When the Australian High Court recently ruled against the patentability of an isolated naturally-occurring gene sequence, many anticipated that all isolated naturally-occurring material would become patent ineligible. Today, however, the Australian Patent Office has released its much anticipated revised examination guidelines, which indicate that isolated naturally-occurring material such as proteins and micro-organisms remain eligible for patent protection in Australia. A copy of the revised examination guidelines can be found here.
The new guidelines emphasise that patent eligibility should be considered on a case-by-case basis bearing in mind:
- The substance of the claim;
- Has the substance of the claim been “made” or changed by man, or is “artificial”?;
- Does the invention have economic utility?; and
- Does the invention as claimed represent a new class of claim?
Specifically, the guidelines list the following subject matter as being excluded from patentability:
Isolated naturally occurring nucleic acid molecules whether:
- DNA or RNA.
- Human or non-human.
- Coding or non-coding.
Claims to the following are 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.
Interestingly, the guidelines suggest ambiguously that “it is not enough that the subject matter of the claims is artificial”. This no doubt relates to claims that cover cDNA which, as indicated above, are artificial but nonetheless are not considered patent eligible when they replicate the genetic information of a naturally-occurring organism. This potentially introduces a clarity issue into the new guidelines because cDNA in many cases does not replicate naturally-occurring genetic information because of either differential splicing and/or the deletion of introns. Accordingly, there is an opportunity to argue that artificial nucleic acid sequences derived from nature such as cDNA are patent eligible.
The new guidelines also state that technical subject matter that has been previously considered by Courts without rejection include:
- Recombinant or isolated proteins;
- Pharmaceuticals and other chemical substances;
- Methods of treatment;
- Methods of applying herbicides; and
- Applications of computer technology.
Moreover, the guidelines state that claims directed to plants and micro-organisms should be examined against normal requirements including whether what is in substance claimed is “made”.
The revised Patent Office Examination practice will no doubt be challenged by those who believe that the High Court decision should be interpreted more broadly to exclude from patentability isolated proteins and micro-organisms and Shelston IP will keep you promptly informed in this regard.