"Myriad Case" is the first decision to specifically address whether DNA
isolated from its natural state is patentable subject matter. The Federal
Circuit found that isolated DNA is patentable subject matter thereby reversing
the decision of the district court. However, with regard to the subject matter
patentability of isolated DNA, all three judges in the panel provided their own
opinions. In this Analysis, Brian R. Dorn, Ph.D. discusses Association for Molecular Pathology v. U.S. Patent & Trademark
Office, 653 F.3d 1329 (Fed. Cir. 2011) [enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law].
Subject Matter Patentability of Isolated DNA
highest profile aspect of this case was the issue of subject matter
patentability for isolated DNA. The panel split two to one whether isolated DNA
in general was patentable subject matter. In the majority decision, written by
Judge Lourie, the court found that isolated DNA is patentable subject matter
due to its distinctive structural characteristic. Judge Lourie focused on the
breaking of bonds from its natural state: "it has been manipulated
chemically so as to produce a molecule that is markedly different from that
which exists in the body." Thus, the court viewed isolated DNA as a
distinct chemical entity. The court also found that the informational content
is irrelevant to the subject matter patentability of the composition, although
the information content does inform obviousness questions. The court made the
distinction between isolated DNA and purified DNA, reasoning that simple
purification may not impart subject matter patentability whereas the
characteristics of isolated DNA do impart subject matter patentability.
Moore concurred in the judgment of the court, but provided her own reasoning.
Judge Moore also made a distinction between short and long strands of DNA. In
regards to short strands of isolated DNA, Judge Moore agreed with Judge Lourie
that the isolated nature of the DNA made it distinct from its natural state.
Further, Judge Moore emphasized the difference in the utility of isolated DNA
from DNA in its natural state. Specifically, she reasoned that isolated DNA
possesses a new utility that natural DNA does not. For instance, the ability of
the isolated DNA to be used in diagnostic testing is important. She explained:
"Diagnostic testing . . . is not a natural utility . . . . The claimed DNA
does not serve the ends of nature originally provided. Instead, the isolated
DNA sequences have markedly different properties which are directly responsible
for their new and significant utility."
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