Australasian Science: Australia's authority on science since 1938

Court Upholds Patent for Breast Cancer Gene

A landmark decision by the Federal Court has upheld the validity of patents on the breast cancer genes BRCA1 and BRCA2, with Cancer Voices Australia and cancer survivor Yvonne D’arcy losing their case against US-based Myriad Genetics Inc and Melbourne-based Genetic Technologies.

“My initial reaction is that the judge has given a broad reading of the ‘invention’ requirement in Australian law (referred to as manner of manufacture). Using the language from a 1959 case, he says that what is required is an ‘artificially created state of affairs’ and that without human intervention an isolated DNA sequence does not exist outside the cell.

“This approach was clearly open to the judge to take based on prior cases. However, it does mean that this manner of manufacture requirement has very few teeth. It is difficult to think of the circumstances where an artificially created state of affairs would not exist whenever there is some form of human intervention.”

Professor Dianne Nicol is a Law Professor at the University of Tasmania. Her research focuses primarily on regulation of the commercialisation of genetic knowledge and patenting of genetic inventions, and on the specific regulatory issues associated with genetic, cloning and stem cell technology.

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“This ruling means that anything that is artificial is now patentable subject matter. It doesn’t matter where the biological material has actually come from. Corporations are now able to patent any genes connected to a disease or trait – like hair colour. It’s a fairly radical decision.

“It turns patent law on its head. Patents were originally created for something which someone had invented. No matter how important it is to identify a gene linked to a disease, it’s still not something that Myriad or anyone else has invented. It’s now a matter for politicians to get together and correct this through legislation.

“The judge has also made orders for costs against the charity and Yvonne. These people had nothing to gain personally from this action and were acting purely from what they saw as public interest. It is unfortunate that our legal system does not have a mechanism for these sort of important public health cases to proceed in a way where these people and organisations are not left to bear such huge costs.”

Dr Luigi Palombi is a patent lawyer and author of Gene Cartels: Biotech Patents in the Age of Free Trade. He is also an academic at the Centre for the Governance of Knowledge and Development at The Australian National University.

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“Discovering and isolating genetic materials is not inventive, yet the current law gives licence to biotechnology companies to claim ownership of naturally occurring substances. Today’s outcome shows that the law must be changed to protect the community from gene monopolies. The catalyst for this case was the attempt by Genetic Technologies in 2008 to monopolise tests for BRCA1 and BRCA2 genetic mutations, including demands that public hospitals cease providing the tests.

“Following community outrage, the company withdrew its demands. But there was – and still is – nothing in the law to prevent such a demand being made in the future. Genetic science will hold the key to major breakthroughs in cancer detection and treatment. If we don’t change the law now to protect the community from gene monopolies, what almost occurred in 2008 could become commonplace – a handful of commercial interests owning the genetic materials essential to cancer detection and treatment.

“Until the law is changed, we are likely to see more of these challenges between cancer consumers and biotechnology companies.”

Professor Ian Olver is CEO of Cancer Council.

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