Originally published in V&E IP Insights E-communication, August 1, 2011
In a split decision issued on July 29, 2011, the U.S. Federal
Circuit reaffirmed that isolated DNA molecules are patent-eligible
subject matter because such isolated molecules do not exist in
nature. Assoc. for Molecular Pathology v. Myriad Genetics,
No. 2010-1406 (Fed. Cir. 2011). The claims at issue relate to the
isolated genes BRCA1 and BRCA2, which are
associated with a predisposition for breast and ovarian cancers.
According to the majority opinion, authored by Judge Lourie,
isolated DNA molecules are distinct from purified DNA because the
chemical manipulation process involved in isolating the genes gives
them markedly different characteristics from native DNA. Rejecting
the plaintiffs' argument that the isolated DNA retains the same
characteristics as native DNA because both types of DNA provide the
same informational content, the majority explained that materials
having a chemical nature are "best described in patents by
their structures rather than their functions." The isolation
of DNA molecules involves the creation of a new chemical entity
rather than just a physical separation because they must be
chemically cleaved from their chemical combination with other
genetic materials, thus fundamentally altering the chemical
structure of the molecule.
Addressing Myriad's method claims relating to: (1) comparing
and analyzing sequences and (2) screening potential cancer
therapeutics, the court distinguished between methods that are
patent-ineligible for being purely "abstract mental
processes" from those that are patent-eligible because they
involve transformative steps. Applying the
machine-or-transformation test, the court held that the claims
directed to "comparing" or "analyzing" DNA
sequences lack any transformative step and consist only of mental
processes. In contrast, the claim directed to screening potential
cancer therapeutics via changes in cell growth rates is
patent-eligible because it requires the transformative steps of
growing cells and determining growth rates in the presence of
therapeutics.
What This Means for You
With respect to composition claims covering isolated DNA
molecules, the Federal Circuit reaffirmed long-standing precedent
that isolated genes are patent-eligible subject matter and
explained that any change to this norm should come from Congress,
not the judiciary. The decision's impact on method claims is
more complicated. While the court explained that "isolating
genes to provide useful diagnostic tools and medicines is surely
what the patent laws are intended to encourage and protect,"
it carefully circumscribed the class of method claims that will
pass muster. Such claims must recite a distinct physical step
— for example growing, extracting, sequencing, or some
other physical transformation. Finally, given the split decision in
this case, further review by the Federal Circuit and/or Supreme
Court is likely.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
