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Patent on Austism Genetic Test

A new patent on variants in an autism gene is unlikely to hold up in court, some experts say, but may still hamper research.

The patent revives a debate that many scientists hoped was behind them. In 2013, in response to the controversy over a breast cancer gene patent, the U.S. Supreme Court ruled that genes cannot be patented.

“Gene patents restrict access to genetic tests; they restrict access to confirmatory testing and second opinions; they squelch sharing of data and they squelch research,” says James Evans, who headed a government advisory task force on the impact of gene patents. “That should be a settled issue, so it’s very depressing to see that at least in some people’s minds, it’s not.” Evans is professor of genetics and medicine at the University of North Carolina at Chapel Hill.

In December, LabCorp, a healthcare diagnostics company in Burlington, North Carolina, received a patent that appears to cover any test that can identify three variants in the gene HOMER1.

By itself, the HOMER1 test is unlikely to have much clinical value. The gene is a member of a signaling pathway related to autism, but is only weakly linked to the condition. And mutations in any one gene contribute to only a small proportion of cases.

Still, the existence of the patent could pose a roadblock to anyone who finds variants in HOMER1 in their sequencing projects or includes HOMER1 among a panel of several genes linked to autism.

“Companies that are providing clinical diagnostics on the HOMER1 gene have every reason to be skittish about performing those sequences because of this patent out there,” says Jacob Sherkow, associate professor of law at New York Law School.

LabCorp did not respond to queries about its plans for the patent. “We have no information available with respect to the patent in question,” Donald Von Hagen, the company’s vice president of corporate communications, told Spectrum. But, he said, “a test for autism spectrum disorder would provide parents and patients with valuable information, which could be used to support earlier diagnosis and initiation of focused care.”

Case law suggests that the patent is unlikely to hold up to a challenge in court, Sherkow and others say. In 2013, the U.S. Supreme Court overturned patents that gave Salt Lake City, Utah-based Myriad Genetics exclusive rights to sequence the BRCA1 and BRCA2 genes, which greatly increase the risk of breast cancer. The court allowed Myriad to retain a patent on its method for detecting mutations in the genes, however.

The method in the new patent involves routine activity: It involves extracting DNA from an individual and using one of three common methods to detect variants in a gene.

“The claims [in the patent] are not specific to any particular way of detecting these mutations in the HOMER1 gene,” Sherkow says. “The Mayo decision pretty strongly suggests that this patent may not be valid.”

In 2016, a federal court relied on the Mayo precedent to invalidate four patents held by LabCorp, which covered standard techniques for detecting variants in cancer genes.

LabCorp has previously sued companies it believes infringed on similar patents, but it is unclear whether it will attempt to enforce the HOMER1 patent.

Source: The Scientist

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