When the Australian High Court Myriad decision was handed down, there was speculation that it may be viewed in a similar manner to the US Supreme Court Myriad ruling, which was interpreted by the United States Patent and Trademark Office as excluding from patentability all isolated biological material. The Australian Patent Office, however, has taken a narrow view of the High Court’s ruling, limiting patent ineligible subject matter to:

  • Naturally occurring human and non-human nucleic acid sequences encoding polypeptides or functional fragments thereof – either isolated or synthesised;
  • Naturally occurring human and non-human coding RNA – either isolated or synthesised; and
  • cDNA

Importantly, under the proposed examination practice the following subject matter is considered to be patent eligible:

  • 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 and
  • Vectors/microorganisms/animals/plants comprising a transgene.

The proposed new practice appears to validate the majority of my analysis of the High Court decision (found here), which concluded that naturally-occurring material other than genes should remain patent eligible in Australia. On the other hand, the revised Patent Office practice does propose to broadly exclude cDNA from patentability. In my view, this is an incorrect interpretation of the High Court decision. The Commissioner of Patents has invited interested parties to comment on her proposed practice revisions and Shelston IP will, of course, keep you promptly informed of developments.