Australia’s highest court to decide on the patentability of isolated genetic material

The High Court of Australia has granted ‘special leave’ to hear an appeal from a decision of the Full Federal Court of Australia in the BRCA1 case.  The judgement to be appealed was handed down by the Full Federal Court, which upheld the Federal Court’s decision that isolated genetic material is patentable¹.

The High Court appeal will be heard as early as April 2015.

The BRCA1 gene is of significant interest to the public, as mutations in the BRCA1 gene have been associated with increased breast cancer risk. These mutations are used as an indicator of a predisposition towards the development of hereditary breast and ovarian cancers.  Yvonne D’Arcy is seeking the revocation of claims 1 to 3 of Myriad’s Australian Patent AU686004 directed to ‘an isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide…’.
The Federal Court handed down its original decision in February 2013.  In that decision, Justice Nicholas ruled in favour of Myriad, finding that isolated gene sequences are the product of human intervention and are thus patentable².
Later, in September 2014, five judges of the Full Federal Court handed down a unanimous decision that isolated genetic material is not the same as the naturally occurring product and, thus, claims directed to isolated genetic materials are patentable³.  In making their decision the Full Federal Court relied on the principles set down in the NRDC decision4 which requires an invention to be a manner of manufacture, that is ‘it must belong to the “useful arts”; it must provide a material advantage; and its value to the country must be in the field of economic endeavour’.
The US Supreme Court’s Myriad  decision was discussed5 during the special leave application hearing, as was the Federal Court’s criticism of that decision.  There was also discussion as to whether a “law of nature” exclusion could apply in Australian law.  The central issue to be decided by the High Court, however, comes down to whether naturally-occurring DNA in an isolated form constitutes an artificially created state of affairs according to the principles laid out in NRDC.
The High Court’s decision is expected by late 2015.

If you have any specific enquiries about this decision, or gene patents generally, please contact Debra Tulloch.

This article was written by Dr Rosemary Manhire-Heath.

  1. D’Arcy v Myriad Genetics (2014) FCAFC 115.
  2. Cancer Voices Australia v Myriad Genetics Inc. [2013] FCA 65.
  3. D’Arcy v Myriad Genetics (2014) FCAFC 115.
  4. National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 25.
  5. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U. S. (2013).