Federal Court Affirms that Gene patents are Allowable in Australia
The Federal Court today handed down it’s much anticipated decision on the patentability of genes. The BRCA patents, which claim both breast cancer diagnostic methods and BRCA DNA molecules, have courted significant controversy in Australia. Specifically, the Australian licensee’s attempt to centralise BRCA diagnostic testing in-house caused great public concern and triggered the establishment of two Senate enquiries into the impact of granting gene patents. Federal Court litigation was subsequently commenced by Cancer Voices Australia to formally challenge the patentability of the claims to the isolated BRCA nucleic acid molecules. Ironically, the claims to the diagnostic methods, which were in fact the trigger for this controversy, were not challenged by the Applicants.
In a well reasoned decision, the Court has held that an isolated nucleic acid molecule is patentable, even where the sequence of this molecule is the same as the sequence of the native molecule which is present in the body. This Decision is based on the Court’s view that the removal of nucleic acid material from its natural environment, and its separation from other cellular components, can give rise to the “artificial state of affairs” which is the threshold that must be met in Australia for subject matter to be patentable. The Court has more specifically stated that without human intervention, a naturally occurring nucleic acid molecule does not exist outside the cell while isolated nucleic acid molecules do not exist inside the cell. The significant research, expense and intellectual effort required to achieve the isolation of nucleic acid molecules was also considered relevant and the court noted that it would be an odd result if a person whose skill and effort culminated in the isolation of such a molecule could not be rewarded by the grant of a patent. It is important to remember, however, that although this decision confirms the patentability of nucleic acid molecules, patents directed to these molecules will not be granted unless the molecules meet a significant number of other thresholds, including novelty and inventiveness.
This decision is entirely consistent with the positions taken by the Government, Senate Committees, Australian Law Reform Commission and the Advisory Council on Intellectual Property in the context of their gene patent reviews. It is also entirely consistent with Australia’s patenting practice to date and the patenting practices of our major trading partners. This decision now provides certainty, both domestically and internationally, in relation to a controversial issue and is a welcome outcome for our scientific researchers, biotechnology industry and the public who benefit from the diagnostic and therapeutic technologies which are brought to market. When this decision is considered together with the recent changes to Australian patent law which have significantly increased the patentability standards required to be met for the grant of a patent, and which have also introduced a formal research use exemption into our law, it is clear that the Australian patent system provides both the certainty and robustness which the healthcare industry requires in order to continue to support the transition of research from the laboratory to the clinic.
View detailed case summary here.