ARDR-INFO:
Australian High Court ruling on BRCA patent claiming rights

7 October 2015: The High Court of Australia handed down its decision in the D'arcy V Myriad Genetics Inc & Anor case, which considered the patentability of isolated DNA sequences relating to the BRCA 1 gene implicated in breast and ovarian cancer.

The court ruled that the breast cancer gene BRCA-1 was not a “patentable invention”.

The ruling overturns last year’s decision by the Federal Court, who said that the act of isolating the gene was an invention and therefore patentable. A summary of the High Court’s judgment can be read here

Below are expert comments on the decision by Professor Dianne Nicol and Assistant Professor Bruce Arnold, which were provided by the Australian Science Media Centre.

Professor Dianne Nicol is Director of the Centre for Law and Genetics at the University of Tasmania
“We have been waiting almost 30 years for a decision of this nature, on the issue of whether isolated DNA sequences are patentable subject matter. This case considered a patent claiming rights to isolated DNA sequences relating to the BRCA 1 gene, which is linked to increased susceptibility to breast and ovarian cancer in some women.

Incidentally, that patent expired in August this year, so the decision itself will have no effect on the availability of BRCA 1 testing in Australia.

Rather, what is important is its effect on the availability of patents in new areas of technology more generally.

In three separate judgments, the court unanimously held that patent claims of this nature are invalid. My focus here is on the decision of the majority – Chief Justice French and Justices Kiefel, Bell and Keane. Their Honours’ judgment focused primarily on the informational nature of the isolated gene, in much the same way that the US Supreme Court judgment did in the equivalent case in that country. The Full Court of the Federal Court had earlier decided that it was the chemical nature of DNA that was important, and the act of isolation created sufficient chemical differences for there to be an ‘artificially created state of affairs’. Chief Justice French and his colleagues begged to differ, noting that ‘it is the existence of that information [the information stored in the DNA sequence coding for the gene] which is an essential element of the invention as claimed’. The majority provided further guidance on the application of the Australian subject matter requirement to new areas of technology.

Essentially, their Honours said that in areas that open up new fields of patent protection, the patentable subject matter requirement involves more than simple application of the two factors that traditionally have been applied in Australia (whether there is an artificially created state of affairs and whether the invention has economic utility). Rather, it is necessary to consider a range of other factors such as the effect on innovation of opening up a new field to monopoly rights and the coherence of national and international patent law. This is perhaps the most exciting part of the judgment as it signals that the courts and the patent office need to look at broad public policy considerations when considering the appropriate bounds of patents. Time will tell how they rise to this challenge.”

Bruce Arnold is an Assistant Professor in the School of Law at the University of Canberra

“The High Court’s unanimous judgment in Myriad is a victory for common sense. It is a welcome mix of hard science and good law in the face of over-reaching by a US enterprise that’s placed profit ahead of public health.

Most importantly, the judgment demonstrates that the High Court does understand the genome and can provide a coherent response that is legally impeccable and scientifically credible. The Court isn’t out of touch with the science or with the realities of investment and public health.

On that basis there is no need to restructure the Patents Act, something that’s likely to be advocated by some overseas enterprises as part of implementing the TransPacific Partnership Agreement. Amid the hoopla about that agreement as a “foundation” for Australian prosperity it is important to recognise that details matter and that specifics of the agreement are still secret.

Myriad shows that the High Court is acting in the public interest; we shouldn’t take it for granted as protection against problems that will arise with the agreement.”