The Australian Patent Office has commenced a public consultation on their proposed changes to examination practice, as a result of the recent High Court decision in D’Arcy v Myriad Genetics Inc¹.

As reported in our earlier blog² the High Court unanimously decided that claims directed to an isolated nucleic acid coding for mutant or polymorphic BRCA1 polypeptide were not patentable subject matter.

Based on the High Court’s judgment, the proposed changes exclude from patent protection claims to the following:

  • 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.

Whilst there had been concern that the High Court’s judgment would have implications for the patentability of naturally occurring materials more generally, it is clear from the proposed changes that this is not the case.  In this regard, the Patent Office proposes that all of the following will remain patentable 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

Interested parties have until 6 November 2015 to lodge comments on the proposed changes.  Comments can be sent to the secretariat for the Patents Consultation Group at mdb-patents-consultation-group@ipaustralia.gov.au.

Examination of applications having claims that are impacted by the High Court’s decision will be placed on hold pending finalisation of the proposed changes.