Patentability detected in diagnostic methods
We review the Full Federal Court’s decision in Ariosa v Sequenom regarding the patentability of diagnostic testing methods
Ariosa Diagnostics Inc v Sequenom Inc  FCAFC 101 (Ariosa v Sequenom) is the first decision of the Full Court of the Federal Court following the High Court's decision in D'Arcy v Myriad Genetics Inc (2015) 258 CLR 334 (Myriad) to consider the patentability of method claims to genetic diagnostic testing and the results produced from the use of such methods. Ariosa v Sequenom held that broad claims to methods for detecting nucleic acid for the purpose of diagnostic testing are patentable. The Full Court also held that such claims will not be infringed by the importation or sale of the test results themselves.
Ariosa Diagnostics Inc conducts and licenses others, including Sonic Healthcare Ltd and Clinical Laboratories Pty Ltd (together, Ariosa) in Australia, to conduct the ‘Harmony Test’, a non-invasive prenatal test.
Sequenom Inc, the patentee of Australian Patent Number 727919 (the Patent), commenced infringement proceedings against Ariosa alleging that the Harmony Test infringed a number of claims of the Patent. The Patent claims a number of methods for detecting the presence of nucleic acid of foetal origin in maternal serum or plasma from a pregnant female. Ariosa cross-claimed seeking revocation of the asserted claims in respect of the grounds of lack of manner of manufacture, lack of inventive step, lack of utility, lack of sufficiency, lack of fair basis and false suggestion.
At first instance, Beach J held that the Harmony Test fell within the scope of each of the Patent claims asserted by Sequenom to be infringed. Ariosa succeeded in its revocation of claim 26 on the ground of lack of fair basis, but otherwise failed to establish invalidity of any of the other claims. Accordingly, Sequenom prevailed in its infringement case on all but claim 26.
Ariosa appealed the decision of Beach J to the Full Court (Middleton, Nicholas and Burley JJ) challenging his Honour’s conclusions on validity, including lack of manner of manufacture and aspects of the infringement findings.
Ariosa contended that the method claimed in the Patent did not involve a manner of manufacture, in that what was claimed was a mere discovery of a naturally occurring phenomenon and not a method involving a practical application that in substance goes beyond the discovery itself. As a result, there was no artificially created state of affairs arising from the invention as claimed. Ariosa further contended that the ‘end result’ of each claim resulted in information only, being the detection of cell free foetal DNA and accordingly did not involve an artificially created state of affairs.
The Full Court rejected Ariosa’s arguments, affirming Beach J’s conclusion at first instance. The Full Court distinguished the facts of Ariosa v Sequenom from Myriad as the claim in issue in Myriad was for a naturally occurring product, being the isolated BRCA1 gene sequence. In contrast, the claims of the Patent in issue were not, as a matter of substance, directed to genetic information, but to a method involving the practical application of a means for identifying and discriminating between maternal and foetal nucleic acid. Accordingly, the invention as claimed was not merely output, but the detection process which yields an output. The Full Court considered this to be the very type of subject matter to fall on the correct side of the line between discovery of a scientific fact or law of nature, on the one hand, and invention on the other hand. Accordingly, the Full Court concluded that the invention claimed resided firmly within the concept of a manner of manufacture, being an artificially created state of affairs of economic utility. The Full Court also concluded that the invention claimed did not represent a new class of claim involving a significant new application or extension of the concept.
The Full Court also dismissed Ariosa’s other appeal grounds on invalidity, namely lack of sufficiency and lack of fair basis.
Ariosa appealed Beach J’s conclusion on infringement in respect of the ‘send out’ model used by Ariosa between December 2014 and March 2016. The ‘send out’ model involved the collection of blood samples from pregnant women in Australia and sending those samples to Ariosa in the United States. Ariosa then used the Harmony Test to produce results which were then communicated to healthcare professionals in Australia, typically in writing as a report, either in electronic or paper form. Justice Beach had construed the ‘product’ resulting from use of a patented method to encompass ‘anything resulting from the patented method that can be commercially exploited’. On this basis, the ‘product’ resulting from the use of the Harmony Test was the result.
Ariosa argued that not every method or process claim will result in a ‘product’ within the definition of ‘exploit’ in the Patents Act 1990 (Cth) and that Beach J had erred by focussing on the medium in which the Harmony Test results were produced. Rather, Ariosa contended that his Honour should have focused on the output of the infringing method as understood by reference to the claims, which resulted in information only.
The Full Court agreed with Ariosa. The Full Court considered the word ‘product’ in the context of the definition of ‘exploit’ in the Patents Act. The Full Court recognised that not all methods or processes will lead to a product resulting from their use and considered such a construction to be preferred. Accordingly, the Full Court held that it would be more consistent with the purpose of the Patents Act to conclude that the outcome resulting from the use of the methods claimed, does not conform with the meaning of ‘a product resulting from such use’ within the definition of ‘exploit’. Therefore, a claim to information derived from a patentable process or method cannot render the information itself patentable. To do so would extend the patentee’s monopoly to subject matter that is unpatentable.
The Full Court concluded, therefore, that Beach J erred and set aside his Honour’s findings and orders in respect of the ‘send out’ model.
- Claims to diagnostic methods may be patentable in Australia.
- Claims to a process or method that involve the practical application of a means to identify and detect naturally occurring phenomena may also be patentable in Australia.
- The word ‘product’ in the definition of ‘exploit’ in the Patents Act does not include mere information resulting from the use of a diagnostic method claimed in a patent.
- Infringement of diagnostic method claims in Australia will not occur if the diagnostic method is performed overseas and the results themselves are then sent back to Australia.
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