Judge Robert Sweet's decision at the end of March to invalidate Myriad Genetics' patents on BRCA1 and BRCA2 has paved the way for intense discussions on the effect of gene patenting.
In his decision, Sweet found that isolated DNA is not able to be patented and that claiming that DNA is different when it's inside versus outside the body is a "lawyer's trick." Sweet concluded that "the patents at issue directed to 'isolated DNA' containing sequences found in nature are deemed upatentable subject matter."
Shortly after Sweet issued his ruling, Myriad signaled its intent to appeal the decision, with Peter Meldrum, its president and CEO, saying in a statement that he was "disappointed" in the decision but adding that he was "confident" it would be overturned on appeal by the Federal Circuit Court of Appeals.
The eventual outcome of the appeals in this case — and some suspect they may go as far as the US Supreme Court — may have a broad-reaching impact within the biotech field, for better or worse.
"If [the decision] were partially reversed, there will be some lingering uncertainty about what kinds of claims are allowable and which ones aren't," says Robert Cook-Deegan, director of the Center for Genome Ethics, Law, and Policy at Duke University's Institute for Genome Sciences and Policy. "But if the Court of Appeals for the Federal Circuit makes a decision and, in particular, if it goes up to the Supreme Court and they make a decision, then it would probably change practices at the patent office and it would also change the interpretation of all these claims that have been granted in the past."
Cook-Deegan says this won't stifle biotech innovation or investment "across the board." It will, he says, hurt a few companies that rely on single gene patents for products that test for one, or a few genes. "That's not very many companies," he says, adding that "it should make it easier and less uncertain to raise capital for these other kinds of companies … the microarray companies and the whole genome sequencing companies. Suddenly, you're not under the shadow of patent infringement liability."
Indeed, Cook-Deegan suspects that, in the future, fewer and fewer companies will focus on just one gene and will instead be looking at multiple-allele testing. For those tests, he says, companies would be more interested in patenting and protecting their particular way of assessing those genes.
However, not everyone agrees. Tom Meyers, a partner in the law firm Brown Rudnick who focuses on intellectual property, says that the Sweet decision would "be horrible for biotech innovation." The idea of the patent system, he says, is to encourage people to disclose their inventions in exchange for exclusive rights to their invention for a certain period of time. "That full disclosure enables other people to take the information and improve upon it and change it and make their own inventions and that pushes the technology forward," Meyers says. "If you don't have that sort of system, the economic incentives go toward keeping things secret and not telling people."
Meyers says a good patent strategy would be "not only seek to patent the gene, but also seek to patent ways of using it ... how you make it, all of those things, one would seek to patent." This, he says, is what Myriad did.
Though not having a patent on BRCA1 and BRCA2 may not have stopped Myriad from developing a breast cancer test, Meyers says that upholding this ruling would hurt biotech overall. "Patents promote innovation and really have an additive effect because of this exchange of full disclosure for the limited exclusive rights," Meyers says. "When you stop making that trade, you do have a chilling effect on innovation, in my view."