Although the Australian High Court held that claims to naturally occurring DNA (e.g., BRCA1 nucleic acid) were not patent eligible because they were not a “manner of manufacture,” since the encoded information therein was not “made” by human action, in contrast to the USPTO, the Australian Patent Office issued “Examination Practice” guidelines dealing with the requirements to patent products of nature. The Guidelines generally left their Bergy-like examination standards intact outside of the nucleic acid arena. A copy of those guidelines can be found at the end of this post.

Naturally occurring nucleic acid molecules derived from genetic material or synthesized, including fragments thereof like primers, probes and iRNA, as well as cDNA are not patent-eligible since they “merely replicate the genetic information of a naturally occurring organism.”

More encouraging is the reaffirmation by the Australian PTO that “technical subject matter” including recombinant or isolated proteins, pharmaceuticals, methods of treatment and “applications of computer technology” remain patent-eligible, as do plant and microorganisms. The key factor seems to lie in determining whether or not the substance of the claims was “made” – created or modified by human action – or is “artificial.” Merely “artificial” is a bar, but it appears to include inspecting the claim for replicants – Dolly? — or synthetic versions of naturally occurring materials. While the physical difference between the claim and the material in its natural state is one factor to be weighed, the heartening sentence is that “[i]solation or purification can represent making or modification when the substance of a claim is properly directed to a chemical product.”

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