What does the decision mean for patients and the biotech industry? We talked to experts about some of the big takeaways:
1. Naturally occurring genes are no longer patentable.
The Court on Thursday sided with the American Civil Liberties Union (ACLU) and threw out patents held by Utah-based Myriad Genetics used in a popular but expensive breast and ovarian cancer test that detects mutations in the genes BRCA1 and BRCA2.
The test gained national attention after actress Angelina Jolie revealed that herdecision to undergo a double mastectomy was the result of testing positive for one of the mutations.
This week’s ruling, authored by Justice Clarence Thomas, states that naturally occurring DNA segments are not patentable.
“I think the major takeaway is that human genes as they exist in [cells] are unpatentable subject matters going forward,” said Jacob Sherkow, a fellow at Stanford Law School’s Center for Law and the Biosciences.
The ruling applies not only to BRCA1 and 2, but also to thousands of other patented genes associated with various diseases such as colon cancer, Alzheimer’s disease, and muscular dystrophy.
2. Synthetic DNA is still fair game.
The Court tried to strike a balance in its ruling by banning some types of gene patents but not others.
While companies can no longer patent genes with the same sequences found in cells, the decision allows edited forms of genes not found in nature—known as complementary DNA, or cDNA—to be patented.
cDNA is not useful for diagnostic tests, but it is crucial for producing protein-based drugs, explained Robert Cook-Deegan, a professor of genome ethics, law, and policy at Duke University’s Institute for Genome Sciences and Policy.
“Those are the billion-dollar molecule patents,” Cook-Deegan said. “Biotech companies care a great deal about cDNA patents, and it should be reassuring to them that those patents are still fine.”
Hank Greely, a bioethicist and law professor at Stanford University, predicts
cDNA patents will become even more valuable as scientists move beyond merely exploiting naturally occurring proteins.
“In the longer run, as we move into an era of synthetic biology, where we start trying to improve upon nature, then I think [cDNA patents] will be important,” Greely said.
3. Prices for testing genetic diseases are already falling.
Hours after the ruling was announced, other biotech companies announced competing tests for the BRCA1 and 2 genes. One company, DNATraits, said it will offer the test for $995—about one-third the cost of Myriad’s test.
Cook-Deegan said he was surprised at how fast companies reacted to the Court ruling.
“At least one company thinks they can safely enter the market,” he said, referring to DNATraits. “They think they can’t get sued, and I think they’re probably right.”
4. It could get easier to sequence whole genomes.
The high court’s ruling could help clear the way for companies that are developing whole genome sequencing technologies that determine an organism’s entire DNA sequence at once, rather than one gene at a time.
“Because Myriad and other companies had patents directed to pieces of isolated genomic DNA, it was at least an open question whether whole genome sequencing would have infringed on those patents,” Sherkow said.
“I don’t think it resolves the issue definitively, but the Court’s ruling opens the door for whole genome sequencing to proceed without the fear of being sued for patent infringement.”
5. There are implications beyond human genes.
Arthur Caplan, a bioethicist at New York University, says the ruling will extend beyond companies that focus on human genes because it “applies to not just human genes, but also patents over plant, animal, and microbial genes.
“So I think there’s going to be some upheaval in parts of the biotech world beyond just human [gene] companies.”
6. Whether Myriad’s secret patient database will be opened is unclear.
Cook-Deegan of Duke University called the Court’s ruling “really sensible,” but thinks that Myriad should be forced to publicize its database of results from women who have taken its tests over the years.
“Myriad has eight years of data that they have not shared publicly. I want to know what’s going to happen to that data,” Cook-Deegan said. “As far as I’m concerned, everyone who’s done the tests anywhere in the world should have the rights to access that data because they were acquired under an illegal monopoly.”
But Stanford’s Sherkow thinks that’s unlikely to happen. “The Court’s decision does not implicate Myriad’s database of clinical outcomes,” he said. “Myriad can continue to keep those as trade secrets, and they don’t have to disclose that information.”
7. The ruling might not actually matter that much.
While the ACLU hailed the Court’s decision as a major victory for “civil liberties, scientific freedom, patients, and the future of personalized medicine,” Stanford’s Greely argued that the ruling is relatively unimportant.
One reason is that the gene patents held by many companies were set to expire soon anyway—in the case of Myriad, in 2016. “They were going to disappear as a problem,” Greely said.
Furthermore, the old gene patents don’t affect many current tests that only look at small bits of a gene, as opposed to the entire gene.
“The new technologies for sequencing would probably not even infringe on the Myriad patents anyway because of the way the patents were written and how the new technologies actually do the testing,” Greely said.
The Court’s ruling also leaves other legal questions unanswered. For example, can naturally occurring proteins or molecules be patented?
The answer to that question would ultimately have a more significant impact on the biotech industry, Greely says, because many modern drugs start out as naturally occurring molecules.