Researchers await Supreme Court decision on gene patents

May 16, 2013 | by Hiu Chung So

The genetic test for BRCA mutations can be a lifesaver for women at high risk for breast cancer; for Angelina Jolie, who wrote about her experience in a New York Times op-ed this week, the test and subsequent preventive measures shrank her lifetime risk of breast cancer from 87 percent to 5 percent.


In the coming weeks, the Supreme Court will decide whether genes can be patented - impacting future research and development of diagnostic tests, including those for cancer risks. In the coming weeks, the Supreme Court will decide whether genes can be patented - impacting future research and development of diagnostic tests, including those for cancer risks.


But not everyone can readily afford that screening.

The test, offered solely by Myriad Genetics in the United States, costs approximately $3,000. Further, health insurance may not cover the expense without justification, such as having a close relative diagnosed with breast or ovarian cancers.

Meanwhile, 23andMe can test for more than 200 genetically linked conditions for $99.

One reason the BRCA test is so expensive is that Myriad discovered the cancer risks associated with the BRCA genes and patented them, giving the company a 20-year monopoly on their use.

The patenting of this discovery is not without controversy, and a years-long lawsuit against Myriad will culminate in a Supreme Court decision later this year.

Myriad has stated publicly: “We think it is right for a company to be able to own its discoveries, earn back its investment, and make a reasonable profit.” The company added that 95 percent of “appropriate patients” are covered by insurance for their tests and that it has offered free tests to more than 5,000 women who couldn’t afford them otherwise.

Challengers have said that, because the genetic sequences are inherent in nature, they cannot be patented like inventions.

Christopher Hansen, an American Civil Liberties Union lawyer representing the plaintiffs in this case, said on NPR that “all Myriad does is take a part of the body out of the body; it is no different than taking a kidney out of the body. Just because you are the [first] person who takes the kidney out of the body doesn't entitle you to a patent on kidneys."

Gregory Castanias, Myriad’s lawyer, countered that while the genes are naturally occurring, the unique process of locating and isolating them is what makes them patentable. He illustrated this point by noting that a baseball bat is a human invention, despite having originated from a tree.

Myriad’s patents for these genes are set to expire later this decade even if upheld, but the upcoming ruling is highly anticipated for the precedent it will set. The Supreme Court decision will raise not just bioethical issues, but also affect the exchange of information about genetic sequencing and the financial incentives of developing gene-based tests and treatments.

The issue is crucial to researchers. As Eric Topol, director of the Scripps Translational Science Institute in La Jolla, Calif., told the L.A. Times recently, Myriad's patents on the genes "have really held back the field," with the company issuing cease-and-desist letters to some researchers attempting to study the BRCA1 and BRCA2 genes.

The patents also have dampened genomics research because the company's tight control over BRCA1 and BRCA2 test results has limited access to useful data about genes and associated traits, Topol told the L.A. Times.

Said Jeffrey Weitzel, M.D., director of City of Hope’s Division of Clinical Cancer Genetics: “For the most part I am very sympathetic to the plaintiffs in this case.”

Another advocate of the plaintiffs is DNA co-discoverer James Watson, who had filed a brief against the patenting of genes when the case was in the U.S. Court of Appeals.

In the meantime, women at high risk of breast and ovarian cancers should discuss screening measures with their doctors so they can maximize their chances of detecting cancer in an earlier, more treatable stage.

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