Patent examination guidelines in the wake of Myriad

By Trevor Davies PhD
Healthcare Intellectual Property Patents & Trade Marks

In brief

Following public consultation on proposed examination guidelines issued on 16 October 2015, the Commissioner of Patents has established a revised examination practice taking into account the High Court's decision in D'Arcy v Myriad Genetics Inc. Dr Trevor Davies, Partner at Allens Patent & Trade Mark Attorneys, looks at what the new guidelines will mean for innovators.'

Date of new changes

This practice applies from 15 December 2015 to pending patent applications and changes to the Manual of Patent Practice and Procedure will be made on 11 January 2016. (See our earlier Focus on this issue.)

The revised guidelines require patent examiners to consider, on a case by case basis, whether a claimed invention in substance falls within established categories of eligible subject matter (to which the principles set down by the High Court in National Research Development Corporation v Commissioner of Patent (1959) 102 CLR 252; [1959] HCA 67 are relevant) and, if not, whether other considerations articulated by the High Court in D'Arcy v Myriad Genetics Inc [2015] HCA 35 apply.'

New examination process

In considering the manner of manufacture (patentable subject matter) examiners are now required to consider the following questions:

  • What is the substance of the claim (not merely its form)?
  • Has the substance of the claim been 'made' or changed by human intervention, or is 'artificial'?
  • Does the invention have economic utility?
  • Does the invention as claimed represent a new class of claim?

New class of claim

It would appear that the guidelines have been devised to assist examiners when considering new areas of technology where patent protection may not previously have been sought. If it becomes apparent that a claim in substance relates to a new class involving a significant new application or extension of the principles of patentability, the Commissioner must consider other factors as set out in Myriad at [28].

Where it is apparent that the substance of the invention lies outside an established category of patent-eligible subject matter, examiners should object. The matter may only be resolved by a hearing or on appeal to the Federal Court.

Patentable subject matter

Technical subject matter that has been previously considered by the courts to be patentable include:

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

Patentability exclusions

The courts have excluded a range of subject matter including the fine arts, mere schemes, abstract ideas and mere intellectual information.

Following the High Court's decision in Myriad, claims to the following subject matter are excluded because in substance they can only be considered as a claim to genetic information that is not made:

  • Isolated naturally occurring nucleic acid molecules whether:
    • DNA or RNA;
    • Human or non-human; or
    • 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; or
  • Isolated interfering/inhibitory nucleic acids.

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 acids). Other biological inventions should be considered according to the same general principles set out above. If what is claimed properly falls within the requirements for existing categories of products and processes (eg is not for or merely replicates the genetic information of a naturally occurring organism) it will be patent eligible.

Implications to innovators

Although isolated naturally occurring nucleic acid molecules are no longer patentable in Australia, other useful biological materials such as non-naturally occurring nucleic acid molecules, recombinant or isolated proteins, antibodies, antigens, chimeric molecules, modified cells and microorganisms, vaccines, and the like will remain patentable subject matter.

Importantly methods of diagnosis or treatment using nucleic acid material, including nucleic acid material that merely replicates the genetic information of a naturally occurring organism, will remain patent eligible in Australia.'