Gene Patenting Disallowed

about 8 years ago

The High Court has refused to allow a patent claim to an isolated gene.

D'Arcy v Myriad Genetics Inc [2015] HCA 35 (7 October 2015).

Despite 6 judges below agreeing that the claims were patentable, the 7 member High Court has held that the claims are not a manner of manufacture within the meaning of section 6 of the Statute of Monopolies and section 18 Patents Act.

French CJ, Kiefel, Bell & Keane JJ (and Gordon J separately) seem to have been persuaded largely by arguments of high policy, namely the need to avoid gene patenting having a 'chilling effect' on medical procedures and innovation. [8], [93], [259]-[264]. The majority also emphasised that the claims, properly understood, concentrated on the genetic information rather than the chemical composition or any method of creating the product. [90]. This was observed to be in accordance with the approach taken by the US Supreme Court to the same patent application.

Gageler & Nettle JJ seem to have concentrated more on the distinction between a patentable invention and a mere discovery. [126], [147]. They observed that the method of isolating genes was well known and so too was the method for amplifying for genetic testing the fragment comprising the BRCA1 gene. [146]. Myriad might justly lay claim to the discovery that an isolated fragment comprising the BRCA1 gene is found to exhibit the specified mutations and polymorphisms, and that their presence may be indicative of particular kinds of malignancy in the cell. And it was also accepted that a method of using known technology to isolate the gene and examine it for the presence of the specified mutations and polymorphisms for the purpose of predicting such malignancies would be patentable. [147]. However, the discovery of a natural correlation is not patentable as such. A claim for a new use of an old product does not confer a monopoly over the old product (just the new use). [148]. Similarly in this case. One cannot patent a gene as such. [139]. Similarly in this case - one cannot patent a gene as such. [139].

The problem here was that the claims were very broad (no upper limit to the size of the class) and if the claims were allowed, would render all uses of the isolated gene (even if unrelated to the identification for the malignancy of interest the subject of the discovery) infringements. [8].

One can reasonably ask (as some already have) whether this decision, far from avoiding a chilling effect on medical procedures and research by the threat of patent infringement, might in fact create a chilling effect on innovation by not protecting innovation. My guess is that it will not do so because the judgment made clear how such a discovery could have been successfully patented (e.g. [147]). The key will be to concentrate on and confine the claims to, the particular uses for which the discovery has been found to be beneficial.

This decision is in line with the approach taken in the US and imposes a stricter requirement of patentability than was previously believed to exist.