The U.S. Supreme Court on Thursday ruled that human genes cannot be patented, upending 30 years of patent awards granted by the U.S. Patent Office. The court's unanimous decision has enormous implications for the future of personalized medicine and in many ways is likely to shape the future of science and technology.
Myriad Genetics, one of the nation's biotech leaders, isolated two genes with mutations that can indicate a high risk of breast and ovarian cancer. The company patented the genes, known as BRCA 1 and BRCA 2, and developed a test so that women with family or previous cancer histories 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. A group of doctors, patients and researchers went to court to challenge Myriad's patent, and on Thursday they won a prtial victory.
The Supreme Court, while acknowledging the importance of Myriad's discovery, said that Myriad did not create anything by isolating the two BRCA genes and that the genes are a product of nature.
"The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA," Justice Clarence Thomas wrote for the court. "To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act or invention."
Those who are critical of Myriad note that the patent meant that there were no second opinion available.
Rep. Debbie Wasserman Schultz, D-Fla., experienced that limitation firsthand. At age 41, she was diagnosed with breast cancer. Because of her family history, she took the BRCA test and found she had the mutation. Doctors told her there was no second test, so with no other choice she had both breasts and both ovaries removed. With the Supreme Court ruling, she says, women in her position should have more tests available to them.
"This decision allows women to get an independent test repeated so that they can make a decision with a lot more information than the results of one test," she tells NPR.
However, the victory on Thursday was a partial one. The Supreme Court drew a line between what it called "natural DNA" and "complementary DNA" (or cDNA), which is essentially a simplified version of DNA, with certain nonfunctioning portions edited out.
Nobel laureate Richard Roberts, a restriction enzymes specialist at New England Biolabs, compares cDNA to a movie. When making a movie, the director takes thousands of shots but uses only some of them in the edited version of the movie, which is finalized and sent out for distribution. Roberts sees no practical difference between the original cut and the one that appears in the final result.
But the Supreme Court said that cDNA is man-made, and therefore it may be patented in some cases. If there is something really new about the cDNA that would not be obvious to most scientists, then it would be patentable, the court said.
"We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," said Peter D. Meldrum, Myriad's CEO, in a statement. "More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples' lives and lowering overall healthcare costs."
Patent experts were uncertain about the meaning of the court's cDNA rule. Oskar Liivak, who teaches patent law at Cornell Law School, notes that since the template for cDNA is a natural molecule, it's "hard to see" what the line of differentiation is.
The role of the patents that have been allowed is also unclear, says Mark Lemley, a professor at Stanford Law School who specializes in patent law and intellectual property.
"The jury is still out a little bit on whether the [cDNA] patents that were left alive by the court's opinion [Thursday] are going to turn out to be of any use," says Mark Lemley, a patent law specialist at Stanford Law School.
That is likely to be the next battle — and there will be many — over patenting DNA material.
For now, though, there is elation among those who challenged Myriad and won the Supreme Court ban on patenting genes.
Dr. Mary-Claire King of the University of Washington discovered the BRCA1 gene and has been outspoken in her criticism of Myriad's attempt to patent the gene. Now, she says her lab will be ready soon with better and cheaper tests than Myriad's.
"I'm as high as the flag on the Fourth of July," King tells NPR. "[The decision] completely changes the landscape."
Perhaps the greatest fear of those in the biotech industry had been that an adverse Supreme Court ruling in the Myriad case would take away the incentives for innovation. But National Institutes of Health Director Francis Collins, who led the Human Genome Project, says that if the court had ruled the other way, allowing the patenting of genes, the royalty costs would have been enormous.
"Because of all the patents that are required and all the royalty payments that are stacked on top of one another, it would add up to an exorbitant and unaffordable cost," Collins said. "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."
MELISSA BLOCK, HOST:
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. Transcript provided by NPR, Copyright NPR.