In its recent D’Arcy v Myriad Genetics Inc (Myriad) decision, the Australian High Court ruled that claims directed to isolated BRCA nucleic acids were patent ineligible. Since then there has been much speculation on how this decision would be interpreted by the Australian Patent Office. In particular, many in the industry were concerned that the Australian Patent Office would, by analogy to developments at the US Patent and Trademark Office (USPTO), extend the court’s findings to exclude all isolated biological materials.
Following public consultation, new examination guidelines have been issued by the Australian Patent Office, which apply immediately to pending applications. These guidelines state that “the law is to be applied on a case by case basis taking into account the principles and approach taken by the High Court“, and that it is useful for Examiners 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 it “artificial”?
- Does the invention have economic utility?
- Does the invention as claimed represent a new class of claim?
Based on Myriad, the guidelines state that isolated naturally occurring nucleic acids1 are excluded from patentability. In addition, the following nucleic acids are excluded where they “merely replicate the genetic information of a naturally occurring organism“: cDNA and synthetic nucleic acids, probes and primers and isolated interfering/inhibitory nucleic acids. However, the guidelines state that “Subject matter of this type may be patentable where utility of the invention lies in genetic information that has been “made” “(e.g. non-naturally occurring chimeric nucleic acid)“.
The guidelines also provide examples of biotech inventions that are not excluded from patentability, namely: recombinant or isolated proteins, pharmaceuticals and other chemical substances, methods of treatment, methods of applying herbicides and applications of computer technology. The guidelines also note that there are significant factors supporting eligibility of plants and micro-organisms.
Patent applicants will, on the one hand, be relieved that the Australian Patent Office has not excluded all isolated biological materials from patentability. However, on the other hand, the ban on patenting isolated naturally-occurring nucleic acids will make the protection of biotech inventions more challenging in Australia. It will be interesting to see how these guidelines are implemented by examiners as well as how the case law develops over the coming years.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.