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Agribusiness and Plant Science Alert

Update: Full Court of the Federal Court affirms that isolated nucleic acids are patentable in Australia

The Full Court of the Federal Court in D’Arcy v Myriad Genetics Inc [2014] FCAFC 115, upheld the decision of the primary judge who found that isolated nucleic acids are patentable subject matter. Such mutations dispose humans to breast and ovarian cancer.

Importantly, the question to be determined on appeal was whether a claim to isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide could be considered a patentable invention within the accepted principles articulated in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252.  That is, whether it is a product that consists of an artificial state of affairs that brings about an economically useful result.

The Full Court in dismissing the appeal, found the following:

  • the subject matter of the claims is a product and not a claim for information;
  • the claimed product is an artificial state of affairs;
  • an isolated nucleic acid is a chemical molecule which is chemically, structurally and functionally different to what occurs in nature.  An example of a functional difference that was given was that isolated DNA cannot produce a protein without artificial intervention, unlike genomic DNA which can be the subject of cellular processes like transcription and translation; and
  • the claims to the isolated nucleic acid led to an economically useful result being the treatment of breast and ovarian cancer

The outcome of this appeal does not change the current law but confirms that isolated nucleic acids are patentable subject matter. 

Finally, even if the claims to an isolated nucleic acid was not considered to be patentable subject matter, Myriad Genetics Inc would still be in a commercially sound position as the invention also encompasses use of mutations of the BRCA1 gene including methods for diagnosing a predisposition to breast and ovarian cancer.

An application for special leave to appeal to the High Court has since been filed on behalf of Yvonne D’arcy, claiming that the full court was wrong to determine that isolated nucleic acids are patentable subject matter.

Interestingly, the US Supreme Court in June 2013 ruled that the isolation of genomic DNA is not an act of invention and therefore not patentable subject matter.  In addition, the court held that cDNA, (which retains exons only) is not a “product of nature” and is patent eligible.  On one view, it is unlikely that this decision will have much impact on medical or agricultural biotech companies as claims to recombinant proteins and their nucleotide sequences, vectors, transgenic organisms and cells are all still patentable. However, another belief is that biotech companies may become less enthused about investing in innovation and could keep their inventions as trade secrets rather than file patent applications to protect them.