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The Supreme Court ruled unanimously today that human genes cannot be patented. The decision is expected to have an enormous effect on the future of science and medicine and, in particular, the biotech industry. Here's NPR legal affairs correspondent Nina Totenberg.
NINA TOTENBERG, BYLINE: Utah-based Myriad Genetics Inc. isolated two genes with mutations that show a high risk of breast and ovarian cancer. It patented the isolated genes - known as BRCA1 and 2 - and developed a test so that women at risk could see if they had the mutations.
But the patent meant that other researchers could not use the isolated genes to develop potentially more reliable and cheaper tests. Frustrated researchers, doctors and patients went to court. And today, the U.S. Supreme Court ruled that human genes cannot be patented because they are products of nature.
On the other hand, Justice Clarence Thomas, writing for the court, said that a substance known as complementary, or cDNA, can be patented in some instances. cDNA is essentially a purification, or edited form, of regular gene coating with the irrelevant material removed. Therefore, as the court observed, the lab technician creates something new when cDNA is made.
DR. MARY-CLAIRE KING: I'm as high as the flag on the Fourth of July.
TOTENBERG: That's Dr. Mary King of the University of Washington, who discovered the BRCA1 gene but was prevented from developing her own test after Myriad patented the gene. [POST-BROADCAST CORRECTION: The geneticist's first name was misstated. She is Dr. Mary-Claire King.]
KING: It means that patients will have more than one option for obtaining test results. It means that we can move forward developing new test modalities for the most important genes. It's just fabulous news.
TOTENBERG: In short, King says, the Supreme Court's decision will allow tests that are better and cheaper than Myriad's to be available to patients very soon. But Greg Castanias, who represents Myriad, disagrees, noting that Myriad had 24 other patents and 500 others in the works.
GREGORY CASTANIAS: I will point out that anybody who wants to compete ought to read those other 500-some claims and all 24 of those patents before they decide that they're going to start competing with Myriad.
TOTENBERG: Indeed, it was somewhat unclear what the future will hold for the patents that the court did allow today on cDNA. The court went out of its way to say that cDNA is patent-eligible, but that does not mean it's patent-worthy.
If, for example, a company were to seek patent protection for cDNA that was easy to develop - or, in legal terms, it would be obvious to a normal scientist - it would not qualify for patent protection. Mark Lemley is a patent law 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: Stanford's Jacob Sherkow observes that Myriad has been able to amass an enormous amount of information about patients precisely because it had the only test until now.
JACOB SHERKOW: So one of the things that physicians are going to want to look at going forward is, you know, fine, I have a patient. They have a particular mutation. But what does that mean in terms of breast cancer risk? Does it go up? Does it go down? And, you know, Myriad has a lock on this information right now.
TOTENBERG: Most experts expect that to change, though it may take other companies one or two years to get up to speed in competing with Myriad. 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 from the incentives for innovation in genomics. But Francis Collins, the director of the National Institutes of Health and the man who led the Human Genome Project, sees the court's decision working the other way.
If the court had not called a halt today, he said, patent royalties could have cost huge sums of money, making it impossible to achieve the goal of tailoring each person's treatment to his or her own genomics. The court's decision, he says, dispels that cloud.
DR. FRANCIS COLLINS: I think that will be a great boon to the development of the field. More laboratories and companies will be interested in developing ever more accurate and more inexpensive methods to obtain that information for medical benefit without fearing that their technical advances will be overshadowed by extremely high royalty costs.
TOTENBERG: Nina Totenberg, NPR News, Washington.
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