Last week, in Ariosa Diagnostics Inc v. Sequenom Inc, a
district court issued a declaratory judgement, finding that claims
directed to a diagnostic method involving detection of cell-free
fetal DNA (cffDNA) were invalid as unpatentable subject matter
under 35 U.S.C. § 101. The case is only a district court
decision which typically has no binding precedential effect. It is
also likely to be appealed. The district court's opinion was
based on the Supreme Court's recent decision in Association
for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct.
2107 (2013) discussed
here.
The patent in question related to the detection of paternally
inherited cffDNA in maternal plasma or serum.
In this case the parties had agreed "that neither cffDNA nor
the discovery of cffDNA in maternal plasma or serum is patentable,
because the presence of cffDNA in maternal plasma or serum is a
natural phenomenon".
The Court found that conventional techniques of DNA detection,
known at the time of the invention, were applied to paternally
inherited cffDNA as opposed to other types of DNA. Thus, the Court
concluded that the only inventive concept contained in the patent
was the discovery of cffDNA, which is not patentable. The
Court's decision does not appear to adequately take into
account that it often requires inventiveness to use DNA detection
tools.
The Court also concluded that the claims in question also wholly
preempted all known methods of detecting cffDNA at that time and
that the claims at issue posed a substantial risk of preempting the
natural phenomenon, which the court said supported its conclusion
that the claims were not drawn to patent eligible subject
matter.
If this decision is followed or upheld on appeal, it will add to
the already existing hurdle to be surmounted for obtaining broad
patent protection for diagnostic claims that rely on novel
correlations. More insight on the patent eligibility of diagnostic
claims is likely to be garnered in the not too distant future in
light of the various lawsuits between Myriad and its competitors
which are presently before the courts.
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.
