Introduction

In a recent order issued by The Hague Local Division of the UPC, an application for a preliminary injunction was denied because the Court felt that, on the balance of probabilities, the asserted patent was invalid for reasons of added matter.

Interestingly, the added matter issue was an ‘impermissible intermediate generalisation’, and the Court applied the EPO’s notoriously strict case law on added matter to come to its conclusion. Does this mean that the EPO’s ‘gold standard’ for added matter is going to be part of UPC practice? In this article, Senior Associate, Ben Chapman, takes a look at the case and its possible implications.

What were the facts in this case?

This order relates to an application for a preliminary injunction, which was brought by Abbott Diabetes Care Inc. (Abbott) against Sibio c.s (Sibio) in relation to Sibio’s GS1 continuous glucose monitoring (GS1) device.

In its application, Abbott alleged that Sibio’s GS1 device infringed some claims of its EP3831283B1 patent (EP283) and sought an order preventing Sibio from (amongst others) offering and bringing its GS1 device to the market in the UPC contracting Member States in which EP283 was in force, namely Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Ireland (which was later deleted from the requests), Italy, Latvia, Lithuania,  Luxembourg, The Netherlands, and Sweden.

Sibio argued that the patent was invalid because the independent claim did not find basis in the original (grandparent) application, and that the claim therefore added matter, under the validity rules of the EPC which are incorporated in the Agreement on a UPC (UPCA).

What is an ‘impermissible intermediate generalisation’ and what is the established case law at the EPO?

The grounds for the order applied the established case law of the Board of Appeals of the EPO with respect to added matter. Both parties had argued their case based on this case law and, because of this, the Court saw no reason to apply a different standard than that established in the case law of the EPO’s Boards of Appeal. This is not the first time a UPC decision implies that parties should be creative to help UPC judges shape the nascent case law.

The so-called ‘gold standard’ test for added matter at the EPO is whether or not a particular amendment (including new claims inserted in a divisional filing) provides new technical information to the skilled person, compared to the original application documents as filed.

An ‘impermissible intermediate generalisation’ refers to a specific kind of amendment that introduces features from a particular embodiment of the invention into a broader context. This can result in an added matter issue unless the broader context of the application justifies the generalisation (for example, the omitted features are not necessary or essential features of that embodiment).

As noted in the grounds for the order, the underlying principle behind the EPO’s approach is an attempt to provide legal certainty for third parties relying on the content of the original application – it is seen as necessary to ensure that third parties are not ‘surprised’ by the combination of features ultimately claimed to ensure that patent proprietors do not ‘benefit from an unwarranted advantage’.

As summarised in paragraph 4 of the grounds: “Following from these principles, the original application cannot be treated by the patent proprietor as a reservoir of features, from which he can pick and choose features to assemble them as he wishes to draft new claims. There must be a pointer towards the combination of features selected by the proprietor.”

This is in line with the UPC’s key objectives, as “enhancing legal certainty” is in the 5th recital of the UPCA Preamble.

How did the Court apply these principles to the present case?

The Court confirmed that, to meet the EPO’s requirements, it was not necessary to draft a claim based only on originally filed claims, nor was it necessary to use language found verbatim in the original application documents. Nevertheless, under paragraph 4.1 of the grounds, the Court gave the following warning:

“However, in a case such as this, where the patent proprietor relies on several different passages of the description, on several embodiments and on various drawings of the original application as a support for claim 1, and where the patent proprietor has introduced wording in the claim which is not even present in the original application as filed, a careful assessment is necessary.”

The Court found itself convinced by Sibio’s arguments that claim 1 constituted an impermissible intermediate generalisation because of the omission of the one particular feature (the presence of ‘an elastomeric seal’) from claim 1.

In line with arguments presented by Sibio, the Court found that, because the feature in question was present in all embodiments which might provide basis for the claim, there had been an intermediate generalisation of the original disclosure.

The Court then considered (in paragraphs 5.4 onward) whether the generalisation was permissible.

Ultimately, the Court found the generalisation to be impermissible, stating that “Abbott has failed to demonstrate the absence of a structural and functional link between the seal and the recess [of the base portion]”. The Court instead considered that “the elastomeric seal would appear to be important for the proper functioning of the device … to ensure a sealed connection (keeping out moisture) as the device is assembled by the end-user”.

The Court found that the particular combination of features provided in claim 1 did not find basis in the original application and that the patent would therefore more likely than not be found to be invalid for reasons of added matter in the full proceedings on the merits. The Court also found this to be the case for each of the dependent claims which had been asserted by Abbott (noting that, whilst dependent claim 10 does define the elastomeric seal, that claim had not been asserted by Abbott in its application for a preliminary injunction).

What does this mean going forward?

The first thing to note is that, even when considering an application for provisional measures, the UPC has again shown itself willing to robustly interrogate validity issues. Moreover, the Court will consider all grounds of invalidity, including added matter. This is not what the Düsseldorf Local Division found in recent the 10x v Curio preliminary injection order of 30 April 2024, where added matter issues were considered irrelevant by the Court.

Therefore, defendants against applications for preliminary injunctions should feel confident in bringing forward invalidity arguments under all grounds available to them – although bearing in mind the discrepancies between local divisions. Similarly, applicants should make sure their claims are fully compliant with the EPO’s standards on added matter and be prepared to deal with such attacks – a challenge which is compounded by the short timescales which apply in provisional measures before the Court. Indeed, the rules do not set a deadline for filing, and some local divisions have decided that PI applications needed to be initiated within a month of knowledge of infringement, others have oscillated and said 1 to 2 months depending on the cases.

Secondly, the EPO’s approach to added matter is notoriously strict, and Court users (applicants and defendants alike) will likely take a keen interest in the fact that the Court applied the EPO’s standard in this case.

However, at least in this author’s view, it is not a forgone conclusion that the Court will only apply the EPO’s standard, as the decision does leave open the possibility that the Court would consider other standards, or may yet develop its own standard.

In paragraph 3.4 of the grounds, the Court provided the following (emphasis added):

“Both parties relied on the case law of the (Technical and Enlarged) Boards of Appeal of the European Patent Office (EPO) to substantiate their arguments regarding added matter. They did not indicate whether – and if so in which way – the court should apply a different standard. This court will also apply that long-standing case law, and the court will therefore in particular apply the so called “gold standard” disclosure test in this context, which is also the standard used in many [but, notably, not all] Contracting Member States of the UPC.”

Therefore, the fact that the Court applied the EPO’s case law on added matter in this instance doesn’t necessarily indicate an inherent desire to follow all of the EPO’s case law on matters of validity. Rather, the Court has made the point that neither party proposed a different added matter standard. This underlines the need for creative argumentation at the UPC. It is also notable in this instance that this decision was reached in a local division in The Netherlands; Dutch judges are accustomed to discussing added matter arguments in their national proceedings.  However, although both parties’ teams involved Dutch lawyers, based on the reasoning in the decision, they seem to have focussed on EPO case law.

The question remains what might have happened if one or other party had sought to a different standard (for example, one more in line with a national court of a contracting Member State, or a new standard altogether). It remains to be seen how the Court will react when presented with arguments based on national practice which diverge from principles established at the Boards of Appeal of the EPO.

We can expect the jurisprudence with regard to invalidity to develop rapidly over the next year as more and more proceedings on the merits are heard before the UPC. It will be interesting to see whether the Court will draw only on EPO case law, or whether it will develop its own case law based maybe on a hybrid approach taking into account also case law and practice of the national courts. Ultimately, we will have to wait for appealed decisions to have a clear view of how validity standards will be applied in the UPC.