14 NEWS

SEPTEMBER 28, 2014 SUNDAY AGE

SUNDAY EXPLAINER

Patently absurd? Courting your genes

This month the Federal Court decided that private companies have the right to control human genes
in an important test case. A sensible win for private investment in research or a scary corporatisation
of our shared genes? Jane Lyons sequences the debate.
What was the breast-cancer
gene court case about?
Social justice law rm Maurice
Blackburn, which launched the
court case in 2010, has gone two
rounds with US biotech behemoth
Myriad Genetics to invalidate its
Australian patent for a mutation of
the BRCA1 gene. This gives the
patent holder a monopoly over the
breast and ovarian cancer gene
itself as well as its diagnostic test.
It lost the rst Federal Court
round last year and copped another
beating in the appeal this month.
But while this case was ostensibly
about one patent, both sides have
had their eyes rmly on the bigger
prize. For Maurice Blackburn, the
BRCA1 case tests the controversial
practice of gene patenting, which
has been happening in Australia
since the 1990s and has never been
legally challenged here.
The lawyers argue the practice is
based on an invalid premise: that
isolating a gene from the body
makes it an articial state of affairs and therefore an invention
(which can be protected by a patent), rather than a discovery
(which cannot). Their problem
with these patents? Monopolies,
higher test costs for patients, the
stiing of genetic research and the
questionable ethics of a company
owning the rights to our genes.
Over in the other corner, Myriad
has been ghting not only for its

future but also for the biotech

industry, which has anxiously
watched the outcome. Myriads
20-year BRCA1 patent expires next
August, but it has more genepatent irons in the re. It argues
that the isolation and chemical
modication of BRCA1 needed to
analyse it in the laboratory makes
it an innovation worthy of patent
protection.
Interestingly, the company and
its supporters share a key argument with their adversaries the
future of research. They argue that
patents risk stiing genetic
research if they are overturned.
Patents are the pied piper call for
investors who are critical for taking
research from lab to patient, they
say.
What did the full bench of the
Federal Court decide?
The court decided the BRCA1 patent was A-OK under Australian patent law. It ruled that the structure
and function of the gene made it
different from the naturally occurring gene in the human body. It had
therefore resulted in an articially
created state of affairs for economic
benet, which met the patentability criteria of the Patents Act 1990.
What will happen to costs and
access to tests for people with
breast cancer?
Australian patients can now access

Fitness a family
affair for trio
Tom Cowie
In the build-up to a fun run it is
always good to have someone on
your case making sure you are
training hard for the event.
As he prepares this year for The
Sunday Ages City2Sea, presented
by Westpac, Middle Park account
manager Chris Long is being
pushed along by his daughters,
Ciara and Niamh.
All three will compete in the
15-kilometre run from the
Melbourne central business
district to St Kilda, and Mr Long
said running-mad 15-year-old
Ciara is keeping him honest on the
training track around Albert Park.
Ciara runs six days a week, up to
10 kilometres in total, as well as
taking part in rowing training on
most days. She also helps her
father train for events such as the
City2Sea and other fun runs.
After school shell say, Hey,
have you been on a run today? Mr
Long said. We both track each
others training and time and make
sure were ready to be able to
perform on the day.
This years event will be the
fourth time the family has
competed in the City2Sea. Mr
Long said fun runs provided
NATAGE A014

motivation for the family to stay t

and keep training. While he said his
times were getting slower each
year, Ciara is warming up to beat
last years effort of one hour and
seven seconds good enough to
place her second in her age group.
Even if their personal bests
remain unbroken, the event will
provide the family with the chance
to enjoy the benets of exercise.
For me personally, its a really
good way to start the day. Mentally,
you feel really strong afterwards,
Mr Long said.
The 2014 City2Sea will be held
on Sunday, November 16. So far the
event has raised more than
$50,000 for charity.
Entries are open now, visit
thecity2sea.com.au

the government-subsidised BRCA1

test through public laboratories
here. In 2002 and 2008, Genetic
Technologies tried to enforce its
exclusive Australian licence for testing the BRCA1 gene to the tune of
$2100 a test but backed down after
a public furore.
Some question whether the ruling provides the incentive for the
company to try again, while others
raise the likelihood of Myriad suing
for patent infringement back to
1995.
What will happen to investment
in genetic research and in
medical patents?
For the pro-gene patent posse, the
ruling goes to the heart of their
rationale: its a win for investment in
genetic research.
Given a separate recent US decision against gene patents, some pundits suggest the Australian decision
may sweeten the deal for US companies looking to commercialise
their genetic research elsewhere
and for investors looking for the next
big breakthrough. Whether the
oodgates will open on gene patents
is debatable: IP Australia, which
oversees the regime, has previously
reported gene patent applications in
Australia peaked around the completion of the Human Genome
Project in 2003. This reects the
global arena, where an estimated
16,000 gene patents now exist, al-

though thousands more isolated

genes remain unpatented. However,
there is concern over the broader
patenting of other parts of human
DNA, proteins and microbial genes.
Some fear the decision could mean a
renewed drive to patent more genes
and biological products.
Are there other areas of
biomedicine and biotechnology
that will change as a result of this
decision?
Yes, cries the pro-posse, there will be
more critical investment that will
enable these important industries to
grow, Australian biotechs to survive
and research breakthroughs to reach
the public.
A complete furphy, the anti-posse
cries. They say patents will restrict
biomedical research and the shiny
promise of personalised medicine.
Much of this research focuses on the
interplay of multiple genes. Negotiating access to single gene patents can
often be a convoluted, unclear and
expensive process for researchers.
Dealing with multiple patents and
multiple patent holders is likely to
make this process even more of a
research hindrance.
How does the Australian court
decision compare with other
jurisdictions?
The Australian court decision has
been particularly controversial given
a US Supreme Court decision last

year against Myriad and its BRCA1

and BRCA2 patents. The US court
ruled genes extracted from the
human body were not patentable,
invalidating Myriads two breast
cancer gene patents and therefore all
gene patents. The Australian
decision has maintained a legal
status quo that, until the recent US
decision, has been found in most
other international jurisdictions
since the late 80s.
Where to from here for the law in
Australia?
Maurice Blackburn has come out
swinging by lodging an appeal application with the High Court. Meanwhile,
political ire is stirring once again.
Federal Labor MP for Fremantle,
Melissa Parke, is stepping back into
the ring after pushing for a private
members bill to disallow gene patents
in 2012. Shes looking to gather the
troops again in both her party and
across the oor. Liberal Senator Bill
Heffernan, a past advocate for changing the law, says he would back any
renewed effort to amend the Patents
Act. The Cancer Council, a stalwart of
the anti-gene patent campaign, will
also continue to push for the change.
But other anti-gene patent campaigners are less hopeful, saying the
Parliament is incapable of dealing
with the matter. Two previous
attempts at amendment bills have
failed and two inquiries have maintained the status quo.

Niamh and Ciara BoydSquires Long run with

their father Chris Long.
Photo: Patrick Scala