IP Australia has taken a pragmatic approach to the Myriad decision that will give comfort to Australia's biotechnology industry and research organisations that they can continue to carry out biological R&D and be able to obtain patent protection for innovation in Australia. Partner Dr Trevor Davies reports.
In light of the recent High Court decision in D'Arcy v Myriad Genetics in which the High Court unanimously ruled that isolated nucleic acid encoding the mutant BRCA1 polypeptide was not patentable, IP Australia has issued a proposal for patent examination for public comment.
We are pleased to note that IP Australia has taken a pragmatic approach to the Myriad decision and proposes excluding only a limited class of genetic material from patent protection.
This is significant because patent protection will continue to be available for new biological drugs and products, isolated naturally occurring proteins, molecular probes and primers for diagnostic tests, and genetic and diagnostic tests. The Australian biotechnology industry and research organisations should have some comfort in that they can continue to carry out biological R&D and be able to obtain patent protection for this innovation in Australia.
Those investing in the biotechnology industry can be reassured that patent protection will continue to be available to assist in product development, allow new treatments and diagnostics to become available to the public, and receive a return of capital. Unlike the US, IP Australia will continue to grant patents on a wide range of biological materials and diagnostic tests.
The following subject matter will NOT to be eligible for patent protection:
- Naturally occurring (human) nucleic acid encoding polypeptides or functional fragments thereof - either isolated or synthesised;
- Naturally occurring (non-human) nucleic acid encoding polypeptides or functional fragments thereof - either isolated or synthesised;
- cDNA; and
- Naturally occurring human and non-human encoding RNA - either isolated or synthesised.
The following subject matter WILL remain eligible for patent protection:
- 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;
- 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.
The deadline for submitting comments on the proposal ends on 30 October 2015. We will publish the outcome of this consultation process on our website and our Scintilla blog.
Please contact us if you have any questions regarding patent protection in Australia.