T 0265/23 - Combination therapy

Key points

• This decision was taken on 06.11.2025 and issued in writing on 26.06.2026. A Communication under Art. 15(9) RPBA is visible in the online file.
• The claim is a second medical use claim directed to a combination therapy of Hepatitis C virus (HCV) with glecaprevir and pibrentasvir.
• Regarding inventive step: "Example 6 in D6 discloses glecaprevir". D6 is about the treatment of HCV.
• The objective technical problem may thus be formulated as providing a combination of glecaprevir with a further anti-HCV agent for use in the treatment of HCV infection, while avoiding the disadvantages of [the known] interferon/ribavirin-based treatments.
• " The subject-matter defined in claim 1 differs from this prior-art disclosure by the following technical features: (a) the treatment of an HCV patient with a combination of glecaprevir and a further anti-HCV agent is put into clinical practice; (b) pibrentasvir is chosen as the further anti-HCV agent ; (c) the treatment duration is 16 weeks; (d) the concomitant administration of interferon and ribavirin is excluded" (formatting adjusted).
• "the [opponent] argued that the patent in suit ... did not disclose putting the claimed therapeutic application into clinical practice, either. However, since attaining the claimed therapeutic effect in clinical practice is present as a functional technical feature in current claim 1 ... this feature has to be taken into consideration ... as a distinguishing technical feature of claim 1 in comparison with the disclosure in D6.
• "Under the established case law of the boards, where, as in the case in hand, a therapeutic application is claimed in the format provided in Article 54(5) EPC, attaining the claimed therapeutic effect is regarded as a functional technical feature of the claim under consideration"
• "Pibrentasvir is disclosed as one of over 150 exemplified anti-HCV agents in document D7 but is not identified as an NS5A inhibitor. D7 mentions, however, that the compounds according to D7 may be combined with other anti-HCV agents such as, inter alia, HCV protease inhibitors"
• "As to the obviousness of combining glecaprevir with pibrentasvir, the content of D6 and D7 (both published less than a year before the priority date) suggests that both compounds were still at an early stage of development. This is corroborated by the fact that neither compound is mentioned in D8, a review article giving an overview on emerging DAA therapies for HCV that was published around the same time. 
• Based on the available information, it would thus appear that the individual therapeutic efficacy and safety of these compounds had yet to be assessed. Only in vitro data for the single compounds are provided in D6 and D7, and there is no teaching in either document about therapy duration or other potential details of a combination therapy to be administered to HCV patients.
• So, this is a case where the monotherapy may have been patentable (?).
  
  
• For sufficiency, the AAF contained no in vivo data. 
• " The (earlier) application as filed states that the two mandatory DAAs (glecaprevir and pibrentasvir) were known as potent HCV inhibitors and cites the pre-published documents D6 and D7 "
• "in addition, Example 2 in the (earlier) application as filed reports further in vitro data on HCV inhibition by glecaprevir which show inhibitory activity against further genotypes"  (the relevance for the claim at issue is not directly apparent to me).
• "Example 1 relates to mathematical clinical modelling for interferon- and ribavirin-free combination therapy in conformity with claim 1. This was done according to a clinical simulation model described in D3, cited in paragraph [0070] of the (earlier) application as filed  ... . Contrary to the appellant's argument, D3 does not have to be part of the common general knowledge since it is cross-referenced in the (earlier) application as filed as describing the model that was used in Example 1."
• D3 is US 2013/0102526 A1 (25 April 2013). D3 was published in the priority year. In the priority document, the reference was to the US application number (of the then-unpublished application). I leave it as an exercise for the reader if the priority is valid (compare GL H-IV,2.2.1). 
• "the (earlier) application as filed reports that in different scenarios that were evaluated in Example 1 for a 2-DAA combination of glecaprevir and pibrentasvir, administered at various once-daily dosages without interferon and ribavirin over a range of treatment durations to genotype 1 or genotype 3 treatment-naive subjects, the predicted sustained virological response rates for a treatment duration of 12 weeks were favourable "
• "For these reasons, the (earlier) application as filed contains sufficient evidence, going beyond mere verbal statements, of a mechanism and technical concept that supports the suitability of the combination of glecaprevir and pibrentasvir for the therapeutic application defined in claim 1 as granted.
• In this situation, post-published evidence may be taken into account for confirmation.  "

T 0265/23 - Combination therapy

EPO 

The link to the decision is provided after the jump.

T 0855/24 - Deleting paragraph in the description

Key points

• This is the third appeal in this opposition case (opposition received: 2011), and concerns only the adaptation of the description to the amended claims that were held allowable in the first appeal decision. The OD took the first decision in 2013. In 2019, the Board decided to maintain the patent in amended form (those were the days, six years in appeal). Petition for review R 15/19 was allowed, and in 2023 the Board issued a new decision, again to maintain the patent with amended claims and a description to be adapted, and remitted the case to the OD. The OD decided on the adapted description in 2024. The third appeal followed (by the opponent), and the third appeal decision was issued in May 2026 (hence, the adaptation of the description took three years, due to the Board's choice to remit).
• The patent was maintained with only the device claims. The method claims were deleted. The proprietor deleted a couple of paragraphs in the description, but kept one paragraph. According to the Board, that paragraph pertained in the application as filed only to the embodiment of the  (now deleted) method claims. Moreover, the device claims and the former method claims differed in their technical features on precisely the point of that paragraph. Therefore, keeping the paragraph in violated Article 123(2), according to the Board.
• The Board: "the impermissible extension does not arise from the mere fact that individual paragraphs have been deleted, but from the fact that the selective retention of paragraph [0042] establishes a connection between the temperature compensation described therein and the claimed fire detector, which is not immediately and unambiguously apparent to the person skilled in the art from the original disclosure."
• The lower-ranking AR with paragraph 42 also deleted was allowed by the Board, but procedurally that was not trivial.

EPO 

The link to the decision is provided after the jump.

T 0020/25 - Withdrawing other ARs makes AR inadmissible

Key points

• "The requirements of Article 54 EPC are not met, and the main request must fail."
• The Board has to decide on the admissibility of the ARs and first turns to the history of the case.
• "The opposition division decided that the sixth auxiliary request met the requirements of the EPC; the [lower-ranking] request relating to the use did not have to be dealt with. "
• With the statement of grounds of appeal, the patent proprietor filed a new main request and auxiliary requests 1 to 13
• With the reply to the opponent's appeal, the patent proprietor filed auxiliary requests 6 to 21 
• The Board's preliminary opinion was that AR-11 was allowable. "The lower-ranking requests were not dealt with [in the preliminary opinion]."
• "Oral proceedings took place on 8 May 2026. At the beginning of the oral proceedings, the patent proprietor confirmed their requests (and their order). Following the discussion of auxiliary request 11, which was found allowable, and of the main request, which was found not to meet the requirements of Article 54 EPC, the appellant changed the order of their requests and asked that the requests ranking lower than auxiliary request 11, in particular auxiliary requests 14 to 16 and 19 to 21, be discussed. Ultimately, only these auxiliary requests were maintained besides the main request."
• "This is not permissible " A very detailed and principled reasoning of the Board follows. 
• "Reordering claim requests is an amendment to the patent proprietor's appeal case (see Case Law of the Boards of Appeal, 11th edition, 2025, V.A.4.2.3(i), V.A.4.5.4(q); T 1436/19, Reasons 1; T 2564/22, Reasons 2.1; T 622/23, Reasons 3.3). "
• "At least in a case like the present one where the auxiliary requests are not convergent, promoting a lower-ranking request is not merely a formal matter but shifts the subject of the proceedings."
• "The auxiliary requests in question, containing use claims, had always been ranked lower by the patent proprietor, at both the first and the second instance, meaning that they were only intended to be considered if higher-ranking auxiliary requests (i.e. those containing product claims) were not found allowable.
• "This condition did not materialise as higher-ranking auxiliary requests were found allowable (what was then auxiliary request 6 by the opposition division, and auxiliary request 11 in the board's preliminary opinion). As a consequence, there was no need or scope to deal with the lower-ranking auxiliary requests containing use claims during the opposition and appeal proceedings, notably not in the board's [preliminary opinion].
•  "Considering those auxiliary requests in substance now would mean the board having to deal, for the first time, with matters not dealt with either by the opposition division or in their own preliminary opinion. It would, in particular, require discussions which did not take place in the opposition proceedings and are thus not reflected in the impugned decision, with such discussions having to take place either before the board or before the opposition division by way of a remittal of the case."
• "Effectively withholding requests from being dealt with at an earlier stage of the proceedings - as the patent proprietor has done here - and "reserving" them for a later stage of the appeal proceedings runs counter not only to these principles but also to the primary object of the appeal proceedings to review the decision under appeal (Article 12(2) RPBA) and, ultimately, to the very object and purpose of the (subsequent) communication pursuant to Article 15(1) RPBA"
• "It is good board practice in the communication under Article 15(1) RPBA not to deal with requests which are not relevant for the decision to be taken at that moment in time, in particular when they have only been filed in the event that no higher-ranking requests are found allowable."
• A very interesting piece of information.
• As a comment, does this mean that the proprietor may not withdraw AR-11? The Board writes that "Ultimately, only these auxiliary requests [14-16 and 19-21 were maintained besides the main request". Wasn't the procedural situation at that time that AR-1 to 13, including AR-11, were withdrawn? (I'm not saying that this couldn't be legally correct, although it seems a change of case law).
• As a further comment, I wonder whether the phrase "admissibly raised" in Art. 12(4) RPBA perhaps addresses the issue: was the non-convergent AR (then AR-14) relating to the use claim admissibly raised before the OD? 
• "In reply to the notice of opposition, the patent proprietor filed a new main request and six auxiliary requests containing product claims only. In reply to the opposition division's preliminary opinion, the patent proprietor filed seventh to thirteenth auxiliary requests, likewise all containing product claims only. At the same time, a fourteenth auxiliary request containing use claims was filed."

EPO 

The link to the decision is provided after the jump.

R 0014/25 and T 0345/24 - Punished for filing an AR

Key points

• The proprietor filed a new AR-1 during the oral proceedings before the Board. The earlier filed ARs moved "one down". The TBA did not admit the newly filed AR-1 (there were no exceptional circumstances, according to the TBA). Does this course of events affect the admissibility of the lower-ranking ARs?
• The TBA in case T 0345/24 held it did. "
• "Such a re-ranking is ... an amendment to the proprietor's appeal case and its admittance is at the discretion of the Board. Under such circumstances the Board's discretion is to be exercised in view of inter alia procedural economy (see Article 13(1) RPBA, last sentence)."
• The ARs at issue were filed with the SoG of the proprietor. The TBA decision does not indicate whether the ARs were decided on (and rejected) by the OD. 
• The TBA reasons that the re-ranking is a case amendment "due to the procedural effects of such a change, such as consideration of alternate subject-matter"
• Given that the AR was not admitted on procedural grounds, the subject-matter of new AR-1 was not examined on the merits.
• Claim 1 of new AR-1 includes a feature that was not recited in the older, lower-ranking requests. I note that new AR-1 was filed to address a successful objection of intermediate generalisation. 
• The Board then hold the ARs filed with the SoG inadmissible.
• So, if you have a supposedly safe AR (under Art. 12(2)), it may become inadmissible by the filing of another higher-ranking AR, according to this decision.
• A precedent that repeatedly shuffling the order of the requests can render the ARs inadmissible is T 0716/17. However, the present case is not about repeated reordering of requests. 
• See also T 0020/25, to be discussed soon.
• Regarding the petition for review, the EBA declines to review whether the re-ranking was indeed a case amendment, and hence declines to review whether the TBA had a discretionary power to hold the AR inadmissible. 
• "The EBA's review is restricted to the question of whether the petitioners had an opportunity to comment on the Board's qualification of [the old ARs] as an amendment [...]. ... The EBA's review cannot lead to a substantive examination through the back door of the criticised treatment of the [...] filing of new auxiliary request 1 by the Board which lead to the [TBA's] conclusion that the reranking of [the old ARs] was an amendment to the petitioners' case."
• Hence, the EBA does not review whether the reranking of the old ARs -  note, this means simply inserting one higher ranking AR - is a case amendment. 
• Compare R 10/24: "Because of the severity of the interference caused by the non-admission of amended submissions under the provisions of the RPBA, i.e. Articles 12 and 13 thereof, the interpretation and application of those provisions, which qualify the right to be heard, are subject to substantive review and not merely to review for arbitrariness. In this respect, the right to be heard is infringed, for example, also where such provisions are applied in a manifestly incorrect manner. " (translated headnote)
• I consider R 10/24 to be well reasoned. However, see also below for the context of the present case. 
  
  
• Having said all that, the patentee did not simply file new AR-1, but "filed a new auxiliary request 1 and stated that the other auxiliary requests would be withdrawn on the condition that this request be admitted". I could see why the Boards may wish to avoid any appearance of bargaining about requests. 
  
• Also, the Art. 123(2) issue for the MR was as follows: " Relative to claim 1 as filed, feature 1.3 has been introduced into the claim, in which the ADL is defined to be 'in contact with' the body-facing side of the absorbent core. The basis for this amendment was stated by the opposition division to be paragraph [0198] of the application as filed where, however, the ADL is disclosed to be 'in good contact with' the body-facing side of the absorbent core. The Board sees the omission of the qualifier 'good' to lack a direct and unambiguous basis in the application as filed." I can see how adding the term "good" could introduce questions of clarity (if the amendment is open to examination of clarity under G 3/14). 
• The TBA added, obiter, that all the old ARs seemed to suffer from the same Art. 123(2) issue as the main request. That seems entirely logical, given the procedural development of the case. In that event, the old ARs were not a response to the Art. 123(2) objection that was found prejudicial to the MR, and the proprietor's right to be heard to reply to that Art. 123(2) is not affected by the decision to not admit the old ARs, possibly. 

• EPO R 14/25

The link to the decision is provided after the jump.

T 0152/24 - No review of decision to admit

Key points

• The opponent argues that the proprietor's main request should not be admitted. The main request is the version upheld by the OD with minor amendments. The request was filed as auxiliary request 46 or "AR46" in the procedure before the OD (with the written submissions before the hearing). 
• The Board, in translation: " it is self-evident that the version of the request upheld by the Opposition Division was addressed in the contested decision. It is therefore already part of the appeal proceedings pursuant to Article 12(2) RPBA. Consequently, there is no basis under Article 12(4) RPBA for disregarding this request (T 566/24, Reasons 1.4; see also T 1206/19, Reasons 2.5). In contrast, T 989/23 concerned a request which, although admitted by the Opposition Division, was not addressed on its merits and is therefore not relevant here (Reasons 9.6)."
• See also my post on T 0989/23.
• " The current main request differs from the version maintained by the Opposition Division only in that dependent claims have been deleted. While this amendment was made after receipt of the communication containing the Board's preliminary opinion (Article 15(1) RPBA), the aforementioned deletion of dependent claims is, in principle, capable of resolving objections to these claims without raising new questions. Moreover, the request is promising in light of the Board's preliminary opinion. This may constitute exceptional circumstances within the meaning of Article 13(2) RPBA, which warrant consideration at this stage of the proceedings – in consideration of the principles of fair trial and procedural economy inherent in the RPBA (T 1800/21, Reasons 3.4.2 to 3.4.6, following T 2295/19, Reasons 3.4.6)."

EPO 

The link to the decision is provided after the jump.

T 0967/23 - The absolute bar to fresh grounds vs the discretion of Art. 12 RPBA

Key points

•  The Board, in the headnote: "The question of whether a fresh ground of opposition has been raised - and, therefore, of whether the agreement of the patentee is required - has to be distinguished from the question of whether there has been an amendment to a party's appeal case. The admissibility of amendments represents a separate, independent issue and is subject to the discretion of the board under Article 114(2) EPC and Articles 12 and 13 RPBA."
• " In the contested decision, the opposition division held that claim 1 was novel over D1 as it did not disclose at least features 1.4 and 1.7. "
• "The board agrees with the contested decision... that D1 does not disclose ... feature 1.4."
• "The appellant [opponent] argued that, even if considered novel, claim 1 would still lack an inventive step over D1 combined with common general knowledge."
• " The appellant submitted that according to established case law and, in particular, to decision T 131/01, an inventive step attack is admissible on appeal even if only a novelty objection was raised during opposition proceedings, because the inventive step is not considered a fresh ground for opposition."
• I think T 131/01 shows that the case law based on G 10/91 is a hodgepodge of rules. G 10/91 did not identify what a 'ground of opposition' is, leaving that to G 7/95 to resolve.  G 7/95 decided that novelty and inventive step are different grounds (despite the structure of Article 100 EPC). T 0131/01 created an 'exception' in a case that was not even about a fresh ground of appeal (the OD had held the inventive step attack inadmissible; the Board reversed that decision, which is nowadays seen as outside the scope of G10/91). 
• If G 10/91 is about bright-line rules, then there should be no such complexity. If G 10/91 is about equitable considerations, then Article 12(4) and (6) RPBA appear to be, de lege ferenda, the way forward.
• The Board applies Art. 12(6) RPBA and does not admit the attack.
• "Under Article 12(6) RPBA, second sentence, the board shall not admit requests, facts, objections or evidence which should have been submitted, or which were no longer maintained, in the proceedings leading to the decision under appeal, unless the circumstances of the appeal case justify their admittance."
•  In the present case, the patent proprietor's and the opposition division's position that D1 did not anticipate claim 1 was known to the opponent before the opposition oral proceedings (see e.g. annex to the summons to oral proceedings in opposition, point 2.2.1). Hence, the board takes the view that any inventive step attack based on D1 could and should have been filed at the latest during those oral proceedings. Moreover, the board cannot identify any circumstances which would justify the admission of such attack on appeal, nor did the appellant provide arguments in this respect."
• "Accordingly, the board decides not to admit the inventive step attack based on D1 into the appeal proceedings, Articles 12(4) and 12(6) RPBA."

EPO 

The link to the decision is provided after the jump.

T 0216/26 - When the EPO forgets the drawings

Key points

• A Euro-PCT application
• "At no stage during the examination proceedings did the examining division suggest any amendment to the [seven original] drawing sheets, nor did the appellant request or propose any such amendment. The examining division thereafter issued the communication under Rule 71(3) EPC, in which only a single drawing sheet was included. "
• Hence, the EPO "forgets" the drawings. See also: https://justpatentlaw.blogspot.com/2025/11/t-071225-when-epo-forgets-drawings.html; 
• https://justpatentlaw.blogspot.com/2025/03/t-122424-when-epo-forgets-drawings-and.html
• https://justpatentlaw.blogspot.com/2025/03/t-042321-when-epo-forgets-drawings.html
• The applicant paid the grant fee and filed the translated claims.
• The applicant appeals within two months.
• The Board, on admissibility: "The appeal is admissible according to Articles 106 to 108 EPC and Rule 99 EPC; in particular, the appellant is adversely affected by the decision under appeal within the meaning of Article 107 EPC. The patent as granted does not correspond to the application documents filed with the request for entry into the European phase on 10 August 2023, which were never amended as regards the drawings."
• Nice to see the Board can decide this point so easily.
• "The legal consequence of Rule 71(5) EPC, i.e. the deemed approval of the notified text, only arises if the communication sent also complies with the substantive requirements of Rule 71(3) EPC, i.e. if it actually contains the text in which the examining division intended to grant the patent, on the basis of the documents filed by the applicant, possibly supplemented by individual marked amendments 
• " the Board is also satisfied that the text notified under Rule 71(3) EPC does not reflect the true intention of the examining division as regards the documents on which the patent was to be granted. Rather, the omission of drawing pages 2/7-7/7 represents a clear and unintentional omission from the text proposed for grant, in line with the considerations set out in decision T 0387/25 
• "The decision under appeal is therefore to be set aside."
• " the reimbursement of the appeal fee is not held equitable since the applicant made no use of opportunities to participate in the initial proceedings (J 4/09, Reasons 4), as the error made by the examining division was introduced already in April 2025 into the communication under Rule 71(3) EPC, and the applicant could and should have noticed it when checking the text of the communication under Rule 71(3) EPC, because the fact that part of the published drawing were omitted should have alerted it and should have prompted a double check."
• 
  

EPO 

The link to the decision is provided after the jump.