Biotechnology inventions have proven to be a mine-field for patentable subject matter in recent years. Worldwide litigation relating to Myriad Genetics' BRCA1 "gene patents" set in motion divergent approaches to the assessment of patentable subject matter of biotech inventions in Australia as well as a number of major jurisdictions, including the U.S., Europe and Japan.

This divergence has also had flow-on effects for diagnostic method patents in some jurisdictions, so it is welcome news for biotech innovators that the Australian Full Federal Court recently affirmed the validity of diagnostic method claims involving naturally occurring phenomena in Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101.

We are also pleased that Davies Collison Cave Law successfully represented Sequenom in this matter.

Patentable subject matter

A threshold requirement for patentability in Australia is that a claim must be for a "manner of manufacture".1 This arguably antiquated concept requires a claimed invention to involve an artificially created state of affairs and have economic utility.2 In D'Arcy v Myriad Genetics Inc [2015] HCA 35; 258 CLR 334 (Myriad), the High Court attempted to modernise this approach by requiring that a number additional factors must be taken into account (discussed in our previous article) where a new class of claim is at issue, i.e., one that involves significant new application or extension of the concept of "manner of manufacture" as developed through case law.3

The High Court in Myriad found that claims directed to isolated nucleic acid sequences, particularly DNA, RNA and cDNA, are not a manner of manufacture because the "substance" of such claims does not reside in the chemical structure of the sequences, but in the information they carry. As this information is identical to that found in nature, the High Court held that isolation of the sequences was not sufficient to render them an artificially created state of affairs (i.e., the substance of the claims was not "made" by human intervention).

The Sequenom dispute

Sequenom's invention, which is the subject of Australian Patent No. 727919 (the Patent), is rooted in the discovery that cell-free foetal DNA (cffDNA) can be detected in the blood plasma and serum of pregnant women. Claim 1 of the Patent is directed to a "detection method performed on a maternal serum or plasma sample from a pregnant female. This method comprises detecting the presence of a nucleic acid of foetal origin in the sample", and covers Sequenom's non-invasive test marketed as MaterniT® 21 PLUS, which screens for sex as well as certain chromosomal abnormalities including Downs Syndrome.

Ariosa also market a non-invasive prenatal test marketed as Harmony®. Sequenom sued Ariosa for infringement of various claims of the Patent, while Ariosa cross-claimed for revocation, including that the claims do not define patentable subject matter. At first instance, Beach J found, inter alia, that all claims in dispute were valid and several claims infringed.4. Importantly, in contrast to the U.S. position,5 this decision meant that diagnostic methods that involve the practical application of a natural phenomenon were patentable.

Diagnostic methods confirmed patentable

Ariosa appealed the decision on the basis that, inter alia, the diagnostic claims are directed to a mere discovery and the end result of the claimed method was merely information (i.e., the detection of what is naturally occurring). However, the Full Court disagreed, finding that the substance of the relevant claims was an artificially created state of affairs, had economic utility and was not a new class of claim as contemplated by Myriad.

According to the Full Court, the claimed invention did not reside in the mere observation that cffDNA is to be found in maternal plasma or serum, but in the explanation as to how that observation may be put to use – "It is the idea coupled with a practical means of application that makes the invention".6 In this regard, the Full Court raised three important points:7

  • The distinction between mere discovery and an invention lies in its practical application to a useful end;
  • The invention must be considered as a unitary concept, not segregated artificially into parts; and
  • An invention may reside in an abstract idea that is then put to a useful end, even where the way of putting it to that end is already known.

It is clear from the Full Court's decision that a claim to a process need not produce a tangible product in order to be patentable. What it must do, however, is produce a "new and useful effect". This is consistent with the findings of the Federal Court in in Meat & Livestock Australia Limited v Cargill, Inc. [2018] FCA 51, in which methods of identifying particular traits in cattle using genetic information from single nucleotide polymorphisms were found to be patentable.

What else is patentable in Australia?

The principles set out in Myriad have now been applied in several instances by the courts and the Australia Patent Office, providing a patchwork of guidance for biotech innovators. However, there is likely more litigation to come in this hotly contested area. For now at least, in addition to diagnostic methods, the following biotech subject matter remains patentable in the eyes of IP Australia:

  • isolated polypeptides and synthesised or modified polypeptides
  • codon-optimised genes
  • interfering RNA (RNAi)
  • antisense oligonucleotides (in certain circumstances)
  • transgenes comprising naturally occurring gene sequences operably connected to heterologous sequences
  • vectors and genetically modified microorganisms, animals and plants
  • isolated polyclonal antibodies and monoclonal antibodies
  • isolated cells and stem cells
  • naturally occurring isolated bacteria and viruses
  • chemical molecules purified from natural sources

Meanwhile, claims that merely replicate the genetic information of a naturally occurring organism (e.g., isolated DNA, RNA, cDNA, probes and primers) remain ineligible for patent protection.


1 Patents Act 1990 (Cth), s 18(1)(a)
2 National Resource Development Corporation v Commissioner of Patents [1959] HCA 67; 102 CLR 252
3 D'Arcy v Myriad Genetics Inc [2015] HCA 35; 258 CLR 334 at [28]
4 Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011
5 Ariosa Diagnostics Inc. Sequenom, Inc. 788 F3d 1371 (3d Cir 2015)
6 Sequenom at [153]
7 Sequenom at [114]

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.