T 2842/18 (Rituximab for use in a method for treating joint damage/ HOFFMANN-LA … of 1.10.2020

Summary of Facts and Submissions

I. The appeal of the patent proprietors (appellants) lies from the decision of the opposition division revoking European patent No. 1 951 304. The patent, entitled "Method for treating joint damage", derives from European patent application No. 06 837 634.2 which was filed as an international application under the PCT with the application number PCT/US2006/044290, published as WO 2007/059188 ("application as filed" or "application").

Claim 1 as granted reads as follows:

"1. Rituximab for use in a method for the treatment of joint damage in a subject with rheumatoid arthritis (RA), wherein (a) the subject has exhibited an inadequate response to one or more anti-tumor necrosis factor (TNF) inhibitors; (b) the subject received at least one prior course of treatment with rituximab, and (c) the treatment comprises administering at least one further course of treatment with rituximab, wherein the further course of treatment is administered 24-40 weeks after the start of the prior course of treatment with rituximab and each course of treatment comprises administration of two 1000 mg intravenous doses 14 days apart."

II. Seven parties filed oppositions against the patent (opponents 1 to 7). Furthermore, two interventions were filed (opponents 8 and 9). The patent was opposed under Article 100(a) EPC on the grounds of lack of novelty (Article 54 EPC) and lack of inventive step

(Article 56 EPC), and under Article 100(b) and (c) EPC.

III. During the course of the appeal proceedings opponent 5 withdrew their opposition and ceased to be a party to the proceedings.

IV. Opponents 1 to 4 and 6 to 9 are respondents in the appeal proceedings and are referred to as respondents I to IV and VI to IX or "respondents".

V. In its decision, the opposition division, inter alia, held that the claimed subject-matter of the set of claims of auxiliary request 14 did not extend beyond the content of the application as filed (Article 123(2) EPC), was novel (Article 54 EPC) but lacked inventive step (Article 56 EPC).

VI. With their statement of grounds of appeal, the appellants filed sets of claims of a main request and an auxiliary request 1 consisting of a single claim each. The main request is identical to auxiliary request 14 underlying the decision under appeal.

Claim 1 of the main request reads as follows (amendments with respect to claim 1 as granted are indicated):

"1. Rituximab for use in a method for preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis in the treatment of joint damage in a subject with rheumatoid arthritis (RA), wherein (a) the subject has exhibited an inadequate response to one or more anti-tumor necrosis factor (TNF) inhibitors; (b) the subject received at least one prior course of treatment with rituximab and has active disease based on a disease activity score in 28 joints (DAS 28)-erythrocyte sedimentation rate (ESR) >= 2.6, and (c) the treatment comprises administering at least one further course of treatment with rituximab, wherein the further course of treatment is administered 24-40 weeks after the start of the prior course of treatment with rituximab and each course of treatment comprises administration of two 1000 mg intravenous doses 14 days apart, wherein the treatment comprises administration of rituximab and methotrexate."

In auxiliary request 1, claim 1 is amended vis-à-vis claim 1 of the main request by the deletion of the words "or slowing down".

VII. In their statement of grounds of appeal, the appellants submitted arguments, inter alia, to the effect that the opposition division had been right to hold that the subject-matter of the claims of the main request did not extend beyond the content of the application as filed (Article 123(2) EPC).

VIII. In reply to the statement of grounds of appeal, respondents VI, VII, VIII and IX provided their counter-arguments with letters of 19 August 2020. Respondents IV, VII, VIII and IX requested that the appeal proceedings be accelerated based on the circumstance that, in relation to the patent in suit, infringement proceedings were pending before national courts in eight contracting states.

IX. On 18 September 2019, the board issued a summons to oral proceedings to be held on 9 and 10 July 2020. In the accompanying communication, the board informed the parties that the respondents' request for acceleration of the appeal proceedings had been granted.

X. Respondents I, II, III, IV informed the board that they would not attend the oral proceedings.

XI. With letter of 28 February 2020, the appellants provided their response to the respondents' replies containing counter-arguments in relation to priority, clarity, sufficiency of disclosure, novelty and inventive step. In relation to the scheduled oral proceedings, it was indicated that the appellants' party would consist of five people including the three authorised representatives: the signing representative [ ... - deletion by the board in accordance with point 4 of the Reasons], and two further professional representatives of a different law firm.

XII. Respondents VI, VII, VIII and IX provided further arguments with letters dated 17 April 2020, 24 April 2020 and 7 May 2020, respectively, except for the topic of added subject-matter in relation to which respondents VI and VII noted that the appellants had not provided any arguments.

XIII. The board issued a communication pursuant to Article 15(1) RPBA dated 27 May 2020, setting out its non-binding preliminary appreciation of the appeal. As regards the subject-matter of claim 1 of the main request, the board provided its preliminary opinion on the requirements of Article 123(2) EPC with respect to the features "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis", "at least one prior course of treatment with rituximab and (...) at least one further course of treatment with rituximab" and "wherein the treatment comprises administration of rituximab and methotrexate".

XIV. In a letter of 2 June 2020, the appellants requested that the oral proceedings be postponed. Reference was made to the EPO's continually updated coronavirus (COVID-19) information page on the EPO website and it was explained why the appellants' representative did not expect to be able to attend the oral proceedings in person and anticipated to be affected by travel restrictions. It was, inter alia, pointed out that the UK would be introducing mandatory quarantine of 14 days for all travellers entering the UK, including returning UK nationals and that it was unclear when this would be lifted. [ ... - deletion by the board in accordance with point 4 of the Reasons]

XV. In response, respondents VI and VII requested that oral proceedings continue as scheduled referring to the fact that a number of national cases had been stayed pending the outcome of the appeal proceedings. Alternatively, respondent VII requested that the oral proceedings be held via videoconference in accordance with the communication dated 25 May 2020, published on the web section of the boards of appeal, announcing that this technology was now available for the conduct of oral proceedings before the boards of appeal.

XVI. In a communication dated 12 June 2020, the board noted that the appeal proceedings had been accelerated, which set them apart from other appeal cases for which oral proceedings had been rescheduled recently. The board indicated that it was not persuaded that the reasons put forward by the appellants warranted an immediate decision to postpone the oral proceedings, and that a decision would be taken closer to the date of the oral proceedings. The appellants and respondent VI were invited to indicate whether or not they agreed to holding the oral proceedings by videoconference (ViCo).

XVII. In response, the appellants reiterated their request for postponement of the oral proceedings and stated that they could not agree to holding the oral proceedings by ViCo arguing that the present case, involving multiple parties, was not suitable for ViCo oral proceedings using Skype for Business. Respondents VI, VII, VIII and IX maintained their request for the oral proceedings to go ahead as scheduled in person or alternatively, by ViCo in relation to which respondents VII to IX stated that they would consolidate their pleadings.

XVIII. In a communication of 25 June 2020, the board, referring to the communication of the boards of appeal dated 25 May 2020, published on the web section of the boards of appeal, informed the parties that in the absence of the agreement by all parties, the oral proceedings would not be held by ViCo. In the light of the public health measures in relation to the Coronavirus pandemic in force in the UK which included that travellers returning to the UK had to self-isolate for 14 days, they had been postponed to 1 October 2020.

XIX. With letter of 26 June 2020, the appellants requested that the oral proceedings be scheduled for two days.

XX. In a communication dated 14 July 2020, the board informed the parties that the board, following its detailed provisional appraisal of the case, expected that the case could be dealt with in one day but also indicated that, should more time be needed, the oral proceedings would be adjourned and resumed on a future date.

XXI. With a letter of 31 July 2020, the appellants filed sets of claims of auxiliary requests 2 and 3 and provided, inter alia, argumentation with respect to the subject-matter of claim 1 of the main request and the requirements of Article 123(2) EPC.

Claim 1 of auxiliary request 2 reads as follows (amendments vis-à-vis claim 1 of the main request are indicated):

"1. Rituximab for use in a method for preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis in the treatment of joint damage in a subject with rheumatoid arthritis (RA), wherein (a) the subject has exhibited an inadequate response to one or more anti-tumor necrosis factor (TNF) inhibitors; (b) the subject received [deleted: at least] one prior course of treatment with rituximab and has active disease based on a disease activity score in 28 joints (DAS 28)-erythrocyte sedimentation rate (ESR) >= 2.6, and (c) the treatment comprises administering [deleted: at least one further] a single additional course of treatment with rituximab, wherein the [deleted: further] additional course of treatment is administered 24-40 weeks after the start of the prior course of treatment with rituximab and each course of treatment comprises administration of two 1000 mg intravenous doses 14 days apart, wherein the treatment comprises administration of rituximab and methotrexate."

Claim 1 of auxiliary request 3 comprises the same amendments as claim 1 of auxiliary request 2. In addition, the half-sentence after "administration of two 1000 mg intravenous doses 14 days apart," has been amended to read "wherein the treatment comprises administration of rituximab and a stable dose of methotrexate of 10-25 mg/wk, pre-medication with methylprednisolone 100 mg intravenous prior to each dose of rituximab, a stable dose of >= 5mg/week folate, and any background corticosteroids or oral nonsteroidal anti-inflammatory drugs at a stable dose." (amendments vis-à-vis claim 1 of the main request are indicated).

XXII. Respondents VI, VII, VIII and IX provided their counter-arguments with letters dated 21 August 2020, 1 September 2020 and 24 September 2020, respectively.

XXIII. With letter of 7 September 2020, the appellants announced that they intended to attend the oral proceedings "provided of course that international travel restrictions are not introduced (for example any quarantine requirements)" and that the "proprietors' party is to consist of two representatives, each with primary responsibility for speaking in relation to different aspects of the case, with an assistant to manage the many documents and a client principal to instruct and guide". It was assumed that the oral proceedings be held in the Isar building where there were large rooms with ample space suitable for the four parties which had indicated intention to attend along with the board. They also provided their observations on the submissions of respondents VII, VIII and IX.

XXIV. With letter of 23 September 2020, the appellants filed a second request for postponement of the oral proceedings.

XXV. The registrar informed the parties by a communication sent via email on 23 September 2020, that, if they wished to respond to the appellants' submission of 23 September 2020, they were asked to do so until 24 September 2020, 17:00 CEST.

XXVI. Respondents VI, VII, VIII and IX submitted comments on the appellants' submission.

XXVII. The appellants replied to the respondents' comments with letter of 24 September 2020.

XXVIII. The board's registrar informed the parties by a communication dated 25 September 2020, and sent by email on the same day, that the board had decided that the oral proceedings would take place as scheduled and that a communication pursuant to Article 15(1) RPBA would be issued in due course.

XXIX. On 28 September 2020, the board's registrar sent a copy of the communication under Article 15(1) RPBA, see previous section, dated 30 September 2020, to the parties by email. In the communication, the board gave its reasons for rejecting the appellants' second request for postponement of oral proceedings. It was however noted that subsequent developments and any measures taken by national authorities within the coming days might lead the board to reassess whether or not oral proceedings could go ahead as scheduled. The parties were also informed that attendance of all announced persons was possible while still respecting the applicable rules for physical distancing.

XXX. With letter of 28 September 2020, the appellants filed a third request for postponement of oral proceedings.

XXXI. The board's registrar informed the parties by a communication sent by email on 29 September 2020, that, if they wished to comment on the appellants' submission of 28 September 2020, they were asked to do so by 29 September 2020, 15:00 CEST.

XXXII. On 29 September 2020, the board's registrar sent a copy of a further communication of the board pursuant to Article 15(1) RPBA, dated 30 September 2020, and replying to the appellants' letter of 28 September 2020, to the parties by email. In it, the board informed the parties that it "does not doubt the representative's account of his personal status, but notes that no documentary evidence has been provided to confirm that this status indeed puts the representative in a group of persons with an enhanced risk of a serious outcome if infected with Sars-CoV-2" and further that it considered "that documentary evidence is needed in the present case in order to establish the presence of serious reasons which justify the fixing of a new date (Article 15(2)(a) RPBA). Such evidence might for example be in the form of a medical certificate. This evidence, containing personal data relating in particular to the health of a person will be excluded from file inspection ex officio."

XXXIII. In a letter of 30 September 2020, received at 10:30 CEST, respondent VII objected to postponement of oral proceedings, filed their comments on the appellants' third request for postponement and requested that oral proceedings be held on 1 October 2020 as scheduled. In a letter of 30 September 2020, received at 11:42 CEST, respondent VI stated they agreed with respondent VII's statement filed on the same day.

XXXIV. With letter dated 30 September 2020, received at 11:38 CEST, the appellants filed a further letter including an attachment which they requested to be excluded from the public part of the file.

XXXV. The board's registrar informed the parties by a communication dated 30 September 2020 and sent by email on 30 September 2020 at 13:57 CEST, that the appellants' request for postponement of the oral proceedings dated 28 September 2020 was rejected and that the oral proceedings would take place as scheduled on 1 October 2020.

XXXVI. Oral proceedings before the board took place on 1 October 2020. After the board had heard the parties on the requirements of Article 123(2) EPC with respect to the subject-matter of claim 1 of the main request and had announced its opinion, the appellants submitted a document entitled "Proprietors' Protest Note under Article 112a EPC and written objection under Rule 106 EPC". After consideration, the board dismissed this objection.

XXXVII. At the end of the oral proceedings, the Chair announced the board's decision.

XXXVIII. Minutes of the oral proceedings were communicated to the parties by a communication of 14 October 2020.

XXXIX. With a letter of 28 October 2020 the appellants requested that the minutes of the oral proceedings be corrected.

XL. By a communication of 26 November 2020, the parties were informed that a correction of the minutes was not deemed necessary as the minutes did not contain errors which needed correction nor were essentials of the oral proceedings or relevant statements of the parties missing.

XLI. The appellants' arguments, submitted in writing and during the oral proceedings, as far as relevant to the present decision, are summarised as follows:

Appellants' second request for postponement of oral proceedings dated 23 September 2020

The oral proceedings should be postponed.

The in-house client principal based in Switzerland who was intending to attend was in isolation in accordance with quarantine rules due to an encounter with COVID-19 via his school-age children. No other instructing principal could attend in his place.

The situation across Europe and especially in the UK was now such that the risks of international travel were too great to justify the oral proceedings taking place in this case at this time. The restrictions in place in the UK included the requirement to work at home, if possible. There were upward trends concerning the numbers of daily infections in the UK and Germany, Bavaria, and Munich, respectively. The situation was more perilous than when the first oral proceedings were cancelled. The 7-day incidence in Munich was now in excess of 50 cases/100 000 inhabitants. Restrictions concerning the gathering of people were already in place in Munich. The risk of quarantine requirements being imposed on travellers was growing and such measures might be imposed soon at short notice, thus affecting attendance of the oral proceedings or the return to the UK.

Many organisations had travel bans in place until at least the end of the year. The EPO itself had cancelled all events and was holding no opposition division hearings until 2021. Also Mewburn Ellis had "a general travel ban, to protect all of its people". Although a couple of people of the law firm had had to attend appeal oral proceedings in the period of lower infections since July, all appeal hearings with colleagues that were due to take place this week had been postponed.

A "serious reason" within the meaning of Article 15(2) RPBA did not only relate to an existing illness but also encompassed the overt risk of serious illness with respect to the representative and their family.

[ ... - deletion by the board in accordance with point 4 of the Reasons]

Furthermore, there were many scenarios in which a participant might at a late stage be unable to sign the EPO's self-declaration form and attend the oral proceedings, so the oral proceedings would need to be postponed anyway. For everyone to prepare and to travel internationally, was thus unreasonable.

The appellants did not agree to holding the oral proceedings by ViCo. Skype for Business had been judged by epi**(®) [The Institute of Professional Representatives before the European Patent Office] to be unsuitable for multi-party oral proceedings.

The respondents were effectively arguing that parties should choose their representatives based on personal risk profiles and, moreover, choose those who resided in Munich. Such a scenario was, inter alia, contrary to the principles of free choice of representation and to obligations not to discriminate on any basis.

Appellants' third request for postponement of oral proceedings dated 28 September 2020

The "current situation" used by the board as the sole stated basis for its decision of 25 September 2020 no longer applied. A new situation applied. The situation concerning the pandemic would get worse throughout the forthcoming week. The figures for COVID-19 in the UK continued the upward trend, exceeding 50 cases per 100 000 people over 7 days.

Even if the boards of appeal, compared to other units of the EPO, had adopted different measures in the communication dated 29 July 2020 relating to oral proceedings before the boards, no justification for these measures was provided. It was wholly inappropriate to hold hearings that required international travel.

[ ... - deletion by the board in accordance with point 4 of the Reasons]

Main request - claim 1

Claim construction

The purpose of the claimed treatment was "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis in the treatment of joint damage in a subject with rheumatoid arthritis (RA)". This purpose was an essential technical feature of the claim. The case law, including decision T 1859/08, required that all technical features of a medical use claim be taken into account in considerations of patentability.

Amendments (Article 123(2) EPC)

"preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis"

The objection to the above expression had been raised by the board and not by one of the parties.

Direct and unambiguous disclosure

The features of claim 1 were disclosed in the application as filed in a manner that fully met the requirements of Article 123(2) EPC. The language "for preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" in the treatment of joint damage in a subject with rheumatoid arthritis (RA) was found verbatim in the application as filed in Example 3 on page 129, lines 20 to 22. A purely semantic analysis of the contested passages should be avoided, see also decision T 99/13. Instead, it was underlined that the skilled person would take the content of the application as a whole into account.

The application also disclosed that the "primary objective of this study is to evaluate the efficacy of retreatment with rituximab in subjects with active RA who are receiving MTX and who have had an inadequate response to TNF inhibitors", see page 93, lines 1 to 3, while the active disease definition was disclosed on page 94, lines 1 to 3.

Plausibility

Considerations of sufficiency or plausibility of disclosure had no relevance at all in the assessment of compliance with the requirements of Article 123(2) EPC and should be considered separately under other grounds, see also decision T 2593/11.

If the board wished to introduce examination of whether an invention had been carried out, or whether a skilled person would expect to be able to carry it out into considerations under Article 123(2) EPC, then a referral of relevant questions to the Enlarged Board of Appeal was required.

The invention, which lay in the provision of a therapeutic treatment which achieved the effect on joint damage, was set out in claim 1 of the main request, and was in any case plausible in view of the data provided in Example 1. This provided proof-of-concept for the claimed treatment by disclosing positive X-ray data, which conveyed to the skilled person that one course of treatment inhibited radiographic progression in RA patients with an inadequate response to TNF inhibitors, see Figures 13 to 17.

Figure 41 further illustrated the disposition of patients of the REFLEX clinical trial at 56 weeks, including the ongoing treatment of patients selected from both the treatment and placebo arms of the Phase III REFLEX clinical trial.

It was clear from Figure 41 that 128 of the original 277 patients were retreated with rituximab. The exact point in time and the Disease Activity Score (DAS) score were not mentioned, but Figure 43 disclosed retreatment after 24 weeks.

With the data of Example 1 in hand, the skilled person would conclude that the "further course of treatment" with the additional two 1000mg doses would further prevent or slow down progression in structural joint damage and erosion caused by RA, as stated at paragraph [0513] of the patent [note by the board: this section corresponds to page 129, lines 20 to 22, of the application]. Declaration document D116 in sections 17 and 18 confirmed that Examples 1 and 3 of the patent rendered the claimed subject-matter plausible for a skilled person.

Plausibility could only be denied if there were "serious doubts substantiated by verifiable facts" about the skilled person's ability to carry out the invention.

Objection under Rule 106 EPC

The protest was directed against the board's decision to hold oral proceedings on 1 October 2020 in spite of the appellants' written requests to postpone the proceedings, filed on 23 September 2020 and 28 September 2020.

Information about the COVID-19 situation and [ ... - deletion by the board in accordance with point 4 of the Reasons] (see Protest Note, page 2, third paragraph) had been provided in the appellants' submissions of 23 September 2020, 24 September 2020, 28 September 2020 and 30 September 2020.

After having filed confirmation [ ... - deletion by the board in accordance with point 4 of the Reasons] the board again rejected the appellants' request for postponement on 30 September 2020.

The list of reasons provided in Article 15(2) RPBA was not an exhaustive list. It did not exclude the realistic threat of catching (and/or spreading) a serious infection when having to attend oral proceedings. Such a serious threat was equivalent to the reason "(ii) serious illness".

The board's approach was at odds with the communication of the EPO dated 29 July 2020 that there would be no oral proceedings held in first instance oppositions that required personal attendance of the parties until 31 December 2020.

Given the health risks for [ ... - deletion by the board in accordance with point 4 of the Reasons] - which the board was aware of and was of course unable to prevent - he had to decide not to attend. At short notice, he had to appoint a replacement attorney from his firm who only had a few days for preparation.

In preparing for the hearing, the very large workload had been divided amongst different representatives. [ ... - deletion by the board in accordance with point 4 of the Reasons] and colleagues had taken care of the legal matters including support of claims. One of the other two professional representatives and his team had prepared the patentability issues.

In view of the very short time left for additional preparation after the board's first rejection of the request for postponement on 28 September 2020, it was entirely impossible for the two other professional representatives to also take over [ ... - deletion by the board in accordance with point 4 of the Reasons] tasks completely.

Thus, the board had lost sight of the free choice of representation, that there had to be fairness in conducting the proceedings, and that there had to be no discrimination because of nationality or any personal characteristics of representatives.

The board's approach had, at short notice, brought the appellants into an awkward situation where their team of attorneys could no longer defend the case as it had planned and as would have been required. This amounted to a substantial violation of their right to be heard, see also decision T 1505/06.

They had been forced to present the case, but did so under protest.

Auxiliary request 1

Amendments (Article 123(2) EPC)

The subject-matter of claim 1 met the requirements of Article 123(2) EPC for the same reasons as given for claim 1 of the main request.

Auxiliary requests 2 and 3

Admittance into the proceedings

(Article 13(1) RPBA 2007)

The board's initial opinion in relation to Article 123(2) EPC departed from that in the decision under appeal. These requests were a reasonable response to the board's opinion.

XLII. The arguments of respondents VI, VII, VIII and IX, submitted in writing and during the oral proceedings, as far as relevant to the present decision, are summarised as follows:

Appellants' second request for postponement of oral proceedings dated 23 September 2020

Further postponement would result in a significantly prolonged period of legal uncertainty regarding the validity of the patent. There was no certainty that the pandemic situation would be substantially improved in 2021. It was of importance that the proceedings be concluded as soon as possible in view of the numerous active and pending infringement proceedings.

There were no serious reasons provided by the appellants' representative justifying a further postponement.

It was possible to travel from the UK to Munich without any restrictions in either direction, and without any requirement of self-isolation after return to the UK. The restrictions concerning the gathering of people in force in Munich did not apply to the holding of oral proceedings. The mere possibility that the situation might worsen was not sufficient.

The appellants also had two additional authorised representatives, both with a Munich-based law firm. One of them had also participated in the oral proceedings before the opposition division. No serious grounds were provided as to why these authorised representatives were both unable to attend the oral proceedings.

It was irrelevant whether any accompanying party, i.e. the in-house client principal, was unable to attend.

The request for postponement was filed only shortly before the oral proceedings. A postponement would be of disadvantage to the respondents and justified an apportionment of costs incurred in the preparation for oral proceedings.

Appellants' third request for postponement of oral proceedings dated 28 September 2020

It was right to hold the oral proceedings as scheduled. Medical documentation in support of the postponement could have been provided with the appellants' first request or at the latest with the second request for postponement. [ ... - deletion by the board in accordance with point 4 of the Reasons] himself in his letter of 28 February 2020 sub-authorised two other European professional representatives. No serious reasons had been provided why the appellants would not be duly represented by these representatives. The unwillingness to conduct oral proceedings via videoconference as well as the repeated requests for postponement all aimed at prolonging the accelerated proceedings. The board should consider all relevant facts in order to ensure a fair treatment of all parties concerned.

Main request - claim 1

Claim construction

Claim 1 was a second medical use claim. The therapeutic effect was "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis".

Amendments (Article 123(2) EPC)

The objection at issue had already been raised in the opposition proceedings. Claim 1 corresponded to claim 1 of auxiliary request 5 submitted with the appellants' letter dated 27 April 2018 during the proceedings before the opposition division and the objection had been set out on page 14 of respondent VI's letter dated 8 June 2018.

Direct and unambiguous disclosure

The original claims and the general description of the application as filed did not disclose that any treatment prevented or slowed down the progression in structural joint damage and erosion caused by RA.

The passages in Example 3 at page 95, lines 9 and 10, and at page 129, lines 20 to 22, of the application expressed an expectation or hope of a possible outcome. They did not clearly state that by following the protocol the effect was actually achieved. The person skilled in the art could, on the basis of the application as a whole, not derive that the effect arose if the method steps in the claim were performed.

There was thus no direct and unambiguous disclosure that a particular therapeutic effect was actually achieved.

The claimed subject-matter constituted technical information not disclosed in the application as filed.

Plausibility

For an amendment to be allowable under Article 123(2) EPC its direct and unambiguous disclosure was required. Reasonable plausibility was not a criterion to be considered, see also decision T 824/06.

However, the disclosure on page 129, lines 20 to 22 expressed doubt about the effect. The term "expected" was used in the application itself; it was not a criterion added by the board.

A referral to the Enlarged Board of Appeal was not required.

The authors of the application themselves were aware of the results of Example 1 but had, on page 129 of the application, not been in a position to definitively conclude that the effect occurred. This was echoed on page 95 of the application. That the skilled person, reading the application, was invited to look at Example 1 and draw conclusions from Figure 43 did not meet the test of a direct and unambiguous disclosure. The application itself did not draw the conclusion from Example 1 that the effect mentioned in Example 3 was achieved.

Furthermore, Example 1 did not fall within the ambit of claim 1 and was not a proof-of-concept for what was claimed. The DAS 28 score and the time-point of retreatment could not be worked out from Example 1. Figure 41 was mostly black and it was not disclosed in the application that Figure 43 showed data of a retreatment. Nothing in the application suggested retreatment after 24 weeks in Example 1 and Figure 41 suggested that retreatment took place after 56 weeks.

The appellants had made reference to various other documents but none of these had been shown to represent the skilled person's common general knowledge at the filing date.

Objection under Rule 106 EPC

The objection was filed after the board had announced its decision on Article 123(2) EPC and was thus too late. It should have been filed the day before the oral proceedings together with an announcement that [ ... - deletion by the board in accordance with point 4 of the Reasons] would not attend.

The appellants' right to be heard had not been violated. The professional representative attending the oral proceedings was a duly appointed representative of the appellants. He had been given ample time to present the appellants' case. He was well prepared and had an excellent command of the file and the specifics of the case.

Auxiliary request 1

Amendments (Article 123(2) EPC)

The arguments given for claim 1 of the main request applied to the subject-matter of claim 1 of this claim request.

Auxiliary requests 2 and 3

Admittance into the proceedings

(Article 13(1) RPBA 2007)

Auxiliary requests 2 and 3 should not be admitted into the proceedings. They had been filed after the board had issued its preliminary opinion. The grounds and arguments on which the board commented had been raised by the respondents in response to the statement of grounds of appeal and the amendments could have been submitted sooner.

Moreover, the amendments made did prima facie not overcome the issue of the main request under Article 123(2) EPC.

XLIII. Respondents I, II and III made no substantive submissions or requests in the appeal proceedings, while respondent IV relied upon the submissions made by the other opponents, i.e. did not make any explicit requests.

XLIV. The appellants requested that the decision under appeal be set aside and the patent be maintained in amended form on the basis of the single claim of the main request, or alternatively, of auxiliary request 1, both filed with the statement of grounds of appeal, or further alternatively, of auxiliary requests 2 or 3 filed with letter dated 31 July 2020. Admission of the auxiliary requests into the proceedings was requested.

XLV. Respondents VI, VII, VIII and IX requested that the appeal be dismissed and that auxiliary requests 2 and 3 not be admitted into the proceedings.

Reasons for the Decision

1. The appeal complies with Articles 106 to 108 and

Rule 99 EPC and is admissible.

2. A revised version of the Rules of Procedure of the Boards of Appeal (RPBA 2020, hereinafter referred to as "RPBA") came into force on 1 January 2020 (see Article 24(1) RPBA). The transitional provisions are set out in Article 25 RPBA. Pursuant to Article 25(1) RPBA, the revised version applies to any pending appeal. However, pursuant to paragraph 3 of Article 25 RPBA, where the summons to oral proceedings has been notified before the date of the entry into force of the RPBA, Article 13(2) RPBA does not apply. Instead, Article 13 RPBA in the version valid until the date of the entry into force (RPBA 2007) continues to apply. In the present case, the parties were notified of the summons to oral proceedings before 1 January 2020, see section IX. Therefore, Article 13(1) and (3) RPBA 2007 apply to the present case.

Appellants' request for exclusion from file inspection

3. In the context of the appellants' requests for postponement of the oral proceedings, documents relating to the personal status of their representative were submitted.

4. In accordance with Article 128(4) EPC, Rule 144(d) EPC and Article 1(1)(a) and (2)(a) of the Decision of the President of the EPO dated 12 July 2007 concerning documents excluded from file inspection (Special edition No. 3, OJ EPO 2007, J.2, "Decision"), the board decides that the documents which were provisionally excluded from file inspection under Article 1(3) of the Decision, remain excluded, together with the medical certificate which was to be excluded ex officio. Furthermore, in view of the fact that considerations relating to the representative's personal status were relevant for the procedural decision to be taken and the confidential nature of the content of the medical certificate and submissions relating thereto, the board further decides that the present decision will be published in an anonymised and redacted version.

Appellants' second request for postponement of oral proceedings dated 23 September 2020

5. Article 15(2) RPBA provides that a request of a party for a change of the date fixed for oral proceedings may be allowed if the party has put forward serious reasons which justify the fixing of a new date. If the party is represented, the serious reasons must relate to the representative. Pursuant to Article 15(2)(a) RPBA the request must be filed in writing, be reasoned and, where appropriate, supported by documentary evidence. The request must be filed as soon as possible after the summons to oral proceedings has been notified and the serious reasons in question have arisen.

6. In the present case, no serious reasons were present that related to the appellants' representative and which would have justified a postponement of the oral proceedings.

7. That the in-house client principal who had planned to attend the oral proceedings was in quarantine and thus unable to attend could not justify the requested postponement since these circumstances did not relate to one of the appellants' representatives.

8. The appellants' argument that all events organised by the EPO and all oral proceedings before the opposition divisions had been cancelled until the end of 2020 was of no relevance, since the measures for the arrangement of oral proceedings before the boards of appeal differed from those decided by the President of the EPO for the examining and opposition divisions (cf. Communication of the Boards of Appeal dated 29 July 2020, "Oral proceedings before the Boards of Appeal - reassessment of the measures adopted due to the coronavirus (COVID-19) pandemic", https://www.epo.org/law-practice/case-law-appeals/communications/2020/20200729.html).

9. As far as travelling was concerned, the board ascertained that travelling was possible in either direction between the UK and Munich, during the time period of when the request for postponement was made (23 September 2020) and decided upon by the board (25 September 2020), without any restrictions. Nor were there any quarantine or self-isolation obligations. Even though measures relating, in particular, to quarantine had indeed been put in place by governmental authorities at very short notice in earlier months, as submitted by the appellants, no such measures had been publicly announced for the period in question. Moreover, in view of the developments and the situation concerning the COVID-19 pandemic, the board had no reason to expect that any such measures would be implemented in the subsequent days, including the day of the oral proceedings (1 October 2020) and the following days. Thus, all representatives who had to travel to Munich were expected to be able to return without impediment.

10. The representative's reference to the existence, at his firm Mewburn Ellis, of a "general travel ban, to protect all of its people" could also not justify the requested postponement. Not only was this submission confined to a mere short statement without any further explanation or corroboration, but also the asserted travel ban was, according to the appellants' own submission, such that it in fact had allowed "a couple of our people ... to attend Appeal oral proceedings".

11. The board also ascertained that the oral proceedings were allowed to be held in the envisaged room for the number of announced persons and any members of the public, while respecting the applicable rules for physical distancing. That a person might not be able to sign the self-declaration form upon entry into the EPO building, was (and is), indeed, a potential scenario. However, because this scenario was only a potential one, it did not justify postponing the oral proceedings already at the time when the appellants' second request for postponement of the oral proceedings had been filed.

12. The board agreed with the appellants' submission that travelling during the COVID-19 pandemic was something which should generally be avoided, whenever possible. Not only, as particularly emphasised by the appellants, taking into account risks or further consequences for the traveller, their family members or school classes, but also in general, so as to not unnecessarily promote the pandemic. The information available to the board on the date on which it decided on the request, was that travel for business reasons would be possible at and around the date of the oral proceedings.

13. In the present case, acceleration of the appeal proceedings had been granted by the board due to pending infringement proceedings in several contracting states, see section IX. above. In view of the parties' requests, the board had to arrange for holding oral proceedings. In the absence of the agreement of all parties to holding the oral proceedings by ViCo, see section XVII. above, they were held in the physical presence of the parties, thus inevitably involving travel.

14. The representative's submissions relating to his personal condition, [ ... - deletion by the board in accordance with point 4 of the Reasons], were generic in nature and, as such, did not qualify as serious reasons within the meaning of Article 15(2) RPBA.

15. The board was not persuaded that there were serious reasons relating to [ ... - deletion by the board in accordance with point 4 of the Reasons] as the appellants' representative, which would have required a postponement of the oral proceedings. There was therefore no need to consider the relevance of the fact that the appellants had two further authorised representatives, as indicated in the appellants' letter dated 28 February 2020.

16. Accordingly, the request for postponement dated 23 September 2020 was rejected.

Appellants' third request for postponement of oral proceedings dated 28 September 2020

17. The aspect whether or not it was appropriate to hold oral proceedings in the physical presence of the parties at all in the circumstances of the present case had already been considered by the board in the context of the second request for postponement.

18. Compared to the point in time of rejection of the second request for postponement, the situation concerning the COVID-19 pandemic, in particular concerning the infection figures published and to be expected in the time period when the third request for postponement was submitted by the appellants and decided upon by the board, had not deteriorated to such an extent that a postponement had become necessary for that reason. In line with this, no travel restrictions, including quarantine or self-isolation obligations, for travelling from the UK to Munich or vice versa existed; personal protective measures such as wearing masks during travel and during the oral proceedings were possible. In the building where the oral proceedings were to be held, hygiene measures were in place and a hearing room was chosen which allowed all attendees to respect the physical distancing obligations.

19. The further reasons given by the appellants' representative related to the worsening situation with respect to COVID-19, in combination with the representative's personal status which would result in an increased risk of a serious health impairment if infected with Sars-CoV-2. The representative's account of its personal status provided in the letter of 28 September 2020 was not supported by documentary evidence.

20. The board, considered that, in the present case, to be in a position to reach an informed decision which took into account the personal risks to the representative, documentary evidence was required. The parties were informed of the board's view by a communication, see section XXXII. above.

21. However, on the basis of the evidence provided with letter of 30 September 2020, the board was still not in a position to conclude that the representative was at an increased risk of a serious outcome if infected with Sars-CoV-2. [ ... - deletion by the board in accordance with point 4 of the Reasons]

22. [ ... - deletion by the board in accordance with point 4 of the Reasons]

23. [ ... - deletion by the board in accordance with point 4 of the Reasons]

24. [ ... - deletion by the board in accordance with point 4 of the Reasons]

25. [ ... - deletion by the board in accordance with point 4 of the Reasons]

26. On the basis of the evidence and submissions on file, the board therefore was not able to clearly and straightforwardly establish that the representative belonged to a group of people for whom travelling from the UK to Munich for the hearing was, due to the health risk associated with their particular personal medical condition, neither appropriate nor reasonable.

27. [ ... - deletion by the board in accordance with point 4 of the Reasons]

28. The board furthermore took the interest of the respondents in obtaining legal certainty without delay in view of the pending and stayed infringement proceedings in several national contracting states, into account. This had been the ground for acceleration of the case. The board also bore in mind the public interest in the continuation of the administration of justice in general.

29. Moreover the board considered it relevant that the case had already been postponed once due to the COVID-19 pandemic and that the request for postponement, based on the aforementioned increased health risk in view of the COVID-19 pandemic, had only been filed shortly before the date of the oral proceedings, whereas on 7 September 2020, the appellants still had confirmed that they would attend the oral proceedings, "provided of course that international travel restrictions are not introduced". No such restrictions were introduced.

30. In view of the above considerations, the request was rejected.

Main request - claim 1

Claim construction

31. Claim 1 is drafted as a second medical use claim pursuant to Article 54(5) EPC, thus attaining the claimed therapeutic effect is a functional technical feature of the claim. The disease to be treated is "joint damage in a subject with rheumatoid arthritis (RA)", while the therapeutic effect achieved by the treatment is "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis".

32. This was not disputed by the appellants.

Amendments (Article 123(2) EPC) - claim 1

33. This claim request was identical to the claim request of auxiliary request 14 in the proceedings before the opposition division. The opposition division held that the subject-matter of claim 1 derived "directly from Example 3" (see decision under appeal, page 23, point 4.1).

34. Respondents VI, VII, VIII contested this finding of the decision under appeal and submitted that the features "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis", "at least one prior course of treatment with rituximab and (...) at least one further course of treatment with rituximab" and "wherein the treatment comprises administration of rituximab and methotrexate" of claim 1 were not directly and unambiguously derivable from the application as filed (see section VI. for the complete wording of the claim).

35. As the board could arrive at a decision on the present case by considering the requirements of Article 123(2) EPC with respect to the first feature - "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" - this decision does not deal with the requirements of Article 123(2) EPC with respect to the other features.

36. The objection against the first feature was raised during opposition proceedings and maintained on appeal by respondent VI in reply to the statement of grounds of appeal, see section XLII. The appellants' objection that this objection had been introduced by the board is thus without merit.

Direct and unambiguous disclosure

37. In a first line of argument the appellants put forward that the requirements of Article 123(2) EPC were met because the language "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" was disclosed verbatim in the application as filed.

38. It is established jurisprudence of the boards of appeal that the standard for assessing compliance with the requirements of Article 123(2) EPC is the standard set out in decision G 2/10 (OJ EPO 2012, 376, point 4.3 of the Reasons), also known as the "gold standard". Amendments are only permitted 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 application as filed. It is not permitted for the skilled person to be presented with new technical information after the amendment (see decision G 2/10, supra, points 4.3 and 4.5.1 of the Reasons; see also Case Law of the Boards of Appeal of the European Patent Office, "CLBA", 2019, 9th edition, II.E.1.1 and II.E.1.3.1).

39. Claim 1 was amended during opposition proceedings to include the therapeutic effect of "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" as a technical feature of the claim. As a consequence, for the purpose of assessing the requirements of Article 123(2) EPC, it has to be examined whether or not there is a disclosure in the application as filed from which it is directly and unambiguously derivable that this is the effect achieved when the treatment is carried out as claimed.

40. It is undisputed that the claims as filed and the general part of the description of the application as filed do not disclose that administering at least one further course of treatment with rituximab to a subject who has received at least one prior course of treatment with rituximab (retreatment) is "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis".

41. Example 3 of the application describes a phase III randomised, double-blind, placebo-controlled multicenter study of retreatment with rituximab in subjects with rheumatoid arthritis (RA) receiving background methotrexate (see page 92, lines 29 to 32).

42. Example 3 begins with the statement that "[t]he primary objective of this study is to evaluate the efficacy of retreatment with rituximab in subjects with active RA who are receiving MTX [methotrexate] and who have had an inadequate response to TNF inhibitors" (emphasis added; see page 93, lines 1 to line 3). It is explained that subjects with active RA after a first course of rituximab will be treated with a single additional course of rituximab (see page 95, lines 5 to 8) and also that "[t]he purpose of retreatment with rituximab is to prevent flare, promote sustained control of disease, and potentially prevent disease progression" (emphasis added; see page 95, lines 9 and 10). Primary and secondary outcome measures as well as assessments to be performed during the treatment period are defined on page 95, line 30 to page 129, line 19 of the application.

No results of the envisaged retreatment study are reported.

43. Example 3 concludes with the statement that "[i]t is expected that re-treatment under the protocol herein (or with a different CD20 antibody) will be effective in preventing or slowing down the progression in structural joint damage and erosion caused by RA" (emphasis added; see page 129, lines 20 to 22).

44. According to the appellants, this concluding statement provides the basis for the feature "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" of claim 1.

45. The board agrees with the respondents that the statement on page 129, lines 20 to 22, of the application does not amount to an explicit disclosure that retreatment ("under the protocol...") does achieve the effect of "preventing or slowing down the progression...", but rather expresses an expectation of what the outcome of the clinical trial might be. It is the board's view that the skilled person would derive from the passage in question that the above mentioned effect might or might not be achieved. The skilled person would not conclude that the effect was definitely achieved.

46. It is also established jurisprudence of the boards of appeal that a disclosure can be implicit, where an implicit disclosure relates solely to matter which is not explicitly mentioned but is a clear and unambiguous consequence of what is explicitly mentioned (CLBA, supra, section II.E.1.3.3).

47. The board therefore considered the skilled person's understanding of the statement on page 129, lines 20 to 22 when read in the context of Example 3 as a whole, including any implicit disclosure.

48. The skilled person reading Example 3 in its entirety (see point 42. above) would immediately realise that this is in fact a protocol for a proposed clinical study that has yet to be carried out. More importantly, the skilled person would understand that the primary objective of the proposed study was "to evaluate the efficacy of retreatment with rituximab" and that the purpose of this retreatment was to "potentially prevent disease progression". These statements relating to the primary objective of the study and the purpose of the retreatment could not be taken by the skilled person as a clear and unambiguous disclosure that the effect mentioned on page 129, lines 20 to 22, would actually be achieved when retreatment is carried out under the protocol described. Rather, the skilled person would understand that there were uncertainties about whether or not the effects to be tested for were achievable and that these uncertainties made the study necessary.

49. Consideration of the entire disclosure of Example 3 therefore does not lead to a different conclusion with respect to the uncertainty about the outcome of the retreatment study conveyed to the skilled person by the concluding statement on page 129, lines 20 to 22, of the application. Rather, the skilled person's immediate understanding of the carefully worded phrase is confirmed.

50. Therefore, while the wording "preventing or slowing down (...) rheumatoid arthritis" is disclosed in the application, see point 43., the board concludes that the skilled person does not derive from page 129, lines 20 to 22, when read alone or in the context of Example 3 as a whole, a clear and unambiguous disclosure that the therapeutic effect of "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" is achieved when patients with active RA are retreated under the protocol described.

51. That the therapeutic effect of "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" is achieved by following the steps of the claimed treatment thus provides the skilled person with technical information not disclosed in the application.

52. Consequently, the board comes to the conclusion that the subject-matter of claim 1 extends beyond the content of the application as filed and therefore that claim 1 does not meet the requirements of Article 123(2) EPC.

Plausibility

53. The appellants' further lines of argument may be summarised as considering that the board was wrong to include considerations of plausibility when assessing compliance with the requirements of Article 123(2) EPC. In addition, Example 1 rendered the effect plausible.

54. However, the board's conclusion with respect to Article 123(2) EPC, see points 50. and 51., are not based on considerations of plausibility but on the established criteria for assessing the requirements of Article 123(2) EPC, see points 37. to 49. above.

55. In the present case, these considerations include an assessment of the skilled person's understanding of the phrase "it is expected" since this is the wording used in the application, see point 43., in the passage relied on by the appellants as providing a basis for the amendment of claim 1.

56. The criteria for the assessment of direct and unambiguous disclosure of a claimed therapeutic effect are independent of, for example, the presence of data or the assessment of plausibility of the claimed effect. Indeed, there could be direct and unambiguous disclosure of a therapeutic effect that is not plausible at all.

57. Therefore, the board agrees with the appellants' submission that it would be wrong to include considerations of plausibility when assessing compliance with the requirements of Article 123(2) EPC. The appellants' further argument that the requirements of Article 123(2) EPC would be met since Example 1 renders the claimed therapeutic effect plausible, can thus not succeed for this reason alone.

Objection pursuant to Rule 106 EPC

58. After the board announced its opinion on the subject-matter of claim 1 with respect to Article 123(2) EPC, the appellants filed an objection against the board's decision to hold oral proceedings on 1 October 2020 in spite of their requests to postpone the proceedings filed 23 September 2020 and 28 September 2020 and submitted that therefore their right to be heard (Article 113(1) EPC) was violated.

59. The appellants' objection has been summarised in section XLI. above.

60. In the board's judgement, the need to appoint, at short notice, a replacement attorney and the short time left for additional preparation after the board's rejection of the appellants' second and third requests for postponement, were due entirely to the appellants' own actions.

61. While the decision not to postpone the oral proceedings was indeed taken at short notice (see sections XXVIII. XXIX. XXXV. above), this was due to the fact that the appellants requested postponement of the oral proceedings only one week before the scheduled date and then again 3 days before the scheduled date of the hearing (see sections XXIV. and XXX. above). Furthermore, the board's decision to reject the third request for postponement was mainly due to the fact that, in relation to the chosen representative, the board was unable to establish, on the basis of the submissions and documentary evidence presented, the presence of serious reasons which justified the fixing of a new date in accordance with Article 15(2)(a) RPBA (see section XXXII. and points 21. to 27. above).

62. The appellants and their representative had, since 23 June 2020, known that the oral proceedings would be held on 1 October 2020 (see section XVIII. above). Moreover, the representative had clearly known about his own medical condition for a long time. Indeed, he referred to his personal status in the letter of 2 June 2020 (see section XIV. above). It goes without saying that the further circumstances of his personal situation were also known to him in June 2020. Thus, a request for further postponement on this particular ground could have been filed much sooner. This would also have obviated the need to find replacements at short notice in case the request was not granted.

63. In the board's opinion, the appellants cannot rely on their right to free choice of representation to the detriment of the provisions of Article 15(2) RPBA if any alleged restrictions in the exercise of that right results from the appellants' own conduct.

64. Finally, as far as the objection under Rule 106 EPC was aimed at preventing the board from taking a decision terminating the appeal case at the conclusion of the oral proceedings, the board takes the view that it would have been in a position to hold the oral proceedings and to take a final decision even in the appellants' absence pursuant to Rule 115(2) EPC and Article 15(3) RPBA. Under these provisions, a board of appeal is not obliged to delay any step in the proceedings, including its decision, by reason only of the absence at the oral proceedings of a party duly summoned. Considering that the appellants were duly summoned and that the board was of the view that it correctly rejected the second and third requests for postponement, the board regarded itself as being in a position to take a final decision even in the appellants' absence. In fact, however, the appellants were represented at the oral proceedings by three duly appointed representatives.

65. The objection under Rule 106 EPC was dismissed.

Auxiliary request 1

Amendments (Article 123(2) EPC) - claim 1

66. Claim 1 of auxiliary request 1 is directed to rituximab for use in a method "for preventing the progression in structural joint damage and erosion caused by rheumatoid arthritis in the treatment of joint damage in a subject with rheumatoid arthritis (RA)" (see section VI). Therefore, claim 1 of this request does not meet the requirements of Article 123(2) EPC for the same reasons as given above for claim 1 of the main request.

Auxiliary requests 2 and 3

Admittance into the proceedings (Article 13(1) RPBA 2007)

67. These claim requests included amendments to address objections under Article 123(2) EPC. The requests were filed at a stage of the appeal proceedings at which not only the respondents had already filed their replies to the appellants' statement of grounds of appeal, but also the appellants had replied thereto by way of presenting counter-arguments (see submission of 28 February 2020) and the board had given its preliminary opinion on relevant aspects of the appeal case (dated 27 May 2020). The submission of these claim requests therefore represents an amendment of the appellants' case.

68. Respondents VI, VII, VIII and IX objected to the admittance of auxiliary requests 2 and 3 into the appeal proceedings.

69. Pursuant to Article 13(1) RPBA 2007, an amendment to a party's case after the filing of the statement of grounds of appeal or reply may be admitted and considered at the board's discretion. That discretion shall be exercised in view of, inter alia, the complexity of the new subject-matter submitted, the current state of the proceedings and the need for procedural economy.

70. The appellants submitted that the amendments were a reasonable response to the board's opinion which departed from that in the decision under appeal.

71. However, the board's opinion with respect to Article 123(2) EPC of claim 1 of the main request did not introduce a new aspect into the appeal proceedings. It was based on objections made by the respondents in reply to the appellants' statement of grounds of appeal (see respondent VI's letter of 19 August 2019, point 4.3, in particular page 7). These objections could thus have been addressed sooner, i.e. in response to the respondents' replies to the statement of grounds of appeal. The appellants, on 28 February 2020, indeed filed a response thereto in the form of presenting counter-arguments, but did not present any further auxiliary requests at that stage of the proceedings. No persuasive explanation for not filing auxiliary requests 2 and 3 earlier than in response to the board's opinion, i.e. at a very late stage of the appeal proceedings, was provided.

72. Moreover, claim 1 of each of these requests contains the feature "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" and the findings with respect to the subject-matter of claim 1 of the main request thus appeared to apply to these requests as well. Accordingly, they prima facie did not meet the requirements of Article 123(2) EPC and admission into the appeal proceedings would not have served the interests of procedural economy.

73. Accordingly, the board, exercising its discretion pursuant to Article 13(1) RPBA 2007, decided not to admit auxiliary requests 2 and 3 into the appeal proceedings.

Conclusion

74. All claim requests forming part of the appeal proceedings fail to meet the requirements of

Article 123(2) EPC. Accordingly, the patent cannot be maintained in amended form on the basis of any of these requests. Therefore, in the absence of another allowable claim request, the appeal has to be dismissed.

Order

For these reasons it is decided that:

The appeal is dismissed.