Simulations in bioinformatics and the G1/19 referral

What’s all this about?

Claims directed to methods of simulation or modelling of a system or process typically include features that, in isolation, would be considered to represent mathematical methods or mental acts, which are excluded from patentability under Article 52(2) (a)(c) EPC. However, as discussed in a previous post (more topics on this coming soon), such features can nonetheless be considered to contribute to the technical character of the invention if in the context of the invention they contribute to producing a technical effect serving a technical purpose.

It is (currently) established practice at the EPO (see GL G-II, 3.3.2, T1127/05 and CLBoA I.A, 2.4.3.f)) that “[t]he computer-implemented simulation of the behaviour of an adequately defined class of technical items, or specific technical processes, under technically relevant conditions qualifies as a technical purpose. […] Such computer-implemented simulation methods cannot be denied a technical effect merely on the ground that they precede actual production and/or do not comprise a step of manufacturing the physical end product.”

In decision T0489/14, the Board of Appeal (BoA) reviewed a decision from the Examining Division (ED) refusing an application directed to the simulation of pedestrian movement in an environment, for example to aid in the design of a building (e.g. where the location of exits has an impact on occurrence of “pedestrian traffic jams”). 

In the first instance decision, the ED deemed claims directed to “the computer-implemented simulation of the movement of an autonomous entity through an environment” to relate to a non-technical simulation model, where mere implementation on a computer of a non-technical process is obvious. Claims directed to a “method of designing a building structure comprising a step of simulating the movement of pedestrians through the building structure” were also rejected because the claim did not specify how the process of designing a building structure was connected to the simulation process (such that the simulation features could not be seen to contribute to producing a technical effect serving a technical purpose).

In appeal, the applicant argued that the insight that human interaction could be expressed and modelled in the same way as physical interaction underlined the application, that the method steps were themselves technical because they related to physical parameters, and that the method produced a technical effect in the form of a more accurate simulation of crowd movement, where modelling pedestrian crowd movement in an environment constituted an adequately defined technical purpose for a computer-implemented method (by reference to decision T1127/05 which is the foundation for the above-mentioned established practice).

That very last point is what ultimately led to a referral to the Enlarged Board of appeal (G1/19). Indeed, the BoA was “not convinced that numerically calculating the trajectory of an object as determined by the laws of physics is in itself a technical task producing a technical effect” and commented that “[i]n the Board's view, a technical effect requires, at a minimum, a direct link with physical reality, such as a change in or a measurement of a physical entity”. The BoA could follow the analogy between “a method of testing - by simulation - a modelled environment with respect to pedestrian crowd movement” (as in the case under review) and “a method of testing - by simulation - a modelled circuit with respect to noise influences” (as in T1127/05), and agreed that T 1127/05 supports the applicant’s case. However, it doubted the Board’s reasoning in that decision at least because “a computer-implemented simulation of a circuit or environment […] assists the engineer only in the cognitive process of verifying the design of the circuit or environment [;..t]he circuit or environment, when realised, may be a technical object, but the cognitive process of theoretically verifying its design appears to be fundamentally non-technical”.

Therefore, the BoA appeared to be of the opinion that the claims of this application should be considered to lack an inventive step over a general purpose computer (i.e. that all of the features of the simulation should be considered non-technical and ignored in the assessment of inventive step), but recognised that the approach developed in case T 1227/05 suggests a different finding.

The BoA therefore referred three questions to the Enlarged Board of Appeal (EBoA):

  1. In the assessment of inventive step, can the computer-implemented simulation of a technical system or process solve a technical problem by producing a technical effect which goes beyond the simulation's implementation on a computer, if the computer-implemented simulation is claimed as such?
  1. If the answer to the first question is yes, what are the relevant criteria for assessing whether a computer-implemented simulation claimed as such solves a technical problem? In particular, is it a sufficient condition that the simulation is based, at least in part, on technical principles underlying the simulated system or process?
  1. What are the answers to the first and second questions if the computer-implemented simulation is claimed as part of a design process, in particular for verifying a design?


Why should we (computational biologists) care?

As the BoA recognised themselves in their decision, numerical development tools and in particular computer-implemented simulations play an important role in the development of new products, and legal certainty in relation to the patentability of such tools is therefore very important. This is true in many fields (as evidenced by the flurry of amicus curiae briefs that were filed subsequent to the referral), including that of computational biology.

For example, the amicus brief from the European Federation of Pharmaceutical Industries and Associations (EFPIA) makes the point that  “[d]evelopment of new medicines today frequently relies on computer-implemented modelling and simulation of physical systems, such as biological systems, molecules, and their interactions. Examples include model-based drug development, physiologically based pharmacokinetic modelling and simulation or molecular dynamics simulations. Modelling and simulation are also frequently used when developing improved production methods or when developing medical devices delivering drugs.” Similar considerations are applicable to other areas of computationally biology, such as for example the modelling of disease propagation or disease agent mutation to design intervention or prevention strategies, the modelling of biological agents such as e.g. bacteria to control or prevent biofilm formation, the modelling of biochemical assays to enhance their sensitivity, etc.

A decision that requires a physical step going beyond the “cognitive process” such as e.g. the actual manufacture of a product according to the design or the implementation of an intervention step could have particularly important implications to the field of bioinformatics and computational biology because (a) the entities performing the simulation and the entities physically implementing the insights from the simulation are often separate, leading to potential issues of divided infringement that would devalue the European patent system for the form type of entities, and (b) the physical implementation step may in many cases be excluded from patentability as a method of treatment or diagnosis practice on the human or animal body.  In our opinion, such a decision appears unlikely and it is more likely that a decision would, at most, emphasise the need for a link between the simulation steps and a technical purpose (i.e. a direct, causal link between the results of the simulation and the solution of a technical problem). As explained in more detail in a post to come shortly, this would be in line with the current practice in the field of bioinformatics. For example, in a claim to a method of diagnosing a disease by simulating the behaviour of a cell, where the link between the diagnosis and the result of the simulation is apparent, the simulation steps should be considered to produce a technical effect serving a technical purpose in the context of the invention.

So what does this mean in practice?

The most immediate practical consequence of the referral is that some proceedings before the EPO (whether examination, opposition or appeal) may be stayed until the EBoA reaches a decision, either upon the Office’s initiative or on request by a party. However, this would only be the case if the assessment of inventive step required a decision on a simulation of a technical process, and only if the fate of the application / patent depends entirely on this decision. If the simulation is of a non-technical process (e.g. simulation of an administrative scheme), or the application should be refused / the patent revoked for another ground, then proceedings should not be stayed.

As mentioned above, our opinion, confirmed by informal discussions with some examiners in the field, is that the decision, when it is issued, is unlikely to drastically change the practice in the field of bioinformatics. However, as is often the case, the uncertainty (while the referral is pending) could cause more damage than the thing itself. Further, the impact could be more important in relation to inventions that are examined by other art units than bioinformatics, who may be less familiar with what is considered to be a technical purpose in that field (which in particular may not require a physical step and may result in the identification or determination of an objective / physical property of a biological subject, molecule or process).