Court's gene ruling hailed
The Supreme Court ruled Thursday that naturally occurring human genes may not be patented, potentially opening up commercial and scientific terrain to more freewheeling exploration.
In a unanimous decision that is a mixed bag for the multibillion-dollar pharmaceutical and biotechnology industries, the court distinguished between genes found in the human body and those created in the lab.
"A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated," Justice Clarence Thomas wrote for the court.
At the same time, Thomas and his fellow justices determined that so-called "complementary DNA," which is synthetic, is "patent eligible because it is not naturally occurring."
Dr. Mark Israel, director of Dartmouth-Hitchcock's Norris Cotton Cancer Center, called the high court decision very important for medical research.
"The real positive advantage around this ruling is that it shifts the innovation issues from simply discovering the gene, which is a product of nature, to one of using the gene to do something important," Israel said. "The real value of these things is how they can be used to help people."
Supporters of allowing patent protection say it will encourage innovation.
But Israel said allowing free use of the discoveries holds potential for other breakthrough discoveries for which researchers may be entitled to patent protection.
"It's true that you need a starting point, but the reality now is that the discovery of individual genes is routinely available by known technologies," Israel said. "It allows investigators, especially in the academic arena, but also in other companies, to utilize the DNA in order to pursue additional research."
The 18-page decision in the closely watched case rejects several patent claims filed by a Utah-based company called Myriad Genetics. Myriad obtained patents, and with them a profitable monopoly, on the exact location of two genes associated with a higher risk of developing breast or ovarian cancer.
Individual scientists who felt constrained by Myriad's patents sued, along with a group called the Association for Molecular Pathology.
"We are thrilled," said American Civil Liberties Union attorney Sandra S. Park, who argued the case. "The question before the court was a simple one, but it had profound consequences."
The ruling Thursday means that competing firms now have a freer hand in developing cancer-testing tools that involve the genes for which Myriad held the patents.
More broadly, Park said the ruling could call into question the validity of patents that have been issued for about 4,000 other human genes.
"As a result of this, the cost of genetic testing should come down significantly," said Dr. Harry Ostrer, a medical geneticist at the Albert Einstein College of Medicine who challenged Myriad's patents. "I think we will see a much more level playing field. It will drive down costs and improve quality."
Park added that the court's reasoning perhaps could be applied to challenges of patents that have been issued for non-human isolated genes as well.
Myriad officials accentuated the positive in the court's decision, stressing how the court agreed that lab-synthesized genes, dubbed cDNA, still may be patented, as may the scientific methods used in isolating genes.
"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 (gene) test moving forward," Peter D. Meldrum, Myriad's president and CEO, said in a statement.