November 30, 2012

Supreme Court Will Review Gene Patent Challenge: AMP v. Myriad

Today, the Supreme Court granted the petition for certiorari in the gene patent litigation, Association for Molecular Pathology (AMP) v. Myriad Genetics et al. The case focuses on the Myriad Genetics patents on the BRCA1 and BRCA2 (breast cancer) genes. This grant of review follows several years of the patentable subject matter challenge from a coalition of plaintiffs that has made its way through the lower courts, ending this summer with the Federal Circuit upholding the gene patents (again, following the Supreme Court remand to reconsider in view of Mayo v. Prometheus). Three questions were presented in the petition to the court: the patent eligibility of the genes, the eligibility of some method claims, and the last question involving the clarification of standing in the case. The Court will only consider the first question: Are human genes patentable? The Court must consider how to define an an isolated gene (isolated DNA) – as either a product/law of nature (not patentable) or a nonnaturally occurring processed product (patentable). Earlier this year, the Court issued its opinion in Mayo, invalidating a patent claim to a method of optimizing drug dosage which had the effect of preempting a law of nature (a natural correlation). At stake in AMP is how to define the product of nature doctrine in modern biotechnology - whether genes are to be defined by structure (the chemistry argument) or function (the genetic argument). The Federal Circuit took the chemistry route this past summer in its AMP decision, finding enough chemical alteration of an isolated gene to confer patent eligibility. In an amicus brief I filed this summer, I argued that the genetic fidelity (natural DNA sequence) of the isolated genes means that such patenting preempts the genetic code (law of nature), and, in addition, the genetic fidelity further characterizes the molecule as an unpatentable product of nature. From either analytic route, I conclude that genes are not patentable: the genes have a specific patent ineligibility because such patenting preempts a law of nature, and they have a general patent ineligibility because they are products of nature. The first theory (preempting a law of nature) resonates with Mayo; the latter theory (product of nature) resonates with Funk Bros. v. Kalo (1948). Genetic fidelity is not trivial; it is essential to the use of an isolated gene as a testing reagent.

What will the Supreme Court decide? The Supreme Court has exhibited a sensibility which accords significant weight to its role in protecting a public domain in science (the Court has established and refined a set of judicially-created exclusions - laws of nature, natural phenomena, abstract ideas - from patentable subject matter over the years, despite statutory silence). In Mayo, the Court stated that "even though rewarding with patents those who discover new laws of nature and the like might well encourage their discovery, those laws and principles, considered generally, are ‘the basic tools of scientific and technological work’” (quoting Gottschalk v. Benson (1972). The Court did not hesitate to strike a blow against business method patents in Bilski v. Kappos (2010), despite more than a decade of such patenting. With reference to Mayo - and to Justice Breyer's public domain-centered dissent in Labcorp v. Metabolite (2006) - there is a fair chance that the Court could side with the 2010 district court opinion, which found that the "claimed isolated DNA is not markedly different from native DNA as it exists in nature," and, as a result, the gene patent claims were invalid. AMP v. Myriad is not only important for the further clarification of the patent eligibility doctrine, but it has implications for the genetic testing industry (business models that depend on patenting isolated biological molecules) and for women's health (possible future development of a robust marketplace and an unfettered research climate for genetic testing involving the critical BRCA1 and BRCA2 genes). The case has also been a model for assembling a complex coalition of plaintiffs (researchers, genetic counselors, women patients, cancer survivors, breast cancer and women's health groups, and scientific associations) whose diverse interests illustrate the real-world consequences of what may appear to be solely theoretical patent law doctrines.

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