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 King of Washington University discovered the BRCA 1 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."
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