An Australian Court has, for the first time, had the opportunity
to consider whether human genetic information (in the form of
nucleic acids, ie DNA and RNA) can be patented under Australian
The Court confirmed that:
isolated nucleic acids (ie, extracted from the human body and
purified) can be patented; and
naturally occurring nucleic acids cannot be patented.
The Court was asked to consider the validity of a patent owned
by Myriad Genetics Inc. Myriad Genetics' patent claims isolated
nucleic acid sequences coding for the BRCA1 gene. BRCA1 has been
linked to breast and ovarian cancer.
The patent was challenged by Cancer Voices Australia, an
advocacy network for people affected by cancer, and Ms Yvonne
D'Arcy who has a history of breast cancer.
Cancer Voices Australia and Ms D'Arcy contended that the
patent was not valid as it claimed isolated nucleic acid that is
not materially different from nucleic acid that occurs in
The key aspect of the Australian test for patentable subject
matter considered by the Court was whether an isolated nucleic acid
is an "artificial state of affairs". It was accepted that
the isolated nucleic acid sequences claimed have the same chemical
composition and structure as the nucleic acids present in a human.
The Court concluded that an isolated nucleic acid is an
"artificial state of affairs" as;
human intervention is required to extract and purify
'isolated' nucleic acid;
potentially immense research and intellectual effort is
required to isolate nucleic acids; and
Australian law has taken an expansive approach to patentable
US Myriad litigation
The patent subject to the Australian proceedings is related to
the gene patent currently under challenge by the Association for
Molecular Pathology in the United States Supreme Court in the
Myriad Genetics Inc litigation.
In those proceedings, the United States Court of Appeals for the
Federal Circuit (by majority) held that isolated DNA could be
patented. That decision is on appeal to the United Stated Supreme
Court, with oral arguments to be heard on 15 April 2013.
The decision confirms and supports the Australian Patent
Office's longstanding practice of granting patents claiming
isolated nucleic acid sequences. This confirms that patents
protecting isolated nucleic acid sequences will be granted, subject
of course to satisfying other legal requirements such as novelty.
This provides comfort to owners of gene patents who may otherwise
face revocation of their patents, and investors in gene research
who wish to protect their investment by obtaining patents
protecting identified genetic sequences. Conversely, many groups
and individuals opposed to gene patents have already expressed
concern at the outcome of the case. An appeal from the decision is
likely. Any appeal could take at least a year to be resolved.
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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