare version of breast cancer occurring in less than 10 percent of the 200,000 breast-cancer patients diagnosed each year.

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.

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