A specially constituted 5 member Full Federal Court has unanimously upheld1 a patent which covers the isolated nucleic acid (RNA or DNA) of ‘BRCA1’, a gene linked to breast and ovarian cancer.
The Court confirmed that neither a mere discovery nor an idea is patentable. To be patentable, the alleged invention must be an artificially created state of affairs and economically useful.
The Court recognised that the isolated nucleic acids which are covered by the patent “are different to the gene comprising the nucleic acid sequence as it exists in nature”. Isolating the nucleic acid produced both structural and functional changes to the nucleic acid especially in relation to its ability to undergo cellular processes. The chemical changes in the isolated nucleic acid distinguished the claimed product as both artificial and economically useful.
These differences are crucial to determining patentability. The Court specifically stated that nucleic acid as it exists in the human body is not patentable.
The Court provided comments on a June 2013 decision of the United States Supreme Court, which ruled that isolated nucleic acid sequences relating to BRCA1 were a ‘product of nature’ and therefore not patentable in the United States. The United States has an express exclusion from patentability of ‘products of nature’ which is not present in Australian law. Even accounting for this difference, the Australian Court considered that the Unites States Court did not properly account for the differences between the isolated DNA sequence and the DNA sequence which could be found within the body. The Australian Court’s view is that these differences mean the isolated sequence is not a product of nature.
The Court acknowledged that the subject matter of the case is bound to evoke moral and social arguments regarding the patentability of gene sequences. The Court recognised that the patent system is not designed to address these concerns, and such policy considerations are matters for Parliament.
It is also important to remember that patentability is only one criterion that patents relating to isolated nucleic acid sequences need to satisfy. Others include that the subject matter must be new, inventive and useful.
There is still the possibility that this Court is not the final word on the patentability of isolated nucleic acid in Australia. A decision to appeal to the High Court has not yet been confirmed. An application for special leave to appeal is required by 3 October 2014.