Federal Court confirms patentability of gene-based diagnostic methods in Australia

In brief

• The Federal Court at first instance in Sequenom Inc v Ariosa Diagnostics Inc [2019] FCA 1011 held that claims to a gene-based diagnostic method which involves the practical application of a natural phenomenon are patentable in Australia.
• While the law in Australia regarding patentability of such inventions differs from that applied by US courts following Mayo, an appeal in this case will be heard in May 2020.

Background

Sequenom is the owner of a patent entitled ‘Non-invasive prenatal diagnosis’ which claims a method for detecting the presence of a nucleic acid of fetal origin in a maternal serum or plasma sample. The inventors of the patent discovered, using standard and routine techniques, that fetal DNA could not only be detected from fetal cells in the blood of pregnant women but also that non-cellular DNA from a fetus (cell-free fetal DNA or cffDNA) could be detected in the cell-free portion of the maternal blood (i.e. the serum or plasma).

Sequenom sued Ariosa for infringement of the patent, and Ariosa cross-claimed for revocation, including on the ground that the invention claimed is not a manner of manufacture.

Claim 1 of the patent is:

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

Manner of manufacture

The leading authority in Australia on the patentability of claims relating to genetic material is D’Arcy v Myriad Genetics Inc (2015) 258 CLR 334 (Myriad), in which the High Court found that an invention to certain isolated nucleic acids per se was not a manner of manufacture.

In Myriad, the High Court confirmed that there are two essential elements necessary to characterise an invention as a manner of manufacture, namely that the invention must:

• involve an artificially created state of affairs (in that the invention as claimed is for a product made, or a process producing an outcome, as a result of human action)
• have economic utility.

The High Court then identified additional factors to consider where there is a new class of claim which involves a significant new application or extension of the concept of a manner of manufacture. These include whether the invention, if patentable, would have a

chilling effect on activities beyond those formally the subject of the exclusive rights granted to the patentee.

Sequenom’s claimed diagnostic methods

Ariosa conceded that where a new scientific principle is discovered, its practical application might be patented, even if that application is straightforward with the knowledge of that new principle. However, Ariosa contended that the discovery of the location (in maternal serum or plasma) of a known product (fetal DNA) did not involve any new principle. There was no practical application of the discovery that in substance went beyond the discovery itself. Rather, the claimed method simply said ‘detect what is naturally there’, a naturally occurring phenomenon. Ariosa also contended that, as a matter of substance, the ‘end result’ of each claim was merely genetic information.

Beach J did not agree, noting that the claims in suit were not to the product or presence of cffDNA but rather to a method of identifying or detecting a nucleic acid having particular characteristics. His Honour held that they were methods by which the discovery of the existence of cffDNA could be put to practice use. The substance of the methods applied and followed on from, but was different to, the identification of a natural phenomenon. Any use of the method would necessarily involve artificial human action and without it, cffDNA cannot be detected.

In addition, Ariosa submitted that there was no claim in the patent to any new method of detecting cffDNA once it was discovered to be present in the serum or plasma of a pregnant woman. Sequenom had not devised any new method of, for example, fractionating blood or amplifying DNA products. Again, Beach J did not agree, defining the method claimed as new because it was directed to the detection of cffDNA, rather than existing methods which all focused on cellular samples of DNA.

Beach J formed the view that the claimed invention fell ‘squarely within the established concept of manner of manufacture’. Accordingly, it was not necessary to consider the additional factors identified in Myriad, but his Honour did so nonetheless. Notably, his Honour found there was no ‘chilling effect’ as, unlike Myriad, there was no risk that someone could infringe the claim without knowing it.

Key lessons

Ariosa has appealed this decision to the Full Court, and the appeal is listed for hearing in May 2020. In the meantime the Federal Court’s decision confirms that claims to gene-based diagnostic methods involving the practical application of natural phenomena are regarded as patentable in Australia.

The position in Australia presently stands in contrast to that of the US Court of Appeals for the Federal Circuit, which found the claims of the corresponding US patent were directed to non-patentable subject matter, following the US Supreme Court’s decision in Mayo Collaborative Services v Prometheus Laboratories Inc (2012) 566 US 66.

Although this decision should be welcomed by developers of gene-based diagnostic technologies, it appears likely the Full Court will be invited to reconsider Beach J’s analysis of the manner of manufacture question, particularly as it relates to the broadest claims of the patent, which cover any ‘detection method’, irrespective of its particular practical application.

This article was published in Edition 1 of The Prescription.