By Amanda Tattam, National Media Manager
The granting of patents over naturally occurring biological material has generated a great deal of controversy over the past few decades. There are strong philosophical, economic, scientific and religious objections to the commercialisation of the human body and its genetic material.
Large sections of the medical and scientific community believe that human gene patents can limit or extinguish the rights of other people and organisations to conduct research over a gene or develop new tests and treatments.
In Australia, the Federal Government's patents body IP Australia has been granting patents over isolated human genes for some years - no laws have been passed to specifically allow this, and no Australian court has ever decided whether the practice is legal.
However recently there have been some significant legal developments in Australia and the US in this area.
In June 2010, Maurice Blackburn filed a challenge to determine the legal validity of Australian patent 686004 which covers mutations to the BRCA1 gene which are associated with breast and ovarian cancer. US company Myriad Genetics has held this patent since 1994 and licences its rights in Australia to Australian Company Genetic Technologies Ltd.
The application to the Federal Court of Australia in Sydney was made on behalf of advocacy group Cancer Voices Australia Brisbane woman Yvonne Darcy, who has twice survived breast cancer. The application also had the support of the Cancer Council Australia which is keen for law reform in this area.
The case went to trial over five days in February 2012. On Friday 15 February, 2013, the Federal Court of Australia in Sydney, handed down its decision.
The ruling by Justice Nicholas found that the isolation of the gene from the human body is the product of human intervention and isolated gene sequences are therefore patentable. Justice Nicholas stated that when the isolation of naturally occurring DNA and RNA results in an "artificial state of affairs with a discernable effect", it is longer a product of nature. The result is that the patent of Myriad Genetics Inc and the licence to the patent held in Australia by Genetic Technologies Limited remain in place.
There was widespread disappointment about this decision among doctors, researchers and health consumers, with Cancer Voices and Cancer Council of Australia saying "the law must be changed to protect the community from gene monopolies".
The case is now on appeal to the Full Court of the Federal Court and will be heard in August 2013.
US legal developments
There have been some significant legal developments in US on the patenting of human genetic material. The laws in Australia covering patents are not identical to the US and not binding on an Australian Court, however the legal interpretation of patent law by the US Supreme Court is likely to be of significant interest to the Federal Court of Australia.
In 2010, a US District Court ruled that the same patent which we are challenging was invalid because it was simply not a patentable invention. The US case was hailed as a "major victory for medicine and science innovation". In 2011, the decision was overturned by a 2:1 majority in the US Court of Appeals.
In November 2012, the American Civil Liberties Union filed a further suit alleging that patents on two human genes associated with breast and ovarian cancer were unconstitutional and invalid. The Supreme Court agreed to hear argument on the issue in 2013.
On 13 June 2013, the US Supreme Court finally settled the matter ruling unanimously that naturally occurring DNA in genes cannot be patented. The court also ruled that synthetic DNA (such as the cDNA for the BRCA1 and 2 genes) is patentable.
Why is Maurice Blackburn involved in this issue?
Our firm has a long and proud tradition of representing groups and individuals pro bono in public interest litigation as part of our Social Justice Practice.
The firm acknowledges that many people in society cannot afford to take on powerful interests with deep pockets and that laws should work for community and consumer benefit. Monopolies granted patents are of enormous public interest when they relate to human genes.