The Supreme Court ruled unanimously Thursday that companies cannot patent human genes, a decision that patient advocates said would increase competition and lower the cost of screenings for cancer risk and other genetic tests.
DNA is “a product of nature and not patent eligible merely because it has been isolated,” the court said. In something of a compromise, it ruled that genetic material created in laboratories is eligible for patent protection.
The case centered on a Salt Lake City company called Myriad Genetics that was granted patents for isolating two human 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. Jolie herself said that the cost of screening — more than $3,000 in the United States — was an obstacle for most women.
“Myriad did not create anything,” Justice Clarence Thomas said, writing 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 of invention.”
The American Civil Liberties Union, which opposed Myriad, said that the court had “lifted a major barrier to progress” in treating and preventing diseases.
While companies are free to use the genes as a starting point to develop tests and treatments, the genes themselves should remain in the “public storehouse of knowledge” for scientists and companies to study and use, the ACLU said in a blog post.
The court could have ruled that both natural and synthetic genes are ineligible for patent protection, an outcome that would have been much worse for Myriad. Wall Street appeared to view the ruling as at least a partial win for the company and sent its stock up 10 percent.
The justices had wrestled with whether Myriad’s work was a product of invention or nature. The biotechnology industry warned that a ruling against the company would threaten billions of dollars in investment.
The government has already granted patents on 4,000 human genes, mostly to companies and universities.
An oral argument in April was so deeply technical — introns, exons and messenger RNA were all discussed in detail — that justices and lawyers alike had to grope for everyday analogies.
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.
The administration has supported the compromise position — allowing patents for synthetically produced genetic material but not natural genes themselves.
The case challenged seven Myriad patents that are set to expire in 2015.