Patentability of genes: Australia follows the US.

On October 7, 2015, the High Court of Australia in the Myriad Genetics appeal hold that an isolated nucleic acid sequence, coding for a BRCA1 protein, with specific mutations that are indicative of susceptibility to breast cancer and ovarian cancer, is not a patentable invention.

Under Australian law, only “artificially created state of affairs” having “economic significance” are patent eligible. The Court analyzed that isolated naturally occurring nucleic acids are not patentable subject matter in Australia.

However the patentability of non-naturally occurring gene sequences (such as cDNA) in Australia would not be affected by this decision.

The conclusion is consistent with the US Supreme Court decision which held that a claim for an isolated DNA coding for a BRCA1 polypeptide was not patentable as it fell within a “law of nature” exception. The breadth of the relevant claims seems to have some weight in High Court of Australia’s analysis, as it had in the U.S. Indeed the High Court of Australia reasoned that the claims would cover a “very large, indeed unquantified” class of isolated nucleic acids bearing the requisite information. However the comparison with the US should stop there, as it is hoped that the judgment will not impact the patentability of isolated naturally-occurring molecules other than genes.

Europe still stands. The European Patent Convention unambiguously considers that nucleic acids are patentable, as long as they are isolated from their natural environment.