The U.S Supreme Court ruled today that "naturally occurring" human genes cannot be patented because they are a "product of nature," meaning that they cannot be claimed as a human invention. But it also permitted patents based on laboratory reconstructions of human DNA, known as complementary DNAs, or cDNAs.
"Myriad did not create anything," Justice Clarence Thomas wrote for a unanimous court. "To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention." And "groundbreaking, innovative, or even brilliant discovery does not by itself satisfy" the requirements for winning a patent. Overall, the ruling is a victory for two New York City advocacy groups that have waged a long campaign to get the patents knocked down: the American Civil Liberties Union (ACLU) and the smaller Public Patent Foundation (PUBPAT), which initiated the effort. It was a defeat for the diagnostics firm Myriad Genetics, of Salt Lake City. Five of its many patent claims on the human genes BRCA1 and BRCA2 have been gutted, although other claims remain intact.
In legal briefs, ACLU and PUBPAT and argued that Myriad was using its patents to sue clinics and wrongly prevent them from doing independent diagnostic tests. Backed by many geneticists and medical groups, the advocates sought to have Myriad's patents invalidated so that any lab could test without fear of a lawsuit for BRCA genes linked to breast and ovarian cancer. Daniel Ravicher, PUBPAT's executive director, celebrated today with a triumphal statement, saying: "The Court rightfully found that patents cannot be awarded for something so fundamental to nature as DNA. … Bottom line, diagnostic genetic testing is now free from any patent threat, forever, and the poor can now have their genes tested as freely as the rich."
The impact of the decision on other companies may depend on exactly how gene patent claims are worded. While the court ruled out "natural" DNA patents, it also permitted cDNA patents. Although "cDNA retains the naturally occurring exons of DNA … it is distinct from the DNA from which it was derived," the court wrote. "As a result, cDNA is not a 'product of nature' and is patent eligible."
This split legal outcome is exactly what many observers predicted. It is also exactly what the Obama administration asked the court to deliver in a legal petition filed earlier this year.
For many researchers, a split decision was good enough. Francis Collins, director of the National Institutes of Health, who has long argued for limiting private control of DNA data, said today that he was pleased with the ruling. "Our position all along has been that patenting DNA in its natural state does not provide any benefit to the public. There have been concerns that you might have a $1000 genome sequence, but a $500,000 royalty fee to use it. We can breathe a big sigh of relief that this will no longer threaten to inhibit the progress of DNA research."
The main impact of the ruling on diagnostics companies, according to Robert Cook-Deegan, director of a genetics policy institute at Duke University in Durham, North Carolina, will be to make it harder to gain exclusive control of DNA information. Companies will need to do more work to nail down their intellectual property—such as by patenting primers, probes, and testing methods. He predicts that opportunities will expand for companies and academic labs that would like to do multiple-gene testing for cancer risk. Until now, such labs have been forced to leave BRCA genes off their testing list; now, they can include them.
Myriad, however, found a silver lining in the part of the court's decision that will continue to allow patents on cDNAs. The company notes today that the ruling affects only five of the many patent claims protecting its cancer risk test, known as BRACAnalysis. Myriad says that it still has "more than 500 valid and enforceable claims in 24 different patents." In a statement issued today, company president and CEO Peter Meldrum 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. … 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."
Although the court's opinion was unanimous, Justice Antonin Scalia added a divergent view. While he agreed with the decision, he could not personally stand behind the "fine details of molecular technology" cited by his colleagues, he wrote, because "I am unable to affirm those details on my own knowledge or even my own belief."