This just happened, and information is sketchy, but the U.S. Supreme Court has ruled unanimously that naturally-occurring genes can’t be patented. This ruling came from a case in which the company Myriad Genetics was challenged because it holds the patents on the breast cancer genes BRCA1 and BRCA2. Those patents mean that no other organization, clinic, or company can test a woman for the presence of those genes, and Myriad now charges an unconscionable $3000 for such a test. (Having mutant forms of those genes means that your risk of breast and ovarian cancer is hugely elevated.) The test, of course, costs nothing like $3000 (it’s simply a DNA-sequencing technique that’s cheap), but Myriad argues that developing the test took millions of dollars. But anybody with a lab and rudimentary DNA-sequencing equipment could test themselves for a very small sum.
It’s not clear at this point what the ruling means, for, as NBC News reports, synthetic genetifc material can still be patented, and a synthetic gene has the same structure as a natural one, except that it’s not embedded in a chromosome.
The Supreme Court ruled unanimously Thursday that natural human genes cannot be patented by companies, but it said that synthetically produced genetic material can — a mixed ruling for the biotechnology industry.
A naturally occurring piece of DNA is “a product of nature and not patent eligible merely because it has been isolated,” the court said.
The case centered on a Salt Lake City company called Myriad Genetics that was granted patents for isolating two genes, known as BRCA1 and BRCA2, that indicate a higher risk of breast and ovarian cancer. The company now markets tests for those genes.
BRCA1 is the gene carried by actress Angelina Jolie, who determined after a test that she was at higher risk of developing breast cancer and chose to have a double mastectomy.
The court said that Myriad had found something important and useful, but it ruled that “groundbreaking, innovative, or even brilliant discovery” does not by itself guarantee a patent.
The opinion was written by Justice Clarence Thomas.
On Wall Street, investors in Myriad seemed pleased. The company’s stock shot up 7 percent in the minutes after the Supreme Court decision came down.
If I read this decision right, this means that other companies can now test for the breast-cancer genes, since that involves sequencing natural genes: those present in a woman. And that would be a victory.
More on the arguments:
Gregory Castanias, a lawyer for Myriad, likened the isolation of genes to the creation of a baseball bat, which “doesn’t exist until it’s isolated from a tree.”
“But that’s still the product of human invention,” he said, “to decide where to begin the bat and where to end the bat.”
Doctors and scientists who challenged the patents said that their research had been hindered. The lawyer arguing for them said that Myriad deserved credit for unlocking the secrets of genes — just not a patent.
“One way to address the question presented by this case is: What exactly did Myriad invent?” asked the lawyer, Christopher Hansen of the American Civil Liberties Union. “And the answer is nothing.”
Justices on both sides of the ideological spectrum seemed concerned about whether companies like Myriad would scale back investment in research if they were not rewarded with patents.
“What does Myriad get out of this deal?” Justice Elena Kagan wondered. “Why shouldn’t we worry that Myriad or companies like it will just say, well, you know, we’re not going to do this work anymore?
Solicitor General Donald Verrilli, representing the Obama administration, argued that manipulating a gene into something new might qualify for patent protection, but that isolating what’s already there should not.
Who cares what Myriad gets out of the deal? If Myriad hadn’t rushed to find the gene and sequence it, it would certainly have been done by medical researchers. It’s simply a natural thing to do, and the technology for mapping and sequencing disease genes does not require the financial strength of companies like Myriad. The lawyer for the ACLU was absolutely correct: Myriad invented nothing. No invention, no patent. And no exploitation of women.