Wednesday 27 April 2011

R 19/10 – Be Explicit


This petition for review concerns decision T 945/09 wherein the Board set aside the Opposition Division’s decision to reject the opposition and revoked the patent of the petitioner (see also my post on this decision). The petition is based on the grounds of A 112a(2)(c) and (d) in combination with R 104(b). The patent proprietor submitted that the Board had failed to address or to decide on a relevant request of the patentee when revoking the patent.

According to the patent proprietor, it had requested in the appeal proceedings that the Board of Appeal
“uphold the novelty of the patent in suit, on the basis, inter alia, that whatever was disclosed prior to the priority date of the patent in suit by the authors of D3, was not enabling but merely speculative and did not support the efficacy of the claimed medical use”.
However, in its decision, the Board completely failed to address or to decide on this issue. The Board thereby breached A 112a(2)(d), because it had decided on the appeal without deciding on a request relevant to that decision, contrary to R 104(b) EPC. This was also a breach of A 112a(2)(c), as it constituted a fundamental violation of the patentee’s right to be heard under A 113.

The Enlarged Board (EBA) found the petition to be admissible but not to be allowable. Here is why:

[5] With regard to the objection under A 112a(2)(d) in combination with R 104(b), the [patent proprietor] refers to its request to uphold the novelty of the patent in suit, on the basis, inter alia, that whatever was disclosed prior to the priority date of the patent in suit by the authors of D3, was not enabling but merely speculative and did not support the efficacy of the claimed medical use […]. On the other hand, according to the minutes of the oral proceedings (OPs), the [patent proprietor] had requested “that the appeal be dismissed” before the chairman of the Board of Appeal declared the debate closed […]. The question therefore arises which was the [patent proprietor’s] request relevant to the decision within the meaning of R 104(b). 

[5.1] It is true that, as submitted by the [patent proprietor], the EPC does not contain an explicit definition of the term “request”. However, according to the common practice in the proceedings before the EPO, requests are in general directed to executable legal consequences sought by the parties. The arguments provided by the parties in support of these legal consequences do not normally belong to the legally binding requests as can be concluded from A 114(1). 

[5.2] In the circumstances of the present case it is, however, not necessary to further consider this issue. As follows from the file the relevant request confirmed by the [patent proprietor] under Article 15(5) RPBA was that “the appeal be dismissed”. In view of this fact and the common practice referred to above, the Board of Appeal had no reason to assume that the [patent proprietor] requested anything else. This is all the more so as the alleged request which included supporting arguments of the [patent proprietor] was never explicitly formulated during the appeal proceedings. As a basis for it, the [patent proprietor] refers to its observations in the letter of 21 December 2009 under the heading “Insufficient Data for Establishing Disclosure” on pages 10 to 13. However, this passage contains an argumentation without any recognizable request. It is not a procedural duty of the Boards of Appeal under R 104(b) to analyse the submissions of the parties in order to identify potential requests which were not explicitly made by the parties. 

[5.3] For these reasons, the [patent proprietor’s] objections based on A 112a(2)(d) in combination with R 104(b) […] are clearly not justified. 

[6] As to the objection pursuant to A 112a(2)(c) it is to be contemplated whether the Board of Appeal fundamentally violated the right to be heard of the [patent proprietor] with regard to its argument that the results reported in document D3 did not establish an enabling prior use […]. 

[6.1] In point VII of the written decision, the Board of Appeal summarized the arguments of the [patent proprietor]. In particular, the argument of a non-enabling and therefore legally irrelevant prior use was summarized as follows:
“Not everything the authors of document D3 could have done and known before the priority date of the patent in suit had been established as a successful method. They only were beginning to try anything to help a patient in need of some therapy while suffering repeated catheter-related bloodstream infections with no explanation of their origin. Whether this action or any other accompanying administration of antibiotic or antiseptic substances led to success in treating this single - and therefore statistically irrelevant - patient was not known and at that time could not possibly be seen. Consequently, even if the information to be derived from document D3 was clearly disclosed, it was far from an established teaching capable of constituting prior use”.
From this summary it follows that the Board of Appeal had, in fact, duly taken note of the argument of the [patent proprietor] that the patent could not be found to be invalid for lack of novelty, even if a non-confidential prior public disclosure of the teaching of document D3 was assumed, since this teaching was not based on sufficient data with regard to the existence of a therapeutic effect. 

[6.2] The [patent proprietor] further submits that A 113(1) not only enshrines a party’s right to be heard before a decision is issued against it, but also guarantees its right to have the relevant grounds fully taken into account in the written decision […]. The EBA in principle agrees. However, this principle is not without any limitation as explained in decision T 1557/07 referred to by the [patent proprietor] itself: provided that the reasons given enable the parties concerned to understand whether the decision was justified or not, the deciding organ is under no obligation to address each and every argument presented by the party concerned.

[6.3] In the circumstances of the present case the EBA is satisfied that the reasons given in the decision under review enabled the parties to understand, on an objective basis, the grounds for the decision of the Board of Appeal. 

As stated in point [3.4] of the reasons, the Board of Appeal based
“its conclusions on the knowledge of the patient being clear and concise enough that he could take notice of the technique used after replacement of heparin-lock by taurolidine-lock, representing the teaching of claim 1. There was also no reason for him to treat this knowledge as a secret, because at that time the acting doctors simply tried to apply taurolidine of whatever provenance using a technique they derived freely and easily from the state of the art common to them at that time”.
Accordingly, the Board of Appeal concluded in point 3.5 of the reasons 
“that this teaching was performed beginning from July 1995 in the full knowledge of the patient without any obligation of confidentiality and thus was publicly available before the priority date of the patent in suit”.
The decision of the Board of Appeal is therefore clearly based on the finding that what constituted the public prior use was the knowledge of the treated patient himself, as a member of the public. This argument had been introduced into the appeal proceedings by the appellant already with the statement of the grounds of appeal […] and was therefore known to the [patent proprietor].

Against this background it is apparent that it did not matter for the reasoning of the Board of Appeal whether or not the results reported in document D3 provided any clinical evidence of efficacy, as this had no bearing on the public prior use constituted by the direct knowledge of the applied technique by the treated patient, as a member of the public.

This was indicated by the Board of Appeal in point [4.4] of the reasons according to which
“the action in the Canadian hospital of using the taurolidine-lock was not typical of a clinical or even an experimental approach because it was dictated by the instant necessity to help a patient in a very desperate situation and thus had not been planned systematically as a scientific experiment”.
[6.4] In summary, the written decision makes it sufficiently clear that, in the opinion of the Board of Appeal, the public prior use was constituted by the knowledge of the treated patient himself, as a member of the public, so that the issue of whether the teaching of document D3 provided any clinical evidence of efficacy or satisfied the standards of a clinical study was not relevant for deciding on the novelty of the subject-matter of claim 1. Whether or not this finding is correct in substance cannot be the subject of the review proceedings (see R 2/08 [5]; R 9/08 [6.3]). In any case, the EBA is satisfied that the alleged fundamental violation of Article 113 EPC did not occur in the proceedings under review. […]

The petition for review is rejected as clearly unallowable.

To download the whole decision, click here. The file wrapper can be found here.

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