IP Australia has released its revised examination practice following the High Court ‘gene patents’ decision in D’Arcy v Myriad. The practice applies immediately to pending applications.
In considering the principles and approach taken by the High Court, the examination practice sets out that it is useful to ask:
- 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?
Where the substance of a claimed invention falls within an established category, is for a product made, or a process producing an outcome as a result of human action, and has economic utility it will meet the basic manner of manufacture requirement.
Following the High Court’s decision claims to isolated naturally occurring nucleic acid molecules (whether DNA/RNA, human or non-human, or coding or non-coding) and considered to be clearly excluded (because in substance they can only be considered as a claim to genetic information that is not “made”). Claims to the following are considered to be excluded where they merely replicate the genetic information of a naturally occurring organism:
- cDNA and synthetic nucleic acids.
- Probes and primers.
- Isolated interfering/inhibitory nucleic acids.
Subject matter of this type may be patentable where the utility of the invention lies in genetic information that has been “made” (e.g. non-naturally occurring chimeric nucleic acid).
Other biological inventions should be considered according to the same general principles set out in the guidelines. If what is claimed properly falls within the requirements for existing categories of products and processes (e.g. is not for or merely replicates the genetic information of a naturally occurring organism) it will be patent eligible.