Myriad.

In 2013, The Supreme Court unanimously ruled that Myriad could patent cDNA – a sequence of nucleotides generated from naturally occurring mRNA (cDNA contains only the coding exons found in the gene in situ, and not the noncoding introns) – but could not claim a patent on the isolated genetic sequence itself.31 The Court proposed that “Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13” and then proceeded to address the question of whether “this renders the genes patentable” (Myriad, p. 2116). The Court produced three arguments to answer in the negative. First, relying on Funk Brothers Seed Co. v. Kalo Inoculant Co. (1948), the Court reasoned that Myriad’s claim fell within the “law of nature” exception to patentability. On this argument, Myriad had found the BRCA gene mutations, but had not invented anything. Funk concerned a patent on a novel mixture of bacterial supplements designed to facilitate nitrogen fixing by legumes. Different legumes used different bacteria, and they had previously been sold separately, as it had been assumed that they mutually inhibited one another. Bond had discovered a set that did not do so, and so was able to produce a single product that could be used on multiple legumes. The Court begins by underlining that “the qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are ... manifestations of laws of nature, free to all men and reserved exclusively to none.” The successful aggregation of these bacteria present “no more than the discovery of some of the handiwork of nature” and as such not patentable since “each species has the same effect it always had.” As a result, the product amounted to “hardly more than an advance in the packaging” of the bacteria. (Funk Bros., p. 131) Second, the Court made similarly quick dispatch of the argument that the act of removing the nucleotides chemically altered them and therefore rendered them new. Pointing out that Myriad was interested in the information contained in the nucleotide, the Court pointed out that Myriad’s reasoning would allow a competitor to avoid infringing on Myriad’s patents by isolating the BRCA sequence plus one more nucleotide. Since the patent was awarded to a specific chemical composition, the competitor would escape infringement by virtue of having made something different. This argument points to the same problem of arbitrariness noted earlier: Treating all isolations as patentable makes everything patentable. Concluding that Myriad would resist this outcome on the grounds that it was the information contained in the nucleotide that the company was interested in, the Court concluded that the information in the isolated sequence was the same as that found in nature, and so was also subject-matter ineligible. Finally, the Court argued that there was no sufficient reason in this case to defer to the erroneous PTO practice of awarding patents to isolated genetic sequences, even if the practice had been a longstanding one. This was the entire opinion, with the addition of a few caveats that it was not to be taken to deny patents on other aspects of the genetic testing process or the techniques for developing tests, and that the Court was not expressing an opinion on whether cDNA satisfied other standards for patent eligibility beyond §101. Still, the opinion harbors a significant and obvious difficulty in that the Court used competing logics in resolving the eligibility of isolated DNA and of cDNA. If the difference between the cDNA and the isolated DNA is that the former contains only coding exons, and the latter also contains noncoding “junk” introns, then it would seem that the information contained in both is identical.32 Indeed, the Court’s argument here seems rather difficult: “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a ‘product of nature’ and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA” (Myriad, p. 2119). In other words, the Court invokes the material differences between DNA and cDNA to grant patent eligibility to the latter, but uses the informatic identity between DNA in situ and isolated DNA to deny patent eligibility to isolated DNA. The case thus leaves a significant question hanging: When is the criterion for novelty physical, and when is it informatic? Dan Burk put this point particularly strongly, suggesting that the opinion was “at best incoherent,” because: One is ... forced to conclude that molecules that differ structurally from a native molecule are both excluded from and included within patentable matter, while molecules with the same coding information as a native molecule are also both excluded from and included within patentable subject matter. (2014, pp. 507–508) There is also a wide potential impact to the decision, as “pharmaceutical and other chemical developers routinely extract useful organic molecules from a variety of native sources,” and these molecules contain no coding sequences. This means that “depending on whether one believes that structure or information is the determining criterion in Myriad, it is difficult, and perhaps impossible, to fathom how Justice Thomas’s reasoning is to be applied to the patent eligibility of such novel chemicals” (2014, p. 509). One problem with the Myriad decision is the lack of “a coherent theory as to why the differences in certain molecular characteristics should be overlooked in favor of the similarities in other characteristics” (2014, p. 516). It seems to me that the Court is struggling to apply juridical understandings of power to the case of gene patenting, but in the service of a public biopolitical concern about excessive enclosure. This happens in at least two ways. First, struggling with the need to look at both the informatic and material aspects of DNA, the Court was attempting, if somewhat incoherently, to articulate a doctrine according to which the chemical composition had to change “enough” to override the informatic similarity. Even if it is not clear where the line is, it would arguably distinguish the case of extracted DNA sequences, which were modified only as much as necessary to extract them from an organism, as opposed to cDNA, which is missing all of the supposedly irrelevant introns. Such a result would align patent jurisprudence not just with precedent about mixing things, but with aspects of copyright, where some de minimis level of originality – and not just hard work – was declared by the Court to be requisite for copyright eligibility in Feist (1991), and which has figured prominently in more current litigation surrounding hip-hop sampling. Second, the Court is assuming a sharp nature/art distinction of the sort that no longer makes sense in modern biology, given the importance of the material/ informatic duality. As Bruno Latour and Donna Haraway both suggested some time ago, modern science is characterized by hybrid or cyborg entities that blur this distinction.33 The move into a post-Fordist economy complicates the distinction yet further when applied to patents. At noted earlier, statutory law defines patentable subject matter as “new and useful processes, machines, compositions or matter, or articles of manufacture” (35 U.S.C. §101). The schema works better in an industrial setting than a post-industrial one because all of these patentable things tended to occur in certain objects that could be claimed as patentable. As Burk notes, “products, at least to the extent that they constitute objects, are inherent in the concept of process ... Making and using entail some type of object: some thing is made, and some thing is used. In classic industrial setting, the substrates of the process were fairly apparent, and extant in what is now §101; machines and materials visibly interacted as inputs generating outputs” (2014, p. 527). With the rise of immaterial goods and a post-Fordist economy, however, it is increasingly difficult to point to discrete things either at the level of product or process, and the ability to characterize immaterial goods informatically suggests that they could be understood as either thing or process. The computer software cases exemplify the problem, since “software defines a set of physical relationships that may model other relationships” and “software routinely collapses the usually comfortable distance between symbolic expression and physical instantiation, concomitantly collapsing the distance between laws of nature and their material substrates” (Burk, 2014, p. 529). These cases, however, are inconsistent and repeat many of the same problems; the work-around is usually in the claims-drafting process, where applicants emphasize the physical machines that are to run their software. Of course, such a strategy usually makes little sense from a computer science or coding standpoint. On Burk’s view, however, the conceptual confusion goes even deeper. Even if we could successfully distinguish processes and products, or laws of nature from their application, the more basic “laws of nature” exclusion itself is problematic because it fails to understand the interpretive work of science. Court decisions routinely cite Newton’s laws, for example. However, those laws meet the criteria established in Mayo insofar as “a Newton or an Einstein constructs a model that entails the qualities or characteristics of the universe, but is not a quality or characteristic of the universe” (2014, p. 519) Evidence for this point is that Newton’s laws have of course turned out limited in scope to certain macro-level measurements. He concludes that what is really going on in those cases, taken as part of the “laws of nature” doctrine, is a judicial attempt to set the limits of what patents can cover: One might conclude that the jurisprudence of “laws of nature” is intended to push patentees toward narrower, more specific claims on tangible instantiations. This policy of maintaining fundamental access to critical constructs is probably correct, and is perhaps the most sensible reading of the process subject matter cases ... Excluding conceptual inventions from patent eligibility pushes exclusivity further downstream to the stage of finished products, requiring narrower claims on concrete implementations, rather than allowing conceptual patents early in the development of a technology. This rationale makes far more sense than to claim that certain ideas are off-limits to the patent system because they are not the product of human invention. (2014, p. 535) Generally, “the degree of abstraction serves as a rough metric of the sort of claim breadth likely to preempt future uses” (2014, p. 540). The preemption doctrine suggested here is well known from real property law (if your property blocks the only access to a public beach, expect to be required to allow a pass-through of some sort), and has been suggested before in the context of gene patenting (Kane, 2004, 2011). Burk’s construal of the opinion pushes it in the direction of the underlying public biopolitics, and away from the Court’s effort at bright juridical lines. In moving away from the metaphysical question as to whether something “is” natural, it also tends to reopen questions about the monopoly power of patent owners. Forcing narrower claims would serve to increase the potential number of products in a given market. Something like a preemption doctrine would serve to limit the ability of patent owners to create entry barriers to new competitors, and might be viewed as akin to restraints on the ability of patent owners to restrict access to nonpatented products by way of tying arrangements.