Patenting microbial crop products in Europe

The development of biological solutions for stimulating and protecting crops is accelerating as growers demand cost-effective performance with reduced reliance on chemical fertilisers and pesticides. Microbial crop products offer a powerful approach to improving soil health and generating resilient plants and stronger growth.

However, microbial crop products are highly complex and their development and testing requires significant investment. Innovators therefore require robust patent protection for their products in order to safeguard their investment. Fortunately, European patent practice provides a wealth of opportunities for protecting many different aspects of microbial crop products.

Claiming bacteria in European patent applications

Firstly, unlike other jurisdictions (such as the US), naturally occurring products are not excluded from patentability in Europe. Patent protection can therefore be pursued at the European Patent Office (EPO) for products that contain naturally occurring bacteria. New species of bacteria may be claimed broadly, and new strains of known bacteria may also be claimed.

Additionally, even if a species or strain of bacteria is already known to have beneficial effects on plants, patent protection for crop products comprising the bacteria may still be sought. For example, consortium products that combine multiple strains or species of bacteria can be claimed because the combination of different bacteria can distinguish the product from known uses of the individual bacteria. With careful claim drafting, patents directed to consortium products may provide broad protection that applies beyond an innovator’s particular combination of strains, to other products that utilise the same species. Additionally, any new feature of a composition may be used to distinguish a patent claim from a prior composition with the same bacteria – for example, inclusion of a fungicide, or a new sprayable formulation.

Any patent application that claims a new strain or species of bacteria will normally require a biological deposit to be submitted with a depositary authority under the Budapest Treaty. Importantly, in Europe (and in many other jurisdictions) it is essential to make the biological deposit before the patent application is filed. Therefore, innovators should prepare to make their deposits and seek appropriate advice well in advance of needing to file their patent application. Although the process of making a deposit and referring to it in a patent application is relatively straightforward, getting it wrong can be fatal to the patent application.

Maximising claim breadth

Patent claims referring to deposited bacteria can be valuable, but they are potentially very narrow and could be circumvented by a competitor selling a product with a very similar strain. Therefore, innovators should aim to pursue patent claims with additional scope around the deposited strain. This can be done with considered claim drafting, ideally supported by relevant data in the application as filed.

In particular, patent applications should claim variants of the deposited strains, defined with reference to functional and metabolic characteristics, in addition to sequence requirements. To strengthen such broader claims, applications should include data for multiple different strains, where possible, and details on how the deposited strain is characterised, what functional attributes are associated with its useful effects, and what assays or rationale could be used to identify further effective strains.

Including this level of detailed characterisation in a patent application may require additional work, but this will provide a more robust patent application that will be more straightforward to prosecute, saving costs and increasing the value of the asset in the longer term.

In relation to medicinal bacterial products, practice at the EPO appears to shifting towards an assumption that the effect of any bacteria is strain-specific, which makes it harder to obtain the grant of broad claims that extend beyond a deposited strain (see in particular T 298/20 – “it was generally accepted that the health benefit provided by a probiotic was strain-specific. Only in exceptional cases had it been observed that the effect of a strain was common to the whole species.”).

However, European examiners assessing bacterial crop products are often more willing to accept that different strains may have similar effects on crops, and allow claims that are not limited to the deposited strain. Innovators in the agbiotech space should exploit this opportunity by making sure that their patent applications are not limited to their deposited strains, and that they include material that supports broader claims.

Taking full advantage of the opportunities

In addition to pursuing claims focusing on the bacteria in a microbial crop product, it is also possible to pursue claims for different methods using the product. Such an approach is particularly useful if a product is already known, but a new use or effect of the bacteria has been identified. For example, a claim may refer to a method of controlling a particular pest, or a method of providing a particular effect on growth, such as increasing flowers or the size of roots, or reducing the effect of abiotic stress.

Significant additional opportunities also exist for protecting genetically modified bacteria. This is because, in addition to the bacteria used in the product, it may be possible to protect the engineering approach more broadly. In brief, the heterologous gene sequences that are introduced, the structure of the constructs, and the edits made may all be patentable.

Therefore, although microbial crop products are complex and demanding to develop, patent protection is available for many different aspects of the products, especially in Europe. To take full advantage of these opportunities, it is necessary to draft patent claims carefully and ambitiously, and to include deposit information and detailed characterisation of new strains in patent applications.

How J A Kemp can help

Bacterial products are particularly complex, and the agbiotech field has unique commercial considerations that must be taken into account when building a patent portfolio. J A Kemp has both one of the largest and most experienced plant and crop science teams in Europe, and extensive experience drafting and prosecuting applications directed to bacterial products. We are therefore ideally placed to support innovators developing and protecting technologies in this fast-moving field.

By Ian MacLeod, Partner, J A Kemp

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