Subject matter excluded from patentability includes isolated naturally occurring DNA and RNA nucleic acid sequences, as well as cDNA, probes and primers, isolated interfering/inhibitory nucleic acids and synthetic nucleic acids that merely replicate the genetic information of a naturally occurring organism. It would appear that most other isolated biological materials, including proteins, mircoorganisms, cells and viruses, will be considered patent eligible subject matter, provided they sastify the four step test set out below, central to which is the requirement that the claimed substance is “made”.
IP Australia has also set out a four-step test to be applied in determining patent eligible subject matter:
1. What is the substance of the claim (not merely its form)?
2. Has the substance of the claim been “made” or is it “artificial”?
3. Does the invention have economic utility?
4. Does the invention as claimed represent a new class of claim?
This practice applies immediately to pending applications and changes to the Manual of practice and Procedure will be made on 11 January 2016.