by Adriana Benedict
Today, Professor Glenn Cohen announced on this blog that he, in conjunction with two others, filed an amicus brief in AMP v. USPTO (Myriad), a case concerning Myriad’s patents on isolated DNA and cDNA. In a paper I have been writing on the natural phenomenon doctrine as applied to biotechnology patents, I arrived at this conclusion about the doctrine’s implications for Myriad:
According to Mayo v. Prometheus, the preemption rationale for the natural phenomenon doctrine suggests that any patent on a diagnostic biotechnology product or process should be limited to the inventive use of that product or process as defined by its associated process or product, respectively. As applied to Myriad, this qualified interpretation of the natural phenomenon doctrine would suggest that ideally these patents ought to be limited to Myriad’s one remaining valid method claim, namely claim 20 of the ‘282 patent, “a method for screening potential cancer therapeutics.” The unavoidable and unsettling problem with such a conclusion, of course, is that at this stage in litigation, it is not possible for the Court to limit Myriad’s gene patents in this way. This procedural limitation sheds some light on the elephant in the natural phenomenon doctrine: If the doctrine was meant to exclude certain categories of discoveries from patentability before Congress had the opportunity to refine more specific patent validity rules, then perhaps it should be limited to carrying out that function at the outset of a patent prosecution. The natural phenomenon doctrine serves the important purpose of ensuring that patents do not contravene their Constitutional objective by too broadly preempting the use of “basic tools of science.” It does so by balancing the scope of preemption against the scope of invention, and ensuring that the scope of preemption does not exceed that which is justified by the inventor’s handiwork in applying natural phenomena. At the patent prosecution stage, the natural phenomenon doctrine is a useful “catch-all” analytical tool that allows flexibility in promoting the spirit of patent law when the letter of patent law has not kept pace with the progress of science. But at the litigation stage, its Achilles heel is that it may prove too much: In the absence of a procedural option to limit a patent at this stage, the natural phenomenon doctrine is forced to err on either the side of all or nothing. While the doctrine may be useful at the patent prosecution stage, it was not (as other statutory patentability requirements were) appropriately designed to assess the validity of patents once they’ve been issued in a way that is compatible with today’s patent litigation procedures. As a doctrine of limitation, it must in this context either fall, and prove nothing at the expense of unwarranted preemption, or rise, and prove too much at the expense of patent holders who have been reasonably relying on guidance from the USPTO regarding gene patents for many years.
I am unable to find any commentary exactly on this point, but some issues concerning the jurisdictional authority of §101 have been raised in response to both Mayo and CLS Bank v. Alice. While these cases concern biotechnology processes and software, respectively, they are extremely relevant to Myriad if we consider isolated genes / cDNA to be the equivalent of biological software. Indeed, Professor Ronald Mann observed that “Though most of the attention to …[Mayo] has focused on its immediate implications for medical providers, the broader effect of the case probably will be on the software industry.”
By Wendy Parmet
New York State Supreme Court’s Justice Milton A. Tingling’s decision last night in New York Statewide Coalition of Hispanic Chambers of Commerce v. New York City Dpeartment of Health and Mental Hygiene, to enjoin New York City’s controversial ban on the sale of large sugary beverages should not have been surprising. As Scott Burris has noted here, “the public health side has been getting killed wherever law is made.” Defeats for new public health regulations, especially new regulations that impinge against powerful economic interests, are becoming the norm.
Still, there were some surprising and troubling, from a public health perspective, notes in Justice Tingling’s opinion, which relied heavily on Boreali v. Axelrod, a 1987 opinion by the New York Court of Appeals striking down a ban on indoor smoking, to find that the Department lacked authority to issue the regulation.
According to Justice Tingling, Boreali required the court to consider four factors including whether the regulation was based on matters beyond its stated purpose, and whether the regulation was “created on a clean slate thereby creating its own comprehensive set of rules without the benefit of legislative guidance.” In looking to whether the ban on sugary sodas was based on factors other than its stated purpose, Justice Tingle noted among other things that the Department had cited the “enormous toll” that obesity places on the “economic health” of New Yorkers. To Justice Tingle any regard for the economic consequences of obesity demonstrated that the Department based its regulation “on economic and political concerns” outside the scope of its authority. Thus the very fact that the Department considered the economic consequences of the issue it addressed, a consideration that many scholars would claim is a critical component of sound regulatory policy, helped to doom the ban on large sodas. Would the Court, one wonders, have been more approving of the regulation if the Department had failed to show that obesity had significant economic consequences? Somehow I suspect not.
I am pleased to announce that Gideon Schor, Vern Noviel, and I filed an amicus brief on behalf of Dr. Eric S. Lander in a pending Supreme Court case that will address whether human genes are patentable. The case is Association for Molecular Pathology v. Myriad Genetics, No. 12-398 and will be argued April 15, 2013. Lander is a leading genomics researcher and is President and Founding Director of the Broad Institute of Harvard and MIT. We think the brief will play a key role in helping the Supreme Court chart a path through this legal thicket. The full brief can be downloaded here http://www.americanbar.org/content/dam/aba/publications/supreme_court_preview/briefs-v2/12-398_neither_amcu_lander.pdf. Here is an excerpt from the brief, the Summary of the Argument:
This case hinges on a scientific question: whether DNA fragments from a human chromosome are (1) products of Nature or (2) at least similar enough to products of Nature that they should not be considered “markedly different.” Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).
The members of the Federal Circuit panel below agreed that the DNA of a whole human chromosome was a product of Nature. But the majority held that isolated DNA fragments of a human chromosome were not products of Nature.
Because the majority made (without citing scientific support) a foundational assumption that isolated DNA fragments of the human genome do not themselves routinely occur in Nature, it considered whether they are similar enough to products of Nature. Employing analogies, the panel members debated whether isolated DNA cleaved from a chromosome was akin to a leaf plucked from a tree, or a kidney surgically removed from a human body.