In the pending case Myriad Genetics v. Association for Molecular Pathology, the United States Supreme Court will consider the patentability of human genes under the “product of nature” doctrine. Patentable subject matter is generally held to encompass materials and artifacts created by humans, and not that which exists independently in nature. However, it is not clear that this is a meaningful or helpful distinction. Given on one hand that the concept of a gene is a human construct, and on the other hand that all human creations are drawn from the material environment, the question of gene patenting is better addressed as a matter of innovation policy than of imponderable labeling. ...
Unfortunately, many of the briefs filed in the AMP case tend to go on as if our view of the universe—and of the patent system—is predestined, rather than a creative human endeavor. Even more unfortunately, some of the worst offenses in this regard are advanced by scientists or scientific societies. But as I have shown here the definition of gene is a human, not a natural, construct, and that the physical properties of DNA molecules are necessarily altered to some degree from their native state anytime they are the subject of human investigation. Indeed, having here taken a hard look at the characteristics of the contested molecules in the AMP case, one wonders whether the most sensible course is to simply abandon the product of nature exercise altogether. At its endpoints, the doctrine either proves everything or proves nothing. Either everything is a product of nature—drawn from and existing in the world—or nothing is a product of nature—having been intellectually and socially constructed by human cognition.
This is not to say that the product of nature doctrine is utterly without content or, at least, that a proper formulation of it need not be. If the universe will not tell us outright what we ought to consider natural or inventive, how do we decide what items fit these categories? We look to the policy work that the doctrine is intended to do. The proper criterion has been articulated by the Supreme Court in the related context of laws or principles of nature: “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Such tools are essential to any technical progress; granting exclusive rights in such fundamental and necessary concepts would likely impede rather than promote innovation. Similarly, if the product of nature doctrine stands for anything, it is surely a shorthand for the parallel concept that there may be some materials so fundamental to further inventive activity that restricting them through grants of exclusive rights would prove detrimental to innovation. At the same time, there is nearly universal agreement that patents are intended to reward inventive activity by means of exclusive rights.
Failure to provide such rights could deter investment in the development or acquisition of fundamental materials. Thus, the product of nature question is not a question of ontology, but a question of epistemology: What do we know or hope to know about a certain material to promote the progress of science and the useful arts? There will be a fine line between enabling access to required tools and undersupplying them.
Drawing the line is purely a matter of public policy informed by economic reality and technical practice. The label “product of nature” does not tell us where that line lies, nor does the fact that a given tool was extracted at some level from material substance. In the end, the label product of nature is a conclusion rather than a criterion, and no substitute for the hard policy choice entailed in the Supreme Court’s question in AMP v. Myriad.