Myraid Corp is evil

http://www.abc.net.au/news/stories/2009/09/29/2699964.htm
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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