The full bench of the Federal Court of Australia has ruled that private companies do have the right to patent human genes.
The court upheld a decision from February 2013 that ruled patents on breast cancer genes were valid because the method of isolating the gene created something new and could therefore be patented.
Last year, Cancer Voices Australia and cancer survivor Yvonne D’Arcy lost their case against US-based Myriad Genetics Inc and Melbourne-based Genetic Technologies when the Federal Court upheld the validity of patents on the breast cancer genes BRCA1 and BRCA2.
D’Arcy and Cancer Voices Australia argued that there is no significant difference between genetic material in its natural and isolated states, and that letting private companies patent components of the genes, whether isolated or not, will stifle Australian research and lead to far higher costs for patients in need of potentially life-saving tests.
In June 2013, the US Supreme Court ruled against human gene patenting, further provoking debates on whether Australia should accept or reject D’Arcy and Cancer Voices Australia’s appeal.
According to the Ministry of Health, breast cancer is New Zealand’s third most common cancer and accounts for more than 600 deaths every year.
Our colleagues at the Australian SMC collected the following expert commentary. Feel free to use these quotes in your reporting. You can also find information and commentary on the US Supreme Court ruling here. If you would like to contact a New Zealand expert, please contact the SMC (04 499 5476; email@example.com).
Dr Luigi Palombi, patent lawyer and Adjunct Professor in the School of Law at Murdoch University and author of “Gene Cartels: Biotech Patents in the Age of Free Trade”, comments:
“The decision ignores the bedrock principle of 400 years of patent law. Only an invention can be the subject of a patent. The decision ignores the scientific facts. It ignores good policy. And it ignores common sense. Australian ingenuity in the biological sciences is now handcuffed by this decision.
“How is it possible that the U.S. Supreme Court unanimously came to the exact opposite result in only three months? Despite the attempt by the Full Federal Court to try and differentiate the precise claims between the Australian and U.S. patents that Myriad has over the BRCA 1 genetic mutations, the so-called invention is the same.
“At the end of the day, the Australian patent claims pieces of genetic material (BRCA 1 gene mutations) extracted from the human body are an ‘invention’. How is that something anyone invented? American scientists, universities and companies now have the freedom to ignore patents over isolated biological materials that are not ‘markedly different to any found in nature’, but Australian scientists, universities and companies cannot. This decision reinforces the need for the Australian parliament to change patent law in Australia.”
Paul Grogan is Director of Advocacy at Cancer Council Australia, comments:
“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.
“Australian women were only protected from an attempted commercial monopoly over the BRCA1 and BRCA2 tests in 2008 because the company that threatened to take those tests away from public laboratories withdrew its patent claims voluntarily.
“There was nothing in the law to protect healthcare consumers from the monopolisation of those diagnostic tests – and there still isn’t.
“The ruling puts Australia out of step with the US, where the Supreme Court invalidated the Myriad patents.
“If the difference is in the way Australian patent law is interpreted, then there is a strong case to change the law. The patents system should reward innovation and help deliver affordable healthcare, not stymie research and increase costs by allowing commercial entities to control the use of human genetic materials.”