cDNA

IP Australia has published its guidelines for examining whether a patent application claims a manner of manufacture under s 18(1)(a) and (1A)(a) in light of the High Court’s ruling in D’Arcy v Myriad.

According to the guidelines, Examiners will find it useful to ask:

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?

In deciding whether the claim is for an established class of invention or a new class of claim, it will not necessarily be relevant that patents have previously been granted for similar subject matter. Examiners are directed to take into account whether the Courts have previously considered the type of subject matter and whether it was rejected or not.

Claims to plants and micro-organisms are not to be considered to fall within a new class merely because they are claims for a plant or micro-organism. Apart from claims to nucleic acid molecules, the guidelines indicate that the Commissioner will consider as excluded subject matter:

• cDNA and synthetic nucleic acids

• Probes and primers

• Isolated interfering/inhibitory nucleic acids,

“where they merely replicate genetic information of a naturally occurring organism”. However, such claims may be patentable where the utility of the invention “lies in genetic information that has been ”made” (e.g. non-naturally occuring chimeric nucleic acid). Other types of biological inventions may also ve patentable where they do not merely replicate the genetic information of a natually occurring organism.

The guidelines should appear in the Manual of Practice and Procedure in January 2016.