Restricting Gene Patents: A Pro-Market Agenda

This commentary is contributed by James P. Evans, clinical professor genetics and medicine at the University of North Carolina and Editor-in-Chief of Genetics in Medicine.

Gene patents have been controversial since they were first granted in the US over two decades ago. The controversy is now reaching a fevered pitch after a surprising US District Court decision which held that human genes are not legitimately patentable and an amicus brief by the Department of Justice largely in support of this contention. How this case will be decided by the Court of Appeals for the Federal Circuit and the Supreme Court (should it accept the inevitable appeal) is anyone’s guess.

But in spite of what might be suggested by the rhetoric often accompanying this debate, the questions at hand are amenable to logical analysis and the application of evidence. Such an analysis argues strongly that if patents on naturally occurring genes are ultimately ruled out of bounds, the net effect on commerce would be positive.

The recent brief filed by the Department of Justice draws a logical bright line between what kind of gene should be eligible for patent protection and what kind is not. Namely, it maintains that a naturally occurring human gene – one that evolved over millions of years and existed long before we humans began dissecting our own genomes – is not legitimately patentable. This seems very hard to debate on logical grounds. If, as is the case under long-settled law, we cannot patent gold, sunshine or an unmodified field mouse, then it is difficult to envision just how we could sanction the patenting of naturally occurring genes. One is perfectly free to patent a novel and inventive method for purifying gold, a new way of capturing sunshine to accomplish some purpose (like powering electrical grids) or a new kind of mouse that has never before existed. Likewise, if one modifies a gene (in such a way that is novel, non-obvious and useful), it is reasonable to expect patent protection on such an invention. But merely isolating a naturally occurring gene or distilling its naturally occurring information – no matter how difficult, ingenious or useful – renders the gene no more patentable than would be gold should I invent a new method for its purification.

But what about the issue of cDNAs and their patentability? While the DOJ brief was indeed largely supportive of Judge Sweet’s decision, it fails to grasp an implication of his perceptive appreciation of the gene as an embodiment of information. An understanding of this basic genetic principle suggests that Judge Sweet got it right. A cDNA is simply genomic information re-written in another form, and patenting it smacks more of a “lawyer’s trick” (in his phrasing) rather than a legitimate endeavor. The essence of a cDNA, the information that it embodies, is no more novel or inventive than the native gene from which it is derived and which has existed for millennia. Thus it is still not logically eligible for patent protection. If I publish a work of literature that resides in the public domain I don’t deserve intellectual property protection simply because I have issued a one volume version of the same work rather than issued it in its original 3 volume form. If, however, I write a new work of literature I can legitimately ask for protection. Likewise, only if I invent a nucleotide sequence that embodies new information should I expect patent protection.

So what will happen if it is ultimately decided that naturally occurring human genes are non-patentable in the case now winding its way through the court system (Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al.)? The evidence suggests that, far from realizing the end of Western Civilization as some claim, we would see a boon to commercial activity. Indeed, we already have evidence that exclusivity at the level of the gene is detrimental to commercial activity and innovation. In a report to the Secretary of Health and Human Services last year by a Federal committee (pdf) , the current landscape of gene patents, especially as it relates to the availability of genetic testing, was extensively evaluated. About 20% of the human genome is under patent. This means that some disease-relevant genes are patented, some are exclusively licensed and others happen to be unconstrained by exclusivity. Comparing the markets among these categories is highly instructive – and reassuring for those who believe in the power of markets to foster innovation. For genes such as those related to cystic fibrosis and Huntington’s disease, which happen not to be under exclusive constraint, a thriving marketplace exists where dozens of laboratories – both private and public – vie to out-compete one another on the basis of innovation, quality and service. However, for those genes controlled by patent-enabled exclusivity, including the breast cancer genes that are at the center of the Myriad litigation, only a single laboratory exists which is permitted to analyze them. As one would expect, in a setting lacking any meaningful competition, quality, innovation and service are undermined.

As we contemplate a future in which whole genome sequencing is about to be a practical reality, the potential for patent thickets and royalty stacking is real and could dramatically dampen our ability to harness this emerging technology to “promote the progress of science and useful arts.” While some argue that the elimination of gene patents will squelch the development of therapeutics, there is little in the way of factual evidence (or logical argument) to support such a contention. As the DOJ brief points out, “nearly every biotechnological or pharmaceutical application of genomic DNA will involve a welter of potentially patentable products and methods.”

The fundamental intent of the patent system often seems to get lost in the passionate arguments that swirl around this controversy. But patents were enshrined in the US Constitution for an explicit purpose: “to promote the progress of science and useful arts,” presumably by harnessing the “fuel of interest” in Lincoln’s memorable aphorism. The primary intent of the patent system is a broad social goal, not merely the stimulation of commerce. Otherwise, as the DOJ brief points out, we would allow the patenting of far more things than we do.

Of course there will be a few losers should human genes be judged non-patentable. The small handful of companies that have staked their business model solely on the hope of eliminating competition through the purchase of patents and exclusive licenses will not thrive. But those myriad (pun intended) companies that compete on the basis of innovation and added value will. Which type of market was the patent system designed to encourage? Which type will benefit us all?

Inappropriately granted patents can suffocate innovation just as surely as thoughtfully granted patents can stimulate it. The elimination of patents on naturally occurring genes is not only logical but is at the heart of a profoundly pro-market agenda. By eliminating toll booths at the extreme upstream position of naturally occurring genes we unleash human ingenuity and self-interest to the benefit of all.