There’s one thing that both sides awaiting the Supreme Court’s high-profile decision on whether human genes are patentable seem to agree on: the decision will have major repercussions. In the case that will be decided this month, the Association for Molecular Pathology joined with patient advocacy groups and researchers to challenge the patents biotechnology company Myriad Genetics holds on breast cancer risk genes.
Depending on who you listen to, the decision could either devastate the foundations of the biotechnology industry or impede research and threaten patients’ health by impeding access to information. The issue was catapulted further into the popular discussion last month when Angelina Jolie announced that she had her breasts prophylactically removed after she tested positive for a breast cancer risk mutation in one of the genes that is central to the Supreme Court case.
But last month in the journal Nature Biotechnology, a group of researchers argue the unusual and somewhat contrary position that the decision—whatever it is—will be less far-reaching than both sides think. The researchers document an evolution in the types of patents being granted in recent years that suggest the decision will affect fewer patents than has been portrayed. They also point out that patents could be redrafted in relatively minor ways to continue to be eligible for protection. And while the discussion has largely focused on human health, they show that the majority of patents likely to be affected are actually on non-human genes, many of which have agricultural applications. Gregory Graff, an associate professor in the department of agricultural and resource economics at Colorado State University, who co-wrote the paper, answered some questions about the paper by e-mail.
Q: Why do you think the Myriad decision is likely to have less impact than both sides are arguing?
A: The more dramatic voices on both sides seem to share the assumption that this will impact a large portion of the patents in biotechnology. Their differences lie mostly in their opinions of whether that large swath of DNA patents assumed to hang in the balance is good or bad.
The main results of our analysis are that the kind of “pure” gene patents that face a material risk in this case make up just a small portion of the industry’s IP [intellectual property] portfolios and that the share is getting smaller and smaller. Firms I have spoken with are not too terribly concerned about the impact the decision will have on their own portfolios, although, in theory, small biotech firms are more likely to be vulnerable than big corporations. From the point of view of those who are against gene patenting, a “win” against Myriad will simply not curtail that much of this bad practice nor cut out that much of the underbrush from any existing patent thickets.
Q: Your analysis shows that the majority of Myriad-like patents are not on human genes. Why is that important? What are the agricultural repercussions of a ruling, either way?
A: What we are simply trying to point out is that agriculture is part of the equation here, while most of the discussion seems to have been fixated on human diagnostics and personalized medicine. DNA is more ubiquitous in industry than is intoned by the question posed to the Supreme Court: “Are human genes patentable?” Really they should have just asked “Are genes patentable?”
Q: Your analysis documents a change in the nature of patents on sequences of DNA over the years;.why has that change occurred?
A: The first and foremost is that “raw” gene sequences may simply have proven less valuable. More needs to be done with them to make them valuable. Those further inventive steps have become the mainstay of DNA patenting.
Q: What do you think is the most likely outcome and how would it affect business and science?
A: If I were a betting man, I would put my money on the Association for Molecular Pathology side of the case. What that would do, however, at least for the short to medium term is to muddy the waters around whether certain claims are still valid or not in light of the decision. Patent practice and the drafting of new claims will continue to shift, as we argue it has already been doing, to steer clear of the resulting uncertainty. Again, I do not expect the effect on business or science to be too dramatic.