T 0832/18 - Post-published evidence and Art. 83

Key points

• The decision is dated 09.12.2024; by Board 3.3.04,  and the written decision was issued 30.10.2025. I assume there were exceptional circumstances, such as the illness of a Board member.
• The interesting point is the importance of a post-published document for the sufficiency of disclosure of an in vitro diagnostic method claim."
• ""1. A method for determining the likelihood of effectiveness of an EGFR tyrosine kinase inhibitor [a class of medicaments] to treat cancer [, the method] comprising: determining whether the erbBl gene obtained from a biological sample obtained from said patient comprises at least one nucleic acid variance, selected from [ a list of mutations] 

  wherein the biological sample is a sample of tissue or fluid isolated from the patient and wherein the presence of the at least one nucleic acid variance indicates that the EGFR tyrosine kinase inhibitor is likely to be effective;

• "Post-published document D132, ... shows that lapatinib, another EGFR-TKi inhibitor, is a better inhibitor of wild type EGFR (EGFR-wt) than of EGFR-L858R mutant ...  the board considers that ... that lapatinib has been shown to be less effective, or ineffective, in inhibiting EGFR-TK and in treating cancer in patients with a nucleic acid mutation according to claim 1(b) or (c), compared to patients who do not have such a mutation.
• "Documents D134, D132, D50 and D72 thus provide serious doubts based on verifiable facts that there is no increased therapeutic effectiveness of EGFR TKis in patients affected with cancer comprising at least one mutation as set out in claim 1. Some TKis, such as lapatinib or neratinib, do not have or have a lower effect on such patients in comparison with patients comprising a wild type EGFR. Hence, the subject-matter of claim 1 of the main request is not sufficiently disclosed (Article 83 EPC)."
• As a comment, it remains interesting that post-published documents cannot be used in some aspects of Article 83, also for functional features (such as second medical use claims), while such documents can be used in other aspects of Art. 83.
• G 2/21, r.77 : "the scope of reliance on post published evidence is much narrower under sufficiency of disclosure (Article 83 EPC) compared to the situation under inventive step (Article 56 EPC). In order to meet the requirement that the disclosure of the invention be sufficiently clear and complete for it to be carried out by the person skilled in the art, the proof of a claimed therapeutic effect has to be provided in the application as filed, in particular if, in the absence of experimental data in the application as filed, it would not be credible to the skilled person that the therapeutic effect is achieved. A lack in this respect cannot be remedied by post-published evidence.
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• EPO

The link to the decision is provided after the jump.

T 1898/23 - (II) Novelty based on patient group

Key points

• At issue is whether a claim is a valid second medical use claim.
• The Board: "4.1 As to whether the claimed use qualifies as a specific use in a method referred to in Article 53(c) EPC which is not comprised in the state of the art, the parties agree that the following three criteria mentioned in the decision T 1491/14 have to be fulfilled for the treatment of the same disease with the same substance in a specific group of patients to be considered a new therapeutic use: (i) the patient group is not disclosed in the relevant prior art; (ii) the patients belonging to the group can be distinguished from those of the prior art by their physiological and pathological status; (iii) there is a functional relationship between the characterising physiological or pathological status and the therapeutic treatment, and thus the selection of the patients is not arbitrary. [formatting added].
• "The Board agrees that a patient group fulfilling these three criteria would render the claimed subject-matter novel."
• As a comment, criterion (i) seems strange: a second medical use claim is no longer a valid second medical use claim if the feature is disclosed in the prior art? Is claim interpretation not a preliminary step before the comparison with the prior art?
• As a further comment, criterion (iii) seems more about inventive step? See T 1688/20 for selection inventions in general ("the Board concurs with the most recent decisions of the Boards of Appeal, including T 261/15, point 2.2.2 of the reasons, according to which this criterion of purposive selection is relevant for the question of inventive step rather than for novelty.")

EPO 

The link to the decision is provided after the jump.

T 1898/23 - Argon-containing plasma as medical composition

Key points

• Claim 1 of the main request reads as follows. "Cold atmospheric plasma for use in treating therapy-refractory actinic keratosis in a patient in need thereof, wherein the cold atmospheric plasma is an argon-containing plasma."
• Is this a valid second medical use claim?
• "it has to be considered: (a) whether claim 1 concerns a substance or composition within the meaning of Articles 54(4) and (5) EPC"
• The Board: "for the sake of argument and in the respondent's [proprietor's] favour, it is ... assumed that the alleged therapeutic effect is indeed caused by the parts of the claimed plasma that qualify as a substance or composition within the meaning of Article 54(5) EPC."
• The Board considers the claim to be obvious, even when assuming that is a valid second medical use claim.
• The Board, obiter, sets out the legal framework: - I omit the case law references from the quote:  "While this "subgroup of the larger group of 'products'" ... excludes medical devices ..., it does not seem justified to say that any product which does not qualify as a medical device because of e.g. a lack of shape automatically qualifies as a substance or composition within the meaning of Article 54(4) and (5) EPC ... . If that were so, any shapeless physical entity (e.g. electromagnetic radiation or ultrasound waves) could qualify as a substance or composition, regardless of whether it is a chemical entity. Having said this, the current Board agrees that whether something qualifies as a substance or composition within the meaning of Articles 54(4) and (5) EPC should be decided, in the first place, on the basis of what is claimed as such and not on the basis of its mode of action ... .
• The Board indicates it does not agree with T 1252/20.
• "In order to benefit from the notional novelty afforded by Article 54 (4) and (5) EPC, it must be a substance or composition - as opposed to other subject-matter not qualifying as such - which is used in a method referred to in Article 53(c) EPC,  ... . In the case at hand, where the method relates a treatment by therapy, it must thus be assessed whether the therapeutic effect can be ascribed to the chemical entities in the plasma or (only) to the other entities, such as the photons"

EPO 

The link to the decision is provided after the jump.

T 0077/23 - Absent proprietor, new attacks oral proceedings

Key points

• The Board in translation: "The Board is aware that the argument of lack of novelty of claim 1 of auxiliary request 8 in relation to document E1 was first raised during the oral proceedings before the Board. However, for the reasons explained below, the Board cannot conclude that this violated the right to be heard (Article 113(1) EPC) of the respondent [proprietor], who was absent from the oral proceedings. 
• Opinion G 4/92: "A decision [in inter partes proceedings] against a party who has been duly summoned but who fails to appear at oral proceedings may not be based on facts put forward for the first time during those oral proceedings." 
• See also point 1 of the reasons: ".... it is clear that the referred question relates to inter partes proceedings. "
• In G4/92, the divergence in the caselaw was that T 574/89 had held "that by choosing to stay away from oral proceedings the parties "had forfeited their right to present comments", and hence that "any arguments or evidence submitted by the parties present at oral proceedings" could "be used as a basis for the decision without it being relevant whether such evidence or arguments were already known to the absent parties from the written submissions or whether they could expect such evidence or arguments to be presented". On the other hand, "T 484/90 ... held that "a decision against a party duly summoned to but failing to appear at oral proceedings which is based on new evidence, such as a new document, on which that party has not had the opportunity to comment, may not be pronounced at the close of those proceedings without infringing that party's right to be heard, unless the absent party indicates that it is forfeiting this right"."
• Puzzling enough, the current Board does not cite or comment on G 4/92 and does not explain how the current decision complies with G 4/92 (viz, that the novelty attack does not involve new facts forward for the first time during the oral proceedings).
• As also noted by Daniel X Thomas on his weblog. 
• Possibly, G4/92 would be decided differently nowadays. However, as of yet, it is valid case law.

EPO 

The link to the decision is provided after the jump.

T 1772/23 - More on Rule 80

Key points

• The Opposition Division had decided that the amendments leading to Auxiliary Request 2 did not meet the requirements of Rule 80 EPC. ... The set of claims of auxiliary claim 2 comprises four independent claims [by splitting claim 1]. 
• The proprietor appeals.
• The Board in translation: "The Board does not follow this view, but considers the amendments to be in conformity with Rule 80 EPC."
• "Rule 80 EPC stipulates as its sole condition for amendments that they must represent a bona fide attempt to overcome a ground for opposition and thus prevent the revocation of the granted patent."
• It must be noted that Rule 80 adds "even if that ground has not been invoked by the opponent".
• "In the present case, in all four independent claims of auxiliary request 2, the claimed method [of granted claim 1] is restricted by additional features from dependent claims, which is to be regarded as an attempt to distinguish the method claimed in the claims from the method known from E1."
• "The excessive use of and/or formulations in the dependent claims of a claim set can make it difficult to anticipate potential future withdrawal positions in the granted claim set. This can also, under certain circumstances, lead to questions as to whether the withdrawal positions were originally disclosed. However, these are questions that would have to be examined under the provisions of Articles 84 and 123(2) EPC and do not affect the assessment of the amendment under Rule 80 EPC."
• " Furthermore, the methods defined in the four independent claims of auxiliary request 2 do not necessarily have to be based on alternative, mutually exclusive embodiments. ... According to the settled case law of the Boards of Appeal, the existence of two alternative embodiments in the patent in suit may lead to the admissibility of using two independent claims if the scope of protection is limited. However, this does not imply that this criterion is mandatory, i.e., that only in the case of several alternatives mentioned in the patent in suit may these be pursued in independent claims. On the contrary, it has already been established in T0262/05 (Reasons in Section 4 to Rule 59a EPC, which corresponds to the current Rule 80 EPC) and T0123/22 (Reasons 3.12) that the replacement of a single granted independent claim with two independent claims is not only permissible in exceptional cases, but that in each specific case the amendments must be individually assessed to determine whether they constitute an appropriate and necessary response to avoid the revocation of the patent in suit on the basis of a ground for opposition."
•  " The Opposition Division is correct in asserting that the submission of more than 100 auxiliary requests can lead to an overload of the proceedings ... However, this is a question to be examined when these applications are admitted, not whether the respective amendments comply with the requirements of Rule 80 EPC. This must be clearly distinguished, as explained in detail, for example, in T0123/22 (see Reasons 3.7 and 3.10). The Board therefore sees no reason why the amendments leading to the claim set of auxiliary request 2 should not be in compliance with Rule 80 EPC and therefore does not follow the decision of the Opposition Division."
• The opponent had withdrawn the opposition during the appeal stage.
• The case is remitted back to the OD.
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EPO 

The link to the decision is provided after the jump.

T 1965/23 - Starting from wrong document, clueless choice

Key points

• Under the PSA, the CPA or starting point document must be a 'feasible' document. What happens if you try the PSA from a document that is not suitable?

• Claim 1 as granted defines: "A medical device containing a separately prepared freeze-dried cake composition comprising aripiprazole as an active ingredient in a storage container whose inner wall is treated with silicone, wherein there is a space between the inner wall of the storage container and the cake composition."

• "The patent addresses the specific issue of the agglomeration of aripiprazole following resuspension when it is provided as a cake composition in a storage container of a medical device, such as a syringe, of which the inner wall is treated with silicone"

• " The patent teaches in this context that by reducing the contact of the cake composition comprising aripiprazole with the silicone this agglomeration can be suppressed  ... . The patent presents experimental results in support of this teaching"

• "According to the established jurisprudence (see [CLBA] I.D.3.4) a central consideration in selecting the closest prior art is that it must be directed to the same purpose or effect as the claimed invention; otherwise, it cannot lead the skilled person in an obvious way to the claimed invention. "

• "if an inventive step can be acknowledged starting from a particular prior art that is convincingly identified as the most promising starting point and therefore indeed constitutes the closest prior art, the attempt to deny an inventive step starting from a less promising starting point must fail"

• The concept of the closest prior art in the problem solution approach not only obviates the need to address repetitive lines of argument, it also allows for the due appreciation of specific effects in relation to the prior art that may be associated with the distinguishing features

• Document D2 describes the preparation of a formulation comprising aripiprazole by freeze-drying a suspension in a vial 

• "documents D12, D11 and D18 describe silicone-treated medical devices comprising freeze-dried formulations without mention of aripiprazole or problems resulting from the presence of silicone. Documents D12, D11 and D18 therefore do not address a similar purpose or effect as the patent. Arriving at the development of a freeze-dried composition comprising aripiprazole in a silicone-treated container of a medical device as disclosed in the patent starting from these documents would require the clueless choice of aripiprazole from all possible candidates of active ingredients, which the Board does not consider a reasonable proposition."

• The Board therefore considers that documents D12, D11 and D18 do not represent reasonable alternative starting points in the assessment of inventive step, irrespective of the number of other features shared with the claimed subject-matter.

• Now, as a question: how could a national court assess inventive step over D12, assuming the court cannot disregard D12 as a starting point, as the Board did?

EPO 

The link to the decision is provided after the jump.

T 0981/23 - Review of positive admittance decisions (?)

Key points

• "Positive admittance decisions by departments of first instance are not regulated in Article 12(6), first sentence, RPBA. Having said this, in this Board's opinion such decisions are still subject to a board's limited power to review discretionary decisions of departments of first instance (see G 7/93, Reasons 2.6; for claim requests, see also T 1202/19, Reasons 39 to 43)."
• G7/93 r.2.6 is the well known remark about "in the circumstances of a case such as that before the referring Board, a Board of Appeal should only overrule the way in which a first instance department has exercised its discretion if it comes to the conclusion either that the first instance department in its decision has not exercised its discretion in accordance with the right principles as set out in paragraph 2.5 above, or that it has exercised its discretion in an unreasonable way, and has thus exceeded the proper limits of its discretion"
• T 1202/19 - blog post
• "In the case in hand, there was no error in the opposition division's exercise of discretion."
• See also T 0909/23: "Nach Ansicht der Kammer ist die Ausübung des Ermessens einer erstinstanzlichen Abteilung auch im Rahmen einer positiven Zulassungsentscheidung einer Überprüfung im Beschwerdeverfahren nach den in G 7/93 dargelegten Grundsätzen zugänglich"
• On the other hand, see T 1884/19 (24-10-2022): "D25 to D30 were not only admitted into the proceedings, but considered by the opposition division for assessing sufficiency of disclosure of claim 6 as granted. There is in such a case no legal basis for excluding documents D25 to D30 from the appeal proceedings (see also T 0487/16, point 3.1 of the Reasons for the decision, as well as the case law developed under RPBA 2007, e.g. T 0026/13, point 2 of the Reasons for the decision; T 1568/12, point 2.4 of the Reasons for the decision; T 2603/18 points 1.1 to 1.2 of the Reasons for the decision)."
• For a more recent case, see T 2036/22 (2024), and T 0189/23 (07-10-2025): "According to a number of decisions to which the present Board agrees (Case Law, V.A.3.4.3 and in particular T 617/16, point 1.1.1 of the reasons or T 2603/18, points 1.1 and 1.2 of the reasons), the EPC does not provide a legal basis for excluding documents, requests or evidence on appeal if the contested decision was based on them. In view of the very aim of the appeal proceedings to review the decision under appeal in a judicial manner according to Article 12(2) RPBA, such submissions are automatically part of the appeal proceedings". 
See also the extensive reivew of the issue in CLBA V.A.3.4.3 "Submissions admitted at first instance are part of the appeal proceedings"
• I wonder whether / how / when this divergence in the case law will be resolved. Can the Board unadmit documents or claim requests that were examined on the merits (and decided on) by the OD?

EPO 

The link to the decision is provided after the jump.