16 Feb 2013

The BCRA1 gene patent case

Submitted by Troy Rollo

Cancer Voices Australia v Myriad Genetics [2013] FCA 65 (Nicholas J)

This was a challenge to the patent on the BCRA1 breast and ovarian cancer disposing gene (or specified mutant forms of it). The sole ground for challenge was that the claims in the patent were alleged not to be a “manner of manufacture” within the meaning of the Statute of Monopolies. The reference from the statute is as follows:

...the sole working or makinge of any manner of new manufactures within this realme to the true and first inventor and inventors of such manufactures,

Therefore “manner” means not “method”, but “kind” or “category”, and “manufacture” is used as a noun, not a verb, to refer to either the thing made (“by the hand” of a person), or the process used to make it. This assists in understanding the relevance of the “machine or transformation” test. It is commonly said (including in this decision at [79]) that the original meaning of the phrase has been replaced by the development of the case law, and the Court here followed NRDC v Commissioner of Patents, which found that any artificially induced state of affairs with a discernible effect, and utility in a field of economic endeavour, can constitute a manner or kind of manufacture (at [88]).

The claims in the patent are not for the gene in place in the human chromosome ([76]-[77]), but for separating it out or “isolating” it. Once it is separated out from the chromosome, what has been created is something different – a thing made by the hand. That thing, and the process for making it, are clearly manufactures. It follows that, given that was the only ground for the challenge, the challenge had to fail.

This says nothing about the questions of novelty and inventive step, which were not put in issue.