Breast cancer genes can’t be patented, federal court rules


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Until today, women who wanted to know whether they had inherited a version of the BRCA1 and BRCA2 genes that increased their risk of breast or ovarian cancer could find out only by sending their DNA to Myriad Genetics Inc.The Salt Lake City company patented the two genes in the 1990s and invented a test to identify some of the telltale mutations.

You might be asking yourself how a company could get a patent on a gene, which isn’t a man-made invention. You wouldn’t be alone. Several medical groups have wondered that too. So have the American Civil Liberties Union and the Public Patent Foundation. Last year, they challenged those patents in a federal district court in New York.


On Monday afternoon, they won. U.S. District Judge Robert Sweet ruled that the U.S. Patent and Trademark Office never should have granted the patents in the first place because the genes are “a law of nature.”

The Patent and Trademark Office has granted patents for roughly 20% of human genes. The office’s rationale was that the patents can be earned by isolating and purifying genes from their “natural state.”

In oral arguments last month, Myriad’s attorney said that companies wouldn’t have any incentive to develop genetic tests if they weren’t allowed to patent genes and warned that a ruling against Myriad could “undermine the entire biotechnology sector,” according to this report from GenomeWeb. The company has not yet commented on the ruling.

The ACLU and other groups argued that women – and the whole of science – have already suffered as a result of the way Myriad treats its BRCA patents. On its website devoted to the case, the ACLU says that individual patients are harmed because Myriad’s monopoly on genetic testing for BRCA1 and BRCA2 keeps prices high and prevents them from getting a second opinion from another company. Scientists are also harmed because the company restricts their ability to conduct research on the genes, according to the ACLU.

Myriad hasn’t said whether it would appeal the decision.

You can read the original lawsuit here.

-- Karen Kaplan