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Mixed messages on gene patenting
A landmark US court ruling against gene patents has reignited debate on the issue in Australia just weeks before the expected release of a senate report.

Responses to the ruling reveal major splits within the Australian scientific and legal communities.

At the end of last month the New York district court ruled that biotechnology company, Myriad Genetics, did not have the right to patent breast cancer genes as they were "products of nature".

Several decades ago patent offices ruled that genes could be patented. Since than, a number of genetic sequences have been laid claim to - even so-called "junk DNA".

"[The US court ruling] totally throws the cat amongst the pigeons," says Professor Dianne Nicol, a legal expert in intellectual property and genetics from the University of Tasmania.

Australia is yet to make a ruling on the issue, with everyone holding their breath for the expected June release of the report from the Senate Inquiry into Gene Patents.

Meanwhile, responses to the US ruling reveals the scientific community is divided on whether genes should be patented, and how the issue should be handled.
Different views

A number of eminent scientists have spoken out against the gene patents, claiming they are restricting research and access to genetic testing.

But the biotechnology industry argues that such patents are needed to encourage the huge investments in genetic research. They say concerns about research being stifled are being overplayed.

Some medical research institutes agree.

Dr Julian Clark, head of business development at the Walter and Eliza Hall Institute (WEHI) is worried about the possibility of the US court decision being upheld as it goes up through the US legal system.

"It will have huge ramifications, given the thousands of products based on gene patents that are already approved and are in the pipeline," he says.

"It seems to me to be fundamentally wrong to go down that track."

Clark says WEHI lodges a new patent application "every one or two weeks". He adds there is little evidence that research is being restricted by gene patents in Australia.

"In my mind it's a non-issue," he says.

Legal expert, Dianne Nicol, who has surveyed Australian researchers, also agrees gene patents have done little to restrict research.

"I don't get the impression that there is a major problem in Australia," she says.

But others disagree.

Dr Graeme Suthers, chair of the genetics advisory committee of the Royal College of Pathologists of Australasia says Nicol's survey findings are out of date given how fast the field of genetics is moving.

Suthers' says his college documented evidence of restrictions on scientific practice in their submission to the senate inquiry.

"We know that developments in test methodology have been constrained by gene patents," he says.
Vested interests?

Some suggest the "mixed messages" from scientists in Australia on gene patenting can be explained by the fact that research institutions are encouraged to patent genes themselves.

"It's a key performance criterion for their senior researchers, where they tally the number of patents that they hold as part of their CV when they're seeking promotion," says Suthers.

Nicol says patenting by researchers themselves is one reason why there have been few court challenges to the patenting of genes.

"It's not in their interest to get a definitive ruling on patenting of gene sequences. Uncertainty is better at the moment because the patent offices are actually interpreting them as patentable," she says.
Options going forward

Some want a blanket ban on patenting genes as they occur in nature, with some allowance for those patents already in the system.

"As a matter of principle it should not be possible to patent human genes in the future," says Suthers.

Professor Ian Olver of Cancer Council Australia agrees.

"I believe that patents were designed for inventions not discoveries," he says.

Olver wants protection for researchers and clinicians, citing a case in which one company tried to stop Australian researchers from testing for breast cancer genes.

"They backed off because of public pressure," says Olver. "But the fact is they could, and did try, to enforce their patent. That could happen - in the research setting as well."

Clark from WEHI says such cases are rare and, in general, there is an "implied" exemption for researchers.
Research exemption?

WEHI favours a compromise recommended by a 2004 Australian Law Reform Commission report, which would, among other things, formalise an exemption for non-commercial research.

But some legal experts doubt this would be practical.

Dr Luigi Palombi from Australian National University's Regulatory Institutions Network says it's "impossible" to draw the line between what is commercial and non-commercial research in today's research environment.

"This idea of a research exemption is nonsense because there's no real way of creating the division," he says.

Meanwhile, legal challenges by non-profit public interest groups in Australia face barriers.

"The expense and difficulties associated with litigation generally frighten the hell out of these organisations," says Palombi.

"You need to have a way for non-interested citizens, for NGOs, charities and public interest groups to bring these actions without fear of having to go bankrupt in the event that they lose."

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