Source: Weekend Australian
Bill Heffernan and Luigi Palombi seem an unlikely pair. But the no-holds-barred Liberal senator and the Australian National University patent law expert agree on one thing: gene patenting. They're against it.
"Originally, Luigi came and saw me. I thought, `Shit, what are we supposed to do about this?' Heffernan recalls. So he picked up the phone to Health Minister Nicola Roxon: "I said to her we need to look at this."
The upshot was the Senate community affairs committee inquiry into gene patents, now under the chairmanship of Greens senator Rachel Siewert. The committee is considering the effect of granting patents over human and microbial genes, stretches of so- called non-coding genetic material, and the molecular products of those blueprints for life.
Due date: been and gone as of last month. The committee extended its reporting deadline to March 18 next year, despite having a draft report in hand.
"It's incomplete," explains Siewert, adding that's not because of internal fisticuffs. "We have a lot of information we're trying to process and we didn't want to rush our findings as this is a very, very significant inquiry."
Siewert and company really do have much to ponder after conducting six public inquiries between March and September this year, as well as receiving 72 primary submissions and numerous supplementary submissions from individuals and groups as diverse as the Australian Medical Association and Queensland biopharmaceutical company Xenome.
As Heffernan sees it: "The question is who owns the rights to the access of the human body and why can it be patented?"
According to Palombi, who contributed a submission and attended five of the hearings, it all boils down to two positions. One: there's no need to change patent law. Two: genes and their ilk should not be patentable.
Wind back the clock to July 7 last year and the reason for such irreconcilable points of view is obvious. That's when Michael Ohanessian, chief executive of Melbourne-based Genetic Technologies, sent out a letter to eight public pathology laboratories advising them the firm would enforce its intellectual property rights over diagnostic testing of the BRCA1 and BRCA2 genes, where mutations linked to breast and ovarian cancer are located.
Ohanessian reminded them his firm listed as GTG on the Australian Securities Exchange held an exclusive license to offer testing of the genes following a deal struck in 2002 with US-based gene patent holder Myriad Genetics. Although in May 2003 GTG described its rights as a "gift to the Australian people", that was about to change. Labs must now refer all such tests to GTG.
The fear was that GTG would crank up the price for testing and restrict genetic research using the BRCA genes. But in November that year GTG's board of directors changed, along with its push for IP rights. Meanwhile, a lawsuit was launched against Myriad Genetics in New York by the American Civil Liberties Union, arguing Myriad's patents are too broad: genes are unpatentable. No resolution is expected until next year. The matter's in legal limbo.
Until it's settled, Palombi says, there's the potential for another patent owner to try on GTG's manoeuvre. And so they should, argues the other camp.
In an extensive submission to the Senate committee, the federal Department of Innovation, Industry, Science and Research and IP Australia a government agency that handles trademarks, patents, designs and intellectual property made a case for maintaining genetic patents. This stance is widely supported by the biotech and IP communities.
"Our observation is that the current system appears to be functioning effectively in achieving its concurrent objectives of encouraging innovation, promoting diffusion of information and providing access to and transfer of technologies," they say.
A key argument is that money is needed to fund research and product development. Patent rights are a source of funds, which can be negotiated depending on the use, whether it's basic research or a commercial application such as genetic testing.
As well, the submission claims that as a small nation competing in an international playing field, Australia must ensure its patent system is consistent with obligations under international agreements. In essence, going it alone won't work.
Not so, argue Palombi and a suite of clinical, research and patient advocacy groups. Patents should be granted only where there is true innovation, such as a novel gene therapy to treat cancer. Simply identifying or isolating material naturally present in the human body does not count as an invention. "You might as well patent the sun," says bioethicist Laurie Zoloth of Northwestern University in Illinois.
What to do? Palombi, for one, suggests a middle ground, a new class of IP based on the identifi-cation of a gene and its functions.
"It's essentially a copyright model. Anyone who wants to use your IP must tell you and pay you," he says, adding that the fee could range from nothing to plenty, depending on who's asking.
Zoloth goes further. She suggests a "creative commons" in which basic genetic information is freely available to all comers, in the same way as the results of the publicly funded human genome project.
"Eventually the work will be commercialised," she says, noting that's a role for venture capital and philanthropy.
That's a big call. Will the Senate committee agree? Not even the outspoken Heffernan can say for now.
