Suzanne Miles logs DNA samples into the Myriad Genetics computer system so they can be tracked during the analysis process.

Scott G Winterton, Deseret News

SALT LAKE CITY The U.S. Supreme Court is expected to announce sometime this month whether it is possible to patent human genes.

The American Civil Liberties Union represented research scientists and health advocates who teamed up in 2009 to challenge patents issued in the 1990s to Myriad Genetics, a Utah-based biotech company, and the University of Utah Research Foundation. Myriad has patented the BRCA1 and BRCA2 genes; mutations indicate a hereditary predisposition to certain breast and ovarian cancers. The Supreme Court heard arguments in April in the case of Association for Molecular Pathology, et al. v. Myriad Genetics Inc.

Before the court

The ACLU briefing notes said that Myriads monopoly on the BRCA genes makes it impossible for women to access other tests or get a second opinion about their results and allows Myriad to charge a high rate for its test over $3,000. Critics said the company, which has vigorously enforced its patents, has blocked development and use of better technologies and driven up costs.

Advocates of the patents and Myriad Genetics said companies must be able to reap financial rewards for investment in genetic research and that isolating genes and other processes amount to invention that can be patented. Myriad spokesman Ron Rogers said the test is covered by all insurance companies and pricing is in line with other molecular diagnostic tests. If someone doesn't have insurance, Myriad provides inexpensive and sometimes free testing, he said.

Theres no question that the tests Myriad developed to find BRCA mutations can be patented. But lower courts have been divided on whether Myriad can claim that isolating and pulling out that gene from the human body is creative enough to patent, since nature cannot be patented. The federal district court tossed the patents. An appeals court disagreed with the lower court, 2-1, and ruled Myriad Genetics made the genes more useful when it isolated segments. That court was unanimous in saying that cDNA, which resulted from removing noncoding material, was patentable.

The choices

The Supreme Court has three options, said Shobita Parthasarathy, associate professor in the Ford School of Public Policy at the University of Michigan.

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Can a human gene be patented? Myriad Genetics says yes; Supreme Court poised to decide

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