Sequenom, Inc. v Ariosa Diagnostics, Inc.  FCA 1011 (27 June 2019)
A recent Federal Court of Australia decision held that methods of medical diagnosis are clearly patentable subject matter in Australia. The Federal Court of Australia has taken the opposite position as compared to the corresponding litigation in the United States of America. 
The main claim of the patent in suit was directed to: 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.
In simple terms, the Court held that the two (2) necessary criteria for eligible patentable subject matter for inventions falling within the boundaries of existing established patentable subject matter such as these are:
1. Whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action; and
2. Whether the invention as claimed has economic utility.
The Court held that there was no claim to the product or presence of cffDNA but rather to a method by which the discovery of the existence of cffDNA can be put to practical use.The significant advantage over existing fetal detection methods has its own economic utility. 
The patent in suit did not simply claim the discovery of cffDNA in maternal blood (the “discovery”). Rather, it claims a new and inventive practical application of the discovery comprising a method requiring human action to detect, in an artificially created sample of maternal plasma or serum, a DNA sequence as being of foetal rather than maternal origin. Prior to the invention, no-one had worked or was working a method comprising detection of cffDNA in plasma or serum samples extracted from pregnant females.
The Federal Court of Australia cited the corresponding case in the United States of America commenting that the result of the US Court’s approach in the dissection of the claims into their constituent parts, is contrary to the legal methodology under Australian Law. It was also noted by the Court that the corresponding litigation in the United Kingdom held such subject matter was patentable.
Adrian M Trioli Patent and Trade Mark Attorney – 25th July 2019
 Sequenom, Inc. v Ariosa Diagnostics, Inc.  FCA 1011 (27 June 2019)
 Ariosa Diagnostics Inc. Sequenom, Inc. 788 F3d 1371 (3d Cir 2015)
 Ibid 1 at ,  & 
 Ibid 1 at paragraph  Citing National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (NRDC) & Cancer Voices Australia v Myriad Genetics Inc (2013) 99 IPR 567 (Myriad)
 Ibid 1 at paragraph 
 Ibid 1 at paragraph 
 Ibid 2
 Ibid 1 at paragraph  Citing NRDC and Myriad
 Ibid 1 at paragraph  citing Illumina, Inc v Premaitha Health Plc  EWHC 2930