IP Australia states
The decision provides clarification of the law as applied to the patenting of isolated nucleic acid sequences and we will move quickly to ensure that patent examination practices are consistent with the findings of the Court.
We are considering the decision and its implications and will provide a response in due course. In the interim, we have suspended examination of patent applications claiming nucleic acid sequences.It also states
The Commissioner has considered the High Court’s decision. 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 High Court unanimously decided that claims 1–3 did not define a manner of manufacture. As a result of this, we are inviting interested parties to comment on The Commissioner’s proposed examination practice.The consultation notice indicates
The decision related to Myriad's patent (686004) on the isolated nucleic acid encoding the BRCA1 mutant polypeptide and to methods of testing for the presence of mutations of the representative BRCA1 gene, and thus an increased likelihood of developing breast or ovarian cancer. The High Court was asked to decide whether claims 1-3, directed to the isolated BRCA1 nucleic acid, defined patent eligible subject matter (i.e. a manner of manufacture).
The High Court unanimously decided that claims 1-3 did not define a manner of manufacture. The Court found that, while formulated as claims to a product (i.e. a nucleic acid molecule), the substance of the invention was the information embodied in the nucleotides of the molecule. The Court decided that the information was an inherent part of the molecule and not created by human action. The Court did not make any finding with respect to the remaining claims of the patent directed to probes, vectors, methods of production and methods of diagnosis.
Our proposed practice for your comment
The Commissioner has considered the High Court's decision. The decision clearly concludes that a claim to an isolated nucleic acid that merely represents information coding for a polypeptide is not patent eligible. On this basis, the Commissioners considers 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
- Naturally occurring human and non-human coding RNA - either isolated or synthesised
In light of the High Court's decision 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
IP Australia in assimilating the HCA judgment appears tro be grappling with confusion about discovery and invention, alongside questions about obviousness. Industry comments over the past week suggest that exclusion of cDNA is likely to be contentious.
- Vectors/microorganisms/animals/plants comprising a transgene
