Following the decision in D’Arcy v Myriad Genetics Inc (“D’Arcy”), in which the High Court of Australia unanimously decided that claims to isolated nucleic acids represent information coding for a polypeptide and as such do not define a ‘manner of manufacture’ (and are therefore not patent eligible), IP Australia now have issued their proposed practice for public consultation.

Proposed Practice

The proposed practice indicates that on the basis of the decision, the Commissioner considers the following are not patent eligible and will not accept claims for:

  • Naturally occurring (human or 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

While it was initially unclear whether the impact of the decision would be limited to nucleic acids which are considered to essentially relate to genetic information, or would extend to other isolated nucleic acids, such as those that are functional in nature (e.g. inhibitory RNA, aptamers, ribozymes, riboswitches, promoters etc.), or non-coding nucleic acids, the Commissioner proposes the following remain patent eligible on the basis that they do not merely represent information coding for a polypeptide:

  • Naturally occurring isolated regulatory DNA (e.g. promoters, enhancers, inhibitors, intergenic DNA)
  • Isolated non-coding (e.g. “Junk”) DNA and isolated non-coding RNA (e.g. miRNA)
  • Naturally occurring isolated bacteria
  • Naturally occurring isolated virus
  • Isolated polypeptides, including isolated polyclonal antibodies
  • Synthesised/modified polypeptides
  • Chemical molecules purified from natural sources (e.g. new chemical entities, antibiotics, small molecules)
  • Isolated cells, including isolated stem cells
  • Probes
  • Primers
  • Isolated interfering/inhibitory nucleic acids (e.g. antisense, ribozymes)
  • Monoclonal antibodies
  • Fusion/chimeric nucleic acids
  • Transgenes comprising naturally occurring gene sequences
  • Vectors/microorganisms/animals/plants comprising a transgene

Given the practice is focused on nucleic acids that merely represent information coding for a polypeptide, the practical impact of the decision is likely to be less of a concern to the Biotechnology sector than the initial uncertainty that followed the High Court decision.

Interested parties will have until 30 October 2015 to comment on the proposed practice. If you consider the proposed practice is likely to have an impact on your portfolio, please contact us and we can work with you to prepare a submission.

Interim Measures

IP Australia has also begun issuing correspondence in relation to patent applications with claims to isolated nucleic acids that are under examination, and also for applications for which an opposition to grant is pending.

The correspondence issuing on Applications approaching their acceptance deadline with claims to isolated nucleic acids, indicates that the Commissioner is still considering how the technology is impacted by the decision of the High Court, and depending on the outcome of this consideration it may be necessary to raise an objection to these claims.  The correspondence proposes options for the applicant to consider in the interim:

  • file amendments to the application to clearly remove any subject matter of concern,
  • allow the application to remain pending in its present form (noting that the application will lapse if the final date for acceptance is reached), or
  • file a divisional application in order to keep this matter pending and the applicant may consider applying for fee waivers for such applications.

Oppositions

In the case of Oppositions to grant involving applications with claims to isolated nucleic acids, IP Australia have been issuing correspondence indicating that the High Court decision in D’Arcy may be relevant to the determination of the opposition and invites both parties to provide written submissions on the relevance of the decision to the claims, within two weeks. The correspondence indicates the hearing officer will take into consideration any submissions made in coming to a decision.  We are yet to have any opposition decisions issue on such claims following the decision in D’Arcy.

Interestingly, the Office has also begun citing D’Arcy v Myriad Genetics in support of the approach taken in Research Affiliates of examining the ‘substance of the invention’ in considering the patentability of a scheme or abstract idea implemented on a computer (see Research Affiliates at paragraph 103):

The Full Court decided that the implementation of a scheme or abstract idea, which itself would not be considered to be patentable subject matter, would not be rendered patentable subject matter through implementation on a computer. The substance of the invention is determined not as a matter of form but involves an analysis of the alleged inventive step compared to the prior art.

This approach of examining the substance of the invention was also mentioned in D’Arcy v Myriad Genetics Inc [2015] HCA 35.

It is clear that ‘manner of manufacture’ now has teeth as a ground of opposition, and that the approach of examining the substance of the invention will form part of considering whether an invention as claimed can be characterised as a manner of manufacture.