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Australia: Court upholds patents to isolated genes

The Full Federal Court, in D'Arcy v Myriad Genetics Inc, has unanimously decided to specifically diverge from the opinions of the US Supreme Court in the corresponding US Myriad case, in holding that isolated genetic/biological material can be patentable subject matter.

The patent claims related to isolated nucleic acids encoding mutant or polymorphic BRCA 1 polypeptides, which are linked to breast and ovarian cancer. The appellant argued that such claims were not to patentable subject matter.

The Court considered a number of factors, including that patent boundaries must continually develop with society, human intervention to create an artificial state of affairs is essential, and expressions such as "work of nature" are unhelpful in deciding these issues. A further factor was that the legislature had failed to enact any restrictive legislation in the area despite a number of inquries.

The Court stated that the unique chemical and physical makeup of an isolated nucleic acid rendered it not only artificial but also different from its natural counterpart and the isolation of a nucleic acid led to an economically useful result – in this case, the treatment of breast and ovarian cancers.

The Federal Court stated "with respect, the Supreme Court's emphasis on the similarity of 'the location and order of the nucleotides' existing within the nucleic acid in nature before Myriad found them is misplaced. It is the chemical changes in the isolated nucleic acid which are of critical importance, as this is what distinguishes the product as artificial and economically useful". The Court's view was that "following Chakrabarty and NRDC, the isolated nucleic acid has 'markedly different characteristics from any found in nature'; Myriad did not merely 'separate that gene from its surrounding genetic material'. Myriad's claim, properly considered is not, as the US Supreme Court considered, concerned 'primarily with the information contained in the genetic sequence [rather than] with the specific chemical composition of a particular molecule'".

Ultimately, it was found that the isolated nucleic acid had resulted in an artificially created state of affairs for economic benefit which was patent eligible subject matter.

Peter Treloar

Shelston IP
Level 21, 60 Margaret Street
Sydney NSW 2000, Australia
Tel: +61 2 9777 1111
Fax: +61 2 9241 4666



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