Seeds Of Dispute – APO Invalidates Limagrain’s Canola Patent Claims

Introduction

The Australian Patent Office (APO) upheld an opposition by Nuseed Pty Ltd and Norddeutsche Pflanzenzucht Hans Georg Lembke KG against Limagrain Europe’s Australian patent application number 2016307234 (the Application) relating to Brassica (canola) plants with pod shattering tolerance.  The Delegate found multiple grounds of opposition successful, namely, certain claims lacked novelty in view of prior use, certain claims lacked inventive step, and all claims lacked sufficiency and support across their full scope.

Limagrain Europe was given two months to propose amendments to remedy the deficiencies and has since filed a request to amend the claims of the application, which is currently being processed by IP Australia.

Background

Australian patent application 2016307234, entitled ‘Brassica plant with pod shattering tolerance’, generally relates to the field of breeding oilseed rape (Brassica napus), which is more commonly known in Australia as canola.  Traditional breeding has focused on reducing harmful seed components (erucic acid and glucosinolates) and improving yield through hybrid vigour.  Canola breeding commonly uses male sterility systems to control pollination, including the Ogura cytoplasmic male sterility (CMS) system from radish (Raphanus sativus), along with its corresponding restorer (Rf) gene.  Introgression of this radish genetic material unexpectedly improved pod shatter resistance, but also caused undesirable traits such as higher glucosinolate levels and lower yield.  Because the genetic mechanisms behind these traits were unclear, the invention aims to provide canola plants with a shortened Raphanus introgression that maintains fertility restoration and pod shatter resistance, while minimising negative traits.  It also discloses SNP (single nucleotide polymorphism) markers to detect the presence or absence of the relevant introgressed regions.  The application is accompanied by a deposit, made under the provision of the Budapest Treaty, of seeds of the B. Napus line R42141F at the National Collections of Industrial, Food and Marine Bacteria in Aberdeen, Scotland.

The application included 27 claims at acceptance, summarised as follows:

• Claims 1 – 11 directed to Brassica plants comprising a Raphanus genomic fragment conferring pod shatter tolerance (POSH+) characterised by the absence of at least one Raphanus SNP within SEQ ID Nos 4–18 and the presence of at least one Raphanus SNP within SEQ ID Nos 19–21.
• Claims 12 – 16 directed to methods of identifying POSH+ Brassica plants by detecting the presence and absence of the specified Raphanus SNPs;
• Claim 17 directed to a method of using one or more primers for detecting one or more of the Raphanus SNPs;
• Claims 18 – 20 directed to conventional uses of the plants for oil, food, or breeding purposes; and
• Claims 21 – 27 directed to marker-assisted selection (MAS) methods.

The application was challenged on the grounds of novelty, inventive step, support, sufficiency, and utility.

Evidence from six expert witnesses was submitted.  The Opponents’ five experts provided technical and historical evidence on canola breeding, marker use, and prior seed availability.  The Applicant’s expert responded on molecular biology and SNP assay issues.  The key issues in dispute in the evidence included the reliability of KASP assays in detecting SNPs; whether seeds used in tests were genetically stable and available before the priority date of the application; and the extent of the common general knowledge, especially in respect of material presented at International Rapeseed Congresses.

Key Issues

Novelty

The Opponents relied solely on prior use to establish a lack of novelty, namely the sale of seeds having the claimed SNPs before the priority date.  Evidence was submitted in respect of the sale of various seeds before the priority date, which were purported to have the claimed SNPs.  The Delegate noted that there is a high burden on the Opponents to establish that the same seeds in question, by necessity tested well after the priority date, had been available free in law and equity many years before.  The Delegate rejected some of the evidence on the basis that it did not establish on the balance of probabilities that the seeds tested were ones that were commercially available before the priority date.  However, the Delegate accepted evidence of a purchase order showing the purchase of Ogura restorer line CR51 seeds before the priority date.  The CR51 seeds were homozygous for Brassica at SEQ ID NO. 9 and were homozygous for Raphanus at all other loci tested.  As these seeds, when grown, would have inevitably made a plant with the properties of claim 1, claim 1 was found to lack novelty according to the reverse infringement test.  The Delegate also found claims 6 – 8, 11 and 18 – 20 to be anticipated by the prior use of the CR51 seeds.

The Delegate rejected the Applicant’s argument that there could have been no public disclosure of the genotype because the claimed SNPs had not yet been characterised.  The Delegate stated that a plant bearing the claimed SNPs would have infringed the claim before the priority date, whether its genotype was known at the time or not.

Inventive Step

The Opponents core submission was that each of the claims involved nothing more than the use of a standard marker-assisted selection approach to a known breeding problem.  The Opponents alleged that the invention as claimed lacked an inventive step in view of the common general knowledge alone, as well as in view of the common general knowledge in combination with the disclosure of three different prior art documents.

The Delegate applied the commonly used test for inventive step, namely the “Cripps Question”: would the skilled worker have been directly led to the claimed invention with a reasonable expectation of success?

All experts agreed that the International Rapeseed Congresses were key information-sharing events in the field, and that information presented there was most likely common general knowledge.  The Delegate noted that before the priority date, it was already known that the Raphanus introgression used for fertility restoration in canola also conferred pod shatter resistance, but introduced undesirable traits like higher glucosinolate content and smaller pods.  Experts agreed there was industry motivation to reduce the size of the introgression to retain benefits while removing drawbacks.  A 2011 Rapeseed Congress poster confirmed this goal and reported successful selection of restorer lines with improved pod size and quality while maintaining pod shatter resistance.  The Delegate accepted this as representative of common general knowledge and concluded that the skilled person would have had a reasonable expectation of success in achieving shorter introgressions through conventional breeding.

Consequently, the Delegate found that claims 1–11 directed to the Brassica plants, and claims 18 – 20 directed to their uses, lacked an inventive step in view of the common general knowledge alone, on the basis that the development of such plants would have been an inevitable outcome of routine breeding, even if the precise molecular basis was unknown.

However, the Delegate found that claims 12 – 17 and 21 – 27 directed to specific SNP markers and primer-based detection methods were inventive.  There was no evidence to suggest that the skilled worker would have been directly led to the particular marker sequences based on the common general knowledge or any of the cited documents. The Delegate noted that the evidence fell well short of the requirement in the Cripps Question of establishing a motivation to try any of the claimed markers with a reasonable expectation of success in distinguishing Raphanus from napus DNA.

Support and Sufficiency

The Opponents identified three areas where they alleged the scope of the claims exceeded the enabled subject matter: the species of Brassica, the identity of the Raphanus SNPs and the combination of Raphanus SNPs.  The Delegate was particularly critical of the breadth of the claims and found the claims to be broader than the Applicant’s technical contribution to the art.  The Delegate noted that the Applicant’s technical contribution to the art in the application is a set of SNP markers from the Raphanus introgression into B. napus Ogura restorer lines, some of which are associated with pod shatter tolerance and some which are not, and claimed plants that have some of the former and lack some of the latter.

In relation to the claim extending to all Brassica species, the Delegate found that there was no evidence that the phenotype of pod shatter resistance would be achieved in Brassica species other than B. napus or with any different introgression.  The technical contribution was limited to B. napus Ogura restorer lines.

In relation to the claims extending to any Raphanus DNA, the Delegate found that the reference to the Raphanus DNA in claim 1 only makes sense when it refers to the introgression found in Ogura restorer B. napus lines, so the technical contribution is limited to that genetic background.  The Applicant did not sufficiently establish a principle of general application in terms of the combination of Brassica species and the nature of Raphanus DNA.

In relation to the nature of the Raphanus SNPs, the Delegate considered the technical contribution with respect to marker assisted selection was only the SNPs at the underlined positions, and the evidence suggests that to identify new Raphanus specific SNPs in those sequences would require restarting the entire research project which would amount to undue experimentation.

On the question of sufficiency, the Delegate was not convinced that any of the above three variables were principles of general application.  In particular, the Delegate was not convinced that it was plausible that the prediction for pod shatter phenotype would be relevant for plants other than B. napus with the Ogura restorer Raphanus introgression on chromosome 9.  The Delegate noted that while it is plausible that other SNPs could exist within SEQ ID Nos 4-21, identifying those would involve undue experimentation.

Utility

The Opponents argued that the claimed plants did not deliver promised benefits of improved pod size and reduced glucosinolates.  The Delegate rejected this argument, finding that the utility of the invention was more limited, namely, to act as markers for selecting out unnecessary parts of the Raphanus introgression while maintaining pod shattering tolerance.  There was nothing in the evidence that was inconsistent with this.

Outcome

The Opposition was successful on the following grounds:

• Claims 1, 6-8, 11 and 18-20 were found to lack novelty in view of the prior use of the Ogura restorer line CR51, which was available free of law and equity before the priority date, and which was demonstrated to lack the Raphanus SNP of SEQ ID 9.
• Claims 1-11 and 18-20 to plants per se were found to lack inventive step in view of the common general knowledge, in that the skilled worker would have been directly led to reduce the size of the Raphanus introgression through conventional breeding techniques.
• All claims were found to lack support and sufficiency over their full scope, to the extent that they encompass plants other than B. napus with the Raphanus introgression on chromosome 9, derived from the Ogura restorer line, and to the extent that they encompass SNPs other than those underlined in Figures 1 and 2.

As there was a clear prospect that these grounds could be overcome by amendment, the Delegate provided the applicant with an opportunity to amend the claims.  The Applicant has since filed a request to amend the claims, namely, to delete claims 1 – 11 and 18 – 20, and to amend claims 12 – 17 to limit the methods to Brassica napus plants comprising a Raphanus Ogura restorer fragment, and to define the Raphanus SNP as corresponding to the underlined nucleotides in Table 1 of the application.  The Opponents will have an opportunity to comment on the proposed amendments before a decision is made as to their allowability or otherwise.

Implications

This decision highlights the APO’s strict approach to claim breadth in biotechnology patents.  The APO in this case emphasised a strict post-raising the bar sufficiency standard – claims must match the demonstrated technical contribution to the art, and evidence must be sufficient to establish any claimed principle of general application.  Where the technical contribution is limited to a specific species, introgression, or identified markers, claims will not be allowed to extend to broader plant categories or uncharacterised SNPs.  To withstand opposition, the specification should provide sufficient description and examples to enable broader claims, and ability to argue a principle of general application.  Clear, narrower fallback options should also be included in the claims to ensure amendment is possible to survive opposition.  Alternatively, claims should be drafted carefully to align with the Applicant’s demonstrated technical contribution to the art.

This decision also highlights that seed sales can be novelty-destroying even if their genetic content is undisclosed or uncharacterised.

A further takeaway is the Delegate’s finding on inventive step, namely that the claims to the Brassica plants per se were not inventive, yet the claims to the MAS methods were.  This highlights that while conventional plant breeding outcomes may be found to be obvious, claims directed to the molecular tools (for example, specific SNPs/primers) used to breed them can still be inventive, and worthy of patent protection.

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