In 2016, Sequenom commence
proceedings in the Federal Court
of Australia alleging infringement
of their Australian patent 727919 by
Ariosa and its Australian licensees.

In response Ariosa cross-claimed
for invalidity of the patent on several
grounds, including that the claims
were not directed to patent eligible
subject matter.

The patent claimed a method of
detecting fetal DNA in the acellular
fraction of maternal blood, namely
the serum or plasma. The method did
not include any specific steps other
than the generic step of “detecting
the presence of a nucleic acid of
foetal origin in the sample”.

At first instance, the Federal Court
of Australia concluded that the
method of detecting fetal DNA in
the mother’s plasma or serum was
patent-eligible. Further, it was also
found that the results of this method
(i.e. the information about the fetus)
constituted a product, which had
economic value, such that importation
of the information into Australia was
considered an infringement.

The Appeal
Ariosa appealed, raising several
grounds, the most notable of which
were that the methods claimed did
not constitute patent-eligible subject
matter and that importation of the
results did not infringe the patent.

Detecting Information
is Patent-eligible
Consistent with the submission made
by the Appellants at first instance, it
was asserted in the appeal that the
claimed methods were simply directed
to detection of the information stored
in the fetal nucleic acid, and there was
no “artificially created state of affairs”
generated by the claims.

The Full Court agreed that
the application of the claimed
methods ‘yielded up’ information
– but disagreed that characterising
the outcome of the claims as
‘information’ meant that they were
not patent-eligible.

To reach this conclusion, the Full
Court relied on the premise that
the detection of the information
could only come about by a process
which required human interaction.

As a result, and despite no specific
method steps being claimed,
the Full Court held that performing
the method of the claim inherently
required human intervention.

Accordingly, the Full Court affirmed
the earlier decision of the primary
judge and confirmed that the method
was patent-eligible.

What constitutes
a product is not
defined in the Act
and is therefore open
to interpretation
by the Courts.

Information is Not a Product
For a period between 2014 and 2016
Ariosa and its Australian licensees
offered a prenatal diagnostic test
marketed under the name Harmony.

The Harmony test utilised fetal DNA
in maternal plasma to distinguish
characteristics of the fetus, such as
gender and trisomy 21. However, the
Harmony test was not performed
in Australia. Rather, blood samples
were collected in Australia and sent
to the US where they were analysed.

The results of the method performed
in the US, such as the sex of the
fetus, were then conveyed to the
parents in Australia. Importantly, an
analogous claim in the US was found
not to be patent-eligible 2 .

As Sequenom could not assert that
the method was being infringed in
Australia, they needed to establish
that conveying the results of the
method was considered importation
of a product of the method. This
is because the Patents Act gives a
patentee exclusive rights to ‘exploit’ a
patented invention in Australia, with
the term ‘exploit’ defined as including:
(a) where the invention is a product—
make, hire, sell or otherwise
dispose of the product, offer
to make, sell, hire or otherwise
dispose of it, use or import it, or
keep it for the purpose of doing
any of those things; or
(b) where the invention is a method
or process—use the method or
process or do any act mentioned
in paragraph (a) in respect of a
product resulting from such use.

As the claims of the patent were
method claims, section (a) of the
definition of exploit could not be met.

Further, the Harmony test was not
performed in Australia meaning the
first part of section (b) was not met.

To establish infringement, Sequenom
needed to show that a ‘product’
resulting from the method was being
sold or otherwise disposed of in
Australia. What constitutes a product is not
defined in the Act and is therefore
open to interpretation by the Courts.

At first instance, the Federal Court
concluded that the term ‘product’
covered anything resulting from
a patented method that can be
commercially exploited. Based on
such a construction the Harmony
test results were a commercially
exploitable product.

However, the Full Court did not agree,
deciding that the result of the claimed
method was information. As has
been long established, information
itself is not able to be the subject of
a patent. Therefore, if the position
adopted by the primary judge was
accepted, anything that resulted
from a patentable method would be
considered a product and this would
create de facto protection for subject
matter which was otherwise patent-
ineligible.The Full Court concluded
that the term ‘exploit’ does not
extend to information and, as a
result, Ariosa and its licensees did
not infringe the claimed method by
importing test results into Australia.

Conclusion Ultimately, the decision of the Full
Federal Court reaffirms the status
quo in Australia regarding claims to
methods of diagnosis. This aligns
us with the position of the UK,
and Europe more generally, but
distinguishes us from the US.

9 Dr Leigh Guerin | Senior Associate
BMedPharmBiotech(1st Class Hons) PhD MIPLaw
2 Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371
Inspire September 2021
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leigh.guerin@pof.com.au