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BRCA1, Breast Cancer Gene can not be Patented, High Court Finds

D’Arcy’s case was previously dismissed by Australia’s Federal Court, which ruled in favor of the two companies holding the patent.

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Breast cancer is the leading cancer killer of women aged between 20 and 59 worldwide, and supporters of the case had argued that patenting a gene could stymie medical research and testing.

But Mr Madden said more importantly the decision highlighted the need for the federal government to take a position on what pharmaceutical and research companies should and should not be able to patent.

In a further concurring opinion, Gordon J focussed on what constitutes “an invention” and opined that Myriad did not invent or “work out” the coding function of isolated nucleic acids, nor “That the specific mutations and polymorphisms are indicative of a predisposition to breast cancer and ovarian cancer”.

The highly-anticipated decision of the High Court of Australia in relation to whether claims to the isolated BRCA1 gene constitute a manner of manufacture (i.e. patentable subject matter) under Australian law was handed down today.

Mutations in the BRCA1 gene put women at an increased risk of breast and ovarian cancer. “Rather, what is important is (the ruling’s) effect on the availability of patents in new areas of technology more generally”, she said.

“While the invention claimed might be, in a formal sense, a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element of the invention as claimed”, the judges said.

“Very happy with High Court decision”.

However the CEO of the National Breast Cancer Foundation, Jackie Coles, says that the patent removal will act towards making treatments cheaper and more easily available.

In court, her lawyers have argued that allowing patents over human genes would be a barrier to cancer research and would make it possible for companies to charge high rates for testing.

“I am only a little person – but it is not the size of the dog in the fight, it is the size of the fight in the dog”.

Interestingly, Myriad’s patent covering the challenged claims expired in August, but the decision sets a precedent for Australia.

The US Supreme Court had already ruled against the patent in 2013.

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The World Heath Organisation estimates that breast cancer kills around 458,000 people every year.=.

Australian High Court rules to disallow patenting of isolated genetic materials