The Full Bench of the Federal Court of Australia has today decided that a private company is within its rights to hold a patent on a specific mutation in a breast cancer gene, which experts say could lead to a derailment of research and an eventual cure.
The case began way back in 2010 and saw Cancer Voices Australia challenge genetic research companies which sought to hold exclusive licenses for doing tests on the gene in Australia. The Federal Court had previously ruled that the gene could be patented, leading to an appeal by Cancer Voices Australia.
The Federal Court today ruled against the appeal, saying that isolated genetic material, namely the BRCA1 gene mutation, can indeed be patented after it's removed from the body.
Experts have panned the Federal Court's ruling, warning that it may seriously hamper cancer research in this country.
Patent lawyer and Adjunct Professor in the School of Law at Murdoch University, Dr Luigi Palombi, is baffled by the Australian court's decision, when courts in the US went the opposite way. He has said today that Australia needs to change its patent law so that medical breakthroughs like the BRCA1 gene cannot be patented and kept from other research projects:
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.
Paul Grogan is the Director of Advocacy at the Cancer Council Australia, and said that the ruling risks creating "gene monopolies" that could end up hurting those in need of treatment in Australia:
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.
Law firm Maurice Blackburn hasn't ruled out a challenge in the High Court. [SMH]