Issue 19 / 21 May 2012

SHOULD commercial operators be allowed to patent genes? It’s a question that has been sparking debate since at least the 1980s when the first such patents appeared.

On one level, the answer seems obvious.

As substances found in nature, genes can be considered “discoveries” rather than “inventions” and therefore should not be patentable — any more than you could patent the human leg and then charge others a licence fee for their use of it.

But things are rarely that simple — in life or in the law.

The line between discovery and invention can be a blurry one: just how much work do you have to put into isolating, purifying or modifying a substance found in nature before it achieves patentable status?

The biotech industry claims, as you’d expect, that patents are essential to protect companies’ intellectual property and ensure they receive a return on their research investment.

On the other side, medical and patient groups have long argued gene patenting should not be allowed because it can effectively grant one company a monopoly over tests or treatments related to a particular gene, driving up costs and potentially restricting access.

Professor Ian Olver, chief executive officer of the Cancer Council, told the ABC’s Lateline last week that patents could block other researchers from working on a particular gene, stifling development of new treatments.

The Cancer Council has long argued genes should not be patentable and is now backing a campaign by federal Labor backbencher Melissa Parke to have the patents banned in Australia.

It’s not the first time an Australian politician has taken on the issue. On the other side of politics, Senator Bill Heffernan failed in his 2010 attempt to introduce legislation that would have banned patents over genes and biological materials.

Ms Parke’s proposed Private Member’s Bill would be somewhat narrower in impact, according to the Lateline report, banning patents on genetic material only.

But it certainly goes further than the federal government’s recently passed “Raising the Bar” legislation, which makes a gesture towards open access by allowing medical researchers to work on a patented gene for non-commercial purposes.

As Professor Olver points out though, researchers won’t always be able to determine potential commercial applications of their work at the outset, making it difficult to apply the exemption in practice.

Anything that stifles research into new diagnostic tools and treatments is clearly a bad thing and, intuitively, it seems to make sense that gene patenting would have that effect — though there doesn’t seem to be an overwhelming amount of quality research supporting either that argument or the industry’s counterclaim that patents foster innovation.

Perhaps the most surprising thing is that we still have so little clarity in this area, three decades after the first gene patents were granted in Australia and elsewhere.

Part of the problem may be that courts and legislators seem singularly ill equipped to deal with the complex scientific arguments involved.

The ongoing legal battles in the US over patents covering the BRCA1 and BRCA2 genes certainly haven’t thrown a lot of light on the issue.

A coalition of lobby groups, including the American Civil Liberties Union and the American Medical Association, have for several years been fighting patents granted over the genes, mutations in which are the basis of tests for familial breast and ovarian cancer.

In 2010, a district court ruled that human genes could not be patented but the decision was reversed on appeal last year, meaning the battle is now likely to go all the way to the Supreme Court.

The ownership of the human genome is a vital issue, and one that is only going to become more important.

If we want to take full advantage of our ever-expanding knowledge in this area, we are going to need a clear legislative framework that has a solid grounding in science as well as the law.

It’s good to see parliamentarians putting the issue on the table but, really, that’s just the beginning.

Jane McCredie is a Sydney-based science and medicine writer.

Posted 21 May 2012

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