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.

3.2 It goes without saying that the board has to ensure the proper administration of justice by way of a fair, orderly and efficient conduct of the proceedings. With respect to the parties' rights relevant for the conduct of the appeal proceedings, the board notes that the parties have a right that their case be decided "within a reasonable time" (Article 6(1) of the European Convention on Human Rights (ECHR); see T 823/11 of 21 December 2015, point 2). There is no right to have proceedings delayed. Furthermore, due respect to the parties' right to be heard has to be given. This is also explicitly stated in the Notice from the Vice-President Directorate-General 3 dated 17 March 2015 (OJ EPO, 2008, 220; hereinafter referred to as notice) which is taken into account by the board when considering a request for acceleration.

3.3 According to the notice, parties with a legitimate interest may ask the boards of appeal to deal with their appeals rapidly. The notice mentions situations which could justify such acceleration. However, acceleration is not limited to those exemplified situations and is a matter to be decided at the discretion of the board on the particular facts of the case before it (see e.g. decision T 895/13 and T 1125/13 of 28 March 2014, Reasons 10). While trivial reasons would clearly not justify acceleration, it follows from the scenarios exemplified in the notice that the term "legitimate interest" is not to be construed as requiring compelling reasons. Rather, objective reasons have to be put forth that warrant giving the appeal priority.

3.4 In the present case, appellant 1 requested acceleration of the appeal proceedings on the grounds that arbitration proceedings had been brought against an affiliate company in Portugal.

3.4.1 In view of the additional information and evidence filed by appellant 1 with its letter dated 16 February 2017 regarding the legal nature of the arbitration proceedings pursuant to Portuguese law No. 62/2011 of 12 December 2011 (document (82), Exhibit E), the board was satisfied that the national proceedings in Portugal, albeit relying on arbitration, were mandatory and not merely voluntary and could thus be considered de facto as infringement proceedings as argued by the appellant 1 (see point XV above). In the board's judgement, the arbitration proceedings which had been instituted in Portugal were thus circumstances that could justify acceleration as explicitly acknowledged in the notice.

3.4.2 From Exhibit A of document (81) and Exhibit D (see translation filed with letter dated 16 February 2017, document (82)) it is apparent that the patent in suit - i.e. European patent No. 2 275 103 - has been invoked in the arbitration proceedings in Portugal. The respondent argued, however, that the arbitration proceedings were based on several intellectual property rights (namely European Patent No. 663 916 and a supplemental protection certificate (SPC) extending the protection conferred by said patent until July 2018) which protected everolismus as a product and served as independent basis for the infringement action. Therefore, a ruling on European patent No. 2 275 103 in the present appeal proceedings had no bearing on the arbitration proceedings which would in any case continue. The board agrees with appellant 1 that it is not appropriate for the purpose of deciding on accelerated processing to embark on a more thorough enquiry into the practical or economic impact of the present appeal proceedings on the arbitration proceedings in Portugal. Indeed, such an analysis would entail a prospective investigation into the arguments, in the infringement proceedings, relying on the patent in suit. Such considerations would clearly exceed the scope of analysis required for deciding on a procedural request for accelerated processing. In view of the fact that the patent in suit has been relied on in the national arbitration proceedings as independent basis for the infringement action and that in this respect the present appeal proceedings are of relevance, even possibly only to a limited extent, for the national arbitration proceedings, the board is satisfied that there were legitimate reasons for giving the present appeal priority.

3.4.3 Finally, while the arbitration proceedings in Portugal have been brought against an affiliate and not against appellant 1, the board judges that it is sufficient to show that a party to the present proceedings belongs to the same group of companies in order to establish a legitimate interest within the meaning of the notice. Indeed, the notice does not establish a requirement for the parties to appeal proceedings to be party to national infringement proceedings in order to request accelerated processing.

3.4.4 For the above reasons, the board gave priority to the present appeal.

Main request

4. Sufficiency of disclosure

4.1 Claim 1 of the main request is a purpose-related compound claim pursuant to Article 54(5) EPC directed to 40-O-(2-hydroxyethyl)-rapamycin for use in the treatment of pancreatic neuroendocrine tumours.

In the decision under appeal sufficiency of disclosure was acknowledged. This decision was challenged by appellants 1 to 4, who maintained their position that technical data or a plausible technical concept, which could demonstrate the suitability of everolismus in the treatment of PNETs, was missing.

4.2 Pursuant to Article 83 EPC, a patent shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.

In relation to claims directed to a second medical use, it is established jurisprudence of the boards of appeal that, for Article 83 EPC to be complied with, unless this is already known to the skilled person at the priority date, the application must disclose the suitability for the claimed therapeutic use (see T 609/02, point 9 of the Reasons; T 433/05, point 28 of the Reasons; T 801/06, point 25 of the Reasons). Clinical data are not always required. Mere verbal statements are however not enough. The patent application must provide some information in the form of, for example, experimental tests to the avail that the claimed compound has a direct effect on a metabolic mechanism specifically involved in the disease. In vitro examples may be sufficient, if for the skilled person they directly and unambiguously reflect the therapeutic application. Post-published evidence may be taken into account, but only to back-up the findings in the application (cf. T 609/02, point 9 of the Reasons).

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.

4.3 As evidence of the suitability of everolismus in the treatment of PNETs, the respondent relied solely on paragraphs [0052] and [0053] of the patent in suit (page 37, lines 1 to 7 of the application as filed). According to the respondent, these paragraphs described a then on-going clinical study and the results that had been observed, namely the inhibition of S6K1 activity and the reduction of chromogranin A (see point XVI above). The disclosure of paragraphs [0052] and [0053] was to be contrasted with paragraphs [0054] to [0056] which described future trials. The post-published documents (6), (19), (49), (56) and (74), in particular documents (49) and (56) confirmed the disclosure in the paragraphs [0052] and [0053].

4.4 The board does not agree.

4.4.1 Paragraph [0052] mentions that in clinical trial studies involving patients having carcinoid or islet cell cancer (the latter is equivalent to PNET, according to column 1, lines 33 and 34 of the patent in suit and page 3, lines 21 and 22 of the application or to a specific type of PNET, according to column 4, lines 2 to 6 of the patent in suit and page 11, lines 15 to 17 of the application) inhibition of S6K1 activity and a reduction of chromogranin A may be observed when administering everolismus alone or in combination with Sandostatin LAR**(®). Response evaluation may be performed every 12 weeks. No data of any kind is provided. It cannot be ascertained which patients, if any, have actually been treated or what results, if any, have been achieved in patients with PNETs. Nothing in this paragraph allows the skilled reader to conclude that paragraph [0052] refers to an on-going study, unlike paragraphs [0054] to [0056], which admittedly reflect future trial studies, and that certain effects had indeed been observed, let alone that these effects correlate to a disease response, in particular in patients with PNETs. 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 board also notes that inhibition of S6K1 activity reflects an expected pharmacodynamic effect of an mTOR inhibitor, such as everolismus (see patent in suit, paragraph [0048]). It is not an indication for an effective treatment of PNETs (see also respondent's reply to the statement of grounds of appeal, page 13 footnote 10). Nor is it a clear sign for the skilled person that a clinical trial study was on-going.

Chromogranin A is a universally helpful biomarker for neuroendocrine tumours of the pancreas and gut. It is primarily important for diagnostic purposes. Elevated levels of chromogranin A are found in most patients with metastatic neuroendocrine tumours. It is considered as a helpful indicator of the effectiveness of treatment (see document (55), title, and abstract). It is also considered to be the best general marker for neuroendocrine tumour, particularly of the carcinoid group. In 92% of active gastrinomas (pancreatic neuroendocrine tumours) the level of chromogranin A has been shown to be elevated (see page 460, left-hand column, lines 6 to 11). None of this is contested by the board. However, chromogranin A reduction only reflects a desired outcome, i.e. one that the skilled person would hope for. 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. This correlation has apparently been made for the first time in post-published document (56), which states that the observed antitumor activity was supported by changes in biomarkers (see page 4316, right-hand column, lines 10 to 12). Document (49) merely states that of 18 patients with elevated chromogranin A at baseline, 9 patients had >50% reduction without identifying these patients (32 patient were treated, 18 with carcinoid tumours, 13 islet cell cancer) and without any correlation to tumour response.

4.4.2 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. The board also concurs with appellant 2 that it is questionable whether the set-up mentioned in paragraph [0052], which refers to the administration of everolismus alone or in combination with Sandostatin LAR**(®) is suitable to demonstrate a synergistic effect, which would also require the administration of Sandostatin LAR**(®) alone. Moreover, document (56), which according to the respondent, reports the full trial results of the on-going trial referred to in paragraphs [0052] and [0053] of the patent, states that synergistic effects were not clear from this single arm study. Thus, contrary to the statement in paragraph [0053], such an effect could not have been observed. Furthermore, as pointed out by the appellants, a trial with everolismus alone had not even started before July 2007 (see document (6), page 517, left-hand column, last paragraph, first sentence).

4.5 The board therefore concurs with the appellants that paragraphs [0052] and [0053] do not make the suitability of everolismus in the treatment of PNETs plausible. The respondent did not rely on any other data or information provided in the patent or patent application.

4.6 What remains to be considered is whether common general knowledge provides the skilled person with a plausible technical explanation which allows him to conclude that everolismus would be suitable for the treatment of PNETs.

In the present case, no such common general knowledge has been relied on by the respondent. On the contrary, according to the respondent, neuroendocrine tumours, in particular PNETs, were difficult to treat and efficacy against different types of cancer was not an indication for efficacy in PNETs. Prognosis for patients with PNETs was poor. Chemotherapeutic treatment of neuroendocrine tumours with cytotoxic agents was apparently of low efficiency (see also patent in suit paragraphs [0005] and [0007] or document (57), page 413, left-hand column, second paragraph). More importantly however, according to the respondent, everolismus was the first mTOR inhibitor to treat PNETs.

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.

4.7 The respondent'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 document (56) 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. Rather the application, taking into account common general knowledge, must contain sufficient evidence or at least a technically plausible concept that allowed the skilled person to conclude that the claimed compound is suitable for the claimed therapeutic use. For the reasons set out in points 4.4 and 4.6 above this is not the case here.

Concerning the "data" in the priority documents, the board concurs with the appellants that the content of the priority documents does not form part of the disclosure of the application. Even if they were to be considered, the disclosure in the priority documents is as insufficient as in the application. The alleged reduction of chromogranin A without any information as to tumour growth regression, progression or stabilisation in the treated patients cannot be considered as evidence that everolismus is suitable in the treatment of PNETs. The board also notes that the statements in the priority documents with regard to the allegedly observed effects (synergistic effect, total inhibition of S6K1, reduction of more than 50% of chromogranin A) are inconsistent with the results provided in the post-published documents (49) and (56), which do not disclose synergistic effects or S6K1-inhibition, and according to which a reduction of more than 50% of chromogranin A is not generally achieved.

4.8 In summary, no common general knowledge existed, which in combination with the disclosure in the patent application could have led the skilled person to the conclusion that everolismus was suitable in the treatment of PNETs. In these circumstances the post-published documents cannot be used to remedy the insufficiency of disclosure (see point 4.2 above). Moreover, as pointed out by the appellants, document (49), and consequently also document (56), do not merely confirm the "study" in paragraphs [0052] and [0053]. Rather they disclose additional information, for example, that the study concerned patients with advanced low to intermediate-grade neuroendocrine tumours (a significant group of which did not even show an increased level of chromogranin A (e.g. 18 of 32 patient in document (49) and 37 of 60 patients in document (56)). No such disclosure can be found in said paragraphs.

4.9 The respondent made reference to points 28 of the decisions T 433/05 and T 801/06. The board agrees with the statements made in these decisions (see point XVI above). However, for the reasons set out above, the board judges that in the present case no data or plausible technical concept is present in the patent in suit at the relevant date that allows the skilled person to conclude that everolismus is suitable in the treatment of PNETs.

4.10 The respondent also referred to T 609/02 and T 801/10 according to which it was sufficient that the observed effect directly and unambiguously reflected the therapeutic application.

However, as explained above (see point 4.4.1) in the present case no effect was observed. It is merely stated that certain effects may be observed. Moreover, a link between mTOR inhibition and treatment of PNETs was not known in the art.

4.11 Hence, in view of the facts and arguments presented to it, the board comes to the conclusion that the ground under Article 100(b) EPC prejudices the maintenance of the patent in suit as granted.

5. Admission of auxiliary requests 3, 6 and 8

5.1 Auxiliary requests 3 and 8 were filed with the reply to the statements setting out the grounds of appeal. Pursuant to Article 12(1), 12(2) and 12(4), second half-sentence, RPBA, these requests are therefore to be taken into account in the appeal proceedings.

The board has however the power to hold inadmissible requests which could have been presented or were not admitted in the opposition proceedings (Article 12(4), first-half sentence, RPBA).

5.2 The mere fact that a request could have been filed in opposition proceedings is not as such a sufficient reason to hold a request inadmissible (see T 134/11, point 3.3 of the Reasons). In the practice of the boards of appeal, such a request is normally inadmissible in exceptional circumstances, for example, if a fresh case is created, which renders the decision under appeal obsolete and requires the board either to conduct the case anew or to remit it to the opposition division, or in cases where the patent proprietor/applicant made a deliberate choice to withhold requests which could have overcome objections raised in the first-instance proceedings and filed them only in the appeal.

5.3 In the present case, there is no indication that the respondent deliberately held back any requests in the opposition proceedings. Indeed, it already submitted auxiliary requests, on which a decision was not required as the opposition division rejected the oppositions. Furthermore, auxiliary requests 3 and 8 do not shift the case to such an extent that the board was required to conduct the case anew or remit it to the opposition division. Finally, the board accepts the respondent's argument that auxiliary requests 3 and 8, like the other auxiliary requests filed with the reply to the statements of grounds of appeal, were submitted in response to the newly filed document (75). This document had been submitted by appellant 1 with the statement of grounds of appeal to address the opposition division's concerns with regard to the teaching of document (14) and to further support its objection of lack of novelty and inventive step.

5.4 Hence, given the circumstances, the submission of the respondent's auxiliary requests 3 and 8, which have been filed without delay at the earliest possible stage in the appeal proceedings, are considered to be a normal and legitimate reaction of the respondent to defend the maintenance of the patent in suit. Accordingly, the board decided to admit auxiliary requests 3 and 8 into the proceedings.

5.5 Auxiliary request 6 was filed with letter of 27 October 2017, less than two weeks before the oral proceedings. The respondent justified the late filing with a change in focus and new arguments that were provided with regard to document (75).

5.6 The board does not agree.

Document (75) was filed by appellant 1 with the statement of grounds of appeal to further support its objections of lack of novelty and inventive step. According to the respondent's own admissions its filing gave rise to the filing of all the respondent's auxiliary requests filed with the reply to the statement of grounds of appeal. The respondent therefore clearly recognised the potential importance of said document and acted accordingly. It is not apparent to the board why the filing of auxiliary request 6 would not have been possible at this stage in the proceedings. A change in focus, which could justify the late filing of auxiliary request 6, is not apparent to the board, irrespective of the fact that further arguments had been provided by appellants 1, 2 and 4 in reply to the respondent's submissions of 21 March 2017. In particular, no new arguments had been provided which could have occasioned the limitation "advanced pancreatic neuroendocrine tumour". Finally, the board concurs with appellant 2 that there is prima facie no clear basis for the amendment made in auxiliary request 6. The passages in the application as originally filed relied on by the respondent refer either to a study of everolismus (compound A) in patients with advanced pancreatic tumours after failure of cytotoxic chemotherapy as monotherapy or mTOR inhibitors in general in the treatment of solid tumours, especially advanced solid tumours.

Accordingly, the board decided not to admit auxiliary request 6 into the proceedings.

Auxiliary request 3

6. Sufficiency of disclosure

6.1 Claim 1 of auxiliary request 3 differs from claim 1 of the main request in that everolismus is used in an amount of 5 mg or 10 mg daily in monotherapy. This amendment does not alter the above assessment with regard to sufficiency of disclosure.

6.2 It was additionally argued by the respondent that by simply following the teaching of paragraphs [0054] and [0056], which clearly identified the patients to be treated (i.e. patients with PNETs), the treatments as monotherapy and the dose to be administered, the skilled person would necessarily find that everolismus is suitable in treatment of PNETs.

6.3 The board does not agree.

Sufficiency of disclosure must essentially be established at the priority date based on the information provided in the application in combination with common general knowledge then available to the skilled person. As set out in point 4 above, this is not the case here. Moreover, according to the respondent'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 (see documents (6), (19) and (59)). 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.

The board also does not agree with the respondent that the information in paragraphs [0054] and [0056] is sufficiently detailed to allow the skilled person to carry out the study. The factual situation in T 108/09, on which the respondent relied in this context, is quite different, as in the case underlying that decision there was a detailed study protocol in the application as filed and in addition clear instructions as to dose, interval, mode of administration, blood serum level of the compound, composition of the pharmaceutical formulation and indication as to specific ingredients and their concentration (see T 108/09, point 2.2.2 of the Reasons). In the present case, it is not even mentioned whether the administration of 5 or 10 mg of everolismus daily relates to a single dose or multiple doses, let alone any blood serum levels that should be achieved. Furthermore as mentioned before the tumours to be treated were apparently of a particular type (i.e. advanced low- and intermediate-grade pancreatic tumours; see documents (49), (56), (6) or (59)), which has also not been mentioned in paragraphs [0054] and [0056] of the patent in suit.

6.4 Decision T 715/03 was not concerned with sufficiency of disclosure, but dealt with the question whether the suitability of ziprasidone for the treatment of Tourette's Syndrome (TS) had been made plausible in the framework of inventive step (i.e. whether the technical problem of providing a treatment for TS had been solved). In T 715/03 the inventor himself had announced in an article published several month before the priority date that a study on the suitability of ziprasidone in the treatment of TS was nearing its completion and confirmed in a declaration that he was already aware of the positive results of the study. The board accepted this as an indication for the plausibility of the statements made in the application. Such a specific constellation does not exist in the present case. In particular, there was no indication at all in the prior art that there was an on-going study nearing its completion. The decision T 715/03 therefore does not support the respondent's case.

6.5 Neither can decision T 950/13 support the respondent's case. In this decision sufficiency of disclosure was acknowledged for the suitability of a compound (dasatinib) in the treatment of a particular cancer (chronic myelogenic leukemia (CML)), although no experimental data were provided in the application. It was, however, clearly and unambiguously disclosed that dasatinib was an inhibitor of BRC-ABL kinase, a fact that could be verified. It was furthermore well established in the art that the BRC-ABL oncogene was the single causative abnormality in chronic myelogenic leukemia. BRC-ABL kinase inhibition was therefore seen as a potential way to treat this disease. Finally, the skilled person was familiar with the fact that CML could indeed be treated by inhibiting BRC-ABL kinase, as it was widely known that imatinib - an effective BRC-ABL kinase inhibitor - had shown excellent clinical results and had been approved for the treatment of CML well before the filing date of the patent application. In other words, the relationship between BRC-ABL kinase inhibition and the claimed therapeutic application had already been established. The analogy to imatinib was also mentioned in the patent application. The board therefore concluded that the application disclosed at least a plausible technical concept, namely that dasatinib based on its functional equivalence to imatinib as a BRC-ABL kinase inhibitor was suitable in the treatment of CML.

In the present case, no such plausible technical concept is apparent for the reasons set out in point 4.6 above.

6.6 The board therefore concludes that the subject-matter of auxiliary request 3 does not meet the requirement of sufficiency of disclosure. For this reason, this request must fail.

Auxiliary request 4

7. Sufficiency of disclosure

7.1 Compared to the claims as granted, claim 1 of auxiliary request 4 limits the amount of everolismus to 10 mg day. This limitation does not change the reasoning concerning sufficiency of disclosure presented in points 4 or 6.3 above.

7.2 The respondent's additional arguments with regard to document (59) (see point XVI above) are not accepted. Document (59) is published almost nine years after the earliest priority date and cannot be used to remedy the lack of sufficiency of disclosure.

Hence, the board concludes that the subject-matter of auxiliary request 4 does not meet the requirement of sufficiency of disclosure. Accordingly, this request must also fail.

Auxiliary requests 5, 7 and 8

8. Sufficiency of disclosure

The amendments made in auxiliary requests 5, 7 and 8 (10 mg in monotherapy; 10 mg in monotherapy of patients with advanced PNETs after failure of cytotoxic chemotherapy; treatment of specific PNETs; see point X above) do not alter the assessment in points 4 or 6.3 above. Indeed, the parties did not submit any arguments specific to these auxiliary requests.

Accordingly, the board concludes that auxiliary requests 5, 7 and 8 must also fail for lack of sufficiency of disclosure.

Further requests

9. Admission of documents (75) to (80)

Having concluded that the requirement of sufficiency of disclosure was not met, a decision on the admission of documents (75) to (80) was not necessary.

10. With regard to the respondent's requests concerning the acceleration of the proceedings and the discussion of T 950/13 (see point XVIII above), reference is made to points 3 and 6.5 above.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is revoked.