The High Court of Australia has unanimously ruled that isolated naturally occurring nucleic acids are not patentable subject matter in Australia.  This decision overturns the earlier ruling of the Federal Court and the unanimous decision of the Full Federal Court.

The present case results from a legal challenge to Myriad’s Australian patent, 686004 from breast cancer survivor, Yvonne D’Arcy.  Commentary in relation to the primary Federal Court decision can be found here and the Full Federal Court decision can be found here.

KEY POINTS

  • This decision will not reduce the cost of genetically-based diagnostic tests in Australia.
  • This decision does not enhance the ability of medical researchers to innovate in Australia.
  • There is uncertainty whether this decision will impact the patentability of isolated naturally-occurring molecules other than genes.
  • The patentability of non-naturally occurring gene sequences in Australia is not affected by this decision.

Under Australian law, patent eligibility is guided by the principles of the High Court’s decision in National Research Development Corporation v Commissioner of Patents (‘NRDC’) [1959] HCA 67. In that landmark decision, it was held that subject matter was considered patent eligible if it was “an artificially created state of affairs” having “economic significance”.

In reaching its decision, the High Court agreed with D’Arcy’s arguments that the relevant claims to isolated naturally occurring nucleic acids were directed to “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 naturally occurring nucleic acids defined in the relevant claims did not represent an artificially created state of affairs, and were therefore not patentable.

Some reports suggest that as a result of the High Court decision artificially synthesised nucleic acids, such as cDNA, may also be excluded from patentability. The reasoning is that the information embodied by such artificially created nucleic acid sequences is replicated by the naturally occurring sequence of DNA coding regions.  This appears to demonstrate the High Court’s lack of understanding in relation to the technical aspects of this case.  The fact is, the arrangement of coding regions in cDNA is not replicated in nature.  As such, there is at least an argument that artificially created nucleic acid sequences, such as cDNA remain patent eligible because information in such nucleic acid sequences is “made by human action”.

In reaching its decision, the High Court seemed to be motivated to rule against the patentability of isolated naturally occurring genes in view of the breadth of the relevant claims, stating somewhat emotively that “[t]here is a real risk that the chilling effect of the claims would lead to the creation of an exorbitant and unwarranted de facto monopoly on all methods of isolating nucleic acids” containing the relevant BRCA sequences and reiterating that the claims could have a “chilling effect” on innovation. It is unfortunate the High Court was not familiar with the independent report on the economics of gene patents in Australia prepared by the Centre for International Economics as this report confirmed patents play a key role in promoting innovation and the public-private partnerships required to bring new human gene-based medicines and diagnostics to market.

A number of commentators have reported that the decision is consistent with the Myriad US Supreme Court decision. It is not yet clear whether the Australian decision will impact the patentability of isolated biological materials other than genes, as did the US Supreme Court decision.