Another look at Myriad and the patentability of “genes”

Towards the end of last year, a unanimous decision of the Full Federal Court of Australia in D’Arcy v Myriad Genetics Inc [2014] FCFCA 115, found in favour of Myriad and upheld the first instance decision of the Federal Court that isolated nucleic acids are patentable in Australia.

The position put forward by the appellant D’Arcy was that a sequence of naturally occurring DNA and RNA, even in isolated form, are products of nature that cannot form the basis of a valid patent.

Myriad argued successfully that the sequence of DNA responsible for coding the BRCA1 gene that it had succeeded in isolating from the cell’s nucleus was a patentable “manner of manufacture” under section 18 of the Patents Act 1990 (Cth).  Myriad’s argument centred on an assertion that the isolated nucleic acid differs from nucleic acid found in a human cell chemically, structurally and functionally and the isolation of the nucleic acid will lead to an economically useful result.

However, far from the finding of the Full Court putting this issue to rest, D’Arcy’s application to appeal the finding of the Full Court was successful, meaning that the High Court of Australia will be considering the issue. According to the solicitors for D’Arcy this is scheduled to take place in April 2015.

The decision to allow the appeal is an important one for a number of reasons:

  • firstly, it is clear that the High Court considers this question to be one of such importance as to require a serious reconsideration and a definitive resolution from Australia’s highest court, especially as the decision to allow the appeal was given in the face of the unanimous decision of the judges of the Full Court of the Federal Court and the judge of the Federal Court at first instance;
  • secondly, it potentially opens the door for the High Court to take a view on the patentability of isolated nucleic acids in Australia which conforms with that in the USA, where an isolated gene sequence is not currently patentable; and
  • finally, the flow-on effects to the biotechnology industry in Australia will be of serious concern, both in terms of the revenue potential of patents, as well as the funding of research and development into this area if a return on that investment will be difficult to obtain.

In its media release of 13 February 2015 on the successful application to appeal, Maurice Blackburn, the solicitors for D’Arcy, stated that the issue “has enormous significance for access to genetic testing, research and the development of treatments for diseases suffered by millions of Australians.” While this statement is intended to demonstrate reasons why the High Court should overturn the decisions of the lower courts, to me it could also be used to support the Full Court’s decision. If researchers are not able to patent the isolated nucleic acids which are the fruits of considerable scientific endeavour and effort, would the impetus to carry out this research and development exist? The failure of research in this area would indeed have significance on access to genetic testing in that the testing would not be available.

The media release further states that the issue for consideration by the High Court “raises a number of ethical, philosophical and legal questions about the commercialisation of the human body” and indeed it does. However, in my view, and, it seems, in the few of the Full Court, these are issues for the consideration of Parliament and not the High Court.

While I fully appreciate that the statements in this media release are not legal argument, they do serve to paint a useful picture of the way that these issues are considered outside of a legal forum. Written submissions are already being made to the High Court by the parties in this matter, and the Institute of Patent and Trade Mark Attorneys of Australia has sought leave to intervene as amicus curiae, and so we wait with baited breath for its decision.

Elizabeth Campbell

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