June 18, 2013
Last week’s Supreme Court ruling banned the patenting of human genes in a decision that has far-reaching implications for the future of scientific and medical research. The ruling stated that genes are a product of nature, and therefore can’t be patented, just like oxygen or wood.
The unanimous decision struck down patents held on two genes by Utah company Myriad Genetics, called BRCA1 and BRCA2. Mutations in these genes have been linked to higher risks of ovarian and breast cancer, however doctor, patient and scientific groups claimed that Myriad’s extensive patents had created a monopoly over the genes, blocking further research into them.
The decision is considered a victory for these groups. But, in somewhat of a compromise, the Court upheld some of the Myriad’s other patents, drawing a distinction between what it called ‘natural DNA’ and ‘complimentary DNA’ (cDNA).
cDNA is essentially a modified version that excludes non-functioning segments that occur in natural DNA.
But the Court decided that modification is enough to make the cDNA a new product and eligible for patenting.
Genetic counselor Erin Houghton says the decision opens doors for wider research efforts and better patient care.
“I think what that does is strikes a nice balance for encouraging innovation and discovery and research and allowing people the opportunity to patent their discoveries when it’s something new and when it’s something that’s been invented,” says Houghton.
On the other hand, the biotech industry argues that the inability to patent genes will act as a deterrent for researchers because labs and companies won’t be able to recoup their R&D costs.
Gail Norris, general counsel at the University of Rochester, says that’s unlikely to shut down genetic research.
“I think it will be an economic deterrent, but I don’t think it’s enough to stop the innovation because identifying the gene sequence is just the first step in the commercial application of it.”
In fact, Norris says being able to patent complementary DNA amounts to a win for companies like Myriad, as cDNA is what’s most commonly used when testing for gene mutations.
She says Myriad can still maintain some control in the testing field through its cDNA patents, although it can’t block further development or research.
Genetic counselor Erin Houghton says any monopoly will be limited, with alternate testing methods already out in the market.
“We already have seen other laboratories offer testing for the gene, within a couple of hours of this decision and it’s because they’re not using cDNA. So what it would mean is that those laboratories could then market a more comprehensive test than what Myriad was previously offering.”
The inability to patent human genes will prevent companies from financially exploiting the process of full genome sequencing, a form of personalized medicine expected to be widely available within a decade.