Isolated DNA Non-Patentable in Australia – High Court Lets Policy Makers Decide

On October 7, 2015, the High Court of Australia (HCA) released its decision in Yvonne D’Arcy v Myriad Genetics Inc & Anor, [2015] HCA 35, ruling that claims to isolated DNA are not patent eligible.  The HCA indicated that creating patent rights for isolated DNA would have far-reaching public policy implications that are best left for legislative determination.

The patent at issue, owned by Myriad Genetics Inc, is directed to mutations in the breast cancer gene BRCA1 associated with an increased risk of breast cancer. The patent also relates to diagnostic methods for detecting breast cancer based on the presence of a mutated BRCA1 gene. However, the appeal related only to claims directed to an “isolated nucleic acid”.

The HCA decision to defer to policy makers on the patentability of isolated DNA aligns Australia with the position taken by the Supreme Court of the United States in Molecular Pathology et al v Myriad Genetics, Inc et al, where it was found that isolated DNA is not patentable subject matter (for prior reporting on the US decision in E-TIPS® newsletter, click here).

The HCA decision overturned a decision of the Federal Court of Australia (FCA) that had found isolated sequences of DNA to be patentable subject matter.  The FCA had considered the US position that isolated DNA was not patentable for being a “product of nature”; however, the FCA found that no such principle existed in Australian patent law.