[author: Andrew Williams]
On April 30th, the Federal Circuit issued an Order in the Association for Molecular Pathology v. U.S. Patent and Trademark Office case vacating its July 29, 2011 opinion and reinstating the appeal. That Order was based on the Supreme Court's decision vacating the Federal Circuit's prior judgment and remanding the case for further proceedings. In addition, the Federal Circuit requested that both parties file supplemental briefs to address the following issue: "What is the applicability of the Supreme Court's decision in Mayo to Myriad's isolated DNA claims and the method claim 20 of the '282 patent?" The Order also scheduled oral argument for this Friday, July 20, 2012, at 10:00 a.m. As a preview of that hearing, we are providing a summary of the supplemental briefs from both parties. This post will address the supplemental brief for Appellees Association for Molecular Pathology, et al. ("AMP").
AMP alleges that Mayo "gave new vigor to three principles for determining whether a law/product of nature has been 'transformed' into something patentable." The first of these principles is whether the claims "preempt what is unpatentable," for example laws and products of nature. The second principle is that what is patented must either be based on an "inventive concept," "add enough" to the natural phenomena, or have "markedly different characteristics from any found in nature." The third principle is that the court must make this determination without regard to industry reliance. Of course, the significant difference between now and nearly a year ago when the original opinion was released is the Supreme Court's Mayo decision. Therefore, it is important keep in mind what Mayo said, and more importantly, what Mayo did not say (regardless of what either party would like to read into the decision).
AMP's first argument is that the claims to isolated DNA preempt the use of laws/products of nature. It begins by quoting Mayo (and other Supreme Court cases) for the proposition that patenting laws of nature, natural phenomena, or abstract ideas is prohibited because "they are the basic tools of scientific and technological work." Mayo, 132 S. Ct. at 1293. However, AMP does not cite to any Supreme Court precedent for the proposition that "products of nature" are not patentable, and indeed because it is a case about a claimed method, Mayo is basically silent on the issue. Nevertheless, there is sufficient support for the idea that machines, manufactures, and compositions of matter can also run afoul of § 101, for example such as when they are "manifestations . . . of nature," as indicated in Chakrabarty. Apparently to cover its bases, however, AMP points out that isolated DNA is both a law and product of nature -- the law is the correlation between the DNA and the BRCA protein, and the product is the DNA itself. In other words, isolated DNA is the physical embodiment of the law of nature. As support for this proposition, AMP alleges that isolated DNA can be reintroduced into a cell, and it will be able to "code for" and "transmit" the same protein with the same traits. However, this is an oversimplification of the biology involved. Clearly one cannot reinsert a naked piece of DNA, without more, into the cell and have any hope of obtaining an expressed protein. In fact, figuring out what else would be required to get an expressed protein from an isolated DNA is not necessarily a trivial matter, and would be highly dependent on what cell you were reintroducing the DNA into.
Nevertheless, AMP highlights several "aspects" of the claims-at-issue that it alleges make "unduly preemptive of laws/products of nature" (emphasis added). AMP's "unduly preemptive" aspects are (1) that because humans did not invent DNA, it is not possible to invent around the claims; (2) the disputed claims are broader than those in Mayo; (3) the claims "threaten to inhibit the development of more refined treatment recommendations"; (4) the claims pose a barrier to the development of targeted cancer therapies, and (5) the contested claims have already inhibited research. In so noting these, however, AMP is implying that it is possible for something to be "less preemptive," and thereby make it patent eligible. However, in doing so, AMP turns the Supreme Court's inquiry on its head. In Mayo, the Court articulated (again) that laws of nature, natural phenomena, or abstract ideas are not patent eligible. The Court went on to explain that one of the reasons for this was the "concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature." However, the Mayo opinion made clear that Supreme Court precedent has "not distinguished among different laws of nature according to whether or not the principles they embody are sufficiently narrow." Instead, as Mayo articulated, there is a bright-line prohibition against patenting laws of nature -- and so the inquiry must be whether isolated DNA claims are (or improperly incorporate) laws of nature.
AMP's second argument is that isolated DNA claims are not based on an inventive concept and therefore do not add enough to the law and/or product of nature to make them patent eligible. AMP's argument is based on the Supreme Court Mayo decision, which pointed out that the claims at issue in that case were nothing more than informing the relevant audience about the law of nature (specifically the correlation of the levels of metabolites). The fact that the claims also had "administering" and "determining" steps was irrelevant, because they were conventional steps, and therefore could not be considered to contribute to an "inventive concept." In an attempt to analogize, AMP alleges that the techniques for the isolation of DNA are similarly well-known, and therefore would add nothing to the law and/or product of nature. First, this argument presumes that the DNA itself is the law (or product) of nature, and the only difference between it and the isolated DNA is the process of isolating it. However, Mayo dealt with a process claim, in which the recited claim steps themselves were found to be conventional -- because people had already been "administering" thiopurine drugs, and methods to "determine" the levels of 6-thioguanine were already known. Therefore, all you were left with in the claim was the correlation -- or the law of nature. In the present case, the claims are to the composition of matter of isolated DNA, regardless of how it was obtained. The Federal Circuit previously found that isolated DNA consisted of a different chemical composition than the full-length DNA. Mayo should not change the conclusion that isolated DNA did not exist in nature, regardless of whether isolating DNA is simply the application of conventional steps.
AMP also cites to Mayo as allegedly changing the "transformation" test, almost to the point of doing away with it in the case of chemical changes. In Mayo, the Supreme Court rejected Prometheus' argument that both the body and the blood were transformed, which could have made the claims patent eligible. First, the body was not transformed because the "administering" step merely selected the individuals for whom the law of nature was to be applied. Second, the "determining" step was not transformative because the method could theoretically be done without transforming the blood. In this case, isolated DNA was found to be transformative because there were at least covalent bonds broken. AMP alleges that this is not enough, because such steps are routine. However, just because the step itself might be routine doesn't mean that the selection of that step, or the decision of which starting chemical entity to use is also routine. In fact, for chemical entities, such a line of reasoning is a slippery slope. A lot of new small-molecule chemical entities can be obtained by routine steps, but this does not (and should not) preclude their patent eligibility. To say that a composition of matter cannot be patent eligible simply because the methods used to obtain it were "routine" would have serious implications on the pharmaceutical and biotechnology industry.
AMP further cites to the fact that the use of small fragments of DNA in diagnostics is well known and conventional. However, this is relevant to determining whether isolated DNA has utility, not whether it is a law/product of nature. Therefore, such an argument is not well suited to the present case.
AMP's final argument against the patent eligibility of isolated DNA claims was that Mayo rejected the idea that you could rely on industry reliance as a factor in applying the law/product of nature doctrine. In making this argument, however, AMP cited to its previous briefs, and those of their amici, that allegedly identified the harms of gene patents. If Mayo teaches that you cannot consider the reliance on the industry in upholding the patents, it also has to stand that you cannot look to alleged harms that result from such patents. Instead, the analysis should be whether the claims attempt to patent a law of nature, a natural phenomenon, or an abstract idea.
As almost an afterthought, AMP briefly addresses method claim 20 of the '282 patent, but only to allege that it is indistinguishable from the method claims in Mayo. However, other than pointing out that the claims are both method claims, AMP does not spend much time explaining why they were otherwise the same. Instead, AMP analogizes the "growing" and "determining" steps of claim 20 to the "administering" and "determining" steps in Mayo, and concludes that the steps in claim 20 could not be transformative. However, with all of the detail found in claim 20, it is difficult to see how it is simply a law of nature, and without more explanation, the Federal Circuit's decision regarding this claim should be the same.
For additional information regarding this topic, please see:
• "Biopharmaceutical Companies Weigh-In on Myriad Case," July 17, 2012
• "Health Care Professionals Contend That Isolated DNA and cDNA Are Patent Ineligible," July 16, 2012
• "Coalition of Amici File Brief in Support of Myriad," July 15, 2012
• "Dr. James Watson: Human Genes Should Not Be Patented," July 12, 2012
• "Scientist-Law Professor Files Amicus Brief in Myriad Case," July 11, 2012
• "U.S. Government: Mayo Decision Supports Prior Argument That Isolated Genomic DNA Is Not Patent Eligible," July 10, 2012
• "IPO Amicus Brief Argues for Patent Eligibility of Myriad's Isolated DNA Claims and Method Claim 20," July 9, 2012
• "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad," June 27, 2012
• "Parties and Amici File Briefs in Myriad Case," June 17, 2012