5.6.8.1 General Principles – Assessing Manner of Manufacture

Date Published

Overview

Manner of manufacture, or patent-eligible subject matter requires asking: 'is this a proper subject of letters patent according to the principles which have been developed for the application of s6 of the Statute of Monopolies?'

The Courts have taken into consideration various principles when deciding whether or not a claimed invention is a manner of manufacture. There is agreement that:

  • The High Court identifies that two criteria, being an artificial effect and economic utility, will generally be sufficient for considering most inventions. 

  • Despite these two criteria, there is no simple or universal principle to be applied – each case needs to be considered on its own merit; and 

  • To assess whether an invention is for a manner of manufacture, it is necessary to properly characterise the claimed invention.

Examiners should consult those parts of 5.6.8 Patentable Subject Matter (Manner of Manufacture) dealing with specific subject matter for more detailed assistance.

Introduction

Schedule 1 defines "invention" as:

"any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies, and includes an alleged invention".

Subsection 18(1)(a) states:

"an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies."

A similar provision applies for innovation patents (s18(1A)(a)).

The definition of "invention" in schedule 1 therefore incorporates both the aspect of newness and the aspect of manner of manufacture, whereas s18(1)(a) and s18(1A)(a) omit reference to the aspect of newness.

In D’Arcy v Myriad Genetics Inc (2015) HCA 35 the majority stated: 

“The legislative history of the requirement for patentability imposed by s18(1)(a) of the Act has been set out in previous decisions of this Court [40]. The question posed by the application of s 18(1)(a) may be framed as in NRDC [41]: 

‘Is this a proper subject of letters patent according to the principles which have been developed for the application of s6 of the Statute of Monopolies?’ 

That question is to be answered according to a common law methodology under the rubric of ‘manner of manufacture’ as developed through the cases, but consistently with ‘a widening conception of the notion [which] has been a characteristic of the growth of patent law.’ [42] That widening conception is a necessary feature of the development of patent law in the 20th and 21st centuries as scientific discoveries inspire new technologies which may fall on or outside the boundaries of patentability set by the case law which predated their emergence.” 

The scope of eligible subject matter, including products, methods and processes, is therefore defined by principles established by the Courts in relation to specific cases. For a list of some of these cases see 5.6.8.20 Annex A - History of Manner of Manufacture. 

In the normal course of examination, many inventions will plainly constitute patentable subject matter on their face.  More detailed considerations are required when considering subject matter such as computer-implemented inventions and nucleic acids/genetic material. 

Residual Considerations (Lack of invention on the face of the specification)

In the decision of the High Court in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd 32 IPR 449 (which was confirmed by Advanced Building Systems Pty Ltd and Anor v Ramset Fasteners (Aust) Pty Ltd (1998) 152 ALR 604; (1998) AIPC 91-40; 40 IPR 243), the majority of the High Court concluded that "newness" was imported into s18(1)(a) to the extent that:

“the phrase “manner of manufacture within the meaning of section 6 of the Statute of Monopolies” in s18(1)(a) should be understood as referring to a process which is a proper subject matter of letters patent according to traditional principles.”

D'Arcy v Myriad Genetics Inc (2015) HCA 35 at [130] qualified, with reference to Mirabella:  

“that the quality of inventiveness must appear on the face of the specification”.  

The High Court went on to state that consideration of manner of manufacture is not to consider any “inventive merit” in light of the prior art, endorsing its earlier decision in Ramset.  Thus, the decisions in NV Philips and Ramset are best understood as being of use to the unique situation where an application self-admittedly lacks newness or inventiveness on the face of the specification.     

Furthermore, the Full Court in Full Court in Bristol-Myers Squibb Company v FH Faulding & Co Ltd (2000) 97 FCR 524 at [45] said:  

“Where the court has evidence on the basis of which it can make a finding about common general knowledge, and the other information referred to in ss 7(2) and 7(3), and about what would or would not have been obvious to persons skilled in the relevant art, it must be only rarely that it will be appropriate to find (by resort to a “threshold test”) lack of inventiveness on the face of a specification.” 

An examiner should proceed similarly, being cautious to find lack of inventiveness on face of the specification. 

Myriad also notes at [12] that the definition of the allegedly patentable invention “depends upon the construction of the impugned claims read in the light of the specification as a whole and the relevant prior art”.  In this regard, while an invention may not fail as a manner of manufacture on its face for lack of novelty or inventive step, an assessment of the nature of what has been created by human action is relevant to understanding whether an invention is patentable using the general principles.  Different considerations may be useful for technologies (see 5.6.8.6 Computer Implemented Inventions, Mere Schemes, and Business Methods and 5.6.8.11 Nucleic Acids and Genetic Information for example). 

Assessing manner of manufacture

The assessment of whether an application defines patent eligible subject matter is considered with respect to each claim.

In general, the principles set out in D'Arcy v Myriad Genetics Inc (2015) HCA 35 (Myriad), Commissioner of Patents v RPL Central Pty Ltd (2015) FCAFC 177 (RPL), Research Affiliates LLC v Commissioner of Patents (2014) FCAFC 150, Encompass Corporation Pty Ltd v InfoTrack Pty Ltd (2019) FCAFC 161, Aristocrat Technologies Pty Ltd v Commissioner of Patents (2025) FCAFC 131, and other cases suggest that examiners can approach the examination of manner of manufacture as follows:

  1. Construe the claim; (see 5.5 Construction of Specifications) 

  2. Characterise the substance of the claimed invention in view of the specification as a whole standing in the shoes of the skilled addressee  

  3. Ask whether the substance of the claimed invention lies within established principles of what does not constitute a patentable invention (for example, is the characterisation of the invention merely a scheme, plan, rules of gameplay, intellectual information or the fine arts?) 

  4. Does the characterised substance of the claimed invention otherwise lie outside existing concepts of manner of manufacture and is it to be treated as a “new class” of subject matter? (This leg of the approach will only be used in rare situations; see Is the claim for a "new class" of subject matter? below).  

Construe the claim

The normal rules of construction apply when determining the scope of a claim for this purpose (see 5.5 Construction of Specifications). Examiners should however be very careful in considering broad or indefinite terms or adopting constructions suggested by the applicant that pre-empt a determination of the substance of the invention, for example, by taking an unduly broad or narrow construction of the claim.

Characterise the substance of the claimed invention

In characterising the substance of a claimed invention it will often not matter in what form the invention is claimed, the substance of the invention can be the same whether claimed as a product, method or system. However, each case needs to be considered on its particular facts. For example, if the substance of a claim is to a mere discovery, then this would not be patentable. However, if another claim is directed to an application of that discovery then the substance of that claim may be the application of the discovery and may in substance be a patentable invention (see 5.6.8.4 Discoveries, Ideas, Scientific Theories, Schemes and Plans). Characterisation of the substance of the invention is conducted in light of the specification as a whole and must take into account all integers of the claimed invention.   

When considering a combination claim, the substance of the invention can lie in an individual integer of the combination, or a collection of integers. In determining the substance, it is a mistake to determine the substance of the invention solely by excluding known integers and examiners must ultimately consider the claim as a whole. The requirement to consider the claims as a whole should encompass the combination of both the inventive and non-inventive elements of the claimed invention. One should not place undue weight on the inventive aspects of a claim over non-inventive aspects, and give recognition to the physical elements which may be non-inventive but are fundamental to an invention’s operation. 

The enquiry seeks to arrive at ‘a characterisation of the invention claimed,’ rather than a determination of the scope of the claim. The construction task, for the purposes of determining the substance of the claimed invention, can have regard to the relevant prior art which is generally limited to the common general knowledge. In determining what the substance of the claimed invention is, examiners should consider and weigh up all the material before them; see 5.6.1.4 Balance of Probabilities. 

Relevant factors to consider and weigh up may include: 

  • The contribution to the invention made by all the claimed integers; 

  • How do the physical features of the claim, although potentially well-known, interact with each other and the features of any method forming part of the claim, to give rise to the operation of the invention?  

  • The level of detail provided in the specification with regard to various aspects of the invention; 

  • How does the invention work; 

  • The form of words, breadth and emphasis of the claim; 

  • What problem does the invention address; 

  • What are the actual or alleged advantages of the invention. 

Examiners need to assess the substance of the claimed invention at every report stage. A determination is to be made whether the substance has altered as a result of any amendments and arguments to one that has traditionally been considered patentable. While no general rules can be given to assist in this determination, further guidance and examples are given in the discussions of specific subject matter categories.

Role of the state of the art

The task of characterising the substance of the claimed invention depends upon the construction of the claims read in the light of the specification as a whole and the relevant prior art (Myriad at [12]).  In the Myriad case, the relevant prior art was reflected in expert evidence at trial and set out in a scientific primer agreed between the parties.  For the purposes of examination, as laid down in the Commissioner of Patents v Rokt Pte Ltd [2020] FCAFC 86 (Rokt) matter at [85], this would generally not involve ‘a review of the common general knowledge beyond the use of the common general knowledge, to the extent necessary, to construe the specification’.

Is the substance of the claim patentable in view of established principles?

In most cases where the issue arises, the substance of a claimed invention can be assessed against existing concepts of manner of manufacture that have been developed through case law. Consequently, the question will normally be whether the substance of the invention falls within an established category of ineligible subject matter (for example, the fine arts, discoveries, or schemes). If so, then the invention does not relate to patent eligible subject matter. How the assessment is made is dependent on the particular exclusion and specific guidance is provided in 5.6.8 Patentable Subject Matter (Manner of Manufacture).

Is the claim for a "new class" of subject matter?

If the substance of a claimed invention appears not to fall within established concepts of manner of manufacture and does not fall within established exceptions, it is considered to be a “new class” requiring special consideration as set out in Myriad at paragraph 28.

To decide whether a claim relates to a “new class”, the relevant consideration is whether the Courts have previously dealt with subject matter of that type and whether that subject matter has been excluded in the context of manner of manufacture.

In general, the Courts have indicated that, subject to other requirements and aside from particular exceptions, patents are available for products, methods of making, and using products and methods that otherwise result in a new and useful effect. Technical subject matter that has been previously considered by Courts without rejection includes:

  • recombinant or isolated proteins;

  • pharmaceuticals and other chemical substances;

  • methods of treatment;

  • methods of applying herbicides; and

  • certain applications of computer technology.

Where it is apparent that the substance of the invention lies in a new class of subject matter that is outside the established categories of patent eligible inventions, examiners should discuss the matter with their supervising examiner and Oppositions to determine the approach to be taken.

Ethics and Social Policy

It is the role of Parliament to reflect community expectation in the development of legislation, for example, in exclusions from patentability. Where a claimed invention falls within an established class of patentable subject matter (as outlined above in Assessing manner of manufacture), it is not appropriate to exclude patentability on the basis of separate notions of ethics or social policy that are not reflected in the legislation (Anaesthetic Supplies Pty Limited v Rescare Limited (1994) AIPC 91-076; 28 IPR 383). Where the claimed subject matter relates to a “new class”, patentability is to be assessed according to the factors identified by the High Court in D’Arcy v Myriad Genetics Inc. (2015) HCA 35 (as described above in Is the claim for a "new class" of subject matter?).

Amended Reasons

Amended Reason Date Amended

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