A Queensland grandmother has won a high court challenge to stop a US company having a patent on a human gene.
The case will have a far reaching impact on medical research and on the ethics of using parts of the human body for commercial gain.
Yvonne D’Arcy, 69, a breast cancer survivor, challenged a biotech company’s right to patent BRCA-1 which has been linked to an increased risk of breast and ovarian cancer.
D’Arcy, who says the genes were discovered rather than invented, hopes the decision will lead to a better and more affordable genetic test for cancer.
“The costs will come down and more geneticists will be able to test,” D’Arcy told a media briefing today.
“For all the people who do have the genetic footprint, it’s a win for them.”
She has had cancer three times, cervical followed by two bouts of breast cancer.
“Emotionally, it’s very draining to have to listen to the court cases and the paraphernalia that goes with them,” she says.
“Regardless what the decision was — they were wrong and I was right.”
The company, Myriad Genetics, argued that patents helped innovation and that commercialisation benefited all. The Utah-based company patented the BRCA1 gene in the 1990s.
However, civil liberties groups in the US say the company’s monopoly makes genetic testing more expensive.
The case was taken up by lawyers Maurice Blackburn in 2010.
However, Justice Nicholas ruled, in the Federal Court in February 2013, in favour of Myriad and agreed that isolated gene sequences are the product of human intervention and are therefore patentable.
An appeal to the Full Federal Court was launched but Justice Nicholas’ ruling was upheld.
An appeal was then made to the High Court which today ruled that BRCA1 was not a “patentable invention” within the meaning of Australia’s Patents Act, which required that something be manufactured.
“The court held that, having regard to the relevant factors, an isolated nucleic acid, coding for the BRCA1 protein, with specified variations, is not a manner of manufacture,” the High Court ruled.
“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 concept of a manner of manufacture would need to be broadened for patentability to be claimed.
In 2013 Angelina Jolie learned she carried the same gene, BRCA 1. The actress then had a double mastectomy.
In the US, the Supreme Court has also ruled that companies cannot patent human genes.
That court ruled that a DNA segment is a product of nature and not eligible for patent just because it has been isolated.
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