Recently, we reported on an Australian Patent Office decision – Arrowhead Research Corporation [2016] APO 70 (13 October 2016) (Arrowhead decision), which confirmed that gene-based pharmaceuticals, namely interfering RNA (iRNA) compositions, do represent patentable subject matter in Australia. This decision sets a significant legal precedent in relation to the patentability of iRNA compositions, which were previously considered to be patent ineligible. It also, however, provides important guidance in relation to the patentability of other gene-based inventions. This article considers the broad implications of the Arrowhead decision for the patentability of gene-based inventions generally in Australia.

Background

In 2015, the High Court of Australia[i] ruled against the patentability of isolated human genes, claimed in a patent owned by Myriad Genetics Inc., and useful for determining susceptibility to breast and ovarian cancers. The High Court held that the relevant Myriad claims to isolated naturally-occurring DNA sequences were directed to “genetic information embodied in the arrangement of nucleotides” and that “this information is not made by human action”. As a result, it was considered that the isolated DNA sequences were not patent eligible.

Genetic information and the substance of a claim

The focus of the Australian High Court on “genetic information” rather than a “product of nature” resulted in a finding that artificially-created gene sequences such as cDNA, which arguably embody the same genetic information as a gene sequence that occurs in nature, (i.e. ability to encode a protein) is not patent eligible. The “genetic information issue” also means that currently isolated naturally-occurring material other than genes, for example proteins and microorganisms are patent eligible subject matter in Australia because they do not embody genetic information.

Many commentators consider that the Australian High Court introduced ambiguity into the question of whether gene-based inventions are patentable by stating the importance of “substance over form”. Thus, a critical aspect of current Australian practice is a determination of the substance of a claim; where patent eligibility requires the “substance of the claim” to go beyond what occurs in nature. This is currently a highly contentious issue in Australian law but has been clarified somewhat by the recent Arrowhead decision.

Is my gene-based invention patentable in Australia?

In the Arrowhead decision, it was found that the working of the claimed iRNA compositions (i.e. the substance of the claim) did not solely reside in the naturally-occurring sequence of defined nucleotides. Rather, it was held that the non-naturally-occurring double-stranded RNA architecture of the claimed compositions was at least equally significant to the workings of the invention – with the chemical and structural elements of the double-stranded RNA being crucial. This approach is consistent with another recent determination from the Patent Office in Cargill Incorporated v Dow AgroSciences LLC [2016] APO 43 (5 July 2016) which found that codon-optimised DNA is also patent eligible because although it encodes the same protein as naturally-occurring DNA, it can be expected to enhance production of the protein above that which would be expected from the naturally-occurring sequence.

Conclusion

On the basis of the recent Patent Office decisions discussed above, for a gene-based invention, which is derived from nature, to be considered patent eligible in Australia, it is currently necessary to demonstrate that the workings of the invention rely, at least in part, on a non-naturally-occurring feature of the claimed invention.

Grant Shoebridge is a Principal at Shelston IP and acted on behalf of:

  • Arrowhead Research Corporation in Arrowhead Research Corporation [2016] APO 70 (13 October 2016); and
  • Cargill Incorporated in Cargill Incorporated v Dow AgroSciences LLC [2016] APO 43 (5 July 2016).