By Kevin E. Noonan --
The United States government (or at least that part of it constituting the Department of Justice) has filed an amicus curiae brief in the AMP v. USPTO case (Myriad) in which it advocates a change in policy regarding the patent-eligibility of isolated genomic DNA. Written by two DOJ officers with little evident background in science, technology, or patent law (there are no USPTO lawyers on the brief), the brief makes a distinction between isolated DNA that is the subject of "human manipulation" (such as cDNA) that it argues is patent-eligible, and human DNA that has been merely "isolated," which should not be. While seemingly poised to mollify (if not satisfy) all parties to the dispute, the seeming ignorance of the consequences of the patent-eligibility criteria espoused by the government on a wide range of fields important to "the national economy, to medical science, and to the public health" is disturbing as well as contrary to sound patent policy.
The brief characterizes the questions presented as (1) whether "human-engineered DNA molecules, such as cDNAs, are patent-eligible subject matter," and (2) whether "isolated but otherwise unmodified genomic DNA is patent-eligible subject matter." These questions are not the ones presented to the Federal Circuit, if only because the District Court made no such distinction in its decision below: isolated human DNA was not patent-eligible, according to the District Court, because it is "the physical embodiment of genetic] information." The particular pin the DOJ has constructed upon which its rhetorical angels dance has no basis in the issues before the Federal Circuit.
One hint of where the DOJ went astray is evident in its discussion of molecular biology, where it explains that:
DNA can be extracted from the natural cellular environment in which it occurs through established laboratory techniques . . . . A particular segment of DNA of interest, such as a gene, can then be excised from the extracted material. The result of this laboratory process -- a DNA molecule excised from the genome and separated from its cellular environment -- is commonly termed "isolated DNA."
While on its face not manifestly incorrect, the simple phrase "through established laboratory techniques" ignores and trivializes the nature of what it takes to isolate human DNA that encode particular genes. This is an error that at various times the USPTO and the Federal Circuit have made, but in the context of the brief's conclusions it is the basis for the fundamental misunderstanding that permits the DOJ to place the modifier "merely" before "isolated human genomic DNA." The wide-ranging effect of this error is found immediately after this "explanation" of the process of isolating DNA, where as an example of such "merely" isolated genomic DNA the brief cites U.S. Patent No. 4,472,502, which claims a gene from Lactobacillus. Perhaps the brief writers are not aware that bacteria and other microorganisms do not have their genes split into introns and exons as mammalian genes are. The consequence of this ignorance is that in the regime they espouse, isolated DNA from microorganisms would perforce not be patentable, because it was merely "isolated." While not relevant to the '502 patent (which long ago expired), what will be the effect on the economics of producing vaccines for the next pathogenic outbreak if the DNA comprising the vaccine cannot be protected? The brief writers are clearly ignorant of the existence of the question, much less capable of proposing an answer.
The brief properly castigates the District Court for "erroneously cast[ing] doubt on the patent-eligibility of a broad range of manmade compositions of matter whose value derives from the information encoding capacity of DNA," specifically reciting "cDNAs, vectors, recombinant plasmids, and chimeric proteins, as well as countless industrial products, such as vaccines and genetically modified crops, created with the aid of such molecules -- [they] are in every meaningful sense the fruits of human ingenuity and thus qualify as 'human-made inventions' eligible for patent protection under section 101," citing J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124, 130 (2001) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 313 (1980)). The "hand of man" is sufficiently evident for the government that such claims are patent-eligible.
The brief then goes on to argue that the District Court was correct in finding "that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible," based on the rationale that the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a "human-made invention." The brief also states that the "fact" that a disease is associated with a particular mutation is also not patent-eligible, being "simply a law of nature." It must be noted that, like the District Court, the government's brief confuses a claim to a method for detecting the existence of a natural phenomenon with a claim to the phenomenon itself. Also, Myriad's claims were further directed to a specific utility -- identifying women at increased risk for breast or ovarian cancer -- that is outside what was available in nature (i.e., the mutation existed but neither the women nor anyone who could therapeutically intervene was aware of it until the mutation was identified). And in keeping with much of the debate on this issue, the government's conclusion is "supported" by an inapt analogy: that isolated DNA is "no less a product of nature when that structure is 'isolated' from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth." Which would be true, if isolated DNA was anything like cotton or coal, which of course it is not. Similarly, the brief argues that chemical elements like lithium, pure ductile tungsten, uranium, and vanadium are not patent-eligible despite the fact that they do not occur naturally. But isolated DNA is more similar to isolated and purified erythropoietin, or lincomycin, or adrenaline, purified preparations of which are and always have been eligible for patenting.
More apt are decisions of the Commissioner and Board regarding pine needle fibers and whatever was isolated in the Ex parte Berkman case, but the brief seems just as happy to agree with ancient PTO decisions as it is to disagree with the PTO's decision that isolated genomic DNA is patent-eligible (and, as the brief admits, after a statutorily-required notice and comment that fully addressed this issue directly and specifically, rather than being applied far after the fact on other "natural products").
The brief attempts to point out all the things that, in the brief writers' views remain patent-eligible if the line of demarcation should be drawn according to their inclination. Thus, "[n]ew and useful methods of identifying, isolating, extracting, or using genes and genetic information may be patented (subject to the prohibition against patenting abstract ideas), as may nearly any man-made transformation or manipulation of the raw materials of the genome, such as cDNAs. . . . Thus, the patent laws embrace gene replacement therapies, engineered biologic drugs, methods of modifying the properties of plants or generating biofuels, and similar advanced applications of biotechnology." But what would qualify as an "engineered" biologic drug, if the touchstone of making such drugs is for them to be as similar to the protein as possible as it exists in nature? The problem with their approach comes in the following sentence: "[c]rossing the threshold of section 101, however, requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be." Besides their own prejudices, the brief writers do not explain why, nor do they explain (if they are even aware) of the broad swath of heretofore patentable inventions would fall outside the scope of patent-eligibility using the same reasoning.
Insofar as it exhibits reasoning, the brief bases its argument on the idea, unsupported in the case law, that "products of nature" are not patent-eligible. As many on this side of the debate have done before them, the brief bases its argument on Funk Bros. v. Kalo Inoculant Co., 333 U.S. 127 (1948). Arguably overruled, or at least distinguished by the Supreme Court's Chakrabarty decision, the brief further cites the J.E.M. Ag Supply case for its "products of nature" argument, despite the fact that there the question was whether Congress had included plants within the ambit of utility patent protection (which is not the same issue the brief cites the case to support). Regarding Funk Bros., it is informative to review Justice Frankfurter's concurring opinion for a fuller understanding of the reasoning behind Justice Douglas's majority opinion. According to Justice Frankfurter:
Insofar as the court below concluded that the packaging of a particular mixture of compatible strains is an invention and as such patentable, I agree, provided not only that a new and useful property results from their combination, but also that the particular strains are identifiable and adequately identified. I do not find that Bond's combination of strains satisfies these requirements. The strains by which Bond secured compatibility are not identified and are identifiable only by their compatibility. . . . [The patentee] appears to claim that since he was the originator of the idea that there might be mutually compatible strains and had practically demonstrated that some such strains exist, everyone else is forbidden to use a combination of strains whether they are or are not identical with the combinations that Bond selected and packaged together. It was this claim that, as I understand it, the District Court found not to be patentable, but which, if valid, had been infringed. . . . The consequences of such a conclusion call for its rejection. Its acceptance would require, for instance in the field of alloys, that if one discovered a particular mixture of metals, which when alloyed had some particular desirable properties, he could patent not merely this particular mixture but the idea of alloying metals for this purpose, and thus exclude everyone else from contriving some other combination of metals which, when alloyed, had the same desirable properties. In patenting an alloy, I assume that both the qualities of the product and its specific composition would need to be specified. The strains that Bond put together in the product which he patented can be specified only by the properties of the mixture.
Id. at 133-34 (emphasis added).
This is the "phenomenon of nature" that the Funk Bros. Court held unpatentable: a broad claim to any combination of these bacteria that had the desired properties. As such, it is completely consistent with cases like O'Reilly v. Morse, where the Court precluded from patentability any application of electromagnetism for transmitting signals. The Court properly proscribed from patentability such overbroad claims to what an inventor had not invented; these cases do not stand for a broad "product of nature" prohibition unless willfully misinterpreted.
The brief is replete with reasons why "mere" purification should not be sufficient to render a composition of matter patent-eligible, but they all are grounded in the idea that man has not created a "product of nature" and hence is not an inventor. As Judge Rich pointed out in In re Bergy, this analysis misses the point: by isolating something new and useful from nature, man provides the benefits required by the Constitution for the exercise of the Congressional power to grant a patent: to "promote the Progress of Science and the Useful Arts." The question is not whether anyone thinks that there is sufficient "invention" in a particular composition of matter or manufacture. To be patent-eligible, the Constitutional requirements are what is required and all that is required (outside the bounds the Supreme Court has set for natural law, abstract ideas, and phenomena of nature). A "natural product" may reflect natural law or phenomena of nature (but that is not surprising since all we have is nature) but that is not the same as claiming the phenomenon or natural law.
The brief makes no attempt to ignore or deny that this is a change in policy, noting that both the PTO and the NIH have granted or sought patents on isolated DNA. However, it has likely not escaped the administration's attention that making this change by PTO fiat would implicate the Takings Clause of the Constitution in ways that getting a court mandate would not (see "'Takings' by Congress and the Courts").
"The fundamental question under section 101 is whether the inventor has created something through the application of human ingenuity or merely exposed something previously unappreciated in nature," according to the government's brief, citing J.E.M. Ag Supply, 534 U.S. at 134, and Chakrabarty, 447 U.S. at 313. Drawing on its inapt analogies recited throughout the brief, the government argues that isolated human DNA is not patent-eligible just as "mined coal, separated cotton fibers, pure metallic lithium, ductile uranium, and other products of nature whose industrial value to mankind likewise arises when they are extracted from their naturally occurring environments." In the real world, the policies the brief advocates are inconsistent, irrational, and irrelevant to the question of whether "genes" should be patentable. The overwhelming majority of "gene patents" granted over the past 30 years have been directed to cDNA, a synthetic form of DNA produced enzymatically from cellular mRNA. This type of DNA is patentable, according to the government, thus providing no comfort to plaintiffs and no substantial effect on the biopharmaceutical applications of biotechnology. However, there is real danger that the bases for the government's arguments with regard to "merely isolated" human genomic DNA apply to all "natural products"; the same rationale that the government improperly applies to come to its conclusion that merely "isolated" DNA is not patent-eligible can be (and will be) applied to any other naturally-occurring substance, including antibodies, antibiotics, antisense and small interfering RNAs (siRNAs), hormones, metabolites, and proteins, precluding them from patentability, as set forth in an amicus brief from the Intellectual Property Owners Association:
These include any naturally-occurring chemical compound, including compounds isolated from petroleum and other sources of organic matter, the products of fermentation by microorganisms, and chemical compounds produced by microorganisms, plants or non-human animals that can be adapted for human use. Taken to its logical conclusion, the district court's "natural products" ban on patent eligibility would extend even to inorganic matter, such as ultrapure silicon used to produce computer microchips, isolated metal products prepared from ore and other natural sources, minerals and glasses produced from silicon and other natural sources, and any other compound produced from any naturally-occurring source.
It is difficult to see the benefits to the public in a patent-eligibility standard that would exclude Blood Clotting Factors VIII and IX, insulin, human growth hormone, erythropoietin, tissue plasminogen activator, and all monoclonal antibodies.
One difference between the science-challenged Justice Department and the PTO is that patent officials understand how dependent human beings are to "products of nature" in producing new answers to basic medical challenges. Declaring unpatentable such a vast swath of compounds with real-world applications, for what can only be misguided political reasons, is neither sound policy nor good politics. It may be that many of the same people who contribute to the ACLU also support (and contribute) to the prevailing (for now) political party, but political pandering is no basis for making patent policy. It is especially paradoxical for an administration that has promoted innovation as the means for overcoming the Bush-era recession, and is potentially disastrous for the future of fields like medicinal chemistry and biologic drugs.
The brief is almost Jesuitical in prescribing which angels are competent to dance on the head of its rhetorical pin. It is easy for the uninformed to buy into the fiction that "genes" are merely rows of letters on a page -- the trap laid by an equally scientifically challenged ACLU and fallen for by the District Court; this aspect of the case is argued in Myriad's opening brief. Isolated DNA is a chemical compound, and the fact that it can be represented in sequence listings does not negate its essential nature. And isolating this chemical compound effects a chemical change on the molecule that is profound: rather than being covalently linked to the rest of the 3 billion nucleotides that make up a human genome, it is isolated and thus useful for human manipulation and exploitation. This property, being affected by the hand of man, is the proper touchstone for patent-eligibility as enunciated in Diamond v. Chakrabarty; it shouldn't (but it might) take a Constitutional amendment for such a sound principle to have some repose against courts and ignorant politicians from trying to overturn it, to society's detriment.
The very property the government's brief argues makes isolated genomic DNA patent-ineligible applies with even greater force for all those other valuable and useful "products of nature." Indeed, there is substantially less modification for these compounds, which are merely isolated (separated from other impurities) rather than chemically changed (by breaking covalent bonds that hold the DNA molecule together). Simply put, the government's position will prevent protection (and thus retard commercialization) of any useful compound found in plants, microrganisms, animals, etc. By this rationale, Banting and Best would not have been able to protect insulin; imagine the difference in the lives of millions of Americans (including Justice Sotomayor) if insulin had not been available to manage diabetes.
Myriad and several amici have based a substantial portion of their argument on the procedural question of whether plaintiffs have standing to sue, and if the Federal Circuit decides the appeal on this question the substantive issue of whether isolated human DNA, genomic or otherwise, is patent-eligible will be postponed. The government's brief raises the additional question of whether the Commerce Department (and the Patent Office) will adopt, or be bound by, the poor policies contained in the brief, and whether the PTO will be required to impose the unnecessary preconditions for patent-eligibility that the government brief espouses.
