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June 13, 2013

US High Court: Human Genes Not Patentable

by Steve Baragona

The U.S. Supreme Court ruled Thursday that companies cannot patent human genes in their natural state. Patients’ rights groups are calling the decision a victory. The court, however, left room to protect patents on key biotechnology applications.

Myriad Genetics identified genes that raise a patient’s risk for breast and ovarian cancer. The company lifted those genes from the full set of genetic information that makes up a human being, and patented them. That gave Myriad exclusive rights over the use of those genes.

The U.S. Patent and Trademark Office has been allowing patents on isolated DNA for three decades, said attorney Sandra Park with the American Civil Liberties Union.

“What was problematic about these patents was that Myriad was able to use those patents to stop other laboratories from providing genetic testing, even when those other laboratories were using different methods,” she said.

Park said that means genetic testing for breast and ovarian cancer risk is more expensive than if other labs could compete with Myriad. And patients could not get a second opinion on an important medical issue.  

In a unanimous decision, however, the court struck down this type of patent because the genes are products of nature.

Lisbeth Ceriani was a plaintiff in the case. She is a breast cancer survivor who struggled to afford Myriad’s test.

“Our genes are not being held hostage by a private corporation anymore. We have the right to know that our doctor can look at our own genes and know what is there,” said Ceriani.

Supporters say the ruling will lower costs and improve access to testing for this and other genetic conditions for which companies have patents. Also, researchers will be able to share data that results from genetic testing, hopefully moving them closer to better treatment and prevention.

Myriad Genetics, however, also created versions of the genes called complimentary DNA [cDNA] - basically, cleaned-up versions of the genes - and patented those, too.

The Supreme Court said those patents are okay because cDNA does not exist in nature.

Jennifer Swize, an attorney for the company, said, “To Myriad, the decision is a win. For all practical purposes, companies like Myriad use cDNA to do their testing.”

Swize said the company will continue to move forward because it has 24 patents on its breast and ovarian cancer gene research, and the court only struck down five of those.

And cDNA is hugely important to the biotechnology industry. Insulin to treat diabetics is produced using cDNA, for example.

Paul Berghoff, an attorney for the Intellectual Property Owners Association, wrote in support of Myriad in the case. “Nobody in the biotech industry is going to be dancing in the streets because of this, but I don’t think this is too much of a setback, if any.”

Observers note that Myriad’s stock price rose after the decision, suggesting the markets saw the decision as a positive one for the biotech industry.