Supreme Court: Human Genes Can't Be Patented

NIH official says the decision makes the field of diagnostics 'much more open.'

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The Supreme Court ruled Thursday that naturally-occurring human genes could not be patented, invalidating patents on as many as 5,000 genes.

The case specifically involves Myriad, a company that had patented genes BRCA1 and BRCA2, which are linked to breast and ovarian cancers. Their patents allowed them to have a monopoly on diagnostic genetic testing for hereditary breast and ovarian cancers and, according to the court, the "patents would, if valid, give it the exclusive right to isolate an individual's BRCA1 and BRCA2 genes … [a process] necessary to conduct genetic testing."

In a unanimous opinion, written by Justice Clarence Thomas, the court held that "a naturally occurring DNA segment is a product of nature and not patent eligible."

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According to Larry Brody of the National Institutes of Health's genome technology branch, who helped the Department of Justice prepare its argument, the ruling will make "the field of diagnostics, at least for breast cancer, much more open."

The court's decision should allow biotech companies who create synthetic, or cDNA, to keep their patents. Recombinant DNA is widely used in medicine and represents a huge portion of the biotech industry.

 

"The process where you take the product of a gene and do lab tricks to change it is critically important to the biotech industry," Brody says. "The Supreme Court would say those molecules are still patented. But your genome and the info in your genome exists in nature and is not patent eligible."

That interpretation has been held up in lower courts, who have said that gene sequences of naturally occurring crops could not be patented, but genetically modified crops could.

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The beginnings of the case date back more than a decade, when an international contest was launched to find the genetic sequences that caused breast cancer. That contest took place before the Human Genome Project, which mapped the entire human genetic code, was completed.

"Before there was an entire human genome sequence, to find a diseased gene you had to build a map and identify all the genes near that map," Brody says. "There was an international race 15 years ago, well Myriad built the map first and found which of the genes were related to breast cancer."

Myriad's patents on those genes were set to expire in 2015. The company had what is known as a composition of matter patent, defined as "all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids."

Because the genes occur naturally, they are not patentable, the court said.

The case was brought on by the American Civil Liberties Union and the Public Patent Foundation. The ACLU hailed the decision as a victory that will represent "a major shift in patent policy."

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"Today, the court struck down a major barrier to patient care and medical innovation," Sandra Park, of the ACLU's Women's Rights Project said in a statement. "Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."

According to NIH's Brody, the decision means that scientists searching for specific genes will be able to do so without having to risk a lawsuit. He says more than 5,000 of the 22,000 human genes had been patented or were in the process of being patented.

"A good deal of the human genes have been patented. Those would also be invalidated [by the decision]," he says. "This is critically important if you're [a researcher who is] going to look at the genome as a whole. In our lab, we'd have to learn who owns each different gene. That shouldn't be an issue anymore."

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