1.3. Standard for assessing compliance with Article 123(2) EPC
1.3.1 Gold standard: directly and unambiguously derivable
Any amendment to the parts of a European patent application or of a European patent relating to the disclosure (the description, claims and drawings) is subject to the mandatory prohibition on extension laid down in Art. 123(2) EPC and can therefore, irrespective of the context of the amendment made, 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 these documents as filed (G 3/89, OJ 1993, 117; G 11/91, OJ 1993, 125; G 2/10, OJ 2012, 376, referring to this test as "gold standard"; confirmed for disclosed disclaimers in G 1/16, OJ 2018, A70; for undisclosed disclaimers, see however chapter II.E.1.7.2c)). After the amendment the skilled person may not be presented with new technical information (G 2/10).
In T 1937/17 the board held that, other than for the purposes envisaged in G 1/93 (OJ 1994, 541), a "technical contribution" was of no relevance when deciding on the allowability of amendments under Art. 123(2) EPC. Instead, the "gold standard" set out in G 2/10 was the only criterion that had to be applied.
Similarly, in T 768/20 the board rejected the argument made by the appellant (proprietor) that the "gold standard" concerned only amendments which provided a technical contribution. On the basis of a detailed analysis of the case law of the Enlarged Board, the board concluded that the "gold standard" developed in opinion G 3/89 and decision G 11/91, and reaffirmed by decision G 2/10, was the general rule to be used when examining the compliance of amendments with Art. 123(2) EPC. Undisclosed disclaimers constituted an exception to this rule. As confirmed in G 1/16, they were governed by the rules laid down in decision G 1/03. Point 2 of the Order of decision G 1/93 (and point 16 of the Reasons) also appeared to concern undisclosed disclaimers, which decision G 1/03 examined in greater detail. The board observed that the reasoning in G 1/03 was mainly based on the purpose of Art. 54(3) EPC and took the view that decision G 1/03 was best understood as specifying a limited set of exceptions, namely that, for the sake of consistency of the European patent system and similar teleological reasons, the requirements of Art. 123(2) EPC were deemed to be fulfilled even though the amendment did not meet the "gold standard". The board saw a confirmation for this view in G 2/10. To the best knowledge of the board, the case law of the Enlarged Board did not provide for any further exception in the context of Art. 123(2) EPC. This approach was followed in T 110/20.
As can be seen from the "gold standard", the assessment of the requirements of Art. 123(2) EPC is to be done from the standpoint of the skilled person (see chapter II.E.1.3.2 "Standpoint of the skilled person" below).
The subject-matter must be at least implicitly disclosed (T 860/00; see also G 2/10, OJ 2012, 376), see in this chapter II.E.1.3.3 "Implicit disclosure" below.
The boards have emphasised with regard to various tests developed for different cases of amendments that they are only meant to provide an indication of whether an amendment complies with Art. 123(2) EPC as interpreted according to the "gold standard". They may assist in determining the allowability of an amendment but do not take the place of the "gold standard" and should not lead to a different result.
- T 1535/23
In T 1535/23 the board observed that the Court of Appeal of the Unified Patent Court ("CoA UPC") in UPC_CoA_382/2024 applied the same test as the EPO to determine whether an amendment extended beyond the content of the application as filed. This test is known as the "gold standard" (see G 2/10).
The issue at stake in both T 1535/23 and UPC_CoA_382/2024 concerned the omission of a feature from a claim in the context of added matter. In T 1535/23 claim 1 of auxiliary request 5 essentially differed from independent claim 19 of the parent application as filed in that the specific surface area contained in independent claim 19 of the parent application as filed had been omitted and instead two characteristics of a powder X-ray diffraction pattern had been added. The board explained that the parent application as filed disclosed that the said specific surface area was an essential feature of the invention. All the independent claims of the parent application as filed required the said specific surface area, either directly or by reference to another independent claim. Furthermore, in the summary of the invention, the parent application as filed referred, in a first broad aspect, to a crystalline free base of palbociclib having the said specific surface area. Therefore, it was clear to the skilled person that the passages of the parent application as filed relied on by the respondent referred to embodiments all having this specific surface area. Hence, the board observed that the parent application as filed comprised no teaching that the specific surface area referred to in independent claim 19 of the parent application as filed was not an essential feature of the invention disclosed which could be omitted to characterise Form A of the freebase of palbociclib. The board concluded that the omission of the specific surface area in claim 1 of auxiliary request 5 added subject-matter beyond the content of the parent application as filed.
In turn, in UPC_CoA_382/2024 independent claim 1 of the patent related to an on-body glucose monitoring device comprising a sensor assembly and an enclosure with an electronics assembly. The point of dispute was whether the omission of an elastomeric sealing member for sealing the coupling between the sensor assembly and the electronics assembly in the wording of this independent claim added subject-matter. The CoA UPC found that even though a need for sealing was described in the application as filed, there was no described advantage or function of the use of the specific elastomeric material now omitted from the claim, other than that it provided sealing. Therefore, the skilled person understood from the application as filed that the exact method of sealing did not contribute to, and was thus not relevant for, the technical teaching of the invention as disclosed in the application as filed. The CoA UPC concluded that the omission of the use of an elastomeric sealing member from claim 1 of the patent did therefore not extend beyond the content of the application as filed.
The board explained that its conclusion in T 1535/23 was not in contradiction with the decision of the CoA UPC in UPC_CoA_382/2024. The fact that the CoA UPC acknowledged that the feature in question could be omitted without extending beyond the content of the application as filed while the board in T 1535/23 reached the opposite conclusion was based on different factual situations rather than on a difference in legal considerations. Both the CoA UPC and the board in T 1535/23, and the EPO in general, apply the same principle (the "gold standard") in judging whether an amendment extends beyond the content of the application as filed.