AusBiotech has prepared a submission to the consultation process established by IP Australia in response to the recent High Court decision on gene patents.
In that decision, the High Court overturned previous decisions of the Federal Court and found that isolated gene sequences are no longer patent eligible under Australian law.
Following the decision, IP Australia announced a consultation process and suspended examination of patent applications claiming isolated gene sequences until practices and guidelines have been revised to account for the decision.
While IP Australia has accelerated the consultation period, in recognition of the need to keep the suspension of the examination period as brief as possible, it has extended the consultation period and stakeholders have until 7 November to submit responses.
AusBiotech has prepared a submission in consultation with members who are patent experts.
The submission is generally supportive of the Commissioner's position on what would and would not be considered patent eligible subject matter, but has sought clarity on cDNA.
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; and
- Vectors/microorganisms/animals/plants comprising a transgene.
A copy of the draft is available by emailing Chief Industry Affairs Officer, Lorraine Chiroiu at firstname.lastname@example.org.