Isolated nucleic acids are patentable – landmark “Myriad” decision in Australia

Date: 2013-02-15
Authors: Karen Bentley & Adam Denley

In a landmark decision regarding the patentability of genetic material, the Federal Court of Australia has held that any nucleic acid found in cells, whether it be DNA or RNA, that has been removed from the cellular environment in which it naturally exists, is patentable. The Court held that “Isolated nucleic acid is the product of human intervention…”. The Court went on to say that even if the claimed nucleic acid has precisely the same chemical composition and structure as that found in a cell, the nucleic acid is patentable subject matter on the basis that it has been extracted from cells and purged of other biological materials with which it was associated in the cell.

The case was brought against Myriad Genetics Inc and Melbourne-based Genetic Technologies Ltd, the owner and licensee respectively, of a patent directed to known mutations in the breast cancer gene BRCA1 associated with an increased risk of breast cancer, and a diagnostic test to identify those subjects.

The long awaited decision was handed down on 15 February 2013, after the Court heard the case in February 2012.

This decision means the Australian Patent Office should continue to be allow patent applicants to claim genetic material, provided the claimed material is qualified as having been “isolated”, or words to that effect.

We will report on the reasoning behind the decision in more detail soon.