Following the unanimous decision of the Full Federal Court of Australia to uphold the patentability of isolated nucleic acids in D’Arcy v Myriad Genetics Inc.  FCAFC 115 (see our article of 5 September 2014), the High Court of Australia has today granted Special Leave to Appeal to Ms D’Arcy.
The decision of the Full Federal Court rested on whether isolated nucleic acids are capable of defining a manner of manufacture according to the principles laid down by the High Court in NRDC (1959) 102 CLR 252. Ms D’Arcy contested the decision on the basis that isolating a gene from the human body is not a form of “manufacture”, but rather constitutes a product of nature, as determined by the US Supreme Court.
While the Full Federal Court was critical of the US Supreme Court’s decision to deny the patentability of isolated nucleic acids, the High Court considers the question to be one of such importance as to require a definitive resolution. After a unanimous decision of 5 judges in the Federal Court, the decision by the High Court to hear this matter clearly signals that they believe this this subject is worth serious reconsideration.
A decision by the High Court adverse to Myriad could have devastating consequences for the biotechnology industry in Australia, which relies heavily on the revenue generated by patents to fund research and development.