By: David Fazzolare
In the case of Association for Molecular Pathology v. Myriad Genetics, Inc., the Federal Circuit was asked to reconsider the patent eligibility of Myriad’s isolated DNA claims under 35 U.S.C. § 101 in light of the Supreme Court’s recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012).
In Mayo, the Supreme Court addressed the patent eligibility of claims reciting what the Court considered to be natural laws or natural correlations. In ruling that Prometheus’ patented method claims involving correlations between drug metabolite levels and drug toxicity and efficacy were unpatentable, the Supreme Court held that to be patentable such claims must “add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws. ” According to the Supreme Court, method claims reciting natural correlations might “add enough” to transform an unpatentable natural law or correlation to a patentable application of the natural law or correlation if the additional steps recited in the claim involve more than well-understood, routine, conventional activity previously engaged in by researchers in the field. In other words, a claim that recites a novel natural correlation must include additional novel elements or steps in order for the claim to be considered patentable. In finding that Prometheus’ method claims did not “add enough” to qualify as patentable applications of a natural correlation, the Court expressed concerns that “upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.”
Whereas the Supreme Court’s reasoning in Mayo appears to reflect public policy concerns regarding the alleged impact of broad patent claims, the Federal Circuit in Myriad dismissed similar public policy concerns regarding the potential impact of diagnostic method patents on women’s health – noting that patent law is not concerned with saving lives and that such policy-oriented questions are best left for Congress, and not the courts, to decide.
In upholding Myriad’s isolated DNA patent claims, the Federal Circuit dismissed the relevance of the Supreme Court’s decision in Mayo—concluding that Mayo does not control the patent eligibility of composition of matter claims, which are expressly authorized by § 101. Rather, the Federal Circuit opined that the relevant distinction for purposes of § 101 is between products of nature and human-made interventions. The Court reasoned that isolated DNA is a non-naturally occurring composition of matter that is not found in nature, but rather is a product of human ingenuity, man-made in a laboratory. Additionally, the Court held that isolated DNA molecules are “markedly different,” and have distinct chemical structure and identity as compared to native DNA. Because of the covalent bonds that must be cleaved and separated from associated proteins in order to isolate DNA from its natural chromosomal environment, the court considered isolated DNA to be more than mere DNA purified in its natural form.
Although composition of matter claims directed to isolated DNA remain patentable for the time being, the Federal Circuit’s decision in Myriad is unlikely the final word on the issue as the Supreme Court may grant certiorari and offer its two cents on the issue.
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