The Australian Patent Office has now finalised what will be their approach to examining nucleic acids and other biological inventions following the decision handed down by the High Court in D'Arcy v Myriad Genetics Inc [2015] HCA 35 in October, and a consultation process on their earlier proposed examination practice.

The guidelines

The patent office has developed 4 questions to be applied on a case by case basis:

  • What is the substance of the claim (not merely its form)?
  • Has the substance of the claim been "made" or changed by man, or is "artificial"?
  • Does the invention have economic utility?
  • Does the invention as claimed represent a new class of claim?

Accompanying the questions in the guidelines is a list of relevant factors to be considered. 

Excluded subject matter

Despite the ‘case by case’ approach, the patent office has made a definitive statement that the following subject matter is excluded from patentability:Isolated naturally occurring nucleic acid molecules whether:

  • DNA or RNA
  • Human or non-human
  • Coding or non-coding

And that the following subject matter may be excluded unless it can be shown that the utility of the invention lies in genetic information that has been made and not that they merely replicate the genetic information of a naturally occurring organism:

  • cDNA and synthetic nucleic acids
  • Probes and primers
  • Isolated interfering/inhibitory nucleic acids

This approach is going to permit broader claims than it appears the USPTO will currently allow. But it is going to require more analysis of any given claim and a consideration of its merits in accordance with the 4 questions.

The full guidelines can be found at:'ArcyvMyriad-Genetics-Inc/