On 7 October 2015, the High Court of Australia ruled in favour of the non-patentability of isolated nucleic acids.
This decision overturns the ruling made by the Full Federal Court on 5 September 2014, which considered that isolated nucleic acids did constitute a patentable invention, and thus negating decades of practice.
The unanimous decision by the High Court of Australia was rendered by several judges in the D’Arcy v Myriad Genetics Inc & Anor case, on the grounds that the nucleic acids encoding the BRCA1 protein (whose mutations are indicative of a susceptibility to breast or ovarian cancer) are chemically, structurally and functionally no different from those present in the human body and, therefore, do not fulfil the “manner of manufacture” criterion, according to which a patentable subject must include an action of “doing” that gives rise to a product, process etc.
The High Court of Australia stated that the genetic information contained in the nucleotide sequences is an essential element of the invention as claimed, and that this information is the same as that contained in the DNA of a person from which said sequence was isolated. Its reasoning even extends to cDNA, although this latter does not exist in nature due to the exclusion of intron sequences …
It appears that this decision should only be taken into account for the case in question, and not as a rejection of gene patentability in general. Only time will tell.
Whatever the outcome, Australia is following in the footsteps of the United States, where in June 2013, the Supreme Court, after three years of reverse decisions and decades of protection for isolated nucleic acids, stopped this practice. However, it is interesting to note that cDNA remains patentable in the United States.
Meanwhile, Europe has resisted this approach, with isolated nucleic acids (including cDNA) remaining patentable there.
