IP review
autumn
2015
The end for biodiagnostic
patenting in the US?
Historically, the US Patent & Trademark
Office (USPTO) has been known for its
liberal approach to the kinds of invention
that can be patented, holding the view
that patentable inventions include
“everything made by man under the sun”.
However, following recent US
Supreme Court rulings (in the cases
of Prometheus v Mayo, Association
for Molecular Pathology v Myriad,
and Ariosa Diagnostics v Sequenom)
the situation in the US has changed
radically with regard to what can and
can’t be patented. As a result, the US is
now out of step with Europe and other
countries around the world in which
biodiagnostic methods can benefit
from patent protection.
In the wake of the Supreme Court
rulings the USPTO has issued interim
guidance aimed at helping examiners
and applicants to determine whether
an invention is likely to be excluded
from patentability.
The December 2014 version includes
the test illustrated overleaf, and an
update issued in July 2015 provided
further explanation and examples.
Biodiagnostics have been particularly
hard hit by the USPTO’s new approach.
Indeed, any inventions utilising
biomarkers or metabolites seem to be
at high risk of rejection due to being
deemed natural laws, natural products
or even abstract ideas.
Working through the test, “directed
to [a judicially recognised exception]”
as recited in step 2a means that the
invention, as claimed in a patent
application, “sets forth or describes
the exception (to patentability)”,
which is often the case for inventions
utilising biomarkers or metabolites.
If the claim refers to a natural
product (e.g. a DNA sequence) step
2a includes determining whether
the claimed product has “markedly
different characteristics” from its
naturally occurring counterpart.
According to the USPTO guidance, if
the natural product is structurally or
functionally different from its naturally
occurring counterpart it may satisfy
the “markedly different” test. As an
example, the USPTO has indicated that
an exons-only cDNA (synthetic DNA)
sequence would be markedly different
from a naturally occurring gene.
Conversely, isolation of a DNA
sequence that corresponds to a
naturally occurring gene will not satisfy
the “markedly different” test.
12
Wrong diagnosis:
