T 1868/16 - Plausibility strikes again (Everolimus)

Key points

• In this opposition appeal, the Board gives useful guidance about requests for acceleration of proceedings.
• More importantly, this valuable pharmaceutical patent is revoked essentially for insufficient disclosure of the second medical use due to lack of plausibility.
• " It follows from the above that in the present case it has to be examined whether the suitability of everolismus for the treatment of patients with PNETs has been shown or at least made plausible in the application taking into account the common general knowledge of the person skilled in the art." 
• The Board then analyzes what the patent application discloses.
• " Paragraph [0052] provides nothing more than hypothetical statements indicating the possibility that some effects may be observed. The respondent's argument that the skilled reader would equate the expressions "may be observed" and "may be performed" with "had been observed" and "had been performed" and that the wording in paragraph [0052] was merely the inconsequential stylistic preference of the person drafting the application is not accepted." 
• " The mere statement that chromogranin A reduction may be observed is not an indication that a clinical trial was on-going or that certain effects had actually been achieved. Moreover, in the absence of any information as to whether patients with PNETs have been treated or whether chromogranin A reduction actually correlates with tumour response in these patients, the mere statement that chromogranin A reduction may be observed is not sufficient to demonstrate the suitability of everolismus in the treatment of PNETs." 
• " Paragraph [0053] of the patent in suit consists of a single sentence and states that "also synergistic effects of such combination are obtained" (i.e. the combination referred to in the preceding paragraph). Again this is a mere statement which is not supported by any factual evidence. " 
• " It is the board's conviction that in these circumstances, where there existed no established relationship between mTOR inhibition and the treatment of PNETs, it was imperative to provide at least some technical evidence in the application as filed that allowed the skilled person to conclude that everolismus was suitable for the treatment of PNETs. A mere reference to the (desired) reduction of a biomarker that may be observed or a response evaluation that may be performed is not sufficient in this context." 
• " The [patentee's] argument that it had been aware of intermediate results showing the suitability of everolismus in the treatment of PNETs, as the trial study reported in [D56] had already been on-going for several months before the earliest priority date, is not accepted. For sufficiency of disclosure, it is not relevant what the respondent was aware of, but decided not to disclose. " 
• " Moreover, according to the [patentee's] own admission, the paragraphs on which it relied describe trials which had not yet been carried out and had not yet delivered any results. Indeed, the recruitment for a study of everolismus in monotherapy started well after the earliest priority date and the filing date of the patent in suit and results were apparently not available until several years later []. In the board's judgement, it is not justified to rely on knowledge which was acquired only after the relevant date to be used as a remedy for insufficiency of disclosure." 
Update 02.01.2018: the INN is "Everolimus" but the Board uses "everolismus". I've changed the title of this blog post to recite the INN.

EPO T 1868/16 -  link

Reasons for the Decision

3. Accelerated processing

3.1 As a preliminary remark which, however, is not relevant for the present decision, the board would like to note that it regards acceleration of the appeal proceedings as well as postponement of oral proceedings to be matters pertaining to the conduct of the appeal proceedings which lies within the sole competence of the board. It might therefore be questioned whether the grant or refusal of a request for acceleration or postponement is at all a decision within the meaning of Article 111 EPC for which the board has to give its reasons pursuant to Rule 102 g) EPC. Nevertheless, in the present case, the board agreed to respond to the respondent's request for being given the board's reasons on acceleration.

T 2506/13 - Decision state of the file, procedural violation

Key points

• Another decision according to the state of the file, another procedural violation for lack of proper reasoning.
• The Board: "It is therefore not derivable from the impugned decision, which features of the independent claims according to, in total, four different pending requests, the examining division considered to be disclosed in combination in the prior art and which they regarded as distinguishing features."
• "The board, and in fact any objective reader, is therefore not able to understand how the examining division arrived at their objective technical problem formulation "to adapt the general knowledge to a particular situation" without guess work. It is also not objectively determinable how the examining division arrived at their assessment of the solution."

T 2506/13 -  link

Reasons for the Decision

1. The appeal is admissible

2. Procedural violation

2.1 According to Rule 111(2) EPC, decisions which are open to appeal shall be reasoned.

2.2 In their decision according to the state of the file, the examining division makes reference to the communication of 27 May 2013. In said communication, the examining division argues, based on documents D3 to D10, what, in their own words, the skilled person's general knowledge was. It is not apparent from that communication which combination of features of the claims corresponds to what the examining division identifies to be general knowledge.

2.3 The examining division then goes on to say that

"the subject-matter of the claims differs from the prior art (the general knowledge of the skilled person as set out above) only by simple configuration features. The technical effect and problem solved by these features is to adapt the general knowledge to a particular situation. As adapting this knowledge to a particular situation belongs to the normal endeavours of the skilled person, the recognition of this problem as such does not involve an inventive step.

T 0758/13 - Must restrict to illustrated embodiment

Key points

• In this examination appeal, the Board finds claim 1 to lack support under Article 84 EPC.
"The wording [of the claim feature] is reflected in the description on page 6, lines 22 to 27" 
• "However, in the detailed description of the embodiments, the rendering device consistently receives the first image component and the text component (typically the subtitles) as separate components." The Board then points to Figure 3.
• "Summarising, the wording [of the feature] is partly repeated in the description, but the detailed description of the embodiments does not disclose the text component being an integral part of the first image component. Therefore, the board finds that this repetition of the wording of the claim does not provide support for claim 1 [...]" 
• The Board also notes that according to some other feature of claim 1 "the text component is not an integral part of the first image component" but does not raise a clarity objection, nor explicitly identifies the relevance of this observation for the question of support. 
• The Board refers to CLBA II.A.5.1. The decision indeed seems to be fully in line with that case law.
• As a comment, assuming that the claim is novel and inventive by other features and that the skilled person has no difficulty in carrying out the invention (the Board makes no objection under Article 83)  the application is still refused because there is no drawing or detailed description of the feature. Even though the decision entirely leaves open the possibility that the skilled person would not need such a detailed description to carry out the invention. The feature at issue could even be entirely conventional.  The Board also does not say that the feature is an essential feature. 
• As a further comment, it seems that the in the critical issue "the detailed description of the embodiments does not disclose the text component being an integral part of the first image component" the Board does not use "disclose"  in the sense of Article 123(2) - at least I assume that literally repeating the wording of the claim feature under the caption of "detailed description"  does not help. However, the Board leaves open what is necessary, perhaps because the Board does not identify any technical reason at issue for why the feature is problematic without detailed explanation in the description - at least I don't see such a reason explicitly in the Board's decision. 

EPO T 0758/13 -  link

Reasons for the Decision

1. The appeal is admissible.

2. Support by the description - second, third, fourth and fifth auxiliary requests (Article 84 EPC)

2.1 According to Article 84 EPC, the claims must be supported by the description. It is established case law that this means that the subject-matter of the claim must be taken from the description and it is not admissible to claim something which is not described (see Case Law of the Boards of Appeal of the European Patent Office, 8th edition 2016, II.A.5.1).

Purely formal support by the description through repetition of the mention of a claimed feature does not meet the requirements of Article 84 EPC (ibid., at II.A.5.2).

2.2 Claim 1 of each request specifies:

"a text component embedded in the first image component".

The technical meaning of this feature is that the text is an integral part of the first image component.

2.3 The wording quoted in point 2.2 above is reflected in the description on page 6, lines 22 to 27:

"the step of creating a three-dimensional image signal comprises including the text component in the first image component. The text component (for example a subtitle) [...] does not need to be transferred as a separate component. The receiving apparatus that is going to render the 3D image can still control the 3D display parameters in the region of the subtitle, even if that subtitle is embedded in the first image component of the signal".

According to the quoted passage, the rendering device receives the text component and the first image component as one single component.

T 0588/15 - The gender of the skilled person

Key points

• " The skilled person, with their mind willing to understand, always seeks a technically meaningful interpretation of the claim. Where they experience difficulties they will read the claim in the context of the whole specification, including the claims, description and drawings." 

EPO T 0588/15 -  link



3.3 The skilled person, with their mind willing to understand, always seeks a technically meaningful interpretation of the claim. Where they experience difficulties they will read the claim in the context of the whole specification, including the claims, description and drawings.

T 0287/16 - Contradictory passages in affidavit

Key points

• In this opposition appeal, claim 1 is for a graphite sheet with two properties (thermal conductivity dispersion and roughness). The opponent alleges lack of novelty over a commercial product as prior use. There is no dispute that the graphite sheet was a public prior use, but opponent had measured the two properties only later. 
• "the opposition division raised doubts as to whether the properties of the tested graphite sheets which form the basis for the results of D6 and D7 were identical to those of the graphite sheets available prior to the priority date of the patent in suit" 
• The opponent then files an affidavit to declare " the manufacturing methods, [] have not changed to any material extent. In other words, no significant changes have occurred. (....)   the graphite sheets were created using the same method of manufacture".
• The Board is not  convinced : "the cited passages are contradictory or at least ambiguous. The first of the cited passages permits some (minor) changes in manufacturing methods as well as in the properties of the final expanded graphite sheet compared with the graphite sheets publicly available before the priority date. No further details about the nature and degree of such changes, apart from the subjective statement that they were "no[t] significant", are given. In contrast thereto, [the second passage] stresses that the same method of manufacture (as in the past) was used and that therefore the product had the same physical properties, although this was relativised in the next sentence by a reference to a (quantitatively undefined) margin of error. " 
• " Concerning document E6, this excerpt from a laboratory notebook contains a page dated 8 October 2006. A printed sheet seems to be glued onto that page, the printed sheet bearing a different date, i.e. 13 November 2006. The [opponent] has not provided a convincing reason as to why these two dates are different. " 

EPO T 0287/16 -  link


3.2 Prior use of HS-400

3.2.1 The opposition division found that the "HS-400 Heat Sink Material" having a thermal conductivity in a direction parallel to the surface of 370 W/mK and described in E5 was publicly available prior to the priority date of the patent in suit (see impugned decision, section 5). This finding is not contested.

T 1985/16 - Number of inventive step attacks

Key points

• In this opposition appeal, the opponent complains that the OD's decision contains no reasoning "as to why the [inventive step attack] submitted in writing [before the OD] and based on the combination of document D1 as closest state of the art with document D7 was not convincing." 
• The Board agrees that the "decision contains no reasoning in respect of the line of argument of lack of inventive step presented in writing and based on the combination of [D1 with D7].
• However, the decision contains a reasoning why the claims are not obvious over D13 with D7, and the opponent had acknowledged that D13 was more relevant than D1.
• " Therefore, [the inventive step attack based on] D1 with [ D7]  can be considered to have been implicitly refuted in the decision under appeal in view of the reasoning concerning the combination of document D13 with document D7. The board also notes that during the oral proceedings the [opponent] did not identify the [inventive step attack based on D1] as the closest state of the art among the relevant ones, and in particular as going beyond the line of argument based on the combination of document D13 with document D7." 
• "In view of the above considerations, the board is of the opinion that the lack of reasoning in the decision under appeal in respect of the combination [D1 with D7] did not amount to a procedural violation, at least not to a substantial procedural violation that would justify for reasons of equity the reimbursement of the appeal fee under Rule 103(1)(a) EPC." 

EPO T 1985/16 - link

7. Alleged procedural violations - Request for reimbursement of the appeal fee, and question of remittal of the case to the department of first instance

7.1 The appellant has requested the reimbursement of the appeal fee pursuant to Rule 103(1)(a) EPC and, in support of this request, has alleged a series of violations of the right to be heard (Article 113(1) EPC 1973 and Rule 111(2) EPC). The board has considered whether the alleged procedural violations would have justified the reimbursement of the appeal fee under Rule 103(1)(a) EPC and/or the remittal of the case under Article 111(1), second sentence, EPC together with Article 11 RPBA.

7.2 The procedural violations alleged by the appellant can be summarised as follows:

a) The appellant was not allowed to present during the first-instance oral proceedings arguments in support of the line of argument of lack of inventive step previously presented in writing and based on document D1 as the closest state of the art.
b) The decision contained no reasoning (Rule 111(2) EPC) as to why the line of argument submitted in writing and based on the combination of document D1 as closest state of the art with document D7 was not convincing.
c) During the first-instance oral proceedings the appellant was not allowed to present arguments in support of the admissibility of documents D3a to D3c, D8a to D8d, D9, D11, D12, and D14 to D24.
d) The sole reason given in the decision for the non-admission of documents D3a to D3c, D8a to D8d, D9, D11, D12 and D14 to D24 into the proceedings was that these documents did not appear to be more relevant than documents D1, D7 and D13, and therefore the decision was not properly reasoned (Rule 111(2) EPC).

T 0861/16 - No silent approval of text during OP

Key points

• In this opposition case, the OD had said during the oral proceedings that the description needed to be adapted. The patentee appeals against this. 
• The minutes states that the OD had announced that the adapted text would be included in the Druckexemplar, and had asked the parties whether they wished to comment on that. The parties had no comments. 
• However, the Board considers this silence to be not enough. In particular, if the OD makes amendments of own motion, the procedure of Rule 82(1) is to be followed and an invitation with a time limit of two months is to be sent, or alternatively an express approval of the text by the patentee during the oral proceedings. The principle of "qui tacet consentire videtur" (he who is silent is understood to consent) is not established in the EPC.
• The decision of the OD hence involves a substantial procedural violation of Article 113(2) EPC. 
• The headnote is, in translation" Since the principle of "qui tacet consentire videtur" is not established in the EPC, it is not sufficient to ask the proprietor if she whishes to comment on amendments of the description prepared by the Opposition Division. The OD must ensure that the proprietor agrees" . This is correct, for oral proceedings, Rule 82(1) EPC provides that silence of the patentee to the invitation, is deemed approval. 

EPO Headnote

Le principe de qui tacet consentire videtur n'étant pas établi dans la CBE, il ne suffit pas de demander à la titulaire si elle souhaite s'exprimer sur des modifications de la description préparée par la division d'opposition.
La division d'opposition doit s'assurer que la titulaire donne son accord (voir points 2.4 à 2.4.3).

EPO T 0861/16 - link

Motifs de la décision

1. Le recours est recevable.

1.1 La règle 99(2) CBE spécifie que dans le mémoire exposant les motifs du recours, le requérant doit présenter les motifs pour lesquels il y a lieu d'annuler la décision attaquée ou la mesure dans laquelle elle doit être modifiée, ainsi que les faits et les preuves sur lesquels le recours est fondé.

1.2 La mesure dans laquelle la requérante demande que la décision soit modifiée ressort toutefois clairement de la dernière page du mémoire de recours, dans lequel il est indiqué quels sont les passages de la description qui doivent être modifiés et de quelle manière.

2. Le recours est également fondé parce-que la décision est entachée d'un vice majeur de procédure.

2.1 Le texte du brevet tel que modifié est annexé à la décision contestée, laquelle toutefois ne traite pas les modifications de la description, sauf à la première page du formulaire OEB 2327, qui mentionne que la revendication 1 et la description colonnes 1 à 9 présentent des modifications proposées par la division d'opposition.

2.2 Le procès verbal mentionne (page 5, voir les trois paragraphes finals) que:

"La présidente indique que la description nécessite une adaptation, qui est discutée avec les deux parties pour un accord sur la version. Elle sera introduite par la division dans le druckexemplar et ainsi que les corrections de typographie nécessaires dans le texte de la requête subsidiaire";

et ensuite que:

"la présidente de la division d'opposition demande alors à chacune des parties si elle souhaite s'exprimer, ce à quoi les parties répondent par la négative".

2.3 Selon l'article 113(2) CBE, l'Office européen des brevets n'examine et ne prend de décision sur la demande de brevet européen ou le brevet européen que dans le texte proposé ou accepté par le demandeur ou par le titulaire du brevet.

En outre, selon la règle 82(1) CBE 2000 (correspondant à la règle 58(4) CBE 1973), relative au maintien du brevet européen sous une forme modifiée en procédure d'opposition, avant de prendre la décision de maintenir le brevet européen sous une forme modifiée, la division d'opposition notifie aux parties le texte dans lequel elle envisage de maintenir le brevet et les invite à présenter leurs observations dans un délai de deux mois si elles ne sont pas d'accord avec ce texte.

Comme énoncé dans la décision G 1/88 (point 5.2.2), la règle 58(4) CBE 1973 visait, et par analogie la règle 82(1) vise, à fixer la procédure à suivre dans le cas où la division d'opposition envisage un texte modifié sans avoir encore obtenu l'accord du titulaire du brevet à ce sujet. Si l'accord du titulaire est obtenu pendant la procédure orale, il n'est pas nécessaire d'obtenir une nouvelle fois, "conformément aux dispositions du règlement d'exécution", l'accord du titulaire du brevet, présenté comme absolument obligatoire à l'article 113(2) CBE, alors que cet accord a déjà été donné (voir G 1/88, point 5.2.3).

2.4 La question qui se pose dans le présent cas, dans lequel le texte du brevet n'a pas été proposé par la titulaire (par le biais du dépôt de pages de remplacement), est si on peut considérer que la titulaire a effectivement accepté aux sens de l'article 113(2) CBE le texte du brevet, en particulier le texte modifié de la description tel que proposé par la division d'opposition. La Chambre est d'avis que cela n'est pas le cas pour les raisons suivantes.

2.4.1 Le fait de mentionner pendant la procédure orale (voir le procès verbal, page 5) que la description nécessitait une adaptation, que l'adaptation avait été discutée avec les deux parties pour un accord, et qu'elle serait ensuite introduite par la division dans le druckexemplar ne peut impliquer, en l'absence d'une quelconque indication dans le procès verbal et dans la décision relative à qulles qu'étaient effectivement les modifications qui avaient été discutées et qui allaient être effectuées, que la titulaire était, lors de la procédure orale, en mesure de prendre connaissance de toutes les modifications que la division d'opposition allait elle même effectuer et de pouvoir ainsi donner ou non son accord.

2.4.2 Le fait que la division d'opposition avait préparé le texte de la description modifié, pour le présenter aux parties suite à la délibération sur l'activité inventive, comme le fait valoir la titulaire dans sa lettre du 1er décembre 2016, et qu'elle aurait alors "tenté de contester" mais que la division d'opposition aurait "indiqué que cette décision était déjà prise" ne se retrouve ni dans le procès-verbal ni dans la décision.

Indépendamment du fait que cela puisse correspondre effectivement au déroulement de la procédure orale, force est de constater que nulle part, ni dans le procès-verbal ni dans la décision, il est indiqué que la titulaire aurait donné son accord sur le texte modifié.

Le procès-verbal (page 5, avant-dernier paragraphe) indique que la présidente de la division d'opposition a demandé à chacune des parties si elle souhaitait s'exprimer sur les modifications de la description, ce à quoi les parties ont répondu par la négative.

L'intimée fait valoir dans sa lettre datée 20 septembre 2016 (voir page 4) que la titulaire avait donné son accord sur texte proposé par la division d'opposition. Cependant, elle ne présente aucun fait qui démontrerait que la titulaire avait donné son consensus explicite à un texte qui lui avait été présenté préalablement à la décision de la division d'opposition. Et même si l'intimée avait présenté de tels faits, il resterait des doutes concernant leur force probatoire vu qu'ils ne sont mentionnés ni dans le procès-verbal ni dans la décision.

2.4.3 En tout état de cause, on ne peut pas considérer que le fait que la titulaire ne se soit pas prononcée implique son accord sur le texte du brevet tel que modifié proposé par la division d'opposition. Le principe de qui tacet consentire videtur n'est pas établi dans la CBE et ne peut s'appliquer dans le cas en instance. La division d'opposition aurait dû s'assurer que la titulaire donne son accord (voir aussi, par analogie, le point 2.1 de G 1/88).

2.5 Faute d'un accord de la part de la titulaire à la version maintenue, la procédure devant la division d'opposition est entachée d'un vice majeur de procédure, Article 113(2) CBE.

3. La Chambre de Recours considère approprié de renvoyer le cas à la division d'opposition suite au vice de procédure, afin d'adapter la description et d'évaluer si éventuellement la décision concernant la brevetabilité serait influencée par le texte qui sera soumis ou approuvé par la titulaire, Article 111(1) CBE, Article 11 du règlement de procédure des chambres de recours (RPCR).

4. Au vu de ce vice substantiel de procédure, la chambre considère qu'il est équitable de rembourser la taxe de recours comme prévu par la Règle 103(1)a CBE.

Dispositif

Par ces motifs, il est statué comme suit

1. La décision attaquée est annulée.

2. L'affaire est renvoyée à la division d'opposition pour l'adaptation de la description.

3. La taxe de recours est remboursée.