D'Arcy v Myriad Genetics Inc

The case of D'Arcy v Myriad Genetics Inc involved a dispute regarding the patentability of claims for isolated nucleic acid. The respondent, Myriad Genetics Inc, sought to patent claims for an isolated nucleic acid coding for a mutant or polymorphic protein, characterised by the coding sequence of SEQ ID No:1 and containing one or more mutations. Myriad Genetics Inc argued that the claims were patentable as they represented a manner of manufacture within the meaning of s 18(1)(a) of the Patents Act 1990 (Cth). The primary judge found in favour of Myriad Genetics Inc, concluding that each of the disputed claims was to a chemical composition and not to naturally occurring DNA and RNA as they exist inside the cells of the human body. The primary judge also found that the isolated nucleic acid was itself an artificial state of affairs, removed from the genome and from the cell. The appellant, Ms D'Arcy, appealed the decision, arguing that the isolated nucleic acid did not produce an artificial effect or artificially created state of affairs in the relevant sense. However, the court found that the isolated nucleic acid was an artificial state of affairs, and that the principles discussed in NRDC are equally applicable to products. The court also found that the isolated nucleic acid had economic utility and could bring benefit to mankind. The appeal was ultimately dismissed, and the decision of the primary judge was upheld.

The final orders made by the court were that the appeal be dismissed. The court noted that the entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011. The decision in this case highlights the importance of considering the artificial state of affairs created by the isolation of nucleic acid and the economic utility of the invention in determining its patentability. It also reinforces the principle that the isolated nucleic acid is itself an artificial state of affairs, removed from its natural environment and from the cellular components that enable it to function in vivo.