IP Australia has issued new patent Examination Guidelines following a consultation process that considered how the High Court Myriad decision should be practically implemented during patent examination. As predicted in our previous article of a few weeks ago, IP Australia has adopted a generally restrained approach to what will be excluded as patent-ineligible subject matter.

As part of the process for assessing whether a claim is directed to patentable subject matter, Examiners are to pose the questions:

  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?

An important aspect of this assessment is whether it is clear from the specification, drawings or claims that what is claimed is in any way artificial or “man-made”. Claiming nucleic acid molecules that merely replicate or contain a naturally-occurring nucleotide sequence will certainly fail this test, as was the majority opinion in the High Court Myriad decision.  However, IP Australia has broadened this exclusion to cDNA and synthetic nucleic acids, probes and primers and isolated interfering/inhibitory nucleic acids as well, even though in many cases such molecules do not exist in nature and generally are man made.  IP Australia’s reasoning is that these nucleic acid molecules merely replicate naturally-occurring nucleotide sequences, albeit in an artificial form.

As predicted in our previous article, IP Australia will still consider other isolated, naturally-occurring molecules such as proteins, antibodies and other organic molecules to be patentable subject matter.

These new Examination Guidelines provide some degree of certainty for patent applicants at least during the examination process. However, the Courts are yet to consider how the High Court Myriad decision will affect the validity of claims to molecules that have naturally-occurring counterparts. Such Court decisions will provide even more certainty and perhaps modify the application of the High CourtMyriad decision adopted by IP Australia.