Diagnostic methods are patentable in Australia

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In Ariosa Diagnostics, Inc & Ors v Sequenom, Inc [2021] FCAFC 101, the Full Federal Court delivered significant clarity for companies who provide or conduct diagnostic tests. The Full Court confirmed that diagnostic methods are patentable in Australia, and that where a company uses offshore testing and has the results sent to Australia, there is no infringement.

Key takeaways 

  • Diagnostic methods, including methods that utilise conventional steps to detect a natural phenomenon, remain patent eligible in Australia.
  • Patent infringement will not occur where a company conducts testing offshore using a diagnostic method patented in Australia and the information resulting from the test is communicated back to Australia.
  • Mere information is not a ‘product’ within the meaning of paragraph (b) of the definition of ‘exploit’ in the Patents Act 1990 (Cth) (the Act).

Background

Sequenom, Inc is the patentee of an Australian patent entitled ‘Non-invasive prenatal diagnosis’ (the Patent). The Patent provides a method for prenatal diagnosis by detecting the presence of foetal nucleic acid in the maternal serum or plasma sample of a pregnant female. Prior to the invention, foetal DNA could only be obtained by invasive techniques which increase the risk of miscarriage during pregnancy.

Ariosa Diagnostics Inc conducts and licenses others, including Sonic Healthcare and Clinical Laboratories (collectively, Ariosa) in Australia to conduct a non-invasive prenatal test called the ‘Harmony Test’. The Harmony Test analysed the cell free DNA present in the plasma of pregnant women to provide an estimate of the risk that the foetus carries an abnormal number of chromosomes.

Sequenom commenced infringement proceedings against Ariosa alleging that the supply of Ariosa’s Harmony Test in Australia infringed certain claims in the Patent. Ariosa cross-claimed for revocation of the Patent.

The primary judge upheld the Patent’s validity and found that the use of the Harmony Test infringed all but one of the Patent claims. Ariosa appealed to the Full Federal Court.  

Ariosa had not infringed the Patent

The Full Court’s key findings were as follows:

  • Ariosa had not infringed the Patent through the use of its ‘send out model’. The send out model involved collecting blood samples from pregnant women in Australia and sending those samples to Ariosa in the United States. Ariosa then conducted the Harmony Test in the United States and provided a report containing the test results via a file sharing platform, to Sonic Healthcare and Clinical Laboratories in Australia. The Full Court held that the primary judge erred in concluding that the outcome of the Harmony Test results, communicated to Sonic Healthcare or Clinical Laboratories in Australia, constituted a ‘product’ resulting from the use of the method of the Patent.
  • The Full Court rejected the primary judge’s interpretation of the word ‘product’ in paragraph (b) of the definition of ‘exploit’ in the Act, noting that, if applied, it would likely lead to an illogical result. The Full Court reasoned that, on the primary judge’s reading, the information provided by a test constituted a ‘product’ and the oral communication of that outcome would be considered an infringement, and as such, any person who heard the outcome of the test (e.g. ‘it’s a girl’) and flew into Australia with that information would infringe the Patent by importing the outcome of the test.
  • The Full Court’s preferred construction of the word ‘product’. The outcome resulting from the use of the methods of detection or diagnosis in the Patent does not constitute ‘a product resulting from such use’ within the definition of ‘exploit’. The word ‘product’ in paragraph (b) of the definition of ‘exploit’ should not ‘be interpreted as extending a patentee’s monopoly to information which could not itself constitute patentable subject matter, since it would have the unintended and odd consequence of permitting the patentee to obtain patent protection in respect of subject matter that has long been held to be unpatentable’.

Patentable subject matter

The detection of foetal nucleic acid for prenatal diagnosis was confirmed to be patentable subject matter as it was considered an ‘artificially created state of affairs of economic utility’.

Importantly, the present case was distinguished from D’Arcy v Myriad Genetics Inc 258 CLR 334 (Myriad). The claim in issue in Myriad concerned a product, namely the isolated BRAC1 gene sequence. Unlike Myriad, the Patent was not directed to genetic information per se, but to a method involving the practical application for identifying and discriminating between maternal and foetal nucleic acid. Although foetal nucleic acid occurs in nature, the substance of the invention was not cell free foetal DNA, but the detection of the foetal nucleic acid as part of the method of prenatal diagnosis. A person skilled in the art would understand the method of prenatal diagnosis to ‘unlock the secrets’ of cell free foetal DNA without using invasive techniques associated with detecting and amplifying DNA in the foetal cells of maternal blood.