A specially constituted 5 member Full Federal Court has
unanimously upheld1 a patent which covers the isolated
nucleic acid (RNA or DNA) of 'BRCA1', a gene linked to
breast and ovarian cancer.
The Court confirmed that neither a mere discovery nor an idea is
patentable. To be patentable, the alleged invention must be an
artificially created state of affairs and economically useful.
The Court recognised that the isolated nucleic acids which are
covered by the patent "are different to the gene
comprising the nucleic acid sequence as it exists in
nature". Isolating the nucleic acid produced both
structural and functional changes to the nucleic acid especially in
relation to its ability to undergo cellular processes. The chemical
changes in the isolated nucleic acid distinguished the claimed
product as both artificial and economically useful.
These differences are crucial to determining patentability. The
Court specifically stated that nucleic acid as it exists in the
human body is not patentable.
The Court provided comments on a June 2013 decision of the
United States Supreme Court, which ruled that isolated nucleic acid
sequences relating to BRCA1 were a 'product of nature' and
therefore not patentable in the United States. The United States
has an express exclusion from patentability of 'products of
nature' which is not present in Australian law. Even accounting
for this difference, the Australian Court considered that the
Unites States Court did not properly account for the differences
between the isolated DNA sequence and the DNA sequence which could
be found within the body. The Australian Court's view is that
these differences mean the isolated sequence is not a product of
The Court acknowledged that the subject matter of the case is
bound to evoke moral and social arguments regarding the
patentability of gene sequences. The Court recognised that the
patent system is not designed to address these concerns, and such
policy considerations are matters for Parliament.
It is also important to remember that patentability is only one
criterion that patents relating to isolated nucleic acid sequences
need to satisfy. Others include that the subject matter must be
new, inventive and useful.
There is still the possibility that this Court is not the final
word on the patentability of isolated nucleic acid in Australia. A
decision to appeal to the High Court has not yet been confirmed. An
application for special leave to appeal is required by 3 October
1The appeal was from a 2013 decision in which
Justice Nicholas upheld the patentability of isolated nucleic acid
sequences coding for the BRCA1 gene. Norton Rose Fulbright's
article in relation to Justice Nicholas' decision can be found
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