The High Court of Australia in D’Arcy v Myriad Genetics (link) has held that isolated nucleic acids coding for mutant or polymorphic BRCA1 polypeptide were not patentable subject matter under Australian law.

In doing so, the Court cautioned against the formulaic application of the principles in theNRDC case, namely, whether the invention consisted in an artificially-created state of affairs in a field of economic endeavour.  Rather, whether a new class of invention is patentable should be decided on a case-by-case basis, having regard to factors including the following:

  • could patentability give rise to a large new field of monopoly protection with potentially negative effects on innovation?
  • could patentability have chilling effects on activities beyond the exclusive rights granted to a patentee?
  • would according patentability involve assessing important and conflicting public and private interests and purposes?
  • would according patentability enhance or detract from the coherence of the law relating to patentability?
  • is according patentability consistent with Australia’s obligations under international law and the patent laws of other countries?
  • does according patentability involve law-making which should be done by the legislature?

The Court criticised the lower court’s and Myriad’s characterisation of isolated nucleic acids as a class of artificial chemical compounds as elevating form over substance.

The Court considered that the information stored in the nucleic acids coding for mutant or polymorphic BRCA1 polypeptide was an essential element of the claims in issue.  That information was the same as the information contained in the DNA of a person from which the nucleic acids were isolated.  Because of their underlying emphasis on genetic information, the claims were not directed to patentable subject matter.  This conclusion was reinforced by the fact that the claims could be infringed without the infringer being aware of infringement beforehand, the unquantified size of the relevant class of isolated nucleic acids, and the risk of chilling effects.

D’Arcy v Myriad Genetics has two consequences for patentable subject matter in Australia.  First, while NRDC remains relevant, satisfying the criteria in NRDC is unlikely to be enough to confer patentability in relation to contentious subject matter such as business methods and computer-implemented inventions.  The Court will consider broader policy factors including those identified above.  Secondly, the movement away from NRDC and the focus on the “substance” or “essential element” of the invention give new scope to challenge patentability of inventions because the underlying substance is, or ought to be, unpatentable.