Manner of manufacture (the Australian equivalent of patentable subject matter) is having its judicial moment in the sun across all technology fields. The Full Court decision in Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 adds yet another piece to that puzzle in the diagnostic method space.

The first instance decision and background to the patent under suit is discussed in a previous article, which can be accessed here. In short, the manner of manufacture question relates to Claim 1 of Australian Patent No. 727919, entitled “Non-invasive prenatal diagnosis”:

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.

At the crux of the invention is the discovery of the presence of foetal DNA in maternal plasma and serum, which offers a new approach for non-invasive prenatal diagnosis.

The dispute relates to whether under Australian law the practical application of a natural phenomenon is patent eligible. The Full Court held that in this particular instance, the answer is yes.

Justice Beach found that the subject matter of Claim 1 is a manner of manufacture. Ariosa appealed that decision to the Full Court of the Federal Court of Australia on the grounds that 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).

The Court rejected Ariosa’s approach to assessing manner of manufacture by separating the invention into discrete parts to assert that the result of the detection of foetal nucleic acid is information about a naturally occurring state of affairs and thus not patent eligible.

The Full Court rejected Ariosa’s proposition and their approach (at paragraph 153 (emphasis added)):

However, such an approach tends to obscure the correct identification of the invention. It lies not in the mere observation that cffDNA is to be found in maternal plasma (or serum), but in the explanation as to how that knowledge may be unlocked for others to use it (that is, the explanation of how to extract the cffDNA from the plasma or serum). It is the idea coupled with a practical means of application that makes the invention.

The Full Court also made the following important points regarding distinguishing between mere discovery and invention after considering the relevant authorities (at paragraph 114):

1. The distinction between mere discovery and an invention lies in its practical application to a useful end.
2. The invention be considered as a unitary concept, not segregated artificially into parts.
3. An invention may reside in an abstract idea that is then put to a useful end, even though the way of putting it to that end can be carried out in many useful ways, all of which are otherwise known.

The Full Court agreed with the primary judge’s conclusion that “the artificially created state of affairs is the detection of cffDNA in the tested sample. This “product” is, by definition, the result of human action and is not naturally occurring. The inventive method does not simply produce an abstract, intangible situation. It is not just the “information” encoded by the naturally occurring cffDNA itself.”

In the Full Court’s view, the claim construed as a whole involves an artificially created state of affairs yielding an outcome that is of economic utility and thus qualifies as a manner of manufacture in accordance with Australian law. The Full Court declined to look to the corresponding judgements in the U.S. and the UK as the Australian line of authorities are well developed in this context, despite being divergent from each of these jurisdictions.

Unless the High Court overturns the decision on appeal, the Full Court has affirmed that diagnostic methods, inclusive of diagnostic methods relating to naturally occurring phenomenon or that detect naturally occurring genetical material, are patent eligible subject matter.

Furthermore, this decision does not disturb current IP Australia practice that claims that merely replicate the genetic information of a naturally occurring organism are patentable ineligible, such as:

• Isolated naturally occurring nucleic acid molecules whether:
  • DNA or RNA.
  • Human or non-human.
  • Coding or non-coding.
• cDNA and synthetic nucleic acids.
• Probes and primers.
• Isolated interfering/inhibitory nucleic acids.

A non-exhaustive list of biotechnology inventions not yet regarded as patent ineligible in Australia include:

• Isolated polypeptides
• Synthesised/modified polypeptides
• Antibodies, monoclonal and polyclonal
• Isolated cells, including stem cells
• Naturally occurring isolated bacteria and viruses
• Chemical molecules purified from natural sources
• Transgenes comprising naturally occurring gene sequences, and vectors/microorganisms/animals/plants comprising a transgene
• Interfering RNA