Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101

Sequenom Inc (‘Sequenom’) owned a patent for a non-invasive prenatal diagnostic method used to detect abnormalities in foetal DNA in maternal blood samples (‘Patent’).

Ariosa Diagnostics Inc (‘Ariosa’) used and marketed in the United States a “Harmony Test” to analyse DNA in maternal blood samples for the purpose of detecting genetic abnormalities.  Although Ariosa did not use or market the Harmony Test in Australia, Ariosa’s Australian licensees sent blood samples to Ariosa in the United States for analysis and were subsequently provided with the test results by Ariosa.

Sequenom sued Ariosa and its Australian licensees on the basis that the Harmony Test infringed the Patent. In defence, Ariosa relied upon the findings in Myriad¹ and argued that the claimed invention in the Patent was a discovery of a naturally occurring phenomenon that did not involve methods of practical application beyond the discovery itself, and was therefore invalid on the basis that it was directed to non-patentable subject matter.

The Full Court affirmed the findings the trial judge (Justice Beach) that the claims comprised patentable subject matter in line with the concept of manner of manufacture in NRDC,2 such that the Patent was not directed to genetic information, but involved a process made by human intervention that had economic utility.

Additionally, the Full Court distinguished Myriad since the Myriad invention was in respect of a product claim and not a method claim.

The Full Court also rejected Justice Beach’s interpretation of the term ‘product’ and defined it as something tangible ‘resulting from use of a patented method or process’.3 Since use of the Harmony Test abroad only produced intangible information (i.e., test results), the Full Court found that Ariosa had not infringed Sequenom’s claimed invention by providing its Australian licensees with the results of the Harmony Test.

This decision affirms that diagnostic methods that relate to the practical application of naturally occurring genetic information are patentable.

This decision also highlights how patentees cannot sue for infringement where their patented method is used overseas and produces mere informational results that are communicated in Australia.


¹ D’Arcy v Myriad Genetics Inc 258 CLR 334 (‘Myriad’).

2 National Resource Development Corporation v Commissioner of Patents [1959] HCA 67 (‘NRDC’).

3 Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101, 269.


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