Since the late 1990s, Myriad Genetics has tested more than 1 million women for mutations to two genes, BRCA 1 and 2, associated with breast and ovarian cancers. But because of its patents on those genes, patients have been unable to get a second opinion on Myriad’s test results and, in some cases, have been denied their own genetic information.
Opponents of Myriad’s BRCA 1 and 2 patents contend that those patents have blocked access to testing and stalled advances in medicine. The company, though, counters that patents are a critical part of what makes medical discovery possible.
On April 15, the two sides began arguing their position in a Supreme Court case centered on this fundamental question: Can human genes be patented?
The U.S. patent system offers a temporary economic incentive to those who advance science. But a product of nature or a law of nature cannot be patented. Myriad’s lawyer, Gregory Castanias, has likened the biotechnology company’s work locating and isolating the BRCA 1 and 2 genes to building a baseball bat from wood or a cast iron fence from rock. Those items, he’s said, could be patented even though their raw material came from nature.
Supreme Court justices echoed the baseball bat analogy and offered their own, including chocolate cookies, in their initial response during oral arguments. Overall, the justices appeared skeptical of the legality of Myriad’s patents and suggested isolating the genes does not constitute an invention. But the high court could strike a compromise that allows some of Myriad’s work, if not the genes, to be patented.
There are about 20,500 genes in the human body. It’s said that one-fifth of all genes are patented but many patents have lapsed. Others do not restrict genetic testing.
A report on the Myriad case on National Public Radio addressed the frustrations of patients who haven’t been able to get a second opinion on their test results from Myriad. For example, all the women in Kathleen Maxian’s family were tested for the BRCA 1 and 2 genes after Maxian’s sister was diagnosed with breast cancer. All the women got negative test results. Yet two years later, Maxian was diagnosed with ovarian cancer. A supplemental test from Myriad found the mutation in the women’s BRCA genes.