Yesterday, the Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, in which a coalition of patients, physicians and researchers challenged the validity of Myriad’s patents on the BRCA1 and BRCA2 genes (see here and here). The challenge is based on 35 U.S.C. 101 (patentable subject matter), and it asserts that isolated human genes are natural products which cannot be patented because U.S. patent law denies patents for products or laws of nature. That prohibition is grounded in the Court’s own jurisprudence, which distinguishes “between products of nature, whether living or not, and human-made inventions” (Diamond v. Chakrabarty, 1980). I attended the oral argument, having filed an amicus brief, and here is an initial overview. Counsel for the Petitioners, AMP et al., advanced the importance of the product of nature doctrine in disqualifying patents on genes, and responded to questions on multiple issues: how could DNA patenting could be distinguished from other kinds of drug patents, would a biotech company have an incentive to isolate genes if patents are not available, and whether cDNA, which Justice Kennedy labeled an “economy-class gene,” differed enough from a native gene to be patentable. In an ongoing attempt to frame gene patenting in a more familiar context, the Justices utilized several analogies to genes during the session, from an Amazon plant-derived drug, to a baseball bat excised from a tree, to the ingredients in chocolate chip cookies. The U.S. government, represented by the Solicitor General, emphasized that the product of nature doctrine was essential to maintain a boundary between freely available, unpatented scientific phenomena, and inventive efforts that can be patented, and argued that patents on genes violate that doctrine. He reiterated the government’s view that cDNAs, as “artificial DNA” were patent-eligible, while unmodified genomic DNA was not. The appearance from the executive branch highlights the split on the issue of gene patenting between the Justice Department and the Patent and Trademark Office (PTO), which has granted gene patents for several decades.
Counsel for the Respondent, Myriad, confronted questions regarding how an isolated gene differs from a native gene, and a query from Justice Kagan that probed the limits of patent eligibility: “Do you think that the first person who isolated chromosomes could have gotten a patent on that? Counsel conceded that “it would pass through the Section 101 gate.” Justice Breyer responded to that hypothetical: “Everything is inside something else. Plants, rocks, whatever you want. And so everything will involve your vast taking something out of some other thing where it is, if only the environment. And it's at that point that I look for some other test than just that it was found within some other thing.” Breyer indicated, therefore, that mere extraction alone could not provide a meaningful test for eligibility, and it produced an open-ended 35 U.S.C. 101 with no limits: “[W]e are reducing, then, 101 to anything under the sun, and -- and that, it seems to me, we've rejected more often than we've followed it.” Breyer could certainly been referring to Mayo v. Prometheus (2012), in which the Court invalidated a patent on methods of optimizing drug dosage (in an opinion that he authored). Although respondents raised the issue of industry reliance on gene patents, and urged deference to PTO guidelines that implement the policy of granting patents on genes, Justice Ginsburg noted the disapproval of the PTO's view within the executive branch (“even though the Government has disavowed it”) and she concluded that “the strength of the presumption" of deference would be diluted. Several recurring themes emerged. Questions regarding the eligibility of cDNA comprised a good part of the session, with several Justices seeking to answer how a decision that invalidated isolated genes, but upheld cDNAs would be received by the biotech industry. The focus on cDNA indicates that the Court is trying to define the scope of its decision, and it could indicate that the Court is not struggling over the central issue of the patent eligibility of the isolated gene. On another point, the Justices were concerned with whether and how patents for the methods attendant to the discovery of a new natural molecule (e.g., method of isolation, method of tagging, method of use) might provide enough incentives for investment even if a patent on the molecule could not be obtained. It did not appear that the Court was persuaded that enough differences exist between native genes and isolated genes to survive the prohibition on patenting products of nature. It did appear that the Court might be receptive to the respondents’ and the government’s argument that enough structural and functional differences between native genes and cDNA molecules exist to render the latter patentable, and a decision upholding only the cDNA patent claims might appeal to the Court. Importantly, such an outcome would still affirm the product of nature doctrine. However, if the Court can further clarify the legal analysis for that doctrine, it would be useful for biotechnology in general, as this case presents a rare opportunity for the Court to do so.