The High Court of Australia has unanimously ruled that
isolated naturally occurring nucleic acids are not patentable
subject matter in Australia. This
decision overturns the earlier ruling of the Federal Court and
the unanimous decision of the Full Federal Court.
The present case results from a legal challenge to Myriad's
Australian patent, 686004 from breast cancer survivor, Yvonne
D'Arcy. Commentary in relation to the primary Federal Court
decision can be found here and the Full Federal Court decision can
be found here.
This decision will not reduce the cost of
genetically-based diagnostic tests in Australia.
This decision does not enhance the ability of medical
researchers to innovate in Australia.
There is uncertainty whether this decision will impact
the patentability of isolated naturally-occurring molecules other
The patentability of non-naturally occurring gene
sequences in Australia is not affected by this
Under Australian law, patent eligibility is guided by the
principles of the High Court's decision in National
Research Development Corporation v Commissioner of Patents
('NRDC')  HCA 67. In that landmark decision, it was
held that subject matter was considered patent eligible if it was
"an artificially created state of affairs" having
In reaching its decision, the High Court agreed with
D'Arcy's arguments that the relevant claims to isolated
naturally occurring nucleic acids were directed to
"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 naturally
occurring nucleic acids defined in the relevant claims did not
represent an artificially created state of affairs, and were
therefore not patentable.
Some reports suggest that as a result of the High Court decision
artificially synthesised nucleic acids, such as cDNA, may also be
excluded from patentability. The reasoning is that the information
embodied by such artificially created nucleic acid sequences is
replicated by the naturally occurring sequence of DNA coding
regions. This appears to demonstrate the High Court's lack of
understanding in relation to the technical aspects of this case.
The fact is, the arrangement of coding regions in cDNA is not
replicated in nature. As such, there is at least an argument that
artificially created nucleic acid sequences, such as cDNA remain
patent eligible because information in such nucleic acid sequences
is "made by human action".
In reaching its decision, the High Court seemed to be motivated
to rule against the patentability of isolated naturally occurring
genes in view of the breadth of the relevant claims, stating
somewhat emotively that "[t]here is a real risk that the
chilling effect of the claims would lead to the creation of an
exorbitant and unwarranted de facto monopoly on all methods of
isolating nucleic acids" containing the relevant BRCA
sequences and reiterating that the claims could have a
"chilling effect" on innovation. It is unfortunate the
High Court was not familiar with the independent report on the
economics of gene patents in Australia prepared by the Centre for
International Economics as this report confirmed patents play a key
role in promoting innovation and the public-private partnerships
required to bring new human gene-based medicines and diagnostics to
A number of commentators have reported that the decision is
consistent with the Myriad US Supreme Court decision. It is not yet
clear whether the Australian decision will impact the patentability
of isolated biological materials other than genes, as did the US
Supreme Court decision.
Shelston IP will keep you promptly informed as to how this
decision is interpreted by the Australia Patent Office and the
implications for patentability of biological material other than
isolated naturally occurring genes.
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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