Supreme Court: Human Genes May Not Be Patented

Correction June 14, 2013

We misstate the first name and university affiliation of the geneticist who identified breast cancer genes. She is Mary-Claire, not Mary, King of the University of Washington, not Washington University.

Thursday's decision by the high court upends 30 years of patent awards granted by the U.S. Patent Office. The ruling also has enormous implications for the future of personalized medicine.

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LINDA WERTHEIMER, HOST:

This is MORNING EDITION, from NPR News. I'm Linda Wertheimer.

RENEE MONTAGNE, HOST:

And I'm Renee Montagne. The U.S. Supreme Court has ruled human genes cannot be patented. The unanimous decision upends 30 years of gene patent awards granted by the U.S. Patent Office. It has enormous implications for the future of personalized medicine and in many ways, is likely to shape the future of science and technology. NPR legal affairs correspondent Nina Totenberg reports.

NINA TOTENBERG, BYLINE: Myriad Genetics, one of the nation's biotech leaders, isolated two genes with mutations that show a high risk of breast and ovarian cancer. The company patented the genes - known as BRCA1 and 2 - and developed a test so that women with family or previous cancer histories could see if they had the mutations. But the test was expensive; and there were no alternatives, no second opinions. And because Myriad vigorously enforced its patent, researchers abandoned plans to make alternatives available.

Congresswoman Debbie Wasserman Schultz had a typical experience. At age 41, she was diagnosed with breast cancer and because of her family history, she took the BRCA test and found she had the mutation. Doctors told her there was no second test, and so she had both breasts removed and both ovaries.

REPRESENTATIVE DEBBIE WASSERMAN SCHULTZ: If a woman went through what I did again, now that the Supreme Court has ruled, she would not, if she had the BRCA mutation, have to only rely on the results of one test.

TOTENBERG: Thousands of these examples prompted a group of researchers, doctors and patients to go to court, to challenge Myriad's patent. And yesterday, they won a significant victory. The high court ruled unanimously that nobody can patent human genes because they are products of nature.

The victory, however, was partial. The court drew a line between what it called natural DNA, and complementary or CDNA, which essentially is a purified version of DNA, with the non-functioning parts edited out. Nobel Laureate Richard Roberts, the chief scientific officer at New England Biolabs, compares CDNA to a movie. The director takes tens of thousands of shots, but uses only some of them in the final edited version of the movie, which is then printed and sent out for distribution.

Roberts sees no practical difference between the original cut and the print, as it were. But the Supreme Court said that because CNDA is manmade, it may be patented at least in some cases, though not necessarily all. If there's something really new about the CDNA that would not be obvious to most scientists, then it would be patentable, the court said.

That is likely to be the next of many battles over patenting DNA material, according to Mark Lemley, a patent expert at Stanford Law School.

MARK LEMLEY: The jury is still out, a little bit, on whether the patents that were left alive by the court's opinion today are going to turn out to be of any use.

TOTENBERG: For now, though, there is elation among those who challenged Myriad and won the ban on patenting genes. Dr. Mary King, of Washington University, actually discovered the BRCA1 gene, and has been outspoken in her criticism of Myriad's attempt to patent the gene. [POST-BROADCAST CORRECTION: Dr. King's first name and university affiliation were both misstated. She is Dr. Mary-Claire King, of the University of Washington.] Now, she says, her lab will be ready soon with new, better and cheaper tests than Myriad's.

MARY-CLAIRE KING: I'm as high as the flag on the Fourth of July.

TOTENBERG: Perhaps the greatest fear of those in the biotech industry has been that an adverse Supreme Court ruling in the Myriad case would take away the incentives for innovation. But Francis Collins, director of the National Institutes of Health, who led the Human Genome Project, says that if genes could be patented, the royalty costs would have been enormous.

FRANCIS COLLINS: The costs might be in the hundreds of thousands of dollars - not because the laboratory methods were that difficult but because of all the patents that required all the royalty payments that stacked on top of one another, would add up to an exorbitant and unaffordable cost. That was a real possibility that was lurking out there, potentially putting a real cloud on this personalized medicine horizon. And now, that has been blown away.

TOTENBERG: Nina Totenberg, NPR News, Washington.

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