Diagnostic Methods in Australia

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In Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011, the Federal Court confirmed that diagnostic methods are patentable subject-matter in Australia. This will be a satisfying result for those in the diagnostics industry.

The patent in question is Australian Patent No. 727919 and is entitled ‘Non-invasive prenatal diagnosis’. The patent is based on the discovery that fetal DNA can not only be detected from fetal cells through invasive procedures, but can also be detected from cell-free fetal DNA (cffDNA) in plasma and serum of a pregnant woman through standard techniques. This cffDNA could be used for prenatal testing and allowed for a non-invasive approach for prenatal diagnosis (e.g., sex determination and blood type). The claims of this patent relate to a detection method performed on a maternal serum or plasma sample, and the method comprises detecting the presence of a nucleic acid of foetal origin in the sample.

Claim 1 of the patent is reproduced below:

A detection method performed on a maternal serum or plasma sample from a pregnant female, which method comprises detecting the presence of a nucleic acid of foetal origin in the sample.

The Applicant (Sequenom, Inc.) sought relief for infringement of this patent. The Respondents (Ariosa Diagnostics, Inc. and others, ‘Ariosa’) cross-claimed and sought to have the patent revoked on the basis of a number of grounds, including non-patentable subject-matter. As many will be aware, this patent family has been litigated in several other jurisdictions (most notably in the US and UK). This article will focus on the non-patentable subject-matter ground raised in Australia.

For a claim to be deemed patentable subject-matter in Australia it must be directed to a ‘manner of manufacture’. The High Court in D’Arcy v Myriad Genetics Inc (2015) 258 CLR 334 considered this issue and identified two requirements that are necessary for patentability:

  1. whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action (artificially created state of affairs); and
  2. whether the invention as claimed has economic utility.

Ariosa argued that the claims were directed to a mere discovery of a naturally occurring phenomenon (cffDNA is detectable in maternal blood) and that there is no practical application for the discovery. Ariosa also argued that none of the claims provided an outcome that was an artificially created state of affairs (e.g. that involved human intervention). Ariosa contended that even where human intervention may have been involved, the result is information only (e.g., diagnosis).

The Federal Court disagreed, and instead looked to the substance of the claims and found that they were not directed to cffDNA per se, or to the relevant genetic information that existed in nature. Rather, the Court found that the claims were directed to a method whereby the discovery of the existence of cffDNA can be put to practical use. Whilst the invention is based on a naturally occurring phenomenon (presence of cffDNA in maternal blood), the Court found it builds on and practically applies this to provide a useful and artificial method of detection of cffDNA, and this method is of economic significance. Furthermore, the Federal Court found that the invention offered a non-invasive approach for prenatal diagnosis:

“The invention is undoubtedly an artificial non-invasive detection method involving artificial DNA amplification methods and synthetic probes deriving from the presence of cfDNA in the maternal circulation from both the mother and developing foetus” (Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011, [466]).

In light of the above, the Federal Court found all relevant claims to be directed to patentable subject-matter. This decision provides clarity on the patentability of such diagnostic methods in Australia.

In addition, Ariosa’s cross-claim failed to establish invalidity (except for claim 26, which was found to be invalid on the basis of lack of fair basis) and Sequenom succeeded in its infringement claim (except for claim 26).

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