Following the High Court’s ruling that Myriad’s claims for isolated DNA relating to BRCA1 were not patentable subject matter, IP Australia has released a “consultation” on how it proposes to treat patent applications claiming genetic material.
The Commissioner considers that the High Court’s ruling excludes from ‘manner of manufacture’ a claim “to an isolated nucleic acid that merely represents information coding for a polypeptide is not patent eligible.”
Accordingly, at this stage, IP Australia contemplates rejecting as not manners of manufactures claims to:
- 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
- Naturally occurring human and non-human coding RNA – either isolated or synthesised
On the other hand, IP Australia considers the following could be patent subject matter:
- 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 is interested in receiving comments on her proposed practice by 30 October 2015.
