IP Australia consults on patenting genetic material post Myriad

Following the High Court’s ruling that Myriad’s claims for isolated DNA relating to BRCA1 were not patentable subject matter, IP Australia has released a “consultation” on how it proposes to treat patent applications claiming genetic material.

The Commissioner considers that the High Court’s ruling excludes from ‘manner of manufacture’ a claim “to an isolated nucleic acid that merely represents information coding for a polypeptide is not patent eligible.”

Accordingly, at this stage, IP Australia contemplates rejecting as not manners of manufactures claims to:

  • 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

On the other hand, IP Australia considers the following could be patent 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

The Commissioner is interested in receiving comments on her proposed practice by 30 October 2015.