Patent eligibility in Australia: the winding road ahead
In the highly anticipated decision in D’Arcy v Myriad Genetics, handed down earlier this month, the High Court of Australia has unanimously held that isolated naturally occurring DNA is not eligible for patent protection. This decision overturned two earlier Federal Court decisions (Cancer Voices Australia v Myriad Genetics 2013 and D’Arcy v Myriad Genetics 2014) which had unanimously upheld the patent eligibility of isolated DNA, specifically the isolated BRCA DNA which was the subject of Myriad’s Australian patent number 686004.
This decision has reversed decades of accepted practice in Australia in relation to patent eligibility and although now arguably aligning Australian patent eligibility practice more closely with that of the US, nevertheless sets it at odds with most other jurisdictions, including all of Australia’s major trading partners.
Australian effects
The BRCA patents, which claim both breast cancer diagnostic methods and the mutated form of the isolated BRCA DNA itself, have courted significant controversy. Specifically, attempts by the Australian licensee to centralise BRCA diagnostic testing in-house led to:
(i) The Australian government instigating several enquiries which considered the appropriateness of granting gene patents;
(ii) Litigation challenging the patentability of the claims to the BRCA gene; and
(iii) The introduction of the Patent Amendment (Human Genes and Biological Materials) bill into the Australian parliament in 2012 which proposed to ban the patenting of biological materials which are identical or substantially identical to such molecules as they exist in nature.
Ultimately, the various government-instigated enquiries recommended against excluding isolated genes or other biological materials from patent eligibility, in favour of:
(i) Focusing on raising the standard of the various patentability thresholds;
(ii) Introducing a research use exemption; and
(iii) Ensuring the adequacy of the safeguards provided by Australian law to minimise the abusive monopolistic behaviour.
In terms of the federal court Myriad litigation, both the decision of first instance and the appeal decision held that the isolated BRCA DNA molecule is not the same as its naturally occurring counterpart, there being both structural and functional differences which result from its isolation, thereby giving rise to the “artificial state of affairs in a field of economic endeavour” which, for decades, has been understood as the test for patent eligibility in Australia (National Research Development Corporation v Commissioner of Patents [1959]).
The High Court, however, has now held that test is to be used only as a guide and not a rule. The High Court has indicated that a range of other factors should also be considered in determining patent eligibility, including:
