Full Federal Court confirms isolated genes to remain patent eligible in Australia

Tuesday 30th September 2014

This month we continue our coverage of the ongoing dispute before the Australian Courts to determine the patent eligibility of isolated human genetic material.  We discuss the recent appeal decision in D’Arcy v Myriad Genetics Inc, a judgement which seemingly solidifies Australia’s intent to allow the patenting of isolated naturally occurring nucleic acid sequences.  


In February 2013 the Federal Court of Australia in Cancer Voices Australia Pty Ltd v Myriad Genetics Inc [2013] FCA 65 1 upheld the gene patents in question and thus confirmed the patent eligible status of isolated naturally occurring nucleic acid sequences in Australia.  The Federal Court decision in Cancer Voices is discussed in our previous article, here.

Yvonne D’Arcy, a breast cancer survivor, filed an appeal against the Federal Court’s decision in Cancer Voices.  The Full Federal Court of Australia recently heard the appeal.

Decision on Appeal

A decision on the appeal case was handed down by the Full Federal Court in D’Arcy v Myriad Genetics Inc [2014] FCAFC 1152 earlier this month.  Five judges unanimously dismissed the appeal and upheld the previous decision of the Federal Court affirming the validity of Myriad’s patent claims and the patent eligibility of isolated naturally occurring genetic material.

Notably, the Full Federal Court opted not to follow the recent US Supreme Court decision in Association for Molecular Pathology v Myriad Genetics Inc [2013] 569 U.S. 12-398 which rejected Myriad’s patent claims toward isolated nucleic acid sequences.

Instead, citing the High Court in NRDC 3, the Court concluded that isolation of genetic material from a cell results in structural and functional changes that constitute a new composition or “artificial state of affairs” thus resulting in patent eligible subject matter:

“The “artificial effect” or “artificial state of affairs” to be considered in this case is the isolated nucleic acid itself, removed from its natural environment and from the cellular components that enable it to function in vivo.”

Furthermore, the Court stated the judgment was “not about whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability” concluding that such issues were not for the Court but for Parliament to consider.

Special Leave to Appeal the Appeal

Lawyers representing Ms D’Arcy recently applied to Australia’s High Court for special leave to appeal.  The High Court must now decide whether to grant Ms D’Arcy’s appeal application and undertake a review of the decision handed down by the Full Federal Court.  If the High Court agrees to take up the request, any subsequently issued decision would be binding on all other courts throughout Australia.

We will keep you informed of any progress.


[1] Cancer Voices Australia Pty Ltd v Myriad Genetics Inc [2013] FCA 65 http://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2013/2013fca0065
[2] D’Arcy v Myriad Genetics Inc [2014] FCAFC 115 http://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/full/2014/2014fcafc0115
[3] National Research Development Corporation v Commissioner of Patents [1959] 102 CLR 252

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