Justices Send Back Gene Case
Published: March 26, 2012
Fred R. Conrad/The New York Times
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The appeals court was told to take another look at the case in light of the Supreme Court’s ruling last week that a certain diagnostic test was not eligible for patents because it was a simple application of a law of nature.
The case, Association for Molecular Pathology v. Myriad Genetics, No. 11-725, is being closely watched because it involves the ethically charged but commercially important question of whether genes can be patented.
The company, along with the University of Utah, isolated the two genes in question, known as BRCA1 and BRCA2.
It also developed a test, costing more than $3,000, that examines extracted DNA from the genes for mutations that indicate a woman is at a high risk of getting breast or ovarian cancer. The patent on the genes prevents other laboratories from performing similar tests.
Monday’s rulings came in response to a lawsuit filed by the American Civil Liberties Union and the Public Patent Foundation on behalf of various medical groups, patients and researchers. The suit argued that human genes could not be patented because they were products of nature, and that Myriad’s monopoly on testing for mutations in those genes raised medical costs and prevented women from getting a second, confirmatory test.
In a ruling that shocked the biotechnology industry, a United States District judge in New York agreed, and invalidated the patents in 2010.
But the Court of Appeals for the Federal Circuit, which specializes in patent cases, reversed the ruling last July. In a 2-to-1 decision, it said that DNA isolated from the body could be patented because it was “markedly different” in chemical structure from the DNA inside the body.
The plaintiffs then appealed to the Supreme Court to take the case.
Last week the Supreme Court ruled that a blood test developed by Prometheus Laboratories was not eligible for a patent because it merely reflected a law of nature.
The test looked for the chemicals formed when drugs used to treat certain gastrointestinal diseases are broken down in the body.
Based on the levels of those chemicals in the blood, doctors may increase the dose of the drugs to make treatment more effective or decrease it to avoid side effects.
In the unanimous decision, Justice Stephen G. Breyer wrote that inventors must do more than “recite a law of nature and then add the instruction ‘apply the law.’ ”
That decision dismayed some executives in the diagnostics and biotechnology industries, who said that lack of patentability could undermine incentives to develop personalized medicine, in which tests are used to determine which patients should get a drug, or what their dose should be.
But some doctor groups cheered the decision, saying that patents on tests could actually impede research.
Myriad’s stock fell the day of the Prometheus decision as investors feared it meant that the Supreme Court was inclined also to rule that genes could not be patented.
However, Myriad’s stock rose 56 cents to $23.34 on Monday, perhaps because the Supreme Court will now not be hearing the case itself, instead leaving it to the presumably more patent-friendly appellate court.
Some lawyers and other patent experts said the Prometheus decision might not apply that well to the Myriad case because Myriad’s patents are compositions of matter while the Prometheus patents are methods of testing.
“I think the logic is different because it’s about a thing rather than a method,” said Dr. Robert Cook-Deegan, director of the program on genome ethics, law and policy at Duke University.
Gregory A. Castanias, a lawyer representing Myriad, said the composition of matter patents would be on firmer ground. Referring to the Prometheus case, he said, “We don’t believe that that decision really changes the landscape with regard to our case at all.”
But Daniel Ravicher of the Public Patent Foundation said the Prometheus ruling contradicted the reasoning used by the appellate court to uphold Myriad’s patents. The isolation of DNA is a trivial, well-understood step, he said. “A unanimous Supreme Court has now undeniably declared that a trivial noninventive transformation” is insufficient for a patent, he said.
Myriad also had patents covering the process of analyzing the BRCA genes to see if they had mutations that raised the risk of cancer. The appeals court ruled those claims invalid, saying they involved only “patent ineligible abstract mental steps.”