by Adriana Lee Benedict
In a couple days, petitioners in AMP v. USPTO will be filing their brief on the merits following the Supreme Court’s grant of certiorari in late November. For many, the Supreme Court’s ruling in this case will provide a long-awaited answer to the question of whether or not isolated DNA is patentable subject matter under §101. In August, the Federal Circuit ruled on the case for a second time following a remand from the Supreme Court, in which the Federal Circuit was asked to reconsider its ruling in light of the Supreme Court’s recent ruling in Mayo v. Prometheus. The majority, written by Judge Lourie, found that Mayo did “not control the question of patent-eligibility of such claims. They are claims to compositions of matter” and that while “Plaintiffs and certain amici state, that the composition claims are mere reflections of a law of nature. Respectfully, they are not, any more than any product of man reflects and is consistent with a law of nature.” Judge Bryson’s dissent, on the other hand, explained that, “In cases such as this one, in which the applicant claims a composition of matter that is nearly identical to a product of nature, it is appropriate to ask whether the applicant has done ‘enough’ to distinguish his alleged invention from the similar product of nature,” concluding that Myriad had not made a “substantial ‘inventive’ contribution” or claimed anything more than a combination of “well-understood, routine, conventional” elements.”
It seems likely that the Supreme Court will agree with Judge Lourie that the gene patents in question in Myriad, whether or not they are products of nature, are not laws of nature, as some of the patents in question in Mayo were. Yet I would be surprised if they took this to mean that Mayo therefore does not control the question of patent-eligibility in Myriad. In Mayo, Justice Breyer’s majority opinion was incredibly clear that the metabolic correlation at issue was not patentable under §101 because it tied up a law of nature and therefore preempted its use for further research. Isn’t that exactly what Myriad is about? Certainly all parties would agree that Myriad’s patents, whether natural products (physical phenomena) or not, serve to preempt breast cancer research on the BRCA1 and BRCA2 genes.
When the Supreme Court articulated the §101 exception for laws of nature, physical phenomena and abstract ideas in Gottschalk v. Benson, it explained that these kinds of claims were not patentable because they consist of the “basic tools of scientific and technological work.” It is difficult to dispute that Myriad’s isolated genes are basic scientific tools. But according to Myriad, under this rule, their patents would only be invalid if they claimed real human DNA, and that it is not dispositive that their isolated DNA is nearly identical to real human DNA, because it is not naturally occurring.
Professor Allen Yu would argue that the Gottschalk exception is really about tying up the basic tools of science, rather than clear categorical exceptions. Along these lines, isolated DNA should not be patented because they are basic tools of science, even if they are not technically a physical phenomenon, law of nature or abstract idea. Indeed, this approach resembles a synthesis of Gottschalk and Mayo: Physical phenomena, laws of nature and abstract ideas are not patentable subject matter because they preempt future use of physical phenomena, laws of nature and abstract ideas, respectively. From this approach, the argument against patentability would seem to be even stronger if a patent claim on a physical phenomenon not only preempted its own use, but also the use of laws of nature, as Myriad’s gene patents do.
But what happens when the physical phenomena, laws of nature or abstract ideas at issue are not themselves useful as scientific or technological tools, but require close replicas in order to be useful? Can you escape Gottschalk and Mayo with the convenient reality that it is physically (or at least ethically) impossible to conduct genetic research on real human DNA to the extent that is necessary for advanced medical research? According to the letter of the law, maybe. But that would render judicial precedent increasingly meaningless as science progresses. In my opinion, applying precedent to genetic science demands deference to the spirit of the law—which importantly encompasses those scientific advances which unpredictably redefine our abilities to interact with nature.