New Myriad guidelines create uncertainty for innovators

Article  \  16 Dec 2015

A week after the Australian Government announced a $1.1 billion scheme to stimulate innovation in Australia, IP Australia has announced it has finalised examination guidelines following the High Court decision in D'Arcy v Myriad Genetics. The finalised guidelines expand the categories of excluded material compared to the draft guidelines.

In a new development, they also set forth criteria for patentability of new classes of subject matter. These criteria have the potential to restrict the scope of patent-eligible subject matter and prevent the grant of patents in any new field of innovation.

The draft guidelines

The draft guidelines indicated that IP Australia was prepared to interpret the High Court's decision narrowly. The only subject matter to be excluded from patentability was that specifically mentioned by the High Court, ie, nucleic molecules whose function is to carry information. See our report on the draft guidelines here.

Additional subject matter excluded

Following consultation, the Patent Office has altered its position and now seems to focus on the Court's comments which suggested that subject matter may be excluded if it relates to genetic information that is not 'made', ie, created or modified by human action. Accordingly, IP Australia now considers that isolated, naturally occurring nucleic acid molecules are not patentable, whether:

  • DNA or RNA
  • human or non-human
  • coding or non-coding.

Where they merely replicate the genetic information of a naturally occurring organism, claims to:

  • cDNA and synthetic nucleic acids
  • probes and primers
  • isolated interfering/inhibitory nucleic acids.

are also excluded.

Subject matter of this type may be patentable where the utility of the invention lies in genetic information that has been 'made' (eg, non-naturally occurring chimeric nucleic

Other isolated biological materials should still be open to protection on a case by case basis. Specifically included will be:

  • recombinant or isolated proteins
  • pharmaceuticals and other chemical substances
  • methods of treatment.

Applications, uses, methods and compositions also remain patentable. There should also be ways of protecting micro-organisms. 

Four criteria will be used in assessing patentability of other subject matter.

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

New classes of claims

When it is apparent that a claim in substance relates to a new class, the Commissioner must consider other factors, including whether:

  • allowing the class could give rise to a large new field of monopoly protection with potentially negative effects on innovation
  • whether such claims could have a chilling effect on activities beyond those formally the subject of the exclusive rights granted to the patentee, and
  • whether to accord patentability would involve a court assessing important and conflicting public and private interests and purposes.

These are subjective factors which will be very difficult for IP Australia, or anyone, to analyse.

Our opinion

The draft guidelines gave a narrow interpretation to Myriad which, in our view, reflected the findings in the decision, and was capable of application by IP Australia. The new guidelines are helpful in so far as they specify clearly excluded matter, and provide a four question analysis for other subject matter. Regrettably, IP Australia also now seeks to give effect to broader obiter statements in the decision relating to new classes of claims and have produced a policy statement which seems to create uncertainty for both patent applicants and examiners.