Following the recent High Court of Australia decision on appeal of D’Arcy v Myriad Genetics, isolated gene sequences are no longer patent eligible under Australian law and IP Australia has suspended examination of patent applications claiming isolated gene sequences until examination practices and guidelines have been revised to account for the decision.
This puts Australia in a similar position of the US and out of step with significant economies including the European Union, China, Japan, Canada, Korea and New Zealand.
IP Australia advises that the Commissioner has considered the High Court's decision and the decision “clearly concludes that a claim to an isolated nucleic acid that merely represents information coding for a polypeptide is not patent eligible.” The Commissioners advises that the following are not patent eligible and will not accept claims for:
- Naturally occurring (human) nucleic acid sequences encoding polypeptides or functional fragments thereof - either isolated or synthesised;
- Naturally occurring (non-human) nucleic acid sequences encoding polypeptides or functional fragments thereof - either isolated or synthesised;
- cDNA; and
- Naturally occurring human and non-human coding RNA - either isolated or synthesised.
While the full implications of the High Court decision for Australian innovation are being assessed and anticipated by all, IP Australia has opened a consultation to take comment on the proposed patent eligible and non-eligible matter and has advised “Examination of patent applications containing claims directed to technology that could be impacted by the High Court's decision has been deferred until practice is settled.”
The Commissioner proposes the following remain patent eligible as they “do not merely represent information coding for a polypeptide”:
- Naturally occurring isolated regulatory DNA (e.g. promoters, enhancers, inhibitors, intergenic DNA)
- Isolated non-coding (e.g. "Junk") DNA
- Isolated non-coding RNA (e.g. miRNA)
- Naturally occurring isolated bacteria
- Naturally occurring isolated virus
- Isolated polypeptides
- Synthesised/modified polypeptides
- Isolated polyclonal antibodies
- Chemical molecules purified from natural sources (e.g. new chemical entities, antibiotics, small molecules)
- Isolated cells
- Isolated stem cells
- Probes
- Primers
- Isolated interfering/inhibitory nucleic acids (e.g. antisense, ribozymes)
- Monoclonal antibodies
- Fusion/chimeric nucleic acids
- Transgene comprising naturally occurring gene sequences
- Vectors/microorganisms/animals/plants comprising a transgene
The Commissioner has invited interested parties to comment by 30 October and AusBiotech is preparing a response. Further information can be found at the IP Australia website.
AusBiotech members are invited to submit comments to AusBiotech’s Chief industry Affairs Officer, Lorraine Chiroiu at lchiroiu@ausbiotech.org or 03 9828 1414 by close of business Wednesday 28 October 2015.