Guest Post on Dan Burk's "Curious Incident of the Supreme Court in Myriad Genetics"

This is a guest post by Vikram Iyengar, a J.D. student at Stanford Law School. He thanks Prof. Mark Lemley for introducing him to Patent Law, and Prof. Hank Greely for his guidance with this research topic.

In The Curious Incident of the Supreme Court in Myriad Genetics, Professor Burk argues that because the Supreme Court did not elaborate on the distinction between the Laws of Nature doctrine used in Mayo v. Prometheus and the Products of Nature doctrine in Myriad Genetics, future patentees are left unclear about whether a large molecule they have invented or discovered is patentable.

In Myriad Genetics, the Court held that genomic DNA (gDNA) is unpatentable because, although it has a different chemical structure from the molecule found in nature, it possesses the same coding information and is therefore a product of nature. However, the Court also held that complementary DNA (cDNA) was subject matter eligible for a patent because, although cDNA molecules “code for exactly the same gene product as the gDNA,” there is a structural difference between the native molecule and the cDNA.

It may be possible to explain the Court's distinction between gDNA and cDNA based on the requisite human intervention involved and the self-replicating nature of the molecules. However, Professor Burk's thesis that this unclear holding from the Court puts the patentability of future large molecules somewhat at risk is sound, as illustrated by one of the first cases to apply the Supreme Court's ruling.

Explaining Myriad Based on Human Intervention and Self-Replicating Technology

The Supreme Court’s insistence on cDNA’s patent eligibility appears to have been based on the fact that human intervention is necessary to synthesize cDNA while gDNA (although slightly different in structure) can be synthesized in nature. This distinction goes to the crux of the Supreme Court’s holding in Diamond v. Chakrabarty that patent eligibility hangs on whether an invention is man-made or naturally occurring.

In Chakrabarty, genetic engineer Ananda Mohan Chakrabarty developed a bacterium (derived from the Pseudomonas genus and now known as Pseudomonas putida) capable of breaking down crude oil, which he proposed to use in treating oil spills. His patent application for the bacterium was rejected because under patent law, living things were not patentable subject matter under 35 U.S.C. § 101. However, in a 5–4 ruling, the Supreme Court ruled in favor of Chakrabarty, holding that a live, human-made micro-organism is patentable subject matter. Chakrabarty’s micro-organism constituted a “manufacture” or “composition of matter” within the meaning of the statute. The Court’s holding in Myriad Genetics appears to follow from that in Chakrabarty.

Moreover, gDNA is self-replicating, while cDNA is not. This quality of gDNA may have played a role in the justices’ reasoning. Whether self-replicating technology is patentable could have been clarified by the Supreme Court in the 2013 case Bowman v. Monsanto Co., in which the Court unanimously affirmed the Federal Circuit and held that patent exhaustion does not permit a farmer to reproduce patented seeds through planting and harvesting without the patent owner's permission. The case garnered attention in part of its potential impact on genetic and self-replicating technologies, and how the doctrine of patent exhaustion for self-replicating technologies will be viewed by the court. Among the most interested parties included researchers and businesses that focus on DNA molecules, nanotechnologies and other self-replicating technologies, but the court's narrow ruling applies only to the instant case and its facts. The narrow scope of the ruling made the impact of the case very small, and specifically avoided setting a broad legal precedent.

Applying Myriad: Ariosa v. Sequenom

A result of the Myriad Genetics opinion’s lack of clarity between the Laws of Nature and Products of Nature doctrines is evident in the 2013 Ariosa v. Sequenom decision by the Northern District of California, one of the first trial cases applying Myriad. While the claims in Myriad Genetics were directed to compositions of matter and not processes, the claims in Ariosa were directed to processes that only used the presence of matter, cell-free fetal DNA (cffDNA), which the court would likely have held to be a Product of Nature and hence unpatentable subject matter. However, the district court struck down Ariosa’s process claims as unpatentable under Myriad Genetics’s Products of Nature holding, stating that “paternally inherited cffDNA is a natural phenomenon and the claims of the ’540 patent merely add well-understood, routine, conventional activity in the field to that natural phenomenon.”

Moreover, the court did not state the obvious, that Ariosa could have been fit within the contours of the Mayo decision, as Kevin Noonan has explained. Instead the court said,

The Court’s conclusion conforms to the relevant Supreme Court case law, in particular Flook and Myriad. The patent in Flook, like the present patent, claimed methods that utilized an abstract idea or a natural phenomenon—a mathematical algorithm in Flook, paternally inherited cffDNA in the present case.

The mathematical algorithm in Flook, although abstract, was arguably a process like the method claims in Ariosa, while there were no method claims at issue in Myriad Genetics. The Ariosa decision was an early indication that Professor Burk’s prediction about the lack of clarity of future patent eligibility may be coming true.

Looking Forward

In December, the PTO issued interim guidance on subject-matter eligibility in light of Myriad and the Supreme Court's more recent decision in Alice v. CLS Bank. The next day, the Federal Circuit struck down Myriad's remaining asserted patent claims. But patentable-subject matter doctrine, particularly in the biotech industry, remains far from settled. It remains to be seen how the courts will make sense of the relationships between Myriad and the Supreme Court's other recent ventures into § 101.