In light of the recent High Court Myriad decision, finding claims to a naturally occurring isolated nucleic acid not patentable, IP Australia has released for public consultation a proposed examination practice.
Interested parties are requested to provide submissions to IP Australia by 30 October 2015.
The official notification also indicates that examination of patent applications containing claims directed to technology that “could be impacted” by the High Court’s decision has been deferred until examination practice is settled.
Briefly stated, the consultation paper indicates the Commissioner’s interpretation of the decision as “clearly concluding that a claim to an isolated nucleic acid that merely represents information coding for a polypeptide is not patent eligible.” Consequently, “the Commissioner considers that the following are not patent eligible and [so] will not accept claims for”:
- Naturally occurring human and 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.
Importantly, by also providing a list of relevant subject matter which “remain patent eligible” the consultation paper provides a degree of clarity for applicants. That listing includes isolated regulatory DNA, isolated non-coding DNA and RNA (eg., miRNA), naturally occurring isolated bacteria and viruses, isolated polypeptides, synthesised/modified polypeptides, isolated polyclonal antibodies, cells, and stem cells, chemical molecules purified from natural sources (e.g. new chemical entities, antibiotics, small molecules), probes and 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.
As an initial observation, the proposed examination practice implements a common sense interpretation of the Myriad decision, excluding from acceptability under examination practice only that subject matter which the High Court decided in Myriad to be not patentable under Australian law.