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On Patenting Human Genes, the Evidence Favors Myriad

JURIST Guest Columnist Bruce Abramson of Rimon PC argues that in the absence of sufficient evidence, public policy favors the patentability of genetic tools...

The conventional shorthand for the Association for Molecular Pathology v. Myriad, Inc. case, argued before the Supreme Court on April 15, 2013, is that it is a dispute about the patentability of human genes. This shorthand is misleading. No one suggests that genes, as they appear in the human body, are subject to patent law—and the consequent restrictions, fees and exclusive licenses that patentees may choose to apply. A less misleading, though less beguiling, characterization of the dispute would cast it as considering selected human genetic tools.

As a non-geneticist—my background combines law, economics and computer science—my understanding of the nuanced difference between these descriptions rests in large part on the science represented in the various amici briefs. My understanding of the situation, however, appears to mirror that of all others active on either side of the dispute. To put matters succinctly, geneticists have developed a set of tools that allow them to study, manipulate and work with human genes. Being geneticists, these tools themselves are crafted from genetic matter. The fundamental steps used to craft these tools include copying, decoding, encoding, cutting, pasting, wrapping and unwrapping human genes.

At issue here are two powerful and important genetic tools: isolated DNA and cDNA. The specific genetic tools that Myriad claims and uses are extraordinarily helpful in the prediction, diagnosis and treatment of breast cancer. The crux of the dispute now before the Supreme Court is whether such genetic tools should be patentable.

That question has three critical components, one each grounded in law, fact and public policy. The legal question is, in many ways, the easiest. What distinguishes patent-eligible inventions from patent-ineligible discoveries? The answer is straightforward and undisputed: nature. Items that occur in nature, including those that are difficult to discover, are unpatentable. Inventions, or things crafted from nature, may be patentable—assuming they meet the other requirements for patentability (requirements not at issue in the current dispute). This "easy" legal question thus hinges on a much harder factual one: Are isolated DNA and/or cDNA natural or artificial phenomena?

No amount of legal training, reasoning, research or acuity can answer this question, for it is explicitly a matter of scientific fact. As a quick perusal of the briefs and arguments in this case show, scientists themselves dispute the answer. In fact, there appear to be three schools of thought—the petitioners contend that both isolated DNA and cDNA are natural; Myriad contends that neither are natural; and, the government contends isolated DNA is natural while cDNA is not. Scientific testimony supports all three positions.

A standard application of the rules of evidence suggests that Myriad has the strongest argument. After all, the best evidence of a natural phenomenon is the demonstration of that phenomenon. Were anyone able to produce even a single instance of a natural occurrence of Myriad's claimed genetic tools, the case would be over. Myriad would lose. The absence of such a demonstration suggests but does not prove—as it always does—that the petitioners can produce no such evidence because no such evidence exists.

The petitioners counter with a statistical argument. They claim that phenomena structurally similar to isolated DNA and cDNA do exist and that because all genetic permutations could exist within those structures, it is highly likely that all such permutations—including precisely those at issue here—have existed somewhere, at some point in time. It is thus unnecessary to produce a concrete example to establish their existence.

During oral argument, Myriad's counsel raised the possibility of an analogous "naturally occurring" baseball bat—a discussion that engaged several members of the Court. Tree branches, of course, have existed for millions of years. Throughout that time, winds have blown them against rocks, into the sea and against each other. Natural forces have buffeted them, breaking them, shaping them and texturing them into items far removed from their original form. As a comparable matter of statistics, should not one such branch have emerged somewhere as a perfectly formed baseball bat? If so, should we similarly say that baseball bats are not patentable subject matter?

This sort of statistical argument—more commonly expressed in terms of typing monkeys recreating Shakespeare or Kantian philosophers discovering gold watches—raises an interesting question. Even if true, should the possibility of natural occurrence suffice to qualify an object as "natural," in the sense meaningful to patent law? If so, where should we draw the line? After all, wouldn't an infinite number of collisions of an infinite number of particles also produce a working iPhone (my lack of genetic background notwithstanding, I do have enough training in statistics and formal logic to know that the answer is "yes"), or should we require anyone asserting that Myriad's genetic tools arise naturally produce, as "best evidence," a naturally occurring instance?

It seems that, under normal circumstances, the mere conjecture of a likely phenomenon would not suffice to render an invention unpatentable subject matter. It is the public policy argument at stake here, however, that may allow this dispute to rise above the ordinary. After all, the tools at issue here relate to breast cancer—and the class of genetic tools to which they belong could hold the keys to fundamental improvements in human health. Is it right to grant anyone a monopoly on such advances? The consequences at issue here are relatively benign—the patent monopoly allows Myriad to extract higher prices while providing the service as needed. Unfortunately, patentees are not required to do so. Suppose the next patentee chooses to limit or withhold a critical gene from the market entirely? Such behavior is well within the rights of a patentee. Furthermore, even in the present "benign" world of "mere" higher prices, the situation may appear less benign to women unable to afford Myriad's tests.

The Court, of course, is not supposed to consider such issues, nor is the Court supposed to consider the countervailing public policy arguments that a thriving biotech industry has emerged within the current legal framework, and changes at this point risk roiling the entire industry. Such questions are the proper bailiwick of Congress, which has heard them before (both in the genetic context and the broader therapeutic context), has incorporated them into law in limited ways and, despite that, has not applied them to prohibit patents on these or other genetic tools.

Still, given the amount of attention that these issues have played in the press, in the briefs and in oral arguments—not to mention as the basic motivation driving the petitioners—it is hard to believe that the Court will ignore them entirely.

So where will it all end? Forecasting is a difficult game, but I like to credit people and institutions with doing the right thing. Congress, not the Court, is the proper place for a policy argument. From the narrow perspective of patent law, the only real question is whether or not the genetic tools in question exist in nature. There is no evidence to suggest that they do, only argument to suggest that they must. Courts evaluate such arguments all the time—and invariably take the absence of evidence as damning. I expect the Court to rule in Myriad's favor—though likely with some discussion of the policy issues that Congress may someday choose to address.

Bruce D. Abramson is an expert in the law and economics of technology who holds a Ph.D. in Computer Science from Columbia and a J.D. from Georgetown. His work combines expertise in valuation, strategy, technology assessment, and competitive analysis with experience in patents, copyrights, trade secrets, standards, competitive effects and licenses.

Suggested citation: Bruce Abramson On Patenting Human Genes, The Evidence Favors Myriad, JURIST - Sidebar, April 30, 2013, http://jurist.org/sidebar/2013/04/bruce-abramson-genetic-patents.php.

This article was prepared for publication by John Paul Regan, an Assistant Editor with JURIST's Professional Commentary Service. Please direct any questions or comments to him at professionalcommentary@jurist.org

Opinions expressed in JURIST Commentary are the sole responsibility of the author and do not necessarily reflect the views of JURIST's editors, staff, donors or the University of Pittsburgh.

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