A significant decision has been handed down by the Full Bench of the Federal Court of Australia today in regards to intellectual property and the human body. The decision centres around the BRCA1 gene mutation, commonly known as the ‘breast cancer gene’. In a landmark decision the court has found that a private company is within its rights to hold a patent over this gene.
The case dates back to 2010 when genetic research companies first tried to patent the gene mutation. At the time Cancer Voices Australia challenged this, however the court found that a private company could in fact patent the gene mutation. Cancer Voices Australia appealed this decision and today’s ruling upholds the original decision of the court.
The court has ruled that an isolated genetic material, in this case the BRCA1 gene mutation, can be patented in Australia after it’s removed from the body.
The decision has already caused uproar in the scientific community, with experts voicing their concerns that it could lead to a derailment of research into this gene mutation and have further wide reaching repercussions for other scientific breakthroughs.
Patent lawyer and Adjunct Professor in the School of Law at Murdoch University, Dr Luigi Palombi, voiced his concerns at the ruling, stating:
“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.”
While Paul Grogan, who is the Director of Advocacy at the Cancer Council Australia, has said that the ruling creates the risk of private companies holding “gene monopolies” that could end up hurting those in need of treatment.
There is widespread anger amongst cancer survivors and advocates as the decision of the Court effectively gives the right for private companies to control human genes.
On the other side of the equation though supporters of the decision say that the decision is a fair reflection of the work done by biotechnology companies and may lead to further investment by foreign companies into Australia in the research of the gene.
Patent and Trademark Attorney Bernadette Hawkins was not surprised by the verdict, stating:
"That isolation [of the gene], does produce something that is not inherent in the human body, it is a different structure in the sense it is not surrounded by the things it is in the cell with. This decision is also certainly not going to stifle research and innovation in this field, in fact, I wonder if we will see more US companies starting to try to commercialise things here".
The decision is hard to fathom though, as the basic principle of patent law is that in order for something to be patented it must be ‘invented’. It seems odd that the Court has found that a piece of naturally occurring genetic material can be patented as an ‘invention’.