Judge: DNA isolated in genes can't be patented

A federal judge Monday struck down patents on two genes linked to breast and ovarian cancer. The decision, if upheld, could throw into doubt the patents covering thousands of human genes and reshape intellectual-property law

U.S. District Judge Robert Sweet issued the 152-page decision, which invalidated seven patents related to genes whose mutations have been associated to breast cancer, BRCA1 and BRCA2.

The American Civil Liberties Union and the Public Patent Foundation joined with patients and medical organizations to challenge the patents, arguing that genes, as products of nature, fall outside the realm of items that can be patented. The patents, they argued, stifle research and innovation and limit testing options.

Myriad Genetics, the Salt Lake City company that holds the patents with the University of Utah Research Foundation, asked the court to dismiss the case, claiming the work of isolating the DNA from the body transforms it and makes it patentable. Such patents, it said, have been granted for decades.

Sweet, however, ruled the patents were "improperly granted" because they involved a "law of nature." He said gene-patent critics considered the idea that isolating a gene made it patentable "a 'lawyer's trick' that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result."

The case could have far-reaching implications. About 20 percent of human genes have been patented, and multibillion-dollar industries have been built atop the intellectual-property rights the patents grant.

"If a decision like this were upheld, it would have a pretty significant impact on the future of medicine," said Kenneth Chahine, a visiting law professor at the University of Utah who filed an amicus brief on the side of Myriad.

Chahine, who once ran a biotechnology firm, said the decision could also make it harder for young companies to raise money from investors.

Edward Reines, a patent lawyer who represents biotechnology firms but was not involved in the case, said loss of patent protection could diminish the incentives for genetic research.

The decision is likely to be appealed.

Myriad sells a test costing more than $3,000 that looks for mutations in the two genes to determine if a woman is at a high risk for breast and ovarian cancers. Plaintiffs in the case had said Myriad's monopoly on the test, conferred by the gene patents, kept prices high and prevented women from getting a confirmatory test from another lab.

One of the plaintiffs in the suit, Genae Girard, who has breast cancer and has been tested for ovarian cancer, applauded the decision as "a big turning point for all women in the country that may have breast cancer that runs in their family."

Chris Hansen, an ACLU lawyer, said: "The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas."

Bryan Roberts, a prominent Silicon Valley venture capitalist, said the decision could push more work aimed at discovering genes and diagnostic tests to universities. "The government is going to become the funder for content discovery because it's going to be very hard to justify it outside of academia."