Gene patents & BRCA1: Federal Court appeal

The Full Court of the Federal Court of Australia provided reasons for judgment today in D’Arcy v Myriad Genetics Inc [2014] FCAFC 115, dismissing the appeal brought by Ms D’Arcy against an earlier ruling of the Federal Court.

The difference between the parties was that the appellant submitted that isolated nucleic acid is not materially different to cellular nucleic acid and that naturally occurring DNA and RNA even in isolated form are products of nature that cannot form the basis of a valid patent. The respondents contended that the claims were to a product that consists of an artificial state of affairs providing a new and useful effect that is of economic significance that is, that the product is a manner of manufacture. The respondents contended that isolated nucleic acid differs from nucleic acid found in a human cell chemically, structurally and functionally. (See [162] – [163])

The Court held at [218] that the isolated nucleic acid, including cDNA, has resulted in an artificially created state of affairs for economic benefit. The claimed product was properly the subject of letters patent by Myriad.

The Court commented at [204] – [205]:

This case is not about the wisdom of the patent system. It is about the application of Australian patent law, as set out in the Act and as developed by the courts since the Statute of Monopolies. 

It is not about whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability. That has been considered by the ALRC and by Parliament and has not occurred. It is not a matter for the court, but for Parliament to decide. Parliament has considered the question of the patentability of gene sequences and has chosen not to exclude them but to make amendments to the Act to address, in part, the balance between the benefits of the patent system and the incentive thereby created, and the restriction on, for example, subsequent research.

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