Cancer advocates will appeal to the High Court to overturn a controversial decision that human genes can be controlled by private companies.
Two weeks ago a full bench of the Federal Court unanimously upheld a decision by Justice John Nicholas that a patent on the so-called “breast cancer gene”, BRCA1, should be allowed.
Late on Tuesday Maurice Blackburn lawyers launched an application for special leave to appeal to the High Court on behalf of Yvonne D’Arcy.
Ms D’Arcy has survived two bouts of breast cancer and ovarian cancer.
The structure of the protein produced by the so-called “breast cancer gene”, BRCA1.
She launched the case against Myriad Genetics and Genetic Technologies last year over fears of the potential rise in costs to cancer patients if genes are patented.
“We need to continue for future generations of people who at some point in their life may need treatment for cancers and other diseases,” Ms D’Arcy said when the case was first taken to the Federal Court.
The loss in the Federal Court was a win for the US owner of the patent, Myriad Genetics, which has invested hundreds of millions of dollars in research and development for BRACAnalysis technology, and Genetic Technologies, which owns the right to the patent in Australia.
Maurice Blackburn’s appeal to the High Court claims that the Federal Court was wrong to decide that the process of isolating the gene from the human body constituted a form of manufacturing something, which could be patented. Naturally occurring products can not be patented under Australian law.
It also says that the decision from the full bench to overturn Justice Nicholas’ ruling that isolated nucleic acids, which are large biological molecules such as DNA, are chemically, structurally and functionally different to DNA inside the human body was also wrong.
Rebecca Gilsenan, the principal lawyer at Maurice Blackburn, said the issue was of huge public importance.
“It has significance for access to genetic testing, research and the development of treatments for diseases suffered by millions of Australians,” she said. “This is the final avenue of appeal for Ms D’Arcy and the cancer community which have been strongly critical of the decision.”
She was surprised that the appeal was overturned in light of the US Supreme Court’s ruling that genes were not patentable.
In June the US Supreme Court found that the isolated gene was the same as had occurred in nature, in effect overturning thousands of patents that had been granted on human genes in that country.
“Myriad did not create anything,” US Supreme Court Justice Clarence Thomas said. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
“Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the requirements for winning a patent.”
Lisa Taliadoros, a partner of legal firm Jones Day, which represents Myriad, said it was wrong to conceptualise the patent as one company owning “a person’s own DNA”.
“Rather, the court held that Myriad was entitled to a patent for an isolated nucleic acid that is artificial and ‘leads to an economically useful result – the treatment of breast and ovarian cancer’,” she said.
The High Court will now decide whether or not to accept the appeal.
What is the “breast cancer gene”?
BRCA1 is a “tumour suppressing” gene, which works in the breast and other tissues to fix damaged DNA and destroy cells that cannot be repaired.
When it mutates, that process doesn’t work properly, and the increase in damaged DNA increases the chance a carrier will get cancer.
The patent granted to Myriad is for a number of mutations in a gene known as BRCA1, which are linked to an increased risk for breast and ovarian cancer.
Myriad used the mutations to develop a test to establish a person’s risk of hereditary breast and ovarian cancer.
Since the patent was granted, a number of other mutations that also increase a person’s risk have been found.
with Amy Corderoy