In a recent Australian Patent Office (APO) decision dated 13 October 2016, a Delegate of the Commissioner of Patents (the Delegate) held that a subset of claims in an application filed by Arrowhead Research Corporation (Arrowhead), which were directed to a type of double stranded nucleic acid (structurally similar to DNA) called `interfering RNAs' (iRNAs), were a manner of manufacture.
The claimed iRNAs operate by silencing the expression of `spleen tyrosine kinase' (Syk). This is of clinical significance because the signalling pathways mediated by Syk, if activated, can lead to a number of inflammatory responses and diseases.
The patent examiner had found that, in light of the High Court's decision in Myriad, the substance of the claimed invention was genetic information, since the nucleotide sequence embodied in the iRNA is the same as the target sequence which is part of the genome of the organism. Therefore, the genetic information conveyed by the claimed iRNAs had not been changed from that which occurs in nature.
The Delegate however found that while the genetic information conveyed by the iRNAs is an important element in the claimed invention, the structural and chemical elements of the composition's RNA `architecture' are at least equally significant because they facilitate the recognition and subsequent breakdown of the relevant molecule as part of the RNA interference process. The Delegate accordingly concluded that in contrast to the claims in issue in Myriad to isolated nucleic acids per se, the substance of the invention here was a pharmaceutical composition encompassing informational, structural and chemical elements, rather than merely the genetic information conveyed by a molecule. The Delegate held that the invention therefore involved a manner of manufacture, and consequently, was patentable subject matter.
This decision of the APO provides insight into how the Myriad decision is being interpreted by the APO, highlighting, in particular, the pertinent considerations of:
1. what is the substance (rather than form) of the invention claimed; and
2. whether the substance of the invention merely encompasses information, or whether other elements, such as structural and chemical features assume sufficient significance to render the invention patentable subject matter.