Principles of “manner of manufacture” and characterization of the invention
Patentable subject matter in Australia is governed by the requirement that an invention be a “manner of manufacture” within the meaning of s 6 of the Statute of Monopolies, as incorporated into s 18(1)(a) of the Patents Act 1990 (Cth)1.
Unlike jurisdictions that impose categorical exclusions, Australian law adopts an open‑textured, principled approach.
The central inquiry is whether the claimed invention is a proper subject of letters patent according to judicially developed principles, with the High Court recognising that, in most cases, patentability will be satisfied where the invention gives rise to an artificially created state of affairs of economic significance. However, this formulation is not exhaustive, and the assessment remains inherently evaluative and context-dependent2.
The IP Australia Patent Manual formalises this approach into a structured examination process that places particular emphasis on identifying the substance of the claimed invention.
Examiners are directed to construe the claims, then characterise the invention in substance, before assessing whether that substance falls within established categories of patentable subject matter or, if not, whether it should be recognised as a new class.
This second step – characterisation – is critical. Australian law consistently emphasises that patentability does not turn on the form of the claim, but on where the ingenuity of the invention truly lies.
As such, claims are assessed holistically, and drafting techniques cannot rescue subject matter that is, in substance, no more than a mere discovery, abstract idea, or scheme3. This principle of substance over form is particularly significant in the context of computer‑implemented inventions.
Computer-implemented inventions (CIIs)
While Australian law does not exclude software or business methods per se, such inventions are only patentable where they amount, in substance, to more than the implementation of an abstract idea on conventional computing hardware.
The key distinction is whether the invention involves a technical implementation that produces an artificial state of affairs and a useful result, or whether it merely involves the manipulation of an abstract idea using a computer as a tool4.
Recent case law has reinforced that this assessment must be conducted by considering the invention as a whole, rather than by isolating its purportedly novel features.
In practice, inventions that produce a discernible technical effect – such as improvements in computer functionality or data processing – are more likely to be patentable, whereas business methods or schemes implemented using generic computing infrastructure will often fail for lack of a technical contribution5.
A different but equally nuanced approach applies to nucleic acids and genetic information.
Nucleic acids and genetic information
Following the High Court’s decision in D’Arcy v Myriad Genetics6, the assessment of patentable subject matter in this field turns critically on whether the invention resides in something that has been “made,” as opposed to merely discovered.
The Manual explains that, although claims to isolated nucleic acids are framed as claims to chemical products, their substance may lie in the genetic information embodied in the nucleotide sequence.
Where that information merely replicates naturally occurring genetic information, it is not considered to have been “made,” and accordingly falls outside the scope of patentable subject matter.
The consequence is that claims directed solely to naturally occurring sequences, even in isolated form, are not patentable in Australia. However, the decision does not preclude patentability for all inventions involving nucleic acids.
Claims directed to modified or synthetic sequences, or to specific applications such as diagnostic methods or technological uses, may still satisfy the manner of manufacture requirement where the invention lies in human intervention or the creation of something materially different from what occurs in nature7.
In contrast, inventions involving micro‑organisms and other life forms are more likely to meet the manner of manufacture threshold, provided they reflect sufficient human intervention.
Micro-organisms and other life forms
The Manual indicates that, where the substance of the invention lies in the organism itself (rather than in genetic information), the key inquiry is whether the organism has been “made” through technical means, resulting in an artificial state of affairs.
On this basis, isolated and cultured micro‑organisms, as well as biologically pure cultures, are generally regarded as patentable because the processes of isolation and cultivation involve human technical intervention. Similarly, modified organisms exhibiting new or improved functional properties are likely to qualify.
By contrast, naturally occurring organisms per se are not patentable, as they constitute discoveries rather than inventions, and variants that do not exhibit meaningful functional differences will generally fail to satisfy the requirement.
This area therefore illustrates the same underlying principle seen in Myriad, but applied differently depending on whether the invention is characterised as information or as a physical, functional entity8.
Summary
Taken together, these different strands of authority reflect a consistent and unifying theme in Australian patent law: the decisive issue is always the proper characterisation of the substance of the invention.
| Field | Key characterization question | Typical outcome |
| Computer‑implemented inventions (software / business methods) | Is the substance an abstract idea, or a technical implementation producing an artificial effect? | Patentable if there is a technical effect beyond a mere scheme. |
| Nucleic acids | Does the invention reside in genetic information (natural), or in something “made”? | Natural sequences not patentable; applications/modifications may be. |
| Micro-organisms | Has the organism been “made” via human intervention? | Isolated/modified organisms are generally patentable. |
Patentable vs not patentable (by technology)
| Technology area | Patentable (typical examples) | Not patentable (typical examples) | Key rationale |
| Computer‑implemented inventions (software / business methods) | – Technical implementation producing an artificial state of affairs (e.g., a technical effect beyond generic computing). – Improvements in computer functionality or data processing in a technical sense. | – Mere scheme / abstract idea / business method conducted using conventional computing. – Information presentation or rules without a technical contribution. | Substance must be more than an abstract idea “on a computer”; look for a technical contribution / effect. |
| Nucleic acids / genetic information | – Modified or synthetic nucleic acids where the relevant information is “made” (human intervention creates something materially different). – Uses/applications (e.g., diagnostic methods or technological uses) that embody a practical application rather than a mere discovery. | – Naturally occurring nucleotide sequences, even if “isolated”, where the substance lies in the naturally occurring genetic information. – Claims framed as products but amounting in substance to discovery of genetic information. | If the substance is naturally occurring genetic information, it is not “made”; focus on human-made modification or application. |
| Micro‑organisms | – Isolated and cultured micro‑organisms; biologically pure cultures (human technical intervention in isolation/cultivation) – Modified organisms with new/improved functional properties | – Naturally occurring organisms per se (mere discovery). – Variants without meaningful functional change. | Organism must be “made” or reflect technical intervention; discovery of what exists in nature is excluded. |
Note: This table is a high-level guide to Australian “manner of manufacture” outcomes in these areas; results depend on claim construction and how the substance of the invention is characterized.
- PATENTS ACT 1990 – SECT 18 Patentable inventions ↩︎
- 5.6.8.1 General Principles – Assessing Manner of Manufacture | IPA Manuals ↩︎
- 5.6.8.4 Discoveries, Ideas, Scientific Theories, Mere Schemes and Plans | IPA Manuals ↩︎
- Aristocrat Technologies Australia Pty Ltd v Commissioner of Patents [2025] FCAFC 131 ↩︎
- 5.6.8.6 Computer Implemented Inventions, Mere Schemes, and Business Methods | IPA Manuals ↩︎
- D’Arcy v Myriad Genetic Inc [2015] HCA 35 ↩︎
- 5.6.8.11 Nucleic Acids and Genetic Information | IPA Manuals ↩︎
- 5.6.8.12 Micro-Organisms and Other Life Forms | IPA Manuals ↩︎
