UPC Weekly - UPC Court of Appeal takes a new approach to assessing added subject matter

2025 Week 8

It has always been clear that the UPC Court of Appeal (UPC CoA) would have a hugely significant role in developing and unifying the UPC approach to substantive issues of infringement and validity.  And it’s not surprising that these issues have been first explored in preliminary injunction cases, these being the earliest to get through first instance and reach the UPC CoA.  

First we had the definitive guide to claim interpretation by the UPC in 10x v Nanostring, which we see repeated verbatim in most first instance decisions since.

Now the UPC CoA has set out its approach to the assessment of added subject matter.  Here, the UPC CoA has decided not to follow the strict EPO approach.  Instead, the UPC appears to be taking a less literal and more holistic stance – more willing to consider what the skilled person would understand to be implied from the original disclosure, in particular with an eye to the overall aim and effect of the invention.

Background

In Abbott Diabetes Care v Sibio Technologies, the UPC CoA overturned the decision of the UPC Local Division The Hague.  

Abbott Diabetes Care is the proprietor of European patent EP 3831283 B1, directed to a wearable “on-body” device used in an applicator system for in vivo monitoring of blood glucose levels. The on-body device has a glucose sensor configured to be positioned under the surface of the skin and in contact with bodily fluid, and sensor electronics.

The patent is from a divisional application and therefore the assessment of validity was based on whether the granted claim added matter over the content of the original parent application.

The claims of the patent are built on a simple framework that has literal basis in a claim-like clause in the original application. Added to this were various other features. The EPO examiner raised added matter objections during prosecution of the application, in particular that the features added to the framework were unallowable “intermediate generalisations” from the original disclosure, in that they isolated certain features from the embodiments without also taking with them the other features of the embodiments. These objections were heroically addressed by the attorney firm prosecuting the case, with 14 pages of closely-argued submissions to explain the basis for the claims, and some further amendments to the claims. The patent was granted and no opposition was filed.

In March 2024, Abbott applied for a UPC preliminary injunction, arguing the Sibio’s “GS1 CGM product” infringes the patent.  At first instance, the Local Division refused the preliminary injunction, finding that it was more likely than not that claim 1 added subject-matter and so was invalid. The Local Division relied on, and specifically referred to, the EPO’s strict so-called “gold standard” for assessing added subject matter. We reviewed and commented on this decision in UPC Weekly 2024 week 25.  

Claim interpretation first

Before considering added matter, the UPC CoA first set out its interpretation of the claim. This is interesting in itself, because it appears that it is the claim as interpreted which is subjected to an assessment for added matter. The UPC CoA carefully interpreted various features of the claim to include implied limitations as to how the invention would be implemented.

The court took the opportunity to consider the functional features of the claim. Specifically, means-plus-function features are to be interpreted as any feature that is suitable for carrying out the function. This is not unexpected, but is useful guidance.

The UPC CoA distinguished the use of “configured for” in relation to computer-implemented inventions (as per Part F-IV-3.9.1(ii) of the EPO Guidelines for Examination) from other types of inventions, explaining that, exceptionally for computer-implemented inventions, means-plus-function features are interpreted as means “adapted to” carry out the respective steps/functions. 

Added subject matter and intermediate generalisations

The UPC CoA set out its statement of the test for added subject matter like this:

In order to ascertain if there is added matter, the Court must thus first ascertain what the skilled person would derive directly and unambiguously using his common general knowledge and seen objectively and relative to the date of filing, from the whole of the application as filed, whereby implicitly disclosed subject-matter, i.e. matter that is a clear and unambiguous consequence of what is explicitly mentioned, shall also be considered as part of its content.

It is notable that nowhere in the decision does the UPC CoA refer to the EPO’s approach to added subject matter. In words, the UPC test looks similar to the EPO’s approach, but with greater emphasis on what is meant by “implicit disclosure”.

One of Sibio’s key arguments was that claim 1 introduced features disclosed only in relation to a number of embodiments shown in Figs. 34A-34D, Figs. 36-38 and Figs. 47A-47C of the original application, but without including in the claim the requirement for an elastomeric or elastic material for sealing the coupling between the sensor and the electronics, which was present in all of these embodiments. This was also the Local Division’s main reason for considering claim 1 to included added matter.

However, the UPC CoA decided that this extraction of features was not an unallowable intermediate generalisation. The court acknowledged that the description made clear that sealing is important to ensure that the contacts on the sensor assembly and the contacts on the electronics assembly are protected from moisture to prevent a short circuit. However, they considered the application as filed to disclose other ways of sealing, referring to a generic statement in the application as filed that “or another type of dielectric (non-conductive) compound may be used” for sealing. Although the court stated that “it is clear to the skilled person that there is a need for sealing of the contacts”, they then considered that the exact method of sealing does not contribute to the overall aim and effect of the invention because there is no described advantage or function of the use of elastomeric or elastic material. 

The UPC CoA therefore decided that:

the skilled person would derive directly and unambiguously from the original application, that an embodiment with the configuration of fig. 34A-34D, fig. 36-38 and fig. 47A-47C – or any other embodiment configured as prescribed by claim 1 – but using another manner of sealing than the use of elastomeric or elastic material, would still be covered by the disclosure of the application as filed.

This is interesting wording. Apparently the court is considering whether a hypothetical or generalised embodiment is “covered by the disclosure of the application as filed”. This seems radically different to the EPO’s understanding of subject matter being “directly and unambiguously derivable” by the skilled person from the original application. 

Another interesting factor here is that the UPC CoA was quite explicit that sealing of the contacts is important (albeit the specific method of sealing being less so), but there is no sealing of the contacts required by claim 1 at all. The court did not make clear in their decision why such sealing could be omitted without adding matter. 

On their final point about added matter, the UPC CoA considered whether it was a problem that claim 1 did not explicitly recite electrical contacts, despite these being disclosed in the original application in combination with a recess and the sealing member. The court explained that, based on their interpretation of the claim, electrical contacts would implicitly be present anyway, and so their omission from the claim did not convey new information to the skilled person.

Added matter: EPO v UPC

At a simple level, you could say that this case demonstrates that the UPC and the EPO have a similar approach to added matter – the EPO examining division allowed the application after all, and the UPC CoA agreed.

However, as we have said previously, it seems likely to us that an EPO opposition division would have given the granted claims a serious going-over. Based on our extensive experience of EPO oppositions, the granted claims would likely have faced major problems due to added matter. This new approach to the assessment of added matter by the UPC Court of Appeal seems far more generous to the patentee than the EPO approach.

Can you file auxiliary requests in preliminary injunction proceedings?

The UPC CoA decision looked at various other points. One of these we will mention briefly, just as another “known unknown”. Abbott had filed some proposed amended claims in case the UPC CoA decided that the claims were invalid. On this point, the court decided to keep us waiting, since there was no need to consider the admissibility of the auxiliary requests in this case.

 

 

This blog was co-authored by Lucy Coe and Matthew Naylor.

 

Lucy Coe Circle - January 2025

Lucy Coe

Lucy is an experienced UK and European Patent Attorney and UPC representative specialising in physics and software, and with a specific focus on contentious work and litigation. Her deep knowledge and expertise in the vast array of options for challenging patents in Europe allows Lucy to advise her clients on a pan-European patent litigation strategy, centred on balancing the options available to achieve their commercial goals.