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.

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“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...

The full text of this article can be purchased from Informit.

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