Australia's highest court will decide whether isolated molecules of DNA linked to a gene mutation associated with an increased risk of hereditary breast and ovarian cancers are patentable under Australian law.
The hearing at the High Court, which started on 16 June, is the final appeal against a decision made by the Federal Court of Australia in December 2013, which ruled that patents held by the US biotechnology firm Myriad Genetics over the BRCA1 gene were valid (see BioNews 693).
The federal court upheld this ruling in September 2014 (see BioNews 770), saying that the patents were valid because isolating the gene in question requires human intervention.
The patents have been held in Australia by Myriad Genetics since the late 1990s and relate to mutations in the BRCA1 gene. People with a mutation in one of the BRCA1 or BRCA2 genes have a risk of developing breast cancer of between 50 and 85 percent.
The patents mean that genetic tests to look for BRCA1 mutations can only be carried out in Australia by Myriad Genetics and its licensee, Genetic Technologies, which advocacy group Cancer Council Australia argues increases their price and affects research. Supporters of the patents maintain, however, they are needed to attract funds so a product can reach the market.
Yvonne D'Arcy, who has twice been treated for breast cancer, brought the case with campaign group, Cancer Voices Australia. Her lawyer, Rebecca Gilsenan of law firm Maurice Blackburn, told ABC News: 'The crux of the argument that we'll be putting to the High Court in Australia is that a human gene, merely by the fact that it's isolated from the human body, is not an invention.
'We say that it's a discovery... discoveries are not patentable subject matter; inventions are.'
Lisa Taliadoros, a lawyer acting for Myriad Genetics, which has not to date enforced its BRCA patent rights in Australia, told Sky News after the last ruling: 'The claims relate 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.'
The previous decisions of the Australian courts contrast with the US Supreme Court's ruling in 2013 that human genes in their natural form cannot be patented, since they are a 'product of nature'. The Supreme Court rejected a number of patents held by Myriad Genetics (see BioNews 709), but upheld others relating to synthetically created DNA sequences.
'The fact that scientists and companies interested in developing new diagnostics and treatments in the US can do that without negotiating through a maze of gene patents gives them a distinct advantage', he said.
A decision from Australia's High Court is expected within days.