Following the recent High Court Myriad decision, IP Australia has issued draft guidelines for the examination of patents in technology areas that could be affected by this High Court decision.
It is notable that IP Australia has adopted a very narrow reading of the Myriad decision and intends to only exclude claims to isolated nucleic acids that are naturally-occurring and “merely represent information coding for a polypeptide” as not being directed to patentable subject matter. This would exclude (i) naturally occurring nucleic acid sequences encoding polypeptides or functional fragments thereof, whether isolated or synthesised; (ii) cDNA; and (iii) naturally-occurring coding RNA , whether isolated or synthesised. As a result of this narrow exclusion, claims to isolated, naturally-occurring non-coding nucleic acids such as promoters, enhancers and miRNA as well as artificial constructs such as ribozymes, inhibitory RNA, primer and probes comprising naturally-occurring sequences are deemed to be directed to patentable subject matter . Furthermore, isolated naturally- occurring proteins, antibodies and other molecules obtained from natural sources (such as small organic molecules) and organisms such as viruses and bacteria will be considered to constitute patentable subject matter. IP Australia has set a deadline of 30 October 2015 by which interested parties may provide comments as to the proposed implementation of the High Court Myriad decision. IP Australia will then finalize its post-Myriad examination guidelines.
Assuming the draft guidelines are adopted in their current form, this will provide surety to patent applicants during examination and opposition proceedings that only this limited subject matter will be excluded from patentability in light of Myriad. Ultimately, however, it will be up to the Courts to interpret the scope of excluded subject matter in light of Myriad, but it could be several years before any useful decisions are available. In the meantime, IP Australia’s pro-active approach to implementing the Myriad decision in a realistic manner is welcome news for those engaged in the patent system in Australia.