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ARTICLE · 27 AUGUST 2019

Diagnostic methods in Australia

Recent FC decision confirms that diagnostic methods are patentable subject-matter in Australia.

AustraliaIntellectual Property

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.

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