The Federal Court’s decision in Commonwealth Scientific and Industrial Research Organisation v Urrbrae Foods Pty Ltd [2025] FCA 1591 provides a useful illustration of the “support” requirement under s 40(3) of the Patents Act 1990 (Cth), which has taken on increased significance, particularly for life sciences patents, following the Raising the Bar (RTB) reforms.

The Support Requirement

Prior to the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth), Australian patent law required that claims be “fairly based” on the matter disclosed in the specification. In practice, this was a relatively permissive standard, requiring that the claims be consistent with what the specification describes as the invention. This requirement was satisfied where the specification provides “a real and reasonably clear disclosure” of the claimed invention, or where the claims do not “travel beyond the subject matter” disclosed.

The RTB reforms replaced “fair basis” with the current requirement that the claims be “supported by matter disclosed in the specification.” As explained in the Explanatory Memorandum for the Intellectual Property Amendment (Raising the Bar) Bill 2011, the support requirement, which is intended to align Australian patent law with that of the UK and Europe, ensures that the description contains a basis for each claim and that the scope of the claims is no broader than is justified by the description, the drawings, and the contribution to the art.

How Support is Assessed

Whether claims are supported is assessed by applying the approach articulated in CSR Building Products Ltd v United States Gypsum Company¹ and adopted from Schering Biotech Corp.’s Application²:

• Construe the claims to determine the scope of the invention as claimed.
• Construe the body of the specification to determine the technical contribution to the art.
• Decide whether the claims are supported by the technical contribution to the art.

The “contribution to the art” refers to what the invention adds to the state of the art as a result of the inventive concept disclosed in the specification. In effect, the requirement that the scope of the claims must not be broader than is justified by the inventor’s contribution to the art requires that the claims must be restricted to products and/or processes disclosed in the specification that are novel, inventive and enabled by that disclosure.

Importantly, a claim which is drafted in relatively broad terms is not objectionable just because it is broad. Claims may validly generalise beyond specific examples in the specification where the contribution to the art represents a general principle that can be applied over the scope of the claims.

CSIRO v Urrbrae Foods

Background

The case concerned a patent application filed by Commonwealth Scientific and Industrial Research Organisation (CSIRO), titled High Amylose Wheat – III. The application relates to a genetically modified hexaploid wheat (Triticum aestivum) containing triple-null mutations in the SSIIa genes across its three genomes.

The SSIIa gene encodes the starch synthase IIa (SSIIa) enzyme, which is responsible for amylopectin synthesis. Triple-null mutations, meaning mutations that render each of the three gene copies incapable of producing functional SSIIa enzyme, result in a wheat grain with a higher amylose-to-amylopectin ratio and increased levels of non-starch polysaccharides, such as fructan, β-glucan, arabinoxylan and cellulose. These traits are associated with desirable health benefits.

The main claim of the patent is directed to a wheat grain of the species Triticum aestivum comprising these triple null mutations and having defined phenotypes including specific amounts of amylose, fructan, β-glucan, arabinoxylan, and cellulose, and reduced amylopectin and increased β-glucan content, arabinoxylan content and cellulose content compared to wild-type (i.e. unmodified plant).

Opposition by Urrbrae Foods
The application was opposed by Urrbrae Foods Pty Ltd³ on several grounds, with the main ground being lack of support under s 40(3). Urrbrae Foods argued that the claims were not limited to any particular wheat variety, despite the specification only demonstrating the invention in certain varieties and describing, in an example, that at least one variety (EGA Hume) did not achieve the claimed amylose content.

The Delegate agreed, finding that the specification did not disclose a principle of general application explaining why the invention would work across different genetic backgrounds. While the invention was demonstrated in some varieties, there was no basis for predicting success in others, including EGA Hume.

The Delegate therefore concluded that the skilled person would be left to determine, by trial and error, which varieties would yield the claimed phenotype. As a result, the delegate considered the technical contribution to be limited to the specific varieties in which success had been demonstrated, and held that the broad claims were not supported.

Appeal

CSIRO appealed that decision to the Federal Court. Urrbrae Foods ultimately took a limited role on appeal with the Commissioner of Patents granted leave to appear but electing not to take an active role.

The appeal therefore proceeded primarily on the basis of CSIRO’s new expert evidence and that the patent application provides a proof of principle, such that a person skilled in the art equipped with the common general knowledge, could make the claimed wheat grain in any variety/genetic background.

The Federal Court’s Decision
Justice Beach reached a different conclusion and held that the claims were supported. A key factor in this outcome was CSIRO’s new expert evidence, which the Court accepted.

His Honour found that the specification, read with the common general knowledge, provided a proof of principle that triple null ssIIa mutations would produce the claimed phenotype, and that there was a reasonable and rational basis to expect that this proof of principle would apply equally to any variety of the species Triticum aestivum.

The Court further found that the skilled person would have a reasonable expectation of producing the claimed grain in other varieties, including EGA Hume, using routine breeding and selection processes typical for commercial breeding programs.

Additionally, the fact that the example in the specification involved a relatively small-scale breeding program, which did not yield the claimed phenotype in EGA Hume, was not suggestive that the invention could not be implemented in EGA Hume. Rather, the expert evidence showed that this outcome was unsurprising given the limited number of lines generated from EGA Hume, and having regard to the probability associated with achieving the target genotype, that a large scale commercial breeding program would be expected to produce lines exhibiting the claimed phenotype.

Beach J emphasised that the specification provided all necessary information, including DNA markers, breeding, analysis and selection methods, to enable the skilled person to replicate the process to generate triple null mutants across different genetic backgrounds within a standard and expected timeframe in the field.

For those reasons, the Court was satisfied that the claims were supported, as the patent application supports and enables the person skilled in the art to perform the invention across the breadth of the claims and there is no evidence that to do so would require undue burden.

Take Aways for Patent Practitioners

The judgment affirms that broad claims remain permissible, as long as the specification discloses a principle of general application and provides an enabling proof of principle supporting the full scope of the claims.

In this regard, specifications should explain why the invention is expected to work across the claimed breadth, particularly where claims extend beyond the specific experimental examples.

In life sciences patents, it is important to include sufficient technical reasoning and experimental methodology to support an argument that routine techniques can be used to implement the invention across different embodiments or genetic backgrounds.

Support and sufficiency are considered to be closely related concepts in Australia. In practice, the Court will consider whether the skilled person can perform the invention across the breadth of the claims without undue burden.  Expert evidence will be critical in establishing that the specification supports a broader class of embodiments than those expressly exemplified.

For more information about this decision, and about the support requirement in Australian Patent Law, please contact Dr Catrina Olivera or Daniel McKinley.

[1] [2015] APO 72 at 115

[2] [1993] RPC 249 at 252

[3] Urrbrae Foods Pty Ltd v Commonwealth Scientific and Industrial Research Organisation [2025]APO 12