Private firms are allowed to hold a patent over cancer-causing gene mutations, according to an historic ruling in the Federal Court today that has wide-ranging implications for researchers and cancer patients.
The case centred on a gene mutation called BRCA1, which puts women who have the mutation at a higher risk of breast and ovarian cancer.
A US biotechnology company, Myriad Genetics, had given exclusive rights in Australia to a patent on BRCA1 to a firm called Genetic Technologies Limited.
The group Cancer Voices Australia and breast cancer survivor Yvonne D'Arcy had challenged the firm’s right to the patent in the Federal Court but lost the case today.
Federal Court Justice John Nicholas ruled today that the company may continue to hold the patent.
“We are extremely disappointed and it has far ranging impacts for people with cancer and researchers who want to be able to use these genes that have been patented,” said Sally Crossing AM, spokesperson for Cancer Voices Australia.
“The more we restrict use and allow ownership of human genes to particular commercial interests, the more difficult and costly it is to undertake research,” she said.
“The finding is in relation to one breast cancer gene mutation, BRCA1, but it could be applied to a patent over any human gene.”
Ms Crossing said the judge found that the fact BRCA1 is isolated by human intervention renders it a “manner of manufacture”.
“It’s an unexpected interpretation. It’s still a human gene,” she said.
Cancer Council CEO, Professor Ian Olver, said the case showed patent law should be changed “to protect the community from gene monopolies.”
“Discovering and isolating genetic materials is not inventive, yet the current law gives licence to biotechnology companies to claim ownership of naturally occurring substances,” Professor Olver said.
“The catalyst for this case was the attempt by Genetic Technologies in 2008 to monopolise tests for BRCA1 and BRCA2 genetic mutations, including demands that public hospitals cease providing the tests,“ he said.
“Following community outrage, the company withdrew its demands. But there was – and still is – nothing in the law to prevent such a demand being made in the future.”
Failing to change the law now to protect the community from gene monopolies could lead to “a handful of commercial interests owning the genetic materials essential to cancer detection and treatment,” Professor Olver said.
Professor Dianne Nicol, a law expert from the University of Tasmania who had followed the case said the judge “has given a broad reading of the ‘invention’ requirement in Australian law (referred to as manner of manufacture).”
“Using the language from a 1959 case, he says that what is required is an ‘artificially created state of affairs’ and that without human intervention an isolated DNA sequence does not exist outside the cell. This approach was clearly open to the judge to take based on prior cases,” she said.
“However, it does mean that this manner of manufacture requirement has very few teeth. 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.”
Dr Luigi Palombi, director of the Genetic Sequence Right Project at the Australian National University said he was disappointed by both the result and the reasoning used to arrive at it.
“In my view, it turns patent law on its head. The end result is that effectively now anything that’s artificial – and that can be just simply removing something from its natural environment – has the potential to be patented,” he said.
Dr Palombi said the case had far-reaching consequences.
“Effectively, everything in the human body can be considered patentable, the human body is now a commodity. It’s components are a commodity,” he said.
“It’s absurd because patents are about inventions and no one invented the genetic mutations that are linked to breast cancer. Myriad didn’t invent those genetic mutations.”
The ruling reasoned that merely pulling something out of its natural environment qualifies it to be a patent, said Dr Palombi.
“There is no sense of understanding of what patent law is about, there’s no sense of the policy implications, there’s no sense of the consequences of this ruling,” he said.
“I’m just appalled by the decision and I’m hoping now that the government, or that politicians within the parliament will try and address this.”