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Patients lose out in blue over genes

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The Federal Court has upheld a private company’s claim to own the patent for the mutation of a human gene, fuelling fears life-saving diagnostic tests will be put out of the financial reach of many patients.

In a decision that stunned health campaigners, the full bench of the Federal Court early this month unanimously dismissed an attempt by lawyers acting for cancer survivor Yvonne D’Arcy to strip US company Myriad Genetics of its patent on a mutation of the BRCA1 gene, which forms the basis of common test for breast cancer.

Announcing its ruling, the full bench backed the original judgement of Justice John Nicholas that the process of isolating a gene from the body was an invention rather than a naturally occurring thing, and so could be patented.

The decision stands at odds with a ruling of the US Supreme Court last year that invalidated the Myriad patents, and has reignited concerns the patients could face much higher test costs.

“Australian women were only protected from an attempted commercial monopoly over the BRCA1 and BRCA2 tests in 2008 because the company that threatened to take those tests away withdrew its patent claims voluntarily,” said Cancer Council Australia Director of Advocacy Paul Grogan. “There was nothing in the law to protect consumers from the monopolisation of those diagnostic tests, and there still isn’t.”

The law firm acting for Ms D’Arcy, Maurice Blackburn, has flagged a possible appeal to the High Court, but legal experts said the decision appeared correct under the law, meaning any change would have to be through legislation.

Mr Grogan said the Federal Court decision meant there was now a “strong case” to change the law.

“The patents system should reward innovation and help deliver affordable health care, not stymie research and increase costs by allowing commercial entities to control the use of human genetic material,” he said.

Adrian Rollins