[Ip-health] ABC News: Legal bid against breast cancer gene patents

[Thiru Balasubramaniam]

<SNIP>

Phillip Noonan, the director general of IP Australia - the statutory
authority that grants patents on genes - says the decision to grant
the patent was the correct one, but the company erred in its approach.

"The company sent very disturbing letters that upset a lot of people,
that was a very unwise course of action and promptly the company
recanted," he said.

"I think in evidence before the committee government officials have
spoken about using the compulsory licensing provisions if that threat
had gone ahead.

"The compulsory licence provisions is a really strong tool that
enables people to use a patented product if the reasonable needs of
the public is not being met, so the patent owner just can't sit on
their product and deny reasonable access to it."



http://www.abc.net.au/news/stories/2009/09/29/2699964.htm?section=world

Legal bid against breast cancer gene patents

By Suzanne Smith for Lateline


Women in the United States are being charged $3,700 for a breast
cancer genetic test because only one company has the patent over the
two key breast cancer genes, BRCA 1 and BRCA 2.

Myriad Corporation in Utah owns the patents over the genes and is not
allowing any other laboratory to look at or test women to see if they
are more susceptible to developing breast and ovarian cancer.

A landmark court case has begun in the United States to decide the
vexed issue of whether patents should exist on human genes.

At stake are hundreds of gene patents, which have been granted on the
basis that isolating the genes out of the human body and into a lab
environment is an "invention" and not a "discovery".

The court case, brought by the American Civil Liberties Union, was
prompted by the actions of patent owner Myriad Corporation.

An Australian Senate inquiry into gene patents has just decided to
commission draft amendments to the law to see whether it is practical
to remove patents from human genetic material.

Currently the two patents over the breast cancer genes are not being
enforced in Australia but the situation is unresolved.

In America, Myriad Corporation does all the BRCA analysis and it does
not allow a second opinion from another lab.

Genetic mutation

Lisbeth Ceriani is a 42-year-old single mother from Boston and has
full custody of her nine-year-old daughter, Bella.

She has had weeks of chemotherapy and radiation and a double
mastectomy to remove tumours on both sides of her breasts.

Ms Ceriani only found out about her family history after she was
diagnosed. She learned that several female relatives on her dad's side
developed cancer in their 40s, and died in the early 50s.

"When you have multiple tumours on both sides and fast growing at a
young age usually it is an indication it might be a genetic mutation,"
she said.

"I need to be tested for the BRCA mutation because if I have the
mutation then the chance of developing ovarian cancer is 80 per cent -
that is huge."

But when Ms Ceriani began the process of getting the BRCA analysis
tests her nightmare began.

"It is an expensive test. It is over $US3,200, which may not sound
like a lot to some people but if you have been barely working all year
because of all the treatments - and I have been working one part-time
job at this point - it will then take me a while to save up for the
test," she said.

"So my situation is that I have a type of Medicaid health insurance
which is great, but the lab won't accept that insurance."

Lisbeth Ceriani says there is nothing Medicaid can do to force Myriad
to accept its insurance payment for the test. She has to pay for it
upfront.

"I have had conversations with the lab, the insurance company has had
conversations with the lab, we have tried every possible way."

According to the legal advocate in the American Civil Liberties Union
(ACLU) court challenge, Chris Hansen: "Women who can't afford the
test, don't get the test."

Crucial tests

The two tests are crucial for women with a history of cancer in their
families.

If a woman carries a mutation in the BRCA 1 gene then she has up to an
80 per cent chance of getting breast cancer.

If a woman has one of the mutations and she surgically removes her
fallopian tubes and ovaries, the risk of contracting ovarian cancer
falls to zero, and the risk of getting breast cancer falls to 50 per
cent, and much less with bilateral mastectomy.

Some of America's most prestigious medical and research institutes
have joined the ACLU court case as plaintiffs.

Professor Wendy Chung from Columbia University is one of those. She
says the gene patent has the same effect as a monopoly - if multiple
labs can't do the test there is more room for error.

"From a technical point of view, there are limitations. A lab could
make a mistake and if you were a woman trying to decide whether to
have her breasts removed or are you going to have your ovaries
removed, I would not take that lightly. I would want a second
opinion," she said.

"The most challenging idea is the exclusivity, that single provider
always prevents the competition and doing our best and offering the
best to patients."

In Australia, Melbourne company Genetic Technologies Limited (GTL) has
the exclusive licence from Myriad Corporation to do the BRCA 1 and 2
testing.

In 2003 and in 2008 it sent a legal letter to Westmead Hospital and
the Peter Maccallum Cancer Institute in Victoria demanding the labs
cease all testing for the BRCA 1 and 2 genes.

Associate Professor Judy Kirk from Westmead Hospital says a public
outcry forced GTL to withdraw the legal threat but the situation
remains uncertain for her laboratory and others around the country.

"What has happened in 2003 and 2008 where the public testing of these
genes for Australian men and women was threatened could happen at any
time," she said.

"There is nothing to stop that happening. They still do own the
exclusive licence but they are not enforcing that."

'Middle ground'

Phillip Noonan, the director general of IP Australia - the statutory
authority that grants patents on genes - says the decision to grant
the patent was the correct one, but the company erred in its approach.

"The company sent very disturbing letters that upset a lot of people,
that was a very unwise course of action and promptly the company
recanted," he said.

"I think in evidence before the committee government officials have
spoken about using the compulsory licensing provisions if that threat
had gone ahead.

"The compulsory licence provisions is a really strong tool that
enables people to use a patented product if the reasonable needs of
the public is not being met, so the patent owner just can't sit on
their product and deny reasonable access to it."

Mr Noonan believes any move to ban patents on genes would be
disastrous for Australia's biotech industry. He believes there is a
middle ground.

"The question for the committee is 'do we need to go to this radical
solution from a whole segment of technology out of the patent system
and risk the loss of the innovation'," he said.

"Can we look at the tools we have got against the cases and concerns
that have been raised and sharpen up some of those rules?"

Myriad Corporation refused Lateline's offer of an interview. Gene
Technologies Limited also refused but instead released the following
statement:

"Hypocritically many of the large publicly funded medical institutes
have patents on other biological materials such as antibodies which
they rigorously enforce and charge royalties for access," it said.

"The effect of nullifying gene patents on Australian medical research
and practice could however be catastrophic and any unilateral change
would also put Australia potentially in breach of free trade
agreements and at odds with our WTO obligations."

The Institute of Patent Attorneys' Trevor Davies agrees.

"If there is a ban on the patent of patenting of biological materials
it would have a serious impact on the biotech industry," he said.



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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997