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11 February, 2016

New guidance for Examiners has been issued by the Australian Patent Office in view of the High Court of Australia’s decision in D’Arcy v Myriad Genetics Inc.

In this case the High Court was asked to decide whether claims from Myriad’s patent directed to the nucleic acid sequences encoding the BRCA1 mutant polypeptide represented patent eligible subject matter (i.e. a manner of manufacture).

The High Court decided that these claims did not define a manner of manufacture. Instead they considered that the substance of the invention was the information contained within the sequence of nucleotides of the molecule. The Court concluded that the information was not “made” (i.e. created or modified) by human action but was rather an inherent part of the molecule. Claiming the alleged invention as an isolated product was not sufficient to confer eligibility.

Taking into account the High Court’s decision, the Australian Patent Office guidance contains four questions to be asked when considering patent eligibility:

  1. What is the substance of the claim (not merely its form)?
  2. Has the substance of the claim been “made” or changed by man, or is “artificial”?
  3. Does the invention have economic utility?
  4. Does the invention as claimed represent a new class of claim?

Further details regarding the points to be taken into account when answering each question are found in the guidance document. In particular, the guidance notes that Examiners should take into account categories of inventions that have been previously considered by the Courts and accepted including:

  • Recombinant or isolated proteins.
  • Pharmaceuticals and other chemical substances.
  • Methods of treatment.
  • Methods of applying herbicides.
  • Applications of computer technology.

The guidance also notes that there are significant factors in favour of patent eligibility of claims to plants and micro-organisms.

The guidance explicitly states that following the High Court’s decision claims to the following subject matter are excluded:

  • Isolated naturally occurring nucleic acid molecules whether:
    o DNA or RNA.
    o Human or non-human in origin.
    o Coding or non-coding.

Claims to the following are excluded where they merely replicate the genetic information of a naturally occurring organism:

  • cDNA and synthetic nucleic acids.
  • Probes and primers.
  • Isolated interfering/inhibitory nucleic acids.

The guidance states that subject matter of this type may be patentable where the utility of the invention lies in genetic information that has been “made” (e.g. non-naturally occurring chimeric nucleic acids).

It remains to be seen how the guidance will be implemented by Examiners in practice. If objections raised by Examiners cannot be resolved during normal prosecution a Patent Office hearing can be requested.

It is interesting that Australian law is now in closer alignment with US than European law when it comes to what genetic material constitutes patent eligible subject matter. In Europe isolated genetic material constitutes patent eligible subject matter. Nevertheless, there remain differences between Australia and the US because, to date, the corresponding US jurisprudence has been interpreted more broadly to encompass a wider variety of “products of nature”.

For more information on gene patenting please contact Matthew Spencer or your usual Boult Wade Tennant advisor.