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Friday, September 5, 2014

Isolated genetic material confirmed as patentable

By Dr Tony Shaw, Associate and Patent Attorney

In a unanimous decision handed down today in D'Arcy v Myriad Genetics, the Full Federal Court, comprising a full bench of five judges, has dismissed the appeal from the decision of Justice Nicholas in Cancer Voices v Myriad Genetics and confirmed that genetic materials in their isolated form remain patentable in Australia.

As we have previously reported here, in Cancer Voices v Myriad Genetics Justice Nicholas found isolated nucleic acids to be a 'manner of manufacture' as required by the Patents Act 1990 and therefore patentable subject matter. Applying the High Court's decision in the landmark NRDC case, his Honour held that isolated nucleic acids consist of 'an artificial state of affairs, that has some discernible effect, and that is of utility in a field of economic endeavor' and are patentable. Relevantly, Justice Nicholas noted that NRDC does not require the court to ask whether a composition of matter is a 'product of nature' for the purpose of deciding whether or not it constitutes patentable subject matter.

The appeal centered on claim 1 of Australian Patent No 686004:
1. An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.
The Full Court rejected D'Arcy's arguments and found the isolated nucleic acid of claim 1, including cDNA, is 'an artificially created state of affairs for economic benefit' and that '[t]he claimed product is properly the subject of letters patent'. Accordingly, the appeal was dismissed.

Importantly, genes and other biological materials in their natural state in human cells or in a person's body are not, and have never been, patentable.

The decision will be welcomed by the Australian biotechnology industry and should give comfort to patients that new diagnostics and medical treatments will continue to be developed and commercialised in Australia. As the lawyers for D'Arcy have indicated that they will fight it 'to the end', flagging a potential appeal application to the High Court of Australia, today's decision may not be the last.

Keep an eye on the Allens website for a forthcoming Focus publication analysing the reasoning in more detail.

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