This paper analyses the patent-eligibility of non-invasive prenatal testing (NIPT), an issue considered by the Federal Court of Australia in 2018, set down for judgment in 2019.

NIPT represents an important development in prenatal healthcare and has been taken up rapidly by clinical laboratories worldwide. In the context of Australian patent law, the Court’s verdict on the patentability of NIPT may have important ramifications for the patent-eligibility of methods of genetic testing more broadly.
The paper begins with a discussion of the current requirements for patentable subject matter in Australia. This is followed by an analysis of these requirements in the context of the NIPT claims to be considered by the Federal Court. Included in this analysis is a discussion on whether NIPT is a ‘new class of claim’ and whether the ‘other factors’ test set out in D’Arcy v Myriad Genetics (2015) 258 CLR 334 (‘Myriad’) precludes patentability.

The paper concludes that it is likely that, based on the recent treatment of Myriad by the Federal Court in Meat and Livestock Ltd v Cargill Inc [2018] FCA 51 (9 February 2018), NIPT will be considered patent-eligible subject matter. However, this does not preclude the Court from finding the patent invalid on other grounds, nor does it prevent the decision from being overturned on appeal.