In the wake of the High Court of Australia decision in D’Arcy v Myriad Genetics Inc. (see our report) handed down on 7 October 2015 IP Australia has issued a Consultation Paper in which it outlines how it intends to modify its examination practice. It is pleasing to note that IP Australia has at least at this stage adopted a relatively narrow interpretation of the decision based upon what it interprets as the primary finding of the Court, namely that “a claim to an isolated nucleic acid that merely represents information coding for a polypeptide is not patent eligible”. As a result, the examination practice of IP Australia is proposed to be altered such that claims directed to the following will not be considered patent eligible.

  • Naturally occurring (human) nucleic acid sequences encoding polypeptides or functional fragments thereof - either isolated or synthesised;
  • Naturally occurring (non-human) nucleic acid sequences encoding polypeptides or functional fragments thereof - either isolated or synthesised;
  • cDNA;
  • Naturally occurring human and non-human coding RNA - either isolated or synthesised.

Although there is considerable conjecture about the possible impact of the High Court decision in future patent litigation, and at least some commentators suggest that the effect of the decision should be limited to a prohibition on patent protection of naturally occurring human nucleic acids, the proposed IP Australia examination approach is practical and sensible. The proposed examination approach will be generally welcomed by industry, which requires certainty around patent protection to continue investment in important biotechnology and healthcare innovation.

The Consultation Paper can be viewed at here and comments on the proposed practice change can be made up until Friday 6 November, 2015.