They Don’t Really Own MY Genes, do they?

By Mark Egerton

No, not yours or anyone else’s. A gene patent does not give the patentee ownership of a gene in your body. Instead, a gene patent gives the patentee the exclusive right to use the gene when isolated from the body.

This conclusion was drawn by the Federal Court in Cancer Voices Australia v Myriad Genetics [2013] FCA 65, a case which has gained considerable media attention due to  allegedly being about a battle between personal vs corporate ownership of human genes. The patent owned by Myriad Genetics included claims to “isolated DNA”, DNA being the molecule that is the physical form of a gene. This was not a decision about whether the isolated DNA was novel or inventive, but whether genes, or DNA, is suitable for patent protection at all. The isolated DNA of the Myriad Patent is useful for determining whether a person would develop, or would have an increased likelihood of developing, breast cancer. More particularly, the patent defined variations in particular human genes (BRCA1 & 2) that were associated with an increased risk of developing breast cancer. The benefit of detecting these genetic variations is that enables early treatment of patients to be undertaken thereby improving the prognosis for the patient.  The question addressed by the Federal Court was whether under Australian law, the isolated DNA was merely a discovery of a molecule that naturally occurs in the human body and is hence unpatentable, or was an artifically-created state of affairs that is the proper subject of patent protection. The Federal Court decided that isolated DNA was, by virtue of being in isolated form as a result of human intervention, distinct from the corresponding DNA that exists naturally in the human body. The Federal Court therefore held that isolated DNA constitutes an artificially-created state of affairs suitable for patent protection. The Federal Court made it very clear that its decision was based on  general principles set down over 50 years ago by the High Court’s NRDC decision. Notably, the Federal Court distinguished its reasoning from the reasoning of the US Court of Appeals for the Federal Circuit in the corresponding US patent case, where it was held that isolated DNA was distinguishable from DNA in the human body (and hence patentable) because  chemical bonds had been broken as a result of the isolation process.

This decision maintains the status quo in Australia, namely that isolated DNA is patentable subject matter. This is positive news for the biotechnology industry in Australia which has invested heavily in areas of technology that rely on patented genes

However, this is not the end of the story in Australia, because the present Federal Court decision has been appealed to the Full Court of the Federal Court. Furthermore, the decision of the US Court of Appeals for the Federal Circuit  upholding the corresponding US patent has been appealed to the US Supreme Court.