[authors: Claire Gregg & Martin O'Brien]

Following the recent public consultation in view of the Australian High Court's decision in D'Arcy v Myriad Genetics ("Myriad"), IP Australia has released new Examination Guidelines for applications which may be affected by the decision.

The full Examination Guidelines, which can be found here, apply immediately to pending applications, and will be incorporated into the Examiner's Manual of Practice and Procedure on 11 January 2016.

IP Australia received and considered a broad range of submissions on the issue of patentability of nucleic acids, and has ultimately maintained a fairly narrow interpretation of the High Court's decision.

Blanket exclusions from patentability apply to isolated naturally occurring DNA and RNA, whether human, non-human, coding or non-coding.

Synthetic nucleic acids (including cDNA), probes, primers and isolated interfering/inhibitory nucleic acids are only excluded where they "merely replicate the genetic information of a naturally occurring organism".

In circumstances where subject matter which may be affected by the decision is not expressly excluded from patentability, the new Guidelines call for a case by case consideration of the following factors:

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?

The Guidelines elaborate on the application of these factors, but ultimately, in the absence of legislative changes, it will be up to the courts to determine the breadth of the ramifications of the Myriad decision. In the meantime, the Guidelines have indicated that the following remain patentable subject matter:

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

Substance of the Claim

In Myriad, the High Court expressed concern that the claims at issue elevated form over substance in that "the information stored in the sequence of nucleotides coding for the mutated or polymorphic BRCA1 polypeptide is the same information as that contained in the DNA of the person from which the nucleic acid was isolated".

The Examination Guidelines set out a number of factors to be taken into account in determining the substance of the claim:

• The form of words and breadth of the claim;
• The size of the class of compounds covered by the claim;
• Does the compound embody or convey genetic information that is of importance to the utility of the claimed invention;
• The emphasis of the claim; and
• What did the applicant invent, is the product a step along the way to a process or method that is the real invention.

"Made" vs "Artificial"

The High Court in National Research Development Corporation v Commissioner of Patents (NRDC) stipulated that, in determining whether a claim relates to a manner of manufacture, consideration must be given to whether that claim relates to an artificially created state of affairs.  The High Court in Myriad clarified that artificiality per se is not sufficient -- the substance of the claim must have been created or "made" by human action.

The factors to be considered during examination include:

• Whether the substance of the claim was '"made" (i.e., created or modified, by human action).  It is not enough that the subject matter of the claim is artificial;
• What are the physical differences between the claim and the natural state;
• What was the labour required to produce the product;
• "Made" can include created or modified but not merely through replication; and
• Isolation or purification can represent making or modification when the substance of a claim is properly directed to a chemical product.

New Class of Claim

The High Court in Myriad indicated that the principles laid down in NRDC are only two of the relevant considerations before the Court when determining whether a claim relates to patentable subject matter.  NRDC requires consideration of the following:

1. Whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action; and
2. Whether the invention as claimed has economic utility.

However, when a new class of claim involves "a significant new application or extension of the principles of patentability", the following must also be taken into account:

1. Whether patentability would be consistent with the purposes of the Act;
2. Whether to accord patentability to the invention as claimed would enhance or detract from the coherence of the law relating to inherent patentability;
3. Relevancy to Australia's place in the international community of nations; and
4. Whether to accord patentability to the class of invention as claimed would involve law-making of a kind which should be done by the legislature.

Examiners will look to Myriad and other established case law to determine whether a claim represents a new class and, under the new Examination Guidelines, raise an objection where "the substance of the invention lies outside an established category of patent eligible subject matter".  No doubt this will lead to significant judicial consideration of the above factors in relation to new classes of claims in the future.

Dr. Gregg is a Patent Scientist and Dr. O'Brien is a Principal of Spruson & Ferguson in Sydney, Australia.

This article was reprinted with permission from Spruson & Ferguson.