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Friday, 16 October 2015

A Myriad of Problems: Genetic Patents Refused by High Court of Australia

If years of highly visible US litigation was not enough to satiate your taste for gene patent cases, unbeknownst to some readers Myriad Genetics [Katposts here and here, among several others] have been going through another similar saga in Australia, pertaining to the very same patents that were so hotly contested in the US. After a long road from the Federal Court to the Full Federal Court, the case has finally arrived in its final destination in the High Court of Australia, which handed down its judgment last week; one that this Kat has anticipated with interest.

Even though the facts of the case are known to many, the Australian case still merits some exposition. The case of D'Arcy v Myriad Genetics and Another [2015] HCA 35 dealt with the genetic code relating to the production of the protein BRCA1, whose analysis for specific mutations could indicate an elevated risk of breast and ovarian cancer. Myriad Genetics had acquired a patent for the isolation and subsequent analysis of the genetic sequence [Australian patent no. 686004], exclusively licensing it to Genetic Technologies Limited (the second respondent) in Australia. Yvonne D'Arcy, initially represented by Cancer Voices Australia, challenged the validity of the patent in 2013.

Mittens refused to part with her jeans
The main question the High Court had to answer was whether the isolation of the particular genetic sequence would fall under section 18 of the Patents Act 1990, specifically whether it would be classed as a 'manner of manufacture' defined in the Statute of Monopolies 1623. Applying precedent, and extensive historical consideration on the Statute of Monopolies, the High Court determined that the first assessment is a two-fold one: whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action; and whether the invention as claimed has economic utility. Even if the invention falls within the first two requirements, other outside factors have to be taken into consideration before affording the monopoly through judicial consideration (such as the effects the monopoly can have on scientific development, and whether the patentability of the invention would be consistent with the purposes of the Act).

The High Court's consideration of whether the patent claimed a product hinged on the language used, which did not claim any chemical compounds or specific changes within the chemical composition of the genes when they are isolated. Quoting the Supreme Court of the US: "Myriad's claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes".

This, in previous decision, has been a crucial aspect of the allowance of the patent and its claims; one that the High Court easily rejected, since the genetic material was one that was claimed. The majority quickly dispatched with the Full Federal Court's view in the genes existence as an 'artificially created state of affairs', as the mutation of the genes is pure happen-stance and not something that can be artificially created through their analysis or isolation. The Court put very little thought into the economic benefit of the patentability of genetic sequences, which seemed to be an important consideration for the lower courts. Overall the patentability of Myriad Genetics' claims, in the light of similar future considerations, was seen as non-beneficial for coherence in the law, and something that should not be allowed, especially when taking into account other decisions within the international legal community.

The majority saw that the patent was not a 'manner of manufacture', but did leave us with some final remarks as to the grey area where Myriad Genetics' patent lies:

A patent for the isolation of KAT1
"When proper regard is paid to their emphasis on genetic information, the subject matter of the claims lies at the boundaries of the concept of "manner of manufacture". That it does lie at the boundaries is further evidenced by the odd consequence that if the claims are properly the subject of a patent, the patent could be infringed without the infringer being aware of that fact. That consequence coupled with the very large, indeed unquantified size of the relevant class of isolated nucleic acids, all of which bear the requisite information, raises the risk of a chilling effect upon legitimate innovative activity outside the formal boundaries of the monopoly and risks creating a penumbral de facto monopoly impeding the activities of legitimate improvers and inventors".

To this Kat, who will freely admit is not the most scientifically savvy feline in the room, what seems key is the difference between action and substance in Myriad Genetics' patent. The isolation of a gene, and its subsequent analysis, is very different to a claim to the chemical composition of what is isolated, and it was what toppled Myriad Genetics' case. Although unanimous, the High Court's three, very scientifically comprehensive opinions showcase the difficulty in this case, all the more highlighted by the different outcomes in the Federal and Full Federal courts. In the end the decision follows the same line of thinking as Australia's American cousins', and leaves the future of genetic patents (in the form presented by Myriad Genetics at least) in doubt.

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