Your genes are the same, whether in a test tube or inside your body. But the very act of removing them makes them a patentable invention, according to Australia's Federal Court. Today, it handed down the country's first decision on gene patenting.
By isolating a human gene from the body, even assuming it has "precisely the same chemical composition and structure as that found in the cells of some human beings", Justice John Nicholas said an "artificial state of affairs" had been created, making the gene patentable material.
The ruling relates specifically to a patent for a series of mutations in the BRCA1 genes, which are associated with an increased risk of breast and ovarian cancer. Tests for the genes can help determine the likelihood of someone developing the diseases at a later date. The patent, which was filed by Myriad Genetics in 1994, in principle gives the company exclusive rights to perform such tests in Australia. The firm's patent was later contested by Cancer Voices Australia, a patient advocacy group, and Yvonne D'Arcy, who had previously had breast cancer.
Today's decision has raised eyebrows. "It is difficult to think of the circumstances where an artificially created state of affairs would not exist whenever there is some form of human intervention," says Dianne Nicol at the University of Tasmania, Australia, who specialises in law and human genetics.
She says the counter view is that isolating a gene from the body is similar to snapping a leaf from a tree: since the process is so commonplace, it doesn't represent a substantially artificial state of affairs.
It is likely the applicants will appeal, Rebecca Gilsenan, principal lawyer at Maurice Blackburn who represented Cancer Voices Australia, told New Scientist. "We and our client remain very committed in our opposition to gene patents," she says.
The ruling comes just two months before the US Supreme Court will hear an appeal over a very similar case between Myriad and the American Civil Liberties Union, which was awarded to Myriad in a lower court.
"Since patent criteria are similar, a decision in one jurisdiction can indicate what might happen in another," says Robert Cook-Deegan from the Duke Institute for Genome Sciences and Policy in Durham, North Carolina.
In Australia, Myriad licensed its BRCA1 patents to Genetic Technologies Limited. However, when Genetic Technologies threatened legal action to enforce its rights to the patents in 2008, a public outcry forced the company to allow other labs to freely perform BRCA1 testing.
"But there was ? and still is ? nothing in the law to prevent such an [enforcement] being made in the future," says Ian Olver, an oncologist and CEO of Cancer Council Australia, who is calling for the law to be changed to rule out gene patents.
In the US, where Myriad has enforced its patent, tests for BRCA1 must all be done by that company and can cost $3000.
For Australian genetic researchers, the patent's effect will be mitigated because in 2012 the country's judiciary introduced an "experimental use defence", whereby researchers investigating a patent's subject matter, or related areas, cannot be found to infringe the patent.
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