In a long-awaited decision, a judge of the Federal Court has ruled that claims to isolated human genes are eligible for patent protection in Australia (Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65). Describing the issue as being ‘of considerable importance’, the judge went on to distinguish isolated human genes from naturally occurring genes within the human body. While naturally occurring genes cannot be the subject of a valid patent, the judge found that isolated genes are the product of human intervention and are therefore proper subject matter for a patent.
This was an emotive and highly publicised case, involving the BRCA1 gene, mutations in which have been shown to predispose women to certain forms of breast and ovarian cancer. The disputed claims were directed to isolated nucleic acids coding for mutant forms of the BRCA1 polypeptide. Cancer Voices Australia argued that there was no significant or material difference between the BRCA1 gene in its natural environment, namely within a human cell, and in its isolated state. However, the judge rejected this argument, finding that isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell.
Following the Australian High Court decision in the watershed NRDC case (National Research Development Corporation v Commissioner of Patents [1959] HCA 67; [1959] 102 CLR 252), the judge found that the requirement for patentable subject matter was ‘an artificially created state of affairs which has economic significance’. In the present case, he found that this test was satisfied by an isolated human gene. In a ringing endorsement of the NRDC decision, he described that case as ‘a definitive statement on the question of what constitutes patentable subject matter, and unless some good reason exists to distinguish it, it should be applied in a manner that gives effect to the broad language that was used’.
The judge considered recent legislative history on this issue and found nothing to suggest that it was the intention of the Australian Parliament to exclude isolated human genes from patentable subject matter. The Australian Law Reform Commission’s (ALRC’s) 2004 report on gene patenting did not favour any change to the settled practice of granting patents to isolated genetic material. In 2011, the majority of a Senate Committee found that a controversial Private Members’ Bill to ban the patenting of biological materials should not be passed. Also in 2011, the Australian Government’s response to the ALRC report specifically accepted the ALRC’s recommendation that Australian patent law should not be amended to exclude genetic materials from patentability.
The judge also considered the current state of the law concerning patentability of genetic material in Europe and the USA. In the UK, and in many other parts of Europe, isolated genetic material may be patentable even though it is identical in chemical composition to such genetic material found inside a human cell. In the USA, corresponding patents owned by Myriad have been the subject of a protracted legal battle. The US Myriad case is currently on appeal to the Supreme Court, so the law on patenting of isolated human genes will not be settled in that jurisdiction until the US Supreme Court reaches its own decision.
This is the first decision of an Australian court to consider the issue of gene patenting. However, the long-standing practice of the Australian Patent Office has been to allow claims to purified or isolated genetic material, including human genes. That practice looks set to continue, subject to any appeal from the present decision or legislative intervention.
If you have any specific enquiries about this decision, or gene patents generally, please contact Debra Tulloch.