On Friday the Full Federal Court affirmed that isolated nucleic acids are patentable subject matter in Australia. While an appeal to the High Court of Australia may be possible, absent an appeal, isolated nucleic acids will remain patentable subject matter, unless excluded by an amendment to the Patents Act. Presently we are unaware of a proposal to amend the legislation on this point.
Consistent with previous principles derived from Australian case law, the Full Federal Court held that the claimed isolated nucleic acid resulted in an artificially created state of affairs for economic benefit thereby being proper subject matter of a patent. By being removed from the genome and the cell (in other words removed from the natural environment and from the cellular components that enable it to function in vivo) the Court held that the claimed isolated nucleic acid is itself an artificially created state of affairs.
The decision is clear in distinguishing the relevant considerations for patentability in Australia with those adopted by the US Supreme Court which have been, more recently, interpreted by the USPTO. The Full Federal Court rejected the US Supreme Court’s emphasis on the similarity of the ‘location and order of the nucleotides’ of the claimed isolated nucleic acid and that existing within the nucleic acid in nature. Instead the Court was of the view that, even without a change in nucleotide sequence, the claimed isolated nucleic acid was chemically, structurally and functionally different to what occurs in nature.
This decision means the Australian Patent Office will continue to allow patent applicants to claim genetic material, provided the claimed material is qualified as having been “isolated”, or words to that effect.