A decision is expected later this year from the Australian High Court in D’Arcy v Myriad Genetics Inc. This case is essentially equivalent to the US Myriad Supreme Court case and thus will provide a definitive judgment in relation to the patentability of isolated genes in Australia, which the lower courts have unanimously found to be patentable. The decision will most likely be the final chapter in the gene patent debate in Australia that over the last seven years has included two Senate Inquiries, private members’ Bills and two Federal Court decisions.

Despite the unanimity of six Federal Court Judges in deeming isolated genes patentable, the High Court granted special leave to appeal the decision of the Full Court of the Federal Court.

The High Court’s decision has the potential to affect the biotechnology sector, as well as impact on patentability standards more broadly. For example, as seen in the US, an adverse decision for Myriad may impact the patentability of all isolated biological material.

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”.

Given the relevant principles of patentability, the issues considered by the High Court during the two-day hearing included the construction of the relevant claims and whether the test for patentability requires an association between an invention’s artificialness and its economic use.

In regard to claim construction, the relevant claim in the Myriad patent defines,

An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.

Queen’s Counsel appearing for D’arcy, David Catterns QC, argued that since the relevant claims refer to nucleic acid molecules “coding for” a polypeptide, the claims define sequence information and, that sequence information is identical whether or not the defined nucleic acid molecule is inside a cell or isolated. Mr Catterns also submitted that isolated nucleic acids without any limitation to a useful application are claims to products of nature and should be excluded from patentability. The full bench of seven High Court Judges appeared to be receptive to the arguments presented by Mr Catterns.

In contrast, the High Court Judges were far more interrogative of Myriad’s barrister, Mr David Shavin QC, who argued that the claims in question refer to isolated chemical molecules and, on that basis, define an artificially created state of affairs.  Mr Shavin also submitted that there was nothing in the statute which requires a claim directed to a composition to define the composition’s usefulness (economic utility), which is typically described in the patent specification. Mr Shavin also made submissions in relation to the desired current consistency of Australia’s patent laws with its major trading partners and the Australian Parliament’s repeated decisions not to exclude isolated genes and other biological material from patent eligibility.

The High Court Judges repeatedly queried Mr Shavin in relation to how the isolated nucleic acids defined in the claims were associated with their “economic significance”. The Judges appeared to take the position that the utility of the claimed isolated nucleic acids resided in the sequence information rather than their state of being isolated. If the High Court holds this line in its decision and D’Arcy’s appeal is allowed, there is a possibility that patent eligibility would require a nexus between an invention’s economic utility and its artificialness. At this stage, there is uncertainty how such a decision may impact on the patentability of other isolated biological material such as isolated proteins used, for example, as pharmaceutical agents.

If, on the other hand, the High Court dismisses D’Arcy’s appeal, those opposed to gene patents will almost certainly attempt to have new legislation introduced into the Patents Act, specifically excluding isolated genes and other biological material from patentability. However, given that a Senate Inquiry recommended that isolated genes not be excluded from patentability as well as the failure of Parliamentary Private Members Bills in favour of gene patent reform, the prospect of a change in the law to exclude the patenting of isolated genes appears to be remote.

D’Arcy v Myriad Genetics Inc, when it is handed down, will most likely represent a landmark Australian High Court decision, and Shelston IP will be well placed to provide advice in relation to how the decision may impact the patentability of biological inventions in Australia.