Precision fermentation and patent approaches

Inventions in the precision fermentation space often involve novel strains of microorganisms. For a successful patent application, a mere description of a microorganism by its function or activity, for instance, may not be adequate to clearly describe the invention to obtain a patent that withstands challenge(s) by competitors.

A patent application, at the point at which it is filed, has to have enough information in it to allow the so-called ‘skilled person’ in the field, using common general knowledge and the teaching of the application, to reproduce the invention. This ‘sufficiency’ or ‘enablement’ requirement must be met (among other requirements) to the patent office’s satisfaction if a patent is to be granted. A lack of sufficiency can be a ground for attacking a patent by competitors.

If a patent application lacks sufficiency, it can prove fatal to its success and might be a problem that cannot be remedied after the application is filed at the patent office. Care is needed when drafting.

It can be hard to clearly describe the inner workings and genotype of a microorganism by words alone to the extent that the skilled person is able to reproduce an invention. It would also be difficult to recreate the invention without physical access to the microorganism, or to an enzyme or protein produced by the microorganism. The patent system, though, allows biological deposits of microorganisms to be referenced in a patent application. This will allow a third party to readily retrieve the deposit to perform the claimed invention, thus complying with sufficiency requirements. Therefore, where a microorganism is crucial to practising the invention, it is recommended it is deposited at an approved depositary institution.

If a patent application lacks sufficiency, this can prove fatal to its success and might be a problem that cannot be remedied

Innovative companies might be concerned that referencing a deposit in their application could limit their protection to using that specific microorganism. But that is not always the case, as it is possible to seek protection for a broader claim while referencing the specific organism as a mere example of how to practice the invention. The question of claim scope often comes down to the amount of supporting data contained in the application that justifies a broader claim. There are numerous
patent applications in the food-tech field that refer to deposited microorganisms where a broader claim to a generalized process, and a narrower claim to the specific microorganism, is pursued. For example:

• European patent application EP38971734A1 to Nestlé SA has a broad claim directed to a process for the preparation of a fermented dairy product with narrower claims referencing accession numbers of various Lactobacillus strains used in the process.

• International patent application WO2022169357 to Cooperatie Koninklijke Avebe has a main claim to a method of preparing a baked food product while narrower claims define an enzyme of a Geobacillus deposit that is used in the process.

In Europe, at least, microorganisms relevant to an invention should be deposited at an institution recognized and listed by the European Patent Office. There are stringent requirements to be met when referencing a deposited microorganism in a patent application in Europe. To avoid complications, it should ideally be made by the applicant, and the name of the depositor (i.e. the patent applicant) and the accession number must be contained in the application no later than the date of filing. A copy of the deposit receipt (containing relevant details) should also be filed if you intend to rely on the deposited microorganism. If the depositor is not the applicant, the applicant may need to submit evidence that the depositor has authorized the applicant to make the deposit available to the public.

Regardless of which jurisdiction is concerned, if details of the biological material described above are not regarded to be timely filed, the application may fail on the grounds of a lack of sufficiency/enablement.

The use of deposited microorganisms is a handy way of meeting sufficiency requirements for patent applications but there are complex requirements to be met, particularly around the way in which the deposit is made, how and when it is referenced in the patent application, and the possibility of restricting access to the deposit to authorized persons. Fortunately for you, our dedicated food-tech team of patent attorneys at HGF can provide guidance!

Kerry Rees is a Partner and Patent Attorney at HGF. He holds a Master’s degree in biochemistry from Oxford University and advises clients on IP in a wide
variety of food-tech disciplines. This article is republished from the Q1 2024 edition of Protein Production Technology International, the industry's leading resource for alternative proteins. To subscribe to all future editions, please click here