Isolated genetic material: invention or land grab? The D'Arcy v Myriad Genetics case

Key Points

The Full Federal Court has upheld the lower court decision in the BRCA 1 and 2 gene patent cases, the 5 appeal judges holding unanimously that genetic materials in their isolated form (whether DNA (genomic or cDNA) or RNA) are patentable in Australia. This places the Australian and US position directly at odds on the question of whether or not an isolated gene sequence is or is not currently patentable. The policy debate continues about whether amendments to the Patents Act 1990 (Cth) are needed in light of the Australian decisions. The High Court has yet to hear an application for leave to appeal from this decision so watch this space. How we got here, biotechnically speaking

When the writer was studying biochemistry as an undergraduate, it was in the days when the techniques for isolating human genetic material has just beendeveloped, and it was before the whole human genomehad been sequenced.

It was in fact thought at that time that it would be many years hence that computing power would have the capacity to map the whole human genome.

History has shown that the Human Genome Project was in fact completed years earlier than originally predicted1. Both before and after that time the process of mapping various mutations in human genes and uncovering their significance continued apace.

The diagnostic implications of this new technology are, of course, huge, as are the implications for treatment of a wide range of illnesses and ailments based on gene therapy. The impetus for large scale investment in these technologies is the potential commercial rewards to be delivered via patenting it2.

The argument against granting these patents is on the basis that since genes are naturally occurring substances it should not be possible to obtain a patent over a gene sequence that one discovers to have special significance,as in the case of the BRCA1 and BRAC2 genes, (the patents for which incidentally expire in August and December next year respectively).

The Australian story to date

In our last article on this topic3 we predicted that the full Federal Court in the landmark Australian appeal case of D'Arcy v Myriad Genetics Inc (D'Arcy)4 (5 September 2014) would not overturn the decision of Nicholas J5 at first instance. Indeed, they did not. The enlarged bench of five judges were in fact unanimous in their dismissal of the appeal.

We also argued the wind had largely gone out of the whole debate - with patent filings related to isolated human gene sequence patents declining sharply since 2003, new filings tending to be based on modified gene sequences or method claims6, and the BRCA1 and BRCA2 genes patents heading for expiry. In this we appear to have been mistaken as the lawyers for the appellant have recently announced that they will be seeking leave to appeal this decision to the High Court.7

Why the US position is so different

Perhaps encouraging them is the fact that, as we have previously canvassed, the position in the US remains starkly at odds with the above. The leading decision there remains that of the Supreme Court in Association for Molecular Pathology v Myriad Genetics8 of last year.

As we have previously pointed out, the tests to determine patentability in the US and Australia are different and in the US, the question of whether or not the isolated DNA is a "product of nature" is akin to asking whether human genes are more like chemicals, or computers,9 and is by its nature a more philosophical question. The question of whether the isolated DNA is an "artificially created state of affairs", which is the question that our courts are considering, seems altogether a more practical question to answer, and allows consideration of the methods and techniques that are developed and used to isolate the gene or genes in question.

The Court in D'Arcy was at pains...