As you likely heard, the Supreme Court heard oral arguments yesterday in a case that’s of interest to many biomedical researchers. That case, widely known as the “gene patenting case,” has a single question presented: “Are human genes patentable?” It may irk some researchers and clinicians that the answer isn’t a straightforward "no." But the issues are surprisingly complex: How does one define a “gene,” and a “human” vs. a “synthetic” one at that? What about primers, probes, and cDNA? And what does one mean by “patentable”?
First, a brief lay of the legal landscape. Typically, an inventor cannot patent a “product of nature.” But ever since a 1911 appellate decision (.pdf), a natural product can be patented if it’s “isolated and purified” from its surrounding environment. Thus, the chemical compound adrenaline was itself patented because it was isolated and purified from adrenal glands. Shockingly, the Supreme Court has never directly reviewed this isolated and purified doctrine, even after 102 years.
This all raises the question of whether human genes should be allowed to be patented as a matter of policy, if not law.
And so, on this basis, isolated human genes have long been patented. In 1994, researchers at the University of Utah finally located and sequenced (.pdf) the BRCA-1 and BRCA-2 genes, variants of which put women at astonishingly high risk for early onset breast and ovarian cancer. Those researchers obtained patents on both the isolated sequences and cDNA variants of those, and assigned them to Myriad Genetics, a diagnostic testing company.
Arguments at the Supreme Court - and the justices themselves - grappled with the distinctions between isolated genomic DNA and cDNA. Lower court opinions had made a significant case out of the fact that because the covalent bonds of isolated genomic DNA were cleaved from the surrounding chromosome, an isolated gene was, in fact, a new chemical entity. Similarly, several justices suggested that because cDNA was not found in nature, it too, was patentable - even if it was simply the product of reverse transcribing an mRNA sequence. (For a further breakdown on the oral arguments themselves, see Stanford’s Center for Law and the Biosciences’ oral argument recap.)
But it seems that at least five justices - and thus, a majority - believe that patents on isolated DNA are not eligible for patent protection. They don't seem to buy the argument that simple covalent cleavage renders something a new chemical entity. The Court and lawyers deployed various analogies to make this point: gold from ore, a piece of wood from a tree, a liver from a patient, etc. It seems less clear, however, whether a majority will similarly rule cDNA to be patent ineligible.
This all raises the question of whether human genes should be allowed to be patented as a matter of policy, if not law. Clearly, genetic research is valuable and patents would undoubtedly encourage that research. But that encouragement is diluted where most academic researchers are equally, if not more concerned, with publishing their results in high-impact factor journals and ensuring the continuity of their National Institute of Health grants. To the extent PIs care to “make a few bucks on the side,” there’s no shortage of startups - especially here in the Bay Area - looking for scientific directors and any opportunity to say they have a Stanford faculty member on their boards.
On the opposite end of the spectrum, its similarly clear that prohibiting gene patents would allow researchers to go about their work unencumbered by threats of litigation, or that dreaded phone call from their school’s general counsel’s office. And yet, it seems like many investigators simply ignore patents, even when they know their work infringes. For all the talk about the restrictive effect of gene patents, it seems like - at least in the real world - they don’t restrict much research.
And so, as one could expect, the answers to should human genes be patented is just as diverse as the answers to whether they can be in the first instance.
Jake Sherkow, JD, is a fellow at Stanford Law School's Center for Law and the Biosciences. His current research focuses on the intersection of patent law, biotechnology, and agency regulation.
