The federal court has upheld the rights of corporations to ‘own’ human genetic material in a test case which could have wider implications for research.
Corporations can continue owning the rights to human genes thanks to a federal court ruling but patients at the heart of the legal battle say the practice is immoral.
Central to the test case, between support group Cancer Voices Australia and US biotech company Myriad Genetics, is the susceptibility gene known as BRCA1.
The validity of Myriad’s patent over the so-called “cancer gene” in its isolated state has been challenged, on the basis that under Australian law, patents cannot be granted over products of nature, as opposed to inventions.
But on Friday, the full bench of the federal court upheld the rights of Myriad, the patent owner.
Maurice Blackburn lawyer Rebecca Gilsenan feared the gene patent could stifle research.
“It places limits on genetic testing, genetic research and the development of treatments and cures for genetically associated disease,” she said.
The case began in 2010 on behalf of Queensland cancer patient Yvonne D’Arcy, 68, who was devastated by Friday’s outcome.
“To me now, they’ve made it personal,” she told reporters in Brisbane.
“I don’t think it’s right … I don’t think any private company should own part of a human body.”
Lisa Taliadoros, a partner with legal firm Jones Day, which acted for Myriad, said it was incorrect to say Myriad had attempted to patent the BRCA1 gene.
The scientific evidence was that “the claims related not to a `gene’ but rather to an isolated nucleic acid sequence that is chemically, structurally and functionally different from that which is found in the human body,” Ms Taliadoros said.
The decision left healthcare consumers vulnerable to the monopolisation of diagnostic tests, according to Cancer Council Australia’s director of advocacy, Paul Grogan.
“Given the unanimous federal court ruling is an interpretation of Australian law, the law itself needs to change to protect healthcare consumers from gene monopolies,” he said.
Dr Luigi Palombi, a patent lawyer and adjunct professor at Murdoch University, said the decision ignored the “bedrock principle” of centuries-old patent law – that only an invention can be the subject of a patent.
“The decision ignores the scientific facts,” he said.
“It ignores good policy. And it ignores common sense.”
But other patent lawyers disagreed.
Grant Shoebridge, PhD and senior associate at Shelston IP, argued patents were crucial for laboratory innovations to reach the market, an “incredibly expensive” journey.
“It requires the security of IP (intellectual property) protection to attract sufficient funds,” he said.
“That step of commercialising an innovation hasn’t really been considered by those who oppose things like gene patents.”
Myriad licenses the rights they have under the patent to a Melbourne-based company, Genetic Technologies (GT).
A spokesperson for GT said the company was unable to comment on the case because the patent is owned by Myriad.
The final legal option could involve Ms D’Arcy appealing to the High Court, while advocates could resort to lobbying the federal government for legislative change.
Ms D’Arcy vowed to continue fighting.
“I believe in what I’m doing,” she said.
“I believe it’s a cause worth fighting for.”