A positive result for diagnostic method patents in Australia

By Linda Govenlock PhD, Claire Gregg PhD, Bryanna Workman
Intellectual Property Patents & Trade Marks

In brief 3 min read

In the highly anticipated decision Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011, the Federal Court has confirmed that diagnostic methods remain patent-eligible subject matter in Australia … at least for now. 

The test-case

The relevant patent concerns methods for detecting cell-free fetal DNA (cffDNA) in a maternal serum or plasma sample, and methods of prenatal diagnosis. The patentee, Sequenom, Inc., commenced infringement proceedings against Ariosa Diagnostics, Inc. and its Australian distributors (collectively, Ariosa), alleging that the promotion and supply of Ariosa's 'Harmony' prenatal test in Australia infringed its patent. Ariosa cross-claimed for revocation of the Sequenom patent on various grounds, including that the relevant claims were invalid as they did not define patentable subject matter.

For an invention to be patentable under Australian law, it must be a 'manner of manufacture'. This has been interpreted by the High Court of Australia to mean that the invention must involve an 'artificially created state of affairs' in a 'field of economic utility'. Previously, in D'Arcy v Myriad Genetics Inc [2015] HCA 35, the High Court held that patent claims to isolated nucleic acids were invalid because the substance of the claims was genetic information, which is not made by human intervention.

Ariosa argued that the 'substance' of Sequenom's claims was the mere discovery (and quantification) of a naturally occurring phenomenon: namely, that cffDNA is detectable in maternal blood products. Ariosa argued that there was no practical application of that discovery in the patent, and none of the claims provided an outcome that was an artificially created state of affairs. Rather, the end result of each of these claims was mere 'information' – eg a diagnosis.

The court's diagnosis

Justice Beach held that the High Court's reasoning in Myriad did not assist Ariosa. Unlike the claims in Myriad, none of Sequenom's claims were directed to cffDNA per se. Rather, the Sequenom claims directed to methods of identifying or detecting DNA having a particular characteristic were held to be a practical application of a natural phenomenon. These methods of detection were of economic significance and could be put to practical use – as explained in the patent, the invention offered a new non-invasive approach to prenatal diagnosis of fetal abnormalities, blood type and sex.

Further, Justice Beach found that there was human intervention and an artificially created state of affairs in the steps carried out to detect the cffDNA, such as extraction of the DNA from the plasma component of a maternal blood sample. Accordingly, His Honour found all of the claims to define patent-eligible subject matter.

Results in the US and UK

The Federal Court's decision is consistent with the recent decision from the UK courts, which upheld Sequenom's corresponding UK patent. In contrast, Sequenom's equivalent US patent was found to be invalid by the US Court of Appeal for the Federal Circuit, on the basis that the claims 'both begin and end with a natural phenomenon'. The US Supreme Court recently refused to consider an appeal.

Prognosis for innovators

The Australian Sequenom decision that diagnostic methods involving the practical application of a natural phenomenon remain patentable in Australia is welcome news for biotech innovators. However, Justice Beach's decision is not the end of the matter. As anticipated in our previous Insight: Diagnostic methods remain patentable in Australia, Ariosa and its distributor, Sonic Healthcare, applied for leave to appeal to the Full Federal Court on 16 August 2019. A third appellant, Clinical Laboratories Pty Ltd, the Australian pathology company licensed by Ariosa to promote and supply its Harmony test, also filed a late application for leave to appeal on 22 August 2019. We will provide further updates as the appeal progresses.