Gene patents have been the subject of two Senate Inquiries and
Private Members' Bills. In all instances, the arguments in
support of prohibiting gene patents have been rejected.
Cancer Voices Australia, a national organization representing
cancer patients, and Yvonne D'Arcy, a breast cancer patient,
sought revocation of a Myriad Genetics' patent which is
licensed to an Australian-based company, Genetic Technologies. The
patent relates to genes used in the diagnosis of breast cancer. It
was a "test case" in which Cancer Voices/Yvonne
D'Arcy argued that isolated genes/biological material did not
constitute patentable subject matter in Australia.
The decision is an important milestone in our case law. It is of
special interest internationally given the on-going equivalent
proceedings in the US. It is worth noting that, unlike the
situation in the US, the patent in suit was not being enforced in
Australia at the time the proceedings were commenced. (An earlier
attempt to enforce the patent had been disbanded in light of
The disputed claims of the patent in suit define isolated
nucleic acids encoding mutant or polymorphic BRCA I polypeptides
linked to breast and ovarian cancer.
Cancer Voices/Yvonne D'Arcy argued that naturally-occurring
nucleic acids such as DNA and RNA, even in isolated form, are
products of nature and therefore cannot be afforded patent
In considering the issues, the Court emphasised that:
"naturally occurring DNA and RNA as they exist in a cell
are not within the scope of any of the disputed claims and could
never, at least not until they had been isolated, result in the
infringement of any such claim". This statement counters
the emotive comments put forward by those in favour of gene patent
reform who persistently argued that patentees should not be
entitled to own an individual's genes.
Under Australian law, subject matter eligible for patent
protection is defined as a "manner of manufacture" within
the meaning of section 6 of the Statute of Monopolies
1624. Accordingly, the Court considered the precedent law in
which the definition of a "manner of manufacture" had
been examined, in particular the decision of the High Court in
National Research Development Corporation v Commissioner of
Patents (1959) 102 CLR 252 (NRDC).
The Court found that:
the concept of "manner of manufacture" has a
"broad sweep" intended to encourage developments that are
by their nature often unpredictable;
a product that consists of an artificially created state of
affairs which has economic significance will constitute a
"manner of manufacture"; and
the relevant state of affairs must be the result of some human
Most significantly, Justice Nicholas indicated that
patentability of the isolated nucleic acids defined in the disputed
claims did not turn upon changes that may have been made to the
chemical composition of the nucleic acids as a result of them
having been isolated. In other words, the patentability of the
subject matter considered by the Court related to matter which is
identical to that which occurs in nature but is isolated. As such,
this decision also seemingly applies to any isolated biological
material - for example, peptides and proteins.
Ultimately, it was found that the defined isolated genes
constitute an "artificial state of affairs" consistent
with a "manner of manufacture" based on the
Firstly, the High Court in NRDC was deliberate in its use of
very expansive language and emphasised the "broad sweep"
of the concept involved;
Secondly, in the absence of human intervention,
naturally-occurring nucleic acid does not exist outside the cell,
and "isolated" nucleic acid does not exist inside the
Thirdly, it was considered a mistake and inconsistent with the
decision in NRDC for a person whose skill and effort culminated in
the isolation of biological material not to be rewarded by the
grant of a patent because the isolated material, no matter how
practically useful or economically significant, was held to be
It remains to be seen whether the present Federal Court decision
will be the closing chapter in the gene patenting debate as it is
not yet clear whether the decision will be appealed.
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.
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