Recently, we reported on an Australian Patent Office
Arrowhead Research Corporation  APO 70 (13 October 2016)
(Arrowhead decision), which confirmed that gene-based
pharmaceuticals, namely interfering RNA (iRNA) compositions, do
represent patentable subject matter in Australia. This decision
sets a significant legal precedent in relation to the patentability
of iRNA compositions, which were previously considered to be patent
ineligible. It also, however, provides important guidance in
relation to the patentability of other gene-based inventions. This
article considers the broad implications of the Arrowhead decision
for the patentability of gene-based inventions generally in
In 2015, the High Court of Australia1 ruled against
the patentability of isolated human genes claimed in a patent owned
by Myriad Genetics Inc., and useful for determining susceptibility
to breast and ovarian cancers. The High Court held that the
relevant Myriad claims to isolated naturally-occurring DNA
sequences were directed to "genetic information embodied in
the arrangement of nucleotides" and that "this
information is not made by human action". As a result, it was
considered that the isolated DNA sequences were not patent
Genetic information and the substance of a claim
The focus of the Australian High Court on "genetic
information" rather than a "product of nature"
resulted in a finding that artificially-created gene sequences such
as cDNA, which arguably embody the same genetic information as a
gene sequence that occurs in nature, (i.e. ability to encode a
protein) is not patent eligible. The "genetic information
issue" also means that currently isolated naturally-occurring
material other than genes, for example proteins and microorganisms,
are patent eligible subject matter in Australia because they do not
embody genetic information.
Many commentators consider that the Australian High Court
introduced ambiguity into the question of whether gene-based
inventions are patentable by stating the importance of
"substance over form". Thus, a critical aspect of current
Australian practice is a determination of the substance of a claim;
where patent eligibility requires the "substance of the
claim" to go beyond what occurs in nature. This is currently a
highly contentious issue in Australian law but has been clarified
somewhat by the recent Arrowhead decision.
Is my gene-based invention patentable in Australia?
In the Arrowhead decision, it was found that the working of the
claimed iRNA compositions (i.e. the substance of the claim) did not
solely reside in the naturally-occurring sequence of defined
nucleotides. Rather, it was held that the non-naturally-occurring
double-stranded RNA architecture of the claimed compositions was at
least equally significant to the workings of the invention –
with the chemical and structural elements of the double-stranded
RNA being crucial. This approach is consistent with another recent
determination from the Patent Office in Cargill Incorporated v
Dow AgroSciences LLC  APO 43 (5 July 2016) which found
that codon-optimised DNA is also patent eligible because although
it encodes the same protein as naturally-occurring DNA, it can be
expected to enhance production of the protein above that which
would be expected from the naturally-occurring sequence.
On the basis of the recent Patent Office decisions discussed
above, for a gene-based invention, which is derived from nature, to
be considered patent eligible in Australia, it is currently
necessary to demonstrate that the workings of the invention rely,
at least in part, on a non-naturally-occurring feature of the
Grant Shoebridge is a Principal at Shelston IP and acted on
Arrowhead Research Corporation in Arrowhead Research
Corporation  APO 70 (13 October 2016); and
Cargill Incorporated in Cargill Incorporated v Dow
AgroSciences LLC  APO 43 (5 July 2016).
1D'arcy v Myriad Genetics Inc &
Anor  HCA 35
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.
Shelston IP ranked one of Australia's
leading Intellectual Property firms in 2015.
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