Updated EPO examination guidelines address AI, accelerated oppositions and antibody claims

The newly updated European Patent Office (EPO) Guidelines for Examination contain a number of updates reflecting recent EPO case law. Given the increasing prevalence of artificial intelligence (AI), of particular interest are the updates concerning the disclosure requirements and the designation of inventors for AI inventions. Following the launch of the Unified Patent Court (UPC) last year, the guidelines entered into force on 1 March and address the acceleration of opposition proceedings in cases with pending parallel actions before the UPC.

AI inventions

The disclosure requirements for inventions relating to AI have been set out more explicitly. Applications must be filed with enough detail to enable a skilled person carrying out the invention to achieve the same alleged results in a reliable way. For inventions involving AI, the underlying mathematical methods and datasets must be disclosed with sufficient detail to allow the skilled person to reproduce the technical effect across the entire range claimed. Otherwise, insufficient disclosure may result in something resembling "an invitation to a research programme".

The guidelines acknowledge that the technical effect may be readily apparent or established through supporting data and examples and it continues that "[while] mere allegations are not enough, comprehensive proof is not required, either."

In practice, if the technical effect achieved by a machine learning algorithm is dependent on characteristics of the training dataset used, those characteristics need only be disclosed if the skilled person cannot determine them without undue burden using common general knowledge. However, the guidelines clarify that, in general, there is no requirement to disclose the specific training dataset itself.

In addition, the EPO will check whether the designated inventor is a natural person (although it does not verify the accuracy of the information given in the designation of the inventor). This is in line with a EPO Board of Appeal decision, which formed part of the DABUS global test litigation strategy.

Accelerated EPO oppositions

Proceedings before the UPC now create an additional timeline to consider alongside national and EPO proceedings. The guidelines have been amended to allow a party to submit a reasoned request for acceleration of an EPO opposition in cases where there is a parallel infringement action in respect of the European patent pending before the UPC. (This is in addition to the existing acceleration procedure for cases with a pending parallel action before a national court of a European Patent Convention (EPC) state.) The EPO will also accelerate opposition proceedings if it is informed by the UPC or a national court or competent authority of an EPC state that infringement actions are pending.

However, this update does not cover the EPO's commitment to accelerate opposition proceedings for both parallel infringement and revocation cases.

Permitted definitions for antibody claims

The EPO allows antibodies to be defined by reference to their target antigen or epitope (that is, the structurally defined part of the antigen to which the antibody binds). The updated guidelines provide further clarity on the circumstances in which broad functional claiming of a genus of antibodies will be allowed.

Claims that define antibodies by their ability to compete with a reference antibody disclosed for the first time in the application will normally not be sufficient to identify antibodies in the state of the art. Unless there is an indication to the contrary, it will be assumed that a prior art antibody binding to the same target antigen will have the same functional properties as the claimed antibody. Therefore, a novelty objection can be raised and, if so, applicants will bear the burden of proof.

An application must allow a skilled person to produce the claimed antibodies without undue burden, and allow the skilled person to "easily and unambiguously verify whether they are working inside or outside the scope of the claim." This means that the relevant characteristics of the method used to determine and define the functional property should normally be included in the claim.

Osborne Clarke comment

The guidelines make some important changes on a number of topical issues of which patent applicants should be aware. Notably, applicants with AI inventions need to ensure that they do not fall foul of the disclosure requirements by including relevant supporting data and examples. It is also clear that the designated inventor must be a natural person.

How the EPO's approach to antibody claims is applied in practice will be critical for the biotechnology sector given that monoclonal antibodies are currently the cornerstone therapeutic modality. In particular, it will have critical implications for the strength and scope of protection achieved for the output of research and development projects that require significant expenditure.

Although the guidelines commit to accelerated opposition proceedings where there is a parallel UPC infringement case, they haven’t been likewise updated to cover parallel revocation actions. This will likely happen in due course.

Nevertheless, it remains to be seen exactly what impact the acceleration procedure might have in the context of the UPC. At present, the average length of time for an opposition is 19.6 months (not including appeals). Whereas, the UPC aims to deliver its decision on the merits of a case in a little over a year. So far, the UPC has stuck closely to the tightly prescribed deadlines in the rules of procedure, allowing little or no latitude to parties to extend these deadlines.

Rule 295 states that the UPC may stay its proceedings where the patent is also subject of opposition proceedings at the EPO (or national authority) where a decision may be expected to be given "rapidly". How exactly will "rapidly" be interpreted and will the EPO's accelerated opposition procedure speed things up enough to prompt the UPC to stay its proceedings?

Kieran Ng, a Trainee Solicitor with Osborne Clarke, contributed to this Insight.