Added matter at the UPC: Abbott v Sibionics

Introduction

One of the key features of the Unified Patent Court (UPC) is the ability to challenge the validity of patents granted by the European Patent Office (EPO) centrally. As such, the assessment by the UPC of the grounds for revocation provided by Article 138 EPC is of particular interest to practitioners; in particular where divergent approaches have been taken traditionally between (some) Contracting States in national revocation proceedings and the EPO during opposition proceedings.

One such ground of revocation is the prohibition against introducing “added subject matter” when amending the application. Any amendments must not go beyond the content of the application as originally filed (or in the case of a patent from a divisional application, beyond the content of the earlier application as filed). This concept is relatively common across patent systems (in general, the patentee can only protect what they have described at filing) but the EPO’s approach has been both distinctive and restrictive.

The EPO follows the so-called “gold standard” for assessment of added matter; for example, this has been set out by the Enlarged Board of Appeal decisions in G 3/89 and G 2/10. The gold standard is generally viewed as one of the strictest tests for added matter and may be summarised as follows: “any amendment […can] only be made within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, and seen objectively and relative to the date of filing, from the whole of [the] documents as filed. After the amendment the skilled person may not be presented with new technical information” (Case Law of the Boards of Appeal, II-E, 1.1).

While the underlying principles of the gold standard are in general accepted across EPC Contracting States, there are differences in implementation. For example, it has been argued that German case law takes a more accommodating approach than the EPO in relation to the amendments to include undisclosed disclaimers and generalisations of [1] [2] the specifically disclosed implementations. It is this latter point where the UPC Court of Appeal has also opened up a potential difference with EPO practice in its decision in Abbott v Sibionics.

Abbott v Sibionics: first-instance decision

The first instance decision (ORD_30431/2024) in Abbott v Sibionics provided early guidance on the Court’s approach to added subject matter. This case, heard before The Hague Local Division, concerned an application for provisional measures by Abbott and the technology in question related to an “on-body” continuous glucose monitoring device.

In refusing Abbott’s application, The Hague Local Division found that the divisional patent was more likely than not invalid for added matter as compared with the application as filed and also relative to the parent application as filed.

In particular, The Hague Local Division found that the relevant claims suffer from unallowable “intermediate generalisation”. The concept of intermediate generalisation is well-established before the EPO, but is often not intuitive to practitioners from other jurisdictions, who at times find it to be an overly formalistic approach. In particular, a claim amendment is considered to be an intermediate generalisation by the EPO where a feature is added which itself finds basis in the original application documents, but is said to be only described in combination with one or more other features. For example, where an original claim is to features A+B, and a particular embodiment describes A+B+C+D together, a claim to only A+B+C might be considered an intermediate generalisation. That is, absent the introduction of additional feature D, the EPO is likely to consider that a claim to A+B+C adds to the technical teaching of the application as filed, with little room in this context for assessment of whether the skilled person would have understood C and D to be necessarily linked.

In this case, the specific feature added to the claim (i.e. feature C) was the “base portion of the enclosure [of the device] comprising a recess in a bottom exterior surface”. However, it was argued that this recess was only ever disclosed in combination with “an elastomeric seal in the recess” – since this further feature (i.e. feature D) was not in the claim it was argued that there had been an intermediate generalisation.

The Hague Local Division explicitly adopted the EPO “gold standard” and referred in doing so to several decisions of the Enlarged Board of Appeal, as well as the relevant sections of the EPO’s Case Law of the Boards of Appeal. This included applying the EPO’s approach to intermediate generalisations and in consequence the claim was found to fall foul of the added subject matter provisions.

The Hague Local Division was not alone in appearing to adopt the EPO approach to this aspect of patent law wholesale. Other decisions, including the Düsseldorf Local Division decision in Seoul Viosys v expert klein (ORD_598459/2023) and the Paris Central Division decisions in two cases involving NJOY and Juul Labs (ORD_598482/2023 and ORD_598564/2023), had led commentators to expect that the UPC will be applying the EPO “gold standard” to the assessment of the added matter requirement.

However, in its first consideration of the question of added matter, the UPC Court of Appeal appears to suggest some nuance to that expectation.

Abbott v Sibionics: appeal granted

In its decision of 14 February 2025 (ORD_67504/2024), the Court of Appeal overturned the decision of The Hague Local Division discussed above. Having re-examined the case afresh, the Court of Appeal found that the patent is more likely than not valid and infringed and the circumstances favoured the imposition of provisional measures. As such, a preliminary injunction, as well as other measures, were ordered.

In of itself, the success of the appeal does not necessarily imply a change of heart on the “gold standard”. Indeed, the general principles laid out by the Court of Appeal are not inconsistent with the EPO’s approach, with the Court of Appeal characterising the key test as “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. Where, as here, the patent is a divisional application, this requirement applies to each earlier application”.

However, it does seem that there is some subtlety to be discerned between current EPO practice and the approach of the Court of Appeal in this case on the key issue of “intermediate generalisation”. In particular, the Court of Appeal did not agree that claims reciting the feature of the ““base portion of the enclosure [of the device] comprising a recess in a bottom exterior surface” must also recite “an elastomeric seal in the recess” to avoid adding subject matter.

Importantly, this was not because the Court of Appeal found active disclosure in the application that these two features were separable – the Court of Appeal agreed with the Local Division that the relevant passages of the description all make use of an elastomeric seal. Instead, the Court of Appeal looked to the function of this feature (i.e. the seal is important to avoid moisture ingress) and found the the description provided various ways of achieving the seal other than by the use of elastomeric material.Therefore, the skilled person would understand the need for a sealing member, but “that the exact method of sealing does not contribute to, and is thus not relevant for, the technical teaching of the invention as disclosed in the original application. In other words, the skilled person would not consider the use of an elastomeric sealing to be necessary for achieving the overall aim and effect of the invention”.

It could be argued that this focus on function, rather than the specifics of the particular embodiments from which an amendment had been taken, is closer to German case law on intermediate generalisation than that of the EPO. In particular, it is long-standing case law of the Bundesgerichtshof [3] (or the German Federal Court of Justice, FCJ) that where feature(s) of an embodiment contribute to the solution of the problem that constitutes the invention, then an amendment reciting such feature(s) is allowable if the remaining features of the embodiment do not contribute to a solution of the identified problem (see for example, FCJ decisions X ZR 226/02 – Sammelhefter II, Section 32 to 33, X ZR 107/12 – Kommunikationskanal, section 24, X ZR 119/09 – Schleifprodukt, section 19).

Recent EPO jurisprudence seems to point in a different direction. For example, T1937/17 (at Reasons 4.3.1) explicitly warns that “‘technical contribution’ is of no relevance when deciding on the allowability of amendments under Article 123(2) EPC. Instead, the gold standard set out in G 2/10 is the only criterion which has to be applied” (see also the recent decision in T579/23 (Reasons 1.5)).

Conclusion

The decision of the Court of Appeal in Abbott v Sibionics seems to throw some doubts on the view, shaped by a number of Court of First Instance decisions, that the UPC will follow the EPO’s “gold standard” to the assessment of added matter to the letter. It may be that the patentee has more scope to argue amendments should be allowed based on the skilled person’s understanding of technical function at the UPC than they would do at the EPO. For some, this will be seen as a welcome correction to an EPO approach which had been seen as overly-formalistic at times; for others, this apparent divergence will increase uncertainty. Regardless of their opinion, however, users of the system will need to understand the consequences.

[1] https://www.kluweriplaw.com/document/KLI-KIPL-Schulte-2023-Ch02_03#a1030

[2] https://www.ipwiki.de/patentrecht:unzulaessige_erweiterung_des_gegenstands_der_anmeldung

[3] https://aippi.soutron.net/Portal/Default/en-GB/DownloadImageFile.ashx?objectId=6963&ownerType=0&ownerId=2960, p.101