In our recent webinar we discussed whether you need data to file a patent application in relation to the criteria of sufficiency and plausibility in Europe. Here, we explain what these two terms mean, as well how to meet these criteria in Europe.

What are sufficiency and plausibility?

Sufficiency is the requirement for the patent application to “disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art”. This is governed by Article 83 of the European Patent Convention (EPC). Essentially, this means that there must be enough detail in the application for the invention to be put into practice, by someone knowledgeable in the particular technical field. In addition, this detail must be enough to allow the invention to be performed across the whole area claimed in the application. The “whole area claimed” concerns any embodiment which is covered by the claims.

Plausibility is the requirement for the technical effect of the invention disclosed in the application (that is the benefit or improvement the invention provides) to be “plausible” from the outset. In other words, there must be enough information in the application to make it credible that the invention does indeed provide the technical effect alleged. In Europe, the technical effect of an invention is key to the invention being considered inventive. If the technical effect is not considered to be plausible, the application will not be deemed inventive. Unlike sufficiency, plausibility is not mentioned in the EPC or the UK Patents Act. Instead, the requirement for plausibility developed in the case law as a response to speculative filings, particularly in the pharmaceutical area.

Both sufficiency and plausibility are judged based on the information included on filing; any deficiencies can’t be rectified by submitting further information after filing.  It is therefore important to ensure that you have enough information in your application as filed to meet these criteria. Without this information, your application could be refused. How “enough information” is defined can depend on the technical field of the invention and how well-established the field is. In some instances, enough information can simply be a description of the invention. In other instances, enough information may require detailed protocols, as well as data to demonstrate that a particular technical effect is plausible.

Another way of looking at it

Sufficiency and plausibility can feel like quite abstract concepts and it may be difficult for an inventor to work out what is needed to meet the requirements. There are three key questions which can help determine how much information you need in your application. These are:

1. Reproducibility: How difficult is it for a skilled person to reproduce my invention?

The amount of detail required in an application can depend on how much common general knowledge a skilled person in the field would be considered to have. If a skilled person in the field could work out most of the technical details of an invention using their expected general knowledge, then you won’t necessarily require a detailed description of those commonly known features in the application. This is often the case with relatively simple mechanical inventions – there would be no need to provide a very detailed description of a well-known device like a nut and bolt.

If small changes in the way an invention is reproduced could have a significant impact on the resulting product or method, or the technical effect it has, then more detail is likely to be required. For example, when claiming a new chemical, you will likely need to provide a detailed protocol of how to generate it, especially if any of the steps are particularly crucial to producing that particular compound having the technical effects claimed.

2. Predictability: How predictable is the effect achieved by my invention?

Predictability corresponds to the plausibility requirement. The less predictable your effect, the more information, generally in the form of data, you will need to demonstrate that said effect is plausible.

If the technical effect of your invention is highly predictable, then less or potentially even no data may be required. This may apply when the effect is made clear from the common general knowledge of the skilled person, or when the effect is previously unrecognised or made plausible because of a new theory. However, care must be taken in such instances, since the more predictable an effect, the harder it may be to argue in favour of inventive step.

Effects from inventions in the life sciences field, in particular, are seen as being less predictable. For such applications, data is generally needed to demonstrate a technical effect. 

3. Creative Freedom: How much creative freedom did I have for my invention?

The extent of creative freedom you had when developing your invention can feed into the amount of information required to meet the predictability and reproducibility requirements. A lower level of creative freedom may mean that more data is required to make your invention’s technical effect credible. A higher level of creative freedom can mean less data is required to demonstrate plausibility. In situations with more creative freedom but a fair amount of common general knowledge in the field, less guidance may be required in the application as to how to put the invention into effect. The opposite may apply in situations with less creative freedom; a detailed description of the invention may be required.

The level of creative freedom can depend on the technical area of your invention and/or how established your technical field is.

Mechanical inventions typically have a greater level of creative freedom, in that the problem the invention solves could have been approached another way with different solutions. In contrast, life sciences inventions are frequently more of a “one-way street” – a particular problem can’t necessarily be solved another way.

In less well-established fields, such as early machine learning or gene silencing applications, there is a greater level of creative freedom since these inventions are pioneering.

In summary, meeting the sufficiency and plausibility requirements in Europe requires the provision of enough information in the application, when filed, to both make the effect of the invention plausible, but also to enable the skilled person to carry out the invention. The extent of information required depends on the reproducibility, predictability and creative freedom of your invention. Meeting these requirements is crucial to obtaining a granted patent in Europe.

This is provided for general information only and does not constitute legal advice. If you would like to discuss sufficiency and/or plausibility in more detail, please contact our patents team.