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Consumer watchdog investigates gene company -

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Consumer watchdog investigates gene company

The World Today - Thursday, 23 October , 2008 12:46:00

Reporter: Jennifer Macey

ELEANOR HALL: The Federal Government says it's extremely worried about the threat by a private
company to restrict the use of a genetic test for breast cancer.

The Melbourne-based company Genetic Technologies owns the patent to test for two breast cancer
genes and it has told public hospitals that it will take legal action if they don't stop conducting
the test.

But the Australian Competition and Consumer Commission is investigating whether this contravenes
the law.

Jennifer Macey has our report.

JENNIFER MACEY: For several years now Australian women who have a family history of breast cancer
have been able to do a DNA test to see whether they're genetically predisposed to the disease.

The genes known as BRCA1 and BRCA2 are responsible for up to 10 per cent of cases of breast cancer.

Sally Crossing from the Breast Cancer Action Group says choosing to get the test done can be very
traumatic.

SALLY CROSSING: If you have the BRCA1 or 2 genes, it seems that your chances of getting breast
cancer rise to about 50 per cent which means you know, half and half. You may never get it but you
may.

But then you have to make a decision and this is really very difficult. Do you do something radical
like have a double mastectomy or do you take some drugs like you know tamoxifen or something just
as any other high-risk woman would.

Then you have other decision though. Do you tell your children? Do you check out the rest of the
family. Look, the whole thing is very complex.

JENNIFER MACEY: Now a company in Melbourne, Genetic Technologies are demanding that other
laboratories around Australia stop testing for these two genes.

They say they own the patents to identify these genes and are threatening legal action if labs
don't cease testing within two weeks.

The CEO of the company Michael Ohanessian says negotiations are currently underway with government
bodies and he says he can't comment.

MICHAEL OHANESSIAN: Oh, I am not going to get into the specifics of the negotiations with the
health authorities, no.

JENNIFER MACEY: But you are trying to restrict the tests taking place in other parts of Australia?

MICHAEL OHANESSIAN: We are the only ones who have the licence rights to the patents. Let me just
leave it at that.

JENNIFER MACEY: So you are currently still in negotiations?

MICHAEL OHANESSIAN: There are discussions ongoing and therefore I don't want to comment.

JENNIFER MACEY: Patent law expert at the Australian National University in Canberra, Dr Luigi
Palombi says the legal action is a real threat to public hospitals.

LUIGI PALOMBI: The deadline 6th of November is a real deadline for these organisations because even
though they're government funded, they are independent of government and therefore can be sued in
their capacity, being connected to hospitals or laboratories of various kinds.

And they can be sued in Federal Court and GTG can seek damages and account of profits and
injunctions in respect of any ongoing use of the patented technology.

JENNIFER MACEY: But he says the Government does have some avenues to stop this move.

LUIGI PALOMBI: The Government does have power under Section 163, sub-section 1 of the Patents Act
to authorise the laboratories in writing to effectively carry out services on behalf of the
Commonwealth or the State.

In fact the state governments also have that power, independently of the Commonwealth. So what they
can do, if they choose to, is actually authorise the labs to be these tests and then if they do
that then under the Patents Act, under that Provision of the Patents Act, it is not an act of
infringement.

JENNIFER MACEY: He says under the Patents Act the Government can also compulsory acquire the
patents but it's unlikely they'll consider going down this path.

LUIGI PALOMBI: Two of the patents in question are also joint-owned by the US Government. Now, I can
just imagine the US embassy being on the phone to the Minister very rapidly if this was to happen.

So there might be some sort of diplomatic pressure being applied. There might be pressure applied
from other parts of industry who might suggest that this is going to set a terrible precedent.

JENNIFER MACEY: Cancer organisations are worried that by concentrating this test at one laboratory
in Melbourne will limit access for many women.

Dr Graeme Suthers is a medical adviser to the Cancer Council Australia.

GRAEME SUTHERS: At the moment we have 10 laboratories across Australia which are providing testing
of these BRCA genes and my concern is if the testing is then restricted to one laboratory, that may
make it more difficult for women across Australia to get reasonable access to this testing.

JENNIFER MACEY: But Graeme Suthers from the Cancer Council Australia says while the majority of
women do get their tests paid for by cancer centres - he says concentrating the tests in one lab
will inevitably lead to higher costs for the government.

ELEANOR HALL: Jennifer Macey reporting.