The Full Federal Court today handed down its long awaited decision in relation to the patentability of genes. This decision relates to an appeal from a previous Federal Court decision that upheld the patentability of isolated genes. The case specifically relates to BRCA patents which claim both breast cancer diagnostic methods and BRCA DNA molecules. See background articles here, here and here.
In a well reasoned decision, the Full Court has now unanimously dismissed the appeal, upholding the previous court’s decision and affirming that isolated genes are patentable under Australian law.
While comparative litigation in the US has placed significant roadblocks against patenting isolated gene sequences per se, which is now having far-reaching consequences in the biotechnology and pharmaceutical industries (see here), the decision of the Full Court in this appeal emphasises that the test for patentable subject matter under Australian law is different.
Isolated Genes are a Product of Human Intervention, Plain and Simple
The Appellant, Ms Yvonne D’Arcy, ran the argument that genes ‘exist in nature’, and that they should therefore not be patentable irrespective of whether they are isolated from the body or not.
However, the Full Court, in its analysis, and being explicitly wary that oversimplification of the facts and underlying scientific principles can lead to incorrect conclusions, has clarified that the isolation of DNA is more than just a mere discovery. Moreover, the Full Court considered it important to focus on the differences between isolated gene sequences and their naturally occurring counterparts, rather than their similarities.
More specifically, the Full Court found that the claimed BRCA nucleic acid molecule is not the same as the naturally occurring gene, there being not only structural differences but also functional differences which result from isolation. For example, once isolated, nucleic acid outside the genome and removed from the cell can no longer be the subject of transcription and translation as occurs in the natural environment. Rather, it can only be effected by artificial intervention. The isolation of the nucleic acid was also noted to lead to an economically useful result, one of the criteria for patentability under Australian law, this being the treatment of breast and ovarian cancer.
The Full Court therefore disagreed with the reasoning of the Supreme Court in the US BRCA/Myriad decision on the basis that there do exist chemical changes in the isolated nucleic acid which are of critical importance. An isolated gene is, quite simply, a product of human intervention, irrespective of the information it encodes. The Court stressed several times that it was important not to confuse the isolated nucleic acid molecule with the information which it carries.
Court vs Government
Perhaps rightly so, the decision concludes with comments which stress that it is not the role of the Court to comment on the wisdom of the patent system. Rather, the role of the Court is to apply the Australian patent law, as set out in the Patents Act 1990 and as developed by the courts, and not whether for policy or moral or social reasons patents for gene sequences should be excluded from patentability.
While the Australian government has moved to address public disquiet over inappropriate patenting by proposing an exclusion from patentability for inventions the commercial exploitation of which would be considered ‘wholly offensive’ by the Australian public, it has not yet taken steps to make this exclusion a reality.
It will be interesting to see whether in light of today’s decision the Government may now take these steps.