Scintilla – a flash, a spark, an iota. Shorthand for creativity and an indicator of inventiveness under Australian law.

Thursday, September 18, 2014

High Court may consider patentability of isolated genetic material

By Dr Tony Shaw, Patent Attorney and Associate

We reported here and in our recent Focus article that the Full Federal Court in D'Arcy v Myriad Genetics Inc (D'Arcy) handed down a unanimous decision confirming the decision in the first instance decision, Cancer Voices Australia v Myriad Genetics Inc (Cancer Voices) that genetic materials in their isolated form are patentable in Australia.

The Myriad patent at issue (AU 686004) claims isolated nucleic acids having particular mutations in the BRCA1 gene associated with a predisposition to breast and ovarian cancers. The patent also claims to tests for predisposition to breast and ovarian cancers which are based on detecting those mutations. As correctly stated in D'Arcy, the patent does not claim the genetic code nor claim genes or nucleic acids present in a cell or human body:
'What is claimed is an isolated nucleic acid, a chemical molecule characterised in a certain way, which is chemically, structurally and functionally different to what occurs in nature.'
The judgments in D'Arcy and Cancer Voices have been consistent in the application of Australian patent law in deciding that 'isolated nucleic acids' are patentable subject matter.

As foreshadowed, Ms D'Arcy's lawyers have now filed an application for leave to appeal the D'Arcy decision to the High Court. Ms D'Arcy is seeking leave to appeal on a number of grounds including that the Full Court erred in:

  • holding that 'an isolated nucleic acid' is patent eligible;
  • holding that the isolation of the nucleic acid was sufficient to render the claims as being claims to an 'artificially created state of affairs for economic benefit' and hence to a manner of manufacture;
  • holding that the 'information that the gene encodes' is not relevant in determining patent eligibility; and
  • preferring the reasoning of the US Federal Circuit in Association for Molecular Pathology v US Patent and Trademark Office rather than the US Supreme Court's reasoning in Association for Molecular Pathology v Myriad Genetics.

Keep an eye on Scintilla and the Allens website for details on whether leave to appeal will be granted and the High Court will consider this issue.

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