The Federal Court of Australia’s decision in Commonwealth Scientific and Industrial Research Organisation v Urrbrae Foods Pty Ltd [2025] FCA 1591 is worthy of note on a couple of fronts, namely the requirements for patent specifications under section 40(3) of the Patents Act 1990 (Cth) and the role of expert evidence in patent disputes.
The case is an appeal by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) against a decision by a delegate of the Commissioner of Patents. The delegate had upheld an opposition by Urrbrae Foods Pty Ltd to grant of Australian Patent Application No. 2017292900 in the name of CSIRO, titled “High Amylose Wheat – III,” primarily on the ground of lack of support under section 40(3). The invention pertains to Triticum aestivum wheat grains engineered through breeding to exhibit high amylose content and elevated non-starch polysaccharides, such as β-glucan and fructan, offering potential health benefits like improved gut health and reduced glycaemic index.
Under s40(3), the claim or claims must be clear and succinct and supported by matter disclosed in the specification – otherwise referred to as the “support requirement”. This provision ensures that the monopoly granted by a patent corresponds to the technical contribution made by the inventor/s, thus preventing overbroad claims that extend beyond what is adequately enabled. In essence, the specification must enable a person skilled in the art (PSA) to perform the invention across the full scope of the claims without undue burden or experimentation, often through a “principle of general application” that allows reasonable extrapolation.
In the present case, Claim 1 of the patent application encompassed wheat grains from any Triticum aestivum variety with homozygous null mutations in the SSIIa-A, SSIIa-B, and SSIIa-D genes, resulting in specified starch and non-starch polysaccharide profiles. Claim 1, the independent claim, defined the grain by its genetic mutations, amylose content (45-70%), increased fructan (3-12%), and other non-starch polysaccharide totalling 15-30% of grain weight (i.e., an increased total fibre content). The specification detailed breeding methods, including mutagenesis, crossing parental lines with single or double null mutations, DNA marker screening, and backcrossing into commercial varieties like Sunco, EGA Hume, and Westonia. Examples 4 and 5 demonstrated phenotypic outcomes, such as elevated amylose and fibre, though results varied by genetic background—Sunco showed superior amylose levels, while EGA Hume exhibited lower but still trending increases.
Urrbrae Foods argued during the opposition that the claims lacked support because the specification only provided limited proof-of-principle in specific varieties (e.g., successful in Sunco and Westonia, but suboptimal in EGA Hume – the four EGA Hume mutant lines satisfied the criteria of the invention but for the amylose content, of which one line had 43% amylose content rather than greater than 45% as specified in Claim 1. Urrbrae contended that the claims’ breadth—covering all Triticum aestivum varieties—exceeded the disclosed technical contribution and requiring undue experimentation to adapt to diverse genetic backgrounds of different Triticum aestivum varieties. In fact, Urrbrae argued that the claims were enabled across the entire scope for the Sunco variety only as this was the variety that worked best in the described examples – that is, the technical contribution is the possibility of using Sunco wheat to make a grain with the parameters defined in the claims. Urrbrae emphasized the specification’s small-scale experiments (e.g., limited progeny screening) and absence of guidance for scaling or overcoming background-specific challenges, suggesting the invention was confined to the successful exemplified varieties.
CSIRO countered that the specification disclosed a clear principle of general application: triple-null SSIIa mutations impair amylopectin synthesis, diverting carbon to amylose and fibre, a mechanism applicable across Triticum aestivum due to genetic homology within the species. Moreover, the invention is not simply the generation of the claimed grain lines. Instead, it involves a method of generation, screening and selection. In addition, Example 4 provides a clear enabling disclosure for producing grains within the claim scope from multiple genetic backgrounds. At opposition, CSIRO argued that the patent specification discloses worked examples of the claimed product in nine wheat lines, some with the Sunco genetic background, some with Westonia, such that there is no doubt that the claimed product can be made, and the principles by which it can be made have been disclosed.
The delegate’s acceptance of Urrbrae’s position at opposition focussed on the nature of the work required to take the teachings of Example 4 and application to other Triticum aestivum wheat varies, namely (emphasis added):
“It follows that while I can accept that the specification discloses and enables the skilled person to undertake a breeding and selection program, the approach articulated by the applicant of generating, screening and selecting desired products (essentially reproducing the work reported in Example 4) without any basis for expecting to achieve the claimed phenotype in any given genetic background (other than Sunco and Westonia) seems to me essentially the setting of a research project. That is, a project involving trial and error where the outcome is uncertain – “research to find out which derivatives work”, rather than an enabling disclosure. The technical contribution, that is, what is enabled, is not in my view any wheat grain characterised by the defined parameters. While the possibility of achieving such a grain has been disclosed, this is not what the specification has put “at the disposal of the person skilled in the art” – requiring the skilled person to essentially reproduce a research project in order to (perhaps) arrive at products with the claimed desirable properties cannot be considered to “fairly entitle the patentee to a monopoly” over any products with those desirable properties in circumstances where no principle to assist the skilled person in working towards success has been elaborated.”
In contrast Beach J found, with the assistance of new expert evidence, that the claims of the patent specification are supported by the specification. It is noteworthy that the delegate did not have the benefit of this expert evidence adduced in the present case during the opposition proceedings.
At appeal, CSIRO adduced new evidence from Professor Peter Sharp, an Emeritus Professor at the University of Sydney with a PhD in genetics and over 40 years’ experience in wheat breeding, including work on starch synthase mutants. Professor Sharp provided evidence that when he read the patent specification in light of the common general knowledge at the priority date, Examples 4 and 5 provide “a proof of principle such that he considered that he could produce grain with the claimed phenotype in any variety of bread wheat, including EGA Hume by undertaking the breeding and selection program described in the patent application.”
Professor Sharp distinguished Example 4 from a routine commercial breeding program – since a commercial program is a larger scale, greater number of potential progeny plants with desired phenotype in EGA Hume would be generated and thus increase the likelihood of success of selecting a grain that has all of the characteristics of the grain as claimed in claim 1. Moreover, Professor Sharp considered that the specification provides ample directions (e.g., screening assays, DNA markers, etc) to produce and identify the mutant line with the desired characteristics. It is noteworthy that Professor Sharp stated that despite only three varieties of Triticum aestivum being exemplified in the specification, there is a high level of homology within Triticum aestivum species. That is, the effect of a mutation in a gene of one variety of Triticum aestivum can be more safely extrapolated to another variety of Triticum aestivum, given the much greater level of homology within a species compared to across different species.
Professor Sharp stated that a breeding program may take up to 4 years, however, this is a standard and expected timeframe in the field, including having regard to the time needed to grow the plants. To summarise Professor Sharp’s evidence (as set out by Beach J):
“…the patent application provides all information necessary to enable the skilled addressee to generate triple null ssIIa lines in different genetic backgrounds, including EGA Hume, Sunco and Westonia genetic backgrounds and in other genetic backgrounds within the Triticum aestivum species, and explains how to analyse the grain of the triple null ssIIa lines to determine which grain should be selected. Professor Sharp expects that he would be able to replicate the process to generate triple null ssIIa lines in EGA Hume and other commercial varieties.”
In the present case, expert evidence was pivotal but one-sided. Notably, Urrbrae Foods and the Commissioner presented no opposing expert, relying solely on the specification’s text. This absence weakened their position, as the delegate’s findings on genetic background limitations were deemed speculative without evidentiary support. Criticisms were minimal – none explicit from the opposing parties – but the judge implicitly accepted Sharp’s credibility due to his qualifications and lack of contradiction. The evidence’s influence was decisive: it bridged the delegate’s evidential gap, proving extrapolation feasible and shifting the balance toward support. Without it, the appeal might have failed; with it, the court ruled in favour of enablement, illustrating how expert testimony can tip factual determinations in technical disputes.
The court’s de novo review allowed the appeal, setting aside the delegate’s decision and directing the patent to proceed to grant. This case is a reminder that the patent applicant does not need to demonstrate in the patent application “that every embodiment within the scope of the claim has been tried, tested and proved to have been enabled to be made.” A further and important reminder is the power of compelling and authoritative expert evidence and to never give up if the patent applicant believes in their case!