The United States Supreme Court has
denied Sequenom's petition to review the Federal Circuit's
decision in Ariosa Diagnostics Inc v. Sequenom
Inc1. This is discouraging news for stakeholders in
diagnostics and personalized medicine who had hoped that the
Supreme Court would step back from, or at least clarify, the
current restrictions on obtaining patent protection for diagnostic
In Sequenom, the Federal
Circuit affirmed a district court's finding (discussed here) that claims directed to a diagnostic
method involving detection of paternally inherited cell-free fetal
DNA (cffDNA) in maternal plasma or serum were invalid as
unpatentable subject matter under 35 U.S.C. §
The inventors of the patent in
question had discovered cffDNA in maternal plasma and serum, the
portion of maternal blood samples that had previously been
discarded as medical waste. While the Federal Circuit agreed that
the patent at issue was a "breakthrough" and that it
"combined and utilized man-made tools of biotechnology in a
new way that revolutionized prenatal care", the court noted
that existence of cffDNA in maternal blood is a naturally occurring
phenomenon and methods like PCR for detecting and amplifying cffDNA
were well understood, routine and conventional at the relevant
date. Accordingly, the patent was ineligible in view of the Supreme
Court's ruling in Mayo Collaborative Services v. Prometheus
Labs3 which held that patent claims that do no more
than incorporate a natural law or phenomenon and recite techniques
that are well-known, conventional or routine are invalid.
The sole question presented to the
Supreme Court was as follows:
Whether a novel method is patent-eligible where (1) a researcher is
first to discover a natural phenomenon; (2) that unique knowledge
motivates him to apply a new combination of known techniques to
that discovery; and (3) he thereby achieves a previously impossible
result without preempting other uses of the discovery?
In refusing to take the case, the
Supreme Court has declined to reconsider their prior ruling in
Mayo, which many consider to represent a significant
departure from previous US patent practice. Accordingly,
uncertainty surrounding the validity of diagnostic patents remains.
The USPTO recently released a new guidance document on the patent
eligibility of diagnostic methods4. It is possible that
the USPTO may revisit this guidance in view of the Supreme
Court's refusal to hear Sequenom. In the
meantime, it appears that while diagnostic claims that are strictly
based on correlations will be problematic, claims that include
novel reagents, analytes and/or techniques should be patentable. In
addition, interested parties are continuing to put pressure on the
Government to introduce amendments to 35 U.S.C. § 101 to
clarify the law of subject matter eligibility with respect to
1. 788 F.3d 1371 (Fed. Cir. 2015); Sequenom, Inc v.
Ariosa Diagnostics, Inc et al, in the Supreme Court of the
United States, No. 15-1182.
2. Prior to Sequenom's petition to the Supreme Court,
the Federal Circuit also denied their petition for en banc
rehearing of the Federal Circuit decision before all of the circuit
judges (No. 14-1139 (Fed. Cir. 2015).
A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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