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The US has decided you can't patent a gene - it's time for Australia to do the same

June 14, 2013

The US has decided you can't patent a gene - it's time for Australia to do the same

Cancer Council Australia welcomes the unanimous decision by the US Supreme Court that natural human genes cannot be patented. The court ruled that as "products of nature", human genes lay outside of what can be patented, and merely isolating them from the human body does not change this. The decision invalidates the US patents held by Myriad Genetics over the BRCA 1 and 2 genes linked to familial risk of breast and ovarian cancer.

As well as an important step for the US, the decision highlights the need for changes to patent law in Australia to ensure gene testing and research can remain available to all.

The fundamental premise is that patents require an inventive step, not merely the discovery of a natural product. Commercial monopolies should no longer be able to be held over the gene mutations that are the focus for developing new tests and treatments for cancer.

Here in Australia there is a case under appeal which centres on whether the isolation of a gene makes it patentable. Previously the court ruled that the isolated gene outside of the body met the legal requirement of a method of manufacture, that made the isolated gene patentable. This is clearly at odds with the US decision. But, even if upheld, it merely emphasises the fact the Patent Act in Australia needs to be changed to give the same clarity as in the US, that the natural genes whether in place in the body or isolated are not patentable material.

In 2008 in Australia Genetic Technologies, the Australian licensee for the BRCA 1 and 2 genes, tried to enforce their monopoly over testing for the genes. This could have led to the test being performed by a single laboratory, instead of public laboratories in the states, at a cost to be fixed by the company. It could have also potentially limited the availability or increased the cost of the test to the people who most needed it. The company subsequently withdrew their claim, but there was no legal protection of Australian women against such a monopoly.

Genetic technology is rapidly evolving. An important consequence of the US decision is that researchers will now all have access to the basic genetic material, allowing competitive research striving to develop new tests and cancer treatments to continue and develop. If this research results in innovative changes to the gene, it is at that stage that a patent would be possible, rewarding researchers for their effort. Protection of the new invention is a reasonable reward for that effort. This is akin to not allowing a patent on the basic building bricks but rewarding by patent protecting new structures that are built from them.

The response of government to date, in the "Raising the Bar" bill which clarified the definition of an inventive step but did not address the issue of whether genes are patentable material and the more recent bill to clarify that Crown use provisions could be applied to protecting women from monopolies over genes and test were helpful small steps.

The US Supreme Court has made it clear - human genes cannot be patented. We now need to bring Australia into line with this landmark decision by changing the Patent Act to exclude genes as patentable material.