This week, the full bench of the High Court of Australia will return its verdict on the issue of whether artificially isolated human genes are patentable.
The case was an appeal from the full Federal Court by Ms Yvonne D’Arcy, a survivor of breast cancer, who sought to invalidate the patent held by Myriad Genetics for the isolated mutant gene sequence of the BRCA1 gene. BRCA1 has been the subject of much research by Myriad Genetics and other biomedical researcher companies because of correlations observed that link mutation in BRCA1 to an increased risk of developing breast and ovarian cancer. By analysing a patient’s genome for mutations in the BRCA1 gene, medical diagnostics companies can offer early detection of cancers associated with the gene, which can give patients a head-start on treatment.
According to commentators, upholding Myriad’s patent would have the flow-on effect that all other patent claims over isolated gene sequences are proper subject matter under Australia’s ‘manner of manufacture’ test for patent eligibility. Some Australian patent owners argue that such a conclusion would provide security in the biotechnology sector, enabling select medical researchers to maintain a monopoly over the development and commercialisation of diagnostic methods that utilise these patents.
The counter-argument often advanced by critics, and publicly by Ms D’Arcy, is that allowing gene sequences as patentable subject matter limits access to genetic testing by cancer sufferers. This is because monopolisation of the rights to use the gene means that diagnostic companies, like Myriad Genetics, can charge whatever price for the test that they see fit, without competition. Prior to the ban on gene patents instigated by the US Supreme Court, this was the scenario faced by American cancer patients who were made to pay around $4000 for BRCA1 diagnostic testing.
While the arguments advanced in Ms D’Arcy’s case relate specifically to patent eligibility and do not challenge the patentability of processes using isolated genes for testing or treatment, the decision could still have a profound effect on Australia’s position in the global biotechnology market. This is largely due to the inconsistencies in patent law across our major trading partners. In the US, a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. However, in Europe, biotechnological inventions are protected by the Biotechnology Patent Directive which specifically allows for the patenting of a gene sequence and its industrial application. It will be interesting to see how the High Court considers these inconsistencies when the Australian Government has, in the past, declined to expressly exclude isolated genes from patentability under the Patents Act 1990 (Cth).
The case represents an opportunity for the High Court to add to the growing precedent explaining the ‘manner of manufacture’ test as it applies to emerging technologies. The case also has important implications for the growth of local Australian biotechnology companies, as well as for attracting investment in the sector from big international players. The question that remains is: how much weight does the High Court give to these issues and which of those issues should prevail to form part of Australian patent law? We will know on Wednesday, when the High Court delivers its reasons for judgment on this highly-anticipated case.