Wheat patent specification did support the claims, holds Federal Court of Australia
Jocelyn Bosse
Wheat patent specification did support the claims, holds Federal Court of Australia
Jocelyn Bosse Wednesday, December 17, 2025 - Australia, Jocelyn Bosse, patents, plant varieties, wheat
Earlier this week, Justice Beach handed down his judgment in Commonwealth Scientific and Industrial Research Organisation (CSIRO) v Urrbrae Foods Pty Ltd [2025] FCA 1591. CSIRO's patent application was held to be valid after all. The decision from the Federal Court of Australia provides an example of how the requirement for support can be met in the context of plant breeding.
A Kat enjoying (?) some wheat products. Photo by Anna Shvets via Pexels.
Background
The case concerned Australian Patent App. 2017292900 entitled "High amylose wheat - III." The issue was whether the patent application complied with the Patents Act 1990 (Cth) s 40(3), which requires that "The claim or claims must be clear and succinct and supported by matter disclosed in the specification." This requirement was amended by the Raising the Bar reforms in 2012, which brought the Australian law into line with the UK and European standards for sufficiency - although this continues to operate alongside the "best method" requirement in Australia (see discussion here).
CSIRO is an Australian Government agency that engages in scientific research, including plant breeding to develop high-amylose wheat. Readers are probably aware that wheat grain contains a carbohydrate called starch, and it is healthier to consume wheat products with higher levels of dietary fibre - such as "resistant starch" - because of its beneficial behaviour in the digestive system. A higher ratio of amylose leads to an increase in resistant starch, which motivated CSIRO's efforts to create high-amylose wheat.
The Invention
One of the challenges with bread wheat (Triticum aestivum) breeding is that it's a hexaploid species, which means that it has six sets of chromosomes derived from its three ancestral genomes. Research showed that null mutant variants of the starch synthase IIa gene - these null variants being written as ssIIa - would lead to increased amylose content. However, the loss of function mutations to produce ssIIa are recessive, so the mutations only lead to the desired phenotype in the homozygous state.
This meant that the process for producing the high-amylose wheat involved undertaking a series of crosses until the mutations were homozygous in all three genomes (so-called "triple null"). This could be achieved through a series of backcrosses and screening for the desired ssIIa mutations. But even when the progeny are "triple null," the effect of this genotype on the phenotype is also subject to variation, so there needed to be further selection of plants that achieved the desired phenotypic characteristics (e.g. amylose content). Claim 1 - the only independent claim - included that the amylose content of the wheat grain is between 45% and 70% on a weight basis of the total starch content (amongst other defined non-starch polysaccharide content).
The Decisions
The patent application was opposed on various grounds, but the delegate of the Commissioner of Patents only upheld the opposition on the ground of lack of support. In summary, the opponent argued that the technical contribution of the patent application was the possibility of using 'Sunco' wheat to make a grain with the parameters defined in the claims, but the specification showed that the invention did not work across its scope, namely, using the method on other strains of wheat to achieve the claimed characteristics. Instead, the specification reported different results depending on the genetic background of the wheat. While the possibility of achieving a grain with the claimed parameters was disclosed, the delegate found that the skilled person was required to essentially reproduce a research project using other wheat strains in order to (perhaps) arrive at products with the claimed desirable properties. Therefore, the claims lacked support. CSIRO appealed.
The Federal Court had the benefit of a new expert, Professor Sharp, as a representative of the skilled person. Much of the opposition was directed to Example 4, which described a breeding process to generate triple-null ssIIa mutants in three genetic backgrounds: the commercial wheat varieties 'Sunco', 'EGA Hume' and 'Westonia'. The expert emphasised that the breeding process described in Example 4 was small scale, which is standard for a proof-of-principle research project, as opposed to a commercial breeding program.
The expert reviewed the data from the patent specification and understood these data to demonstrate that the triple-null ssIIa mutations lead to an increase in amylose and the fibre components, irrespective of genetic background. In his view, the patent application provided a reasonable and rational basis to expect that this proof of principle would apply equally to any variety of the species Triticum aestivum.
In the small scale study described in the specification, fewer mutant lines were generated from one of the varieties - 'EGA Hume' - and they fell below the claimed parameters for amylose content. The expert expected that if more lines were developed, there would have been more lines within the parameters in Claim 1. Although more time consuming, the development of more lines would be typical and routine for breeding programs in the field, particularly for commercial programs.
Justice Beach noted that the 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," per Regeneron [2020] UKSC 27. His Honour concluded that "it is apparent that the patent application supports and enables the person skilled in the art to perform the invention across the breadth of each of the claims, and there is no evidence that to do so in, for example, the EGA Hume genetic background would require undue burden."
Final Thoughts
This patent opposition cropped up against the backdrop of a possible suit against Urrbrae Foods Pty Ltd for infringement of two other patents owned by CSIRO (see here and [2023] FCA 504). It's not yet clear whether Urrbrae Foods is likely to appeal.
The case is one of many disputes about sufficiency and support that have reached the Australian courts since the Raising the Bar amendments (see also IPKat here). While other cases have more to say about the legal principles, this was an important opportunity to consider how "support" can be shown in light of the common knowledge in the plant breeding sector. It is notable that Justice Beach took into account of the greater level of homology within a species (vs. across different species) that allows for the effects of mutation in one variety to be more safely extrapolated to another variety of the same species.
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