Home' Australian Pharmacist : Australian Pharmacist April 2013 Contents Australian Pharmacist April 2013 I ©Pharmaceutical Society of Australia Ltd. 21
In February the Australian Federal Court ruled in favor of allowing a company
to patent a human gene -- specifically the BRCA1 breast and ovarian cancer
gene sequence -- which can be used to predict the likelihood of a woman
Justice John Nicholas found against
advocacy group Cancer Voices Australia,
and upheld the patent for the cancer gene
BRCA1 claimed by Genetic Technologies
and Myriad Genetics.
The ruling is the first in Australia about
the patentability of isolated genes, and
sets a precedent in favour of commercial
ownership of genetic material.
In making the ruling, Judge Nicholas said
that under the Patents Act 1990, removing
a specific gene from the body and
isolating it made it into a product 'of new
manufacture', and therefore open to be
patented, despite the fact that the same
gene may occur naturally in other human
beings. He added that being a product of
new manufacture gave the discovery the
equivalence of an invention, which to a
common, non-legal mind is a bit like saying,
Captain Cook invented Australia.
Judge Nicholas said that even if a gene has
precisely the same chemical composition
and structure as that found in the cells of
some human beings -- where it cannot be
the subject of a patent -- isolating it from
the body creates an 'artificial state of affairs,'
making the gene a patentable commodity.
Effectively the decision means that anyone
with the wit and money to patent isolated
gene sequences is now legally allowed to
However, Law firm Maurice Blackburn
has lodged documents to appeal Judge
Nicholas' decision, with the appeal
expected to be heard on 17 April.
The firm's principal lawyer Rebecca Gilsenan
believes the firm had a good basis for an
appeal, saying Justice Nicholas' decision
that isolating the gene outside the body
should be considered a form of new
manufacture was incorrect.
''Our appeal is directed towards saying that
having held that the gene is not relevantly
different inside or outside the body, it was
then an error to say that when it is outside
the body it constitutes an artificial state of
affairs that is therefore patentable subject
matter,' Ms Gilsenan told Fairfax.
Australia's Pirate Party, our newest political
party only approved by the Australian
Genes, judges and politics a
patently bad idea?
By Mark Thornton
Electoral Commission last January, has already
adopted this issue.
Mozart Olbrycht-Palmer, Deputy Secretary
of the Party, said: 'This case highlights
the need for legislative reform to directly
exclude genetic material that is not actually
manufactured from being patented. Private
enterprise should not wield such power over
human life as it is currently able to'.
Judge Nicholas' ruling and the decision to
appeal it have generated legal and biotech
business interest in learned journals around
Dr Robert Cook-Deegan, director of the Centre
for Genome Ethics, Law and Policy, Institute for
Genome Sciences and Policy at Duke University
in the U.S. said: '...it seems odd to patent a
gene, which is why the practice has been
controversial since it began nearly three
'The idea that genes can be owned is
unethical to those who see the human
genome as our common heritage.
One particular concern is that patents make
the cost of genetic tests and genetic therapies
unacceptably high by stifling competition,
a concern expressed perhaps most famously
in the worldwide uproar over patenting
the BRCA1 and BRCA2 genes associated
'Another fear is that gene patents may inhibit
biomedical innovation by blocking scientists'
access to genes and genetic materials that are
essential to research.'
The Federal Court ruling created shockwaves
not only in Australia but far beyond our
shores. You might think the April appeal
would have similar seismic effects, yet two
Senate Inquiries into gene patenting since
2009 ruled out any changes to the Patent Act,
and two private members' bills -- one from
a Liberal and the other from Labor -- failed
because the Government, which has been
seeking to encourage the biotech industry,
did not back either of them.
Gene patenting is no longer some obscure,
arcane science that goes on beyond our care
or ken. The populous now knows about it and
is concerned. In this present age of poll driven
politics this means that our politicians should
be due to discover the gene patent issue in a
big way by about the end of the month and
become definitively involved, one way or the
other -- once the focus group results are in.
Mark Thornton is a Canberra-based
journalist and was a member of the Federal
Parliamentary Press Gallery for many years.
Any opinions expressed are not necessarily
those of PSA, its Board or staff.
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