The recent Meat & Livestock Australia Limited v Cargill, Inc (MLA) Federal Court decision has brought the significant differences that exist between Australian and US “gene patent” practice into sharp focus. These differences predominantly arise from the peculiarities of the US and AU Myriad decisions as well as the US Mayo v. Prometheus and Ariosa v. Sequenom decisions.

In considering the patent eligibility of isolated naturally-occurring gene sequences, the Australian High Court focussed predominantly on the concept of “genetic information”. Consequently, when the High Court ruled against “gene patents”, the decision excluded from patent eligibility only isolated naturally-occurring gene sequences and non-naturally occurring gene sequences that encompass naturally-occurring genetic information – including artificially created sequences such as cDNA. Under the High Court decision, isolated products of nature other than gene sequences (such as proteins and micro-organisms) remain patent eligible in Australia because they do not encompass naturally-occurring genetic information. This situation contrasts with the outcome of the US Supreme Court Myriad decision, which resulted in all isolated products of nature being excluded from patent eligibility including, gene sequences, proteins and microorganisms, but not artificially-created gene sequences such as cDNA.

The Australian Myriad decision did not consider the patentability of claims directed to the practical applications of gene sequences. Such claims, however, have generally been confirmed as patent eligible by the recent MLA decision. This contrasts with the US Sequenom v. Ariosa decision where a claim directed to a method of identifying a correlation between a gene sequence and fetal abnormalities was considered ineligible for patent protection, applying the Supreme Court Mayo v. Prometheus decision.

The differences between US and Australian practice are conveniently summarised in the following table. Notably, Australian law in relation to the patentability of gene-based screening methods may evolve after a decision issues in our Sequenom and Ariosa case, which is set down for a hearing in August 2018. Shelston IP will keep you promptly updated in this regard.

Exactly what gene-based inventions are patentable in Australia and the US?

Isolated naturally-occurring gene sequences No No
Isolated naturally-occurring gene sequences having modified nucleotides Yes Dependent on whether the modification contributes to the working of the invention
Codon-optimised gene sequences Yes Yes
cDNA Yes No
Interfering RNA molecules Yes Yes
Isolated naturally-occurring proteins No Yes
Isolated micro-organisms No Yes
Gene-based screening methods for diagnosis/prognosis Limited Yes