The Full Federal Court of Australia has ruled unanimously that isolated DNA and RNA are patentable subject matter under Australian law.

The ruling reaffirms an earlier decision that gene patenting is permissible under Australian law by the Federal Court. An appeal against this decision was lodged, but has now been dismissed by the Federal Court.

The upholding of the legal capacity to patent isolated DNA including gene sequences is based on a historical test case in the High Court of Australia between the National Research Development Corporation (NRDC) and the Commissioner of Patents, whereby a product found in nature was deemed patentable provided that it involved an ‘artificially created state of affairs’ and had ‘utility in a field of economic significance’.

Upholding the law

Commenting on their final decision, the Court noted that the case did not relate to the wisdom (or, presumably, the lack thereof) of the patent system, nor the moral, social or political acceptability of gene patenting, but rather the correct application of existing Australian patent law.

The ruling diametrically opposed the final position of the US Supreme Court, which after a long legal wrangle concluded that naturally occurring DNA sequences are a product of nature and not patent eligible merely because they have been isolated. This invalidated the US patents for the BRCA1 and BRCA2 gene sequences held by Myriad Genetics Inc.

The latest Australian case was brought by breast cancer patient Yvonne D’Arcy and patient group Cancer Voices specifically against Myriad Genetics as the intellectual property holders for the BRCA gene sequences in Australia, and against the firm Genetic Technologies as their exclusive Australian license holders. The companies are reported to have offered to give the patents to the Australian people as a gift some years ago – an offer that they may be happy to revisit, given that the patent is due to expire soon anyway.

Implications for clinical genetic testing

To date, Myriad’s BRCA patents have not been enforced in the Australia; Associate Professor Clara Gaff of the University of Melbourne commented: “Patients who want tests might fear patenting would restrict their access. But to date, in Australia, that doesn’t appear to have been the case” . Unlicensed BRCA testing costs around AU$500, whereas testing via Genetic Technologies is closer to $2,000. Whilst some years ago they made attempts to enforce their legal monopoly for genetic testing, the company backed down after public protests.

However, enforcement and rising prices of BRCA genetic testing remain a possibility; Myriad has acted aggressively to defend its remaining patent protection in the US, despite the loss of its effective legal monopoly on testing - which will be retained in Australia. Paul Grogan, the Director of Advocacy at Cancer Council Australia, said that Australian law should be changed, commenting: "In 2008, Australian women were only protected from an attempted commercial monopoly over the BRCA1 and BRCA2 genetic tests because the company that threatened to take those tests away from public laboratories withdrew its patent claims voluntarily. There was nothing in the law to protect healthcare consumers ... and there still isn't”.

Looking ahead

As with so many final legal rulings, the decision is not necessarily final; leave to appeal may be sought from the Australian High Court. Yvonne D’Arcy, Cancer Voices and the legal firm acting on their behalf are said to be considering their options. Clinical and patient groups and organisations will wait to see whether or not renewed patent and license enforcement and rising prices for BRCA1/2 gene testing will occur.

In the longer term, the focus may shift to the question of whether or not the Australian law itself should be amended. The National Coalition of Public Pathologists has previously said that preventing patents on basic DNA sequences will be an important element in preparing for genomic medicine, whilst others fear that such a move could, conversely, restrict public access to genetic testing by acting as a disincentive to investment in research and development.