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Friday, February 22, 2013

A step forward for patentable subject matter

By Senior Associate Tom Reid

In a widely-anticipated decision that will be seen as a win for biotech innovators, the Federal Court has confirmed the patentability of genetic materials in their isolated form.

The decision of Justice Nicholas in Cancer Voices v Myriad Genetics is among a recent spate of Australian and overseas cases considering the issue of patentable subject matter, including Research Affiliates (see our post on that case) and the pending decision in RPL Central v Myall Australia, and in the US, Bilski v Kappos, Mayo v Prometheus, and most relevantly, the parallel case of Association for Molecular Pathology v Myriad Genetics, scheduled for an April hearing in the United States Supreme Court.

At a very basic level, a gene is a segment of a nucleic acid molecule (DNA or RNA), and is comprised of four different repeating units called nucleotides. The sequence of those nucleotides 'encodes' (carries a chemical template for) a particular protein. DNA and RNA molecules, and parts of them, may be extracted from cells and isolated in the laboratory, and DNA may also be artificially synthesised from isolated RNA.

Occasionally, there may be a mutation in the sequence of nucleotides in a gene, resulting in a change to the encoded protein. Myriad had found that certain mutations in a particular gene, named BRCA1, were linked to a predisposition to breast and ovarian cancers. The Myriad patent at issue claimed isolated nucleic acids having those mutations, and claimed use of the isolated nucleic acids in tests for predisposition to breast and ovarian cancers.

Justice Nicholas had to consider whether such isolated nucleic acids are a patentable 'manner of manufacture' as required by the Patents Act 1990. Applying the High Court's decision in the NRDC case, his Honour held that they are, inasmuch as they consist of 'an artificial state of affairs, that has some discernible effect, and that is of utility in a field of economic endeavour' (at [101]). Important to that finding was that the three challenged claims of Myriad's patent were to isolated nucleic acids. By contrast, nucleic acids in their natural state, in the form of DNA and RNA in human cells, are not (and have never been) patentable. Justice Nicholas noted that NRDC does not require the court to ask whether a composition of matter is a 'product of nature' for the purpose of deciding whether or not it constitutes patentable subject matter (at [103]).

To be patentable, however, an isolated nucleic acid or any other biological material must also meet the other patentability thresholds of novelty, inventive step and usefulness.

The topic of 'gene patenting' has been an ongoing subject of public debate and government inquiry, even though genes in their natural state are not patentable. Justice Nicholas referred (at [118]) to the lapsing of a Private Members' Bill that would have excluded from patentability 'biological materials (expressly including DNA and RNA) including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature'. Justice Nicholas also noted (at [119]) that the Federal Government's November 2011 response to three inquiries into gene patenting had accepted an Australian Law Reform Commission recommendation that genetic materials and technologies not be excluded from patentability (reported in our Focus). 

Finally, his Honour noted that while some have expressed concerns that gene patents will inhibit future research and the development of new therapies, the experimental use exemption introduced by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (reported in our Focus) goes at least some way towards addressing any such concerns.

For more of Allens' comprehensive coverage of the Myriad decision, listen to Allens Partner, Dr Trevor Davies, discuss the decision on BRR Media or keep an eye on the Allens website for a forthcoming Focus publication analysing the reasoning in more detail.

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