Bifurcation before the UPC 

When infringement and validity are not adjudicated before the same Court 

A case of infringement in a complex technical context 

The dispute opposed Labrador Diagnostics to several entities of the bioMérieux group concerning a European patent with unitary effect relating to a biological diagnostic device. More specifically, the invention concerned an instrument for detecting a biological analyte from a sample, by combining different reagent units and a detection system. 

Labrador Diagnostics alleged that bioMérieux reproduced this invention through its VIDAS 3 system, a diagnostic machine used in medical laboratories. The question put before the Court therefore appeared classic: do the disputed products constitute an infringement of the patent? 

However, the procedural context made the analysis more delicate. 

Bifurcation 

One of the most striking aspects of this case lies in the use of bifurcation. This legal mechanism allows a case to be split into two distinct parts: 

• on the one hand, the question of infringement, adjudicated by a local or regional division; 
• on the other hand, the question of the validity of the patent, referred to the central division. 

In this case, the counterclaim for revocation brought by the alleged infringers was referred to the Milan Central Division, while the Düsseldorf Local Division remained seized of the infringement action. 

Bifurcation pursues an objective of specialisation of the divisions and procedural efficiency. However, this mechanism raises a conceptual difficulty: how can infringement be adjudicated when the validity of the patent has not been finally determined and its examination is carried out independently by another court? 

In this respect, the decision provides a pragmatic answer. 

The effect of decisions of the central division on the local division 

In parallel with the infringement proceedings, the Milan Central Division, responsible for examining the validity of the patent, handed down a decision seeking to amend the patent by substantially limiting the claims as granted. In addition, since parallel opposition proceedings before the European Patent Office were pending, the validity of the patent had not been finally determined. 

The Court, the Düsseldorf Local Division, was therefore faced with a decisive question: should it rule on the basis of the patent as initially granted, or on the basis of the amended patent? 

The answer given by the UPC in this case is unequivocal: the Court must assess infringement by reference to the amended version of the claims resulting from the decision of the Milan Central Division, even if opposition proceedings before the EPO are pending. 

In other words, even in a bifurcated system, decisions handed down on the validity of the patent are binding on the courts seized of infringement. This decision confirms the unity of the Unified Patent Court system, despite the procedural separation of the issues, and in practice encourages alleged infringers to prioritise obtaining a decision on validity, and in this case a limitation of the claims, in order to facilitate the subsequent defence based on lack of infringement. 

The core issue in the infringement action: the interpretation of the “device” 

The outcome of the case essentially rests on the interpretation of a central term of the claims: “device”. 

The patent required that an instrument comprise a “device” itself composed of two elements: 

• an array of reagent units; 
• a sample unit. 

Yet, in the VIDAS 3 system, which is accused of reproducing the features of Labrador Diagnostics’ patent, these elements do indeed exist, but are physically separated: 

• the samples are placed in a distinct unit; 
• the reagents are located in another part of the machine. 

The question therefore became the following: can these separated elements nevertheless be considered to constitute a single “device” within the meaning of the patent? 

A balanced position between function and structure 

The proprietor argued that, since the elements cooperate to perform the technical function, they must be considered as a single device. The Court rejected this interpretation, finding that it would deprive the notion of “device” of any concrete scope. 

But the Court also rejected an excessively restrictive conception. It specified that the device does not need to be monolithic: it may be composed of several distinct elements, possibly modular ones. 

The solution adopted is therefore intermediate: in order to constitute a “device”, the elements must exhibit a form of structural or spatial connection, and not merely a functional link. 

In other words, it is not sufficient for the components to work together; they must also, in some way, be brought together within an identifiable entity. 

In the present case, in the absence of a device within the meaning of the patent, the Court held that an essential feature was not reproduced. 

Infringement by equivalence was also rejected by the Court, in particular because the “decomposed” device of the VIDAS 3 does not perform the same function as the claimed device. 

The limited role of validity in the event of bifurcation 

Another noteworthy contribution of the decision concerns the role of validity in bifurcated proceedings. The Court indicates that, in a case where it does not find infringement, the question of validity is no longer determinative of the outcome of the dispute. 

In practice, if the infringement action fails, the examination of validity becomes unnecessary in that context. This approach thus reinforces the procedural efficiency of the system. 

A structuring decision for practice 

This decision provides several important lessons. 

First, it shows that, despite bifurcation, the revocation action may have an impact on the scope of the claims examined in the context of the infringement action. 

Furthermore, it illustrates the practical effects of bifurcation, by showing that the infringement action may be decided independently of the validity of the patent, in particular in the absence of infringement, which directly affects the parties’ litigation strategy. 

In addition, it confirms that the interpretation of claims remains anchored in an approach that is both technical and concrete: the terms used by the patent cannot be reduced to mere functional abstractions. 

Image by DS stories (Pexels)