Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)
By Donald Zuhn —
In a much anticipated decision,
the Supreme Court issued its opinion this morning in Association for Molecular Pathology v. Myriad Genetics, Inc. In an opinion by Justice Thomas, joined by
Chief Justice Roberts, Justices Kennedy, Ginsburg, Breyer, Alito, Sotomayor,
and Kagan, and Justice Scalia concurring in part, the Court held that a naturally
occurring DNA segment is a product of nature and not patent eligible merely
because it has been isolated, but determined that cDNA is patent eligible
because it is not naturally occurring.
Noting that "[i]t is
undisputed that Myriad did not create or alter any of the genetic information
encoded in the BRCA1 and BRCA2 genes," the Court acknowledged that
"[t]o be sure, [Myriad] found an important and useful gene," but
indicated that "separating that gene from its surrounding genetic material
is not an act of invention."
Justice Thomas also stated that Myriad's claims were not "saved by
the fact that isolating DNA from the human genome severs chemical bonds and
thereby creates a non-naturally occurring molecule" because "Myriad's
claims are simply not expressed in terms of chemical composition, nor do they
rely in any way on the chemical changes that result from the isolation of a
particular section of DNA."
The Court, however, also
determined that "cDNA does not present the same obstacles to patentability
as naturally occurring, isolated DNA segments." In particular, Justice Thomas explained that "cDNA
retains the naturally occurring exons of DNA, but it is distinct from the DNA
from which it was derived," and therefore, "cDNA is not a 'product of
nature' and is patent eligible under §101." Justice Thomas did provide one
caveat, however, noting that "insofar as very short series of DNA may have
no intervening introns to remove when creating cDNA," under such circumstance,
"a short strand of cDNA may be indistinguishable from natural DNA."
Importantly, the opinion
concludes by stating that "[i]t is important to note what is not implicated
by this decision." In addition to
noting that the case did not involve an innovative method of manipulating genes
while searching for the BRCA1 and BRCA2 genes or new applications of
knowledge about the BRCA1 and BRCA2 genes, the Court also indicated that it did
not consider the patentability of DNA in which the order of the naturally
occurring nucleotides has been altered.
Instead, the Court indicated that it was "merely hold[ing] that
genes and the information they encode are not patent eligible under §101 simply
because they have been isolated from the surrounding genetic material."
Patent Docs will provide additional analysis of the opinion in a subsequent post.
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