When Seeds Become Prior Art: A Case Summary on Nuseed Pty Ltd and Norddeutsche Pflanzenzucht Hans-Georg Lembke KG v Limagrain Europe [2025] APO 25

Background

On 18 November 2022, Nuseed Pty Ltd and Norddeutsche Pflanzenzucht Hans-Georg Lembke KG (“The Opponents”), opposed grant of Australian national phase patent application, AU2016307234 (“The Application”), which was owned by Limagrain Europe (“The Applicant”). The Application claims a priority date of 11 August 2015.

During the evidentiary period, amendments to the claims were filed. However, the amendments simply added further dependent claims and did not otherwise alter the scope of the claims.

Of note, although not of material importance, was that the period for filing evidence in support was extended several times pursuant to Regulation 5.9, to allow the Opponents to access and analyse seeds that had been deposited under the Budapest Treaty. As a result, evidence in support was filed in stages, under successive declarations.

The Application was filed post 15 April 2013, which meant that the provisions under the post-Raising the Bar Act 2012 applied. This requires that the burden of proof involve an assessment on the balance of probabilities.

The Invention

It is known in the relevant field that presence of erucic acid in oil and glucosinolates in oilseed rape (Brassica napus), more commonly known as canola, can be harmful at high levels. Thus, breeders of these plants commercially favour canola plants that have low levels of these components. Other genetically favoured modifications for this plant line include reducing the ability of the seed pods to dehisce (“shatter”) to enhance harvestablity, as wild-type canola plants have this phenotype to allow for release and scatter of the seed (the “pod shatter” phenotype).

The invention therefore relates to providing a canola plant with a shortened introgression to improve the production of seeds that exhibit the pod shatter resistance phenotype, while reducing associated undesirable characteristics. It further relates to methods for identifying the presence of the pod shattering tolerance allele in Brassica plants and, in particular, suitable markers (single nucleotide polymorphism genetic markers, SNPs) associated, or not associated, with the pod shattering tolerance phenotype.

Lack of Novelty

The lack of novelty ground pursued by the Opponent related to prior use of the invention. As per Damorgold Pty Ltd v JAI Products Pty Ltd [2015] FCAFC 31, for there to be lack of novelty based on prior use, “the onus lies on the party seeking to establish an enabling disclosure.” The prior art information must also be made “publicly available through the doing of that act”, such that “at least one member of the public had access and would be free in law and equity to make use of it as that person saw fit”. The  skilled addressee must also be able to observe on inspection sufficient detail that would enable him or her to comprehend how to replicate the complete invention.

The Hearing Officer acknowledged that the principles of prior use as stated in Damorgold are somewhat different in the field of plant breeding. For mechanical inventions, the prior use test is satisfied if a skilled person can observe all the component parts in a manner that enables them  to reproduce it. However, to make a plant, the skilled person needs to grow it from a seed, assuming the seed contains the genetic information required to produce the infringing plant. Hence, in this case, the question to ask with respect to prior use was whether the seeds having the claimed SNPs were available, free in law and equity, to a member of the public before the priority date.

The Applicant argued that there was no public disclosure because the claimed SNPs had not been characterised yet. However, the Hearing Officer disagreed with this approach and made reference to Otsuka Pharmaceutical Co. Ltd v Generic Health Pty Ltd (no 4) (2015) FCA 634 at 320. The referenced decision stated that“Novelty of invention is not provided merely because information given as part of the definition of the invention in a claim is new information”. In other words, a plant bearing the claimed SNPs would have infringed the claim before the priority date, regardless of whether the claimed SNPs were characterised at the time. 

The sets of seeds were at the centre of the novelty discussion. The first concerned the DK Excellium seeds provided free of charge for the purposes of carrying out the  experiments. The Hearing Officer held that such sample seeds, when provided under such circumstances, would be limited to experimental use only. Thus, on the balance of probabilities, would not have been “sold” free in law and equity.

On the other hand, the CR51 seeds obtained as part of a large purchase order were considered freely available to purchase. Thus, the CR51 seeds fell within the prior art base for assessing novelty. Due to this finding and given the genetic background of the CR51 seeds, being homozygous for Brassica at SEQ ID No 9 and homozygous for Raphanus at all other loci tested, it was deemed inevitable that a plant would grow with the properties of claim 1, when the reverse infringement test is applied. Thus, claim 1 lacked novelty on the grounds of prior use.

Inventive Step

With respect to inventive step, the Hearing Officer declared the “Cripps question” – which asks whether a skilled person would have been directly led to try the claimed invention, with a reasonable expectation of success in solving the problem – not directly relevant when considering the invention’s application to plant breeding. This is because it is not possible to “try” a particular plant genotype. Rather, conventional plant breeding  involves repeated crosses between parent plants, which may result in the introgressing of traits from one plant into another.

Further to the considerations for inventive step, the Hearing Officer acknowledged that before the priority date, while it was possible to insert foreign genetic material into a plant genome, the techniques for site specific insertion via CRISPR technology had not yet been developed in the field of genetic engineering. Nevertheless, removal or replacement of genetic material was considered to utilise standard plant breeding techniques, which does not require precise knowledge of genomic structure.

When pondering what constituted common general knowledge, it was established that the quadrennial International Rapeseed Congresses was attended by all experts in the field. All information distributed at this conference was considered common general knowledge. As such, disclosure from a poster presented at the 2011 Congress, which demonstrated that the undesirable traits on the Raphanus introgression could be separated from the desirable pod shattering resistance, was deemed common general knowledge in the field. A person skilled in the art would therefore expect a reasonable chance of success that this separation would work should they wish to carry out the relevant techniques and procedures. Through conventional techniques, a skilled person would inevitably select plants with progressively shorter introgressions, even though they may be unaware of the precise genetic basis for these. Plants produced using these techniques would inevitably lose the markers in the region of the introgression unrelated to pod shattering. Thus, these would be genetically indistinguishable from the plants in the claimed invention, regardless of whether selection was performed on the basis of markers.

For ease of reference, claim 1 states:

“A Brassica plant comprising a Raphanus genomic fragment within its genome, wherein said fragment confers pod shattering tolerance phenotype POSH+ and said fragment is characterized by: (i) the absence of at least one Raphanus SNP within at least one of the following markers: SEQIDNOs 4-18, and (ii) the presence of at least one Raphanus SNP within at least one marker SEQIDNo 19, SEQIDNo 20 or SEQIDNo 21. (emphasis added)”

The Applicant’s arguments concerning the non-obviousness of the molecular markers per se were therefore irrelevant for the claims directed to the plants per se. The Hearing Officer did acknowledge that such arguments were persuasive for claims that were limited to use of those markers, since genomic information is required for establishing the identity of the SNP markers and there was no evidence from before the priority date to suggest that the specific markers claimed formed part of common general knowledge.

A selection of the Applicant’s claims (Claims 1-11 and 18-20) were therefore found to lack an inventive step in view of common general knowledge alone, since a skilled person would have been directly led to reduce the size of the Raphanus introgression through conventional breeding techniques alone. The remaining claims, however, were considered inventive as none of the prior art documents disclosed the precise SNPs or provided any rationale for why a skilled worker would have been directly led to these sequences.

Sufficiency and Support

The patent was also opposed on the grounds of sufficiency and support.

The Hearing Officer emphasised that the test for support requires a comparison of the technical contribution – which is to be determined based on disclosures in the specification as a whole – and the scope of the claims.

It was considered by the Hearing Officer that the technical contribution made by the Applicant concerned a set of SNP markers from the Raphnaus introgression into B. napus Ogura restorer lines, some but not all of the markers of which were associated with pod shattering resistance. Thus, the claims were deemed broader than the technical contribution and therefore not supported by the description of the specification.

A lack of sufficiency was also found. The test for sufficiency requires determining whether it is plausible that the invention could work over the full scope of the claims, and whether to do so would involve undue experimentation. The claims did not provide for a principle of general application and as such, could not effectively predict pod shattering resistance in plants other than B. napus with the Ogura restorer Raphanus introgression on chromosome 9. Furthermore, whilst it is plausible that other SNPs could exist with sequence regions (4-21), it was decided that identifying these would require an undue burden.

Outcome and Key Takeaways

The opposition therefore partially succeeded on the grounds of lack of novelty and inventive step, with all claims being found to lack support and sufficiency. Consequently, the Applicant was provided with a period of 2 months from the decision to amend the claims. Costs were also awarded against Limagrain Europe.

Importantly, this case not only highlights that lack of novelty on the basis of prior use requires there to be an enabling disclosure. The information must also be free in law and equity and accessible by at least one member of the public before the relevant priority date, which excludes experimental use. Furthermore, for inventions that rely on their genetic basis (for example, nucleotide variations), there is no need to fully characterise these before the priority date for there to be a finding of infringement, especially if the outcome (in this case the plant product) inevitably develops or grows to display traits characteristic of that particular genotype. 

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