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.