High Court to consider gene patents: D’Arcy granted leave to appeal
On the 13 February 2015 the High Court of Australia granted special leave to appeal the decision of the Full Federal Court in D’Arcy v Myriad Genetics Inc  FCAFC 115 (see our article dated 8 September 2014) where it was unanimously held that isolated nucleic acids were patentable in Australia.
The High Court now has the opportunity to reconsider the decision of the Full Federal Court and determine whether or not a naturally occurring nucleic acid that has been isolated is patentable. The appellants submitted that isolated and naturally occurring nucleic acids are functionally similar, as both molecules retain the capability to “encode” a polypeptide. Consequently, it is argued that there is no relevant difference between the isolated nucleic acid and its naturally occurring counterparts.
The reliance on the function and utility of isolated nucleic acids in submissions made by the appellant drew strongly upon the reasoning of the U.S. Supreme Court in Association for Molecular Pathology v Myriad Genetics Inc, where it was unanimously held that naturally occurring DNA molecules are a product of nature, which are not patentable subject matter by virtue of the fact of having been isolated.
The focus of the U.S. Supreme Court was directed to the information contained within the nucleic acid sequence. By contrast, the Full Federal Court emphasised that isolated nucleic acids should be considered as chemical compositions that are distinct from their naturally occurring counterparts. Applying the decision of the High Court in National Research and Development Corporation v Commissioner of Patents (NRDC), the Court held that the isolated nucleic acid was, in itself, an artificial state of affairs that is associated with economic utility, therefore satisfying the requirements for patentability. Importantly, the Court recognised that the utility of a naturally occurring nucleic acid within a cell and bonded to other genetic material or regulatory proteins was quite distinct to that of an isolated nucleic acid molecule, which can be used across a broad range of technical applications.
The appeal to the High Court of Australia is to be heard in April 2015, with a decision expected in late 2015. The outcome of this appeal is eagerly anticipated by the Australian biotechnology community.