Wednesday, 13 November 2013

T 2003/08 – Fading Memories

In this case the Board also had to deal with an alleged oral disclosure. This part is interesting because it shows the type of evidence gathered in witness hearings and what the Board makes of it.

Oral disclosure

Request not to hear the witnesses Dr Wallukat and Dr Kunze

[30] By an interlocutory decision in accordance with A 117 and R 117 the board decided that it was necessary to hear Dr Wallukat and Dr Kunze as witnesses.

[31] The witnesses were summoned in accordance with R 118. In accordance with the second half-sentence of R 118(2)(c) Dr Wallukat and Dr Kunze were invited to confirm within two months of receipt of the summons that they were prepared to appear before the board. Neither of the two witnesses replied, either within the given time limit or at all. Yet, both witnesses were present on the day for which they were summoned. The appellant-patentee requested the board to refrain from hearing them.

[32] The failure to react to the invitation in the summonses does not have any influence on the board’s view that the witness-evidence of Dr Wallukat and Dr Kunze was necessary in the present case and therefore is no reason for the board to change its interlocutory decision.

[33] R 120(1) indicates as the consequence of a failure to reply to the summons that “if no reply is received within the period specified in the summons, the EPO may, in accordance with A 131(2), request the competent court to hear the person concerned.” However, in the event Dr Wallukat and Dr Kunze were present on the date indicated in the summonses and the board could hear them as witnesses so that it was not necessary to take any other such step.

[34] The appellant-patentee submitted that the missing replies had put it in a disadvantageous situation because it was uncertain whether or not the witnesses would attend and because, if they did not attend, it nevertheless had to be prepared for them to attend. The board has therefore considered whether the appellant-patentee’s right to be heard was violated by the fact that, despite the missing replies, the witnesses would be heard on the date for which they were summoned.

When asked by the chairman of the board at the oral proceedings whether or not the appellant-patentee’s representative was prepared for both eventualities, i.e. for both the presence and absence of the witnesses, the appellant-patentee’s representative confirmed that he was. Also the appellant-patentee had not asked for a break for preparation or even for an adjournment of the hearing. Thus, the appellant-patentee was prepared to hear the witnesses and therefore its right to be heard would not be violated, if the witnesses were in fact heard.

[35] The appellant-patentee also submitted that the appellant-opponent had played a procedural game by withholding the information that the witnesses would attend. However, although it is often a party – here the appellant-opponent – who offers a witness, the witness is not the party itself. This is illustrated, for example, by the fact that the summons for the witness hearing can be sent to the witness directly (as in the present case) and not necessarily to the representative of the party in question. Thus, the appellant-opponent is not responsible for the actions of a witness. It is of course desirable that a party, or its representative, who wishes a witness to be heard, takes all practical steps to ensure the attendance of that witness. That does not mean however, that, if a witness does not itself comply with a request directed to it, the party or representative is indulging in “procedural games”.

[36] Therefore, the board decided to refuse the appellant-patentee’s request not to hear the witnesses. This decision was taken in the particular circumstances of the present case and should not be taken to mean that in other cases the failure to meet the time limit of R 118(c) will always remain without consequences.

Evaluation of evidence: documents E1, E2, E3 and E24;
oral testimony of Dr Wallukat and Dr Kunze

Documents E1, E2 and E3

[37] In the context of the alleged oral disclosure of the subject-matter of claim 1 by Dr Wallukat the board observes that, in contrast to a written document the contents of which are fixed and can be read again and again, an oral presentation is ephemeral. Therefore, the standard of proof for ascertaining the contents of an oral disclosure is high. What has been said, or to use the terms of A 54(2), what has been “made available to the public” has to be put beyond reasonable doubt. In the often-cited decision in case T 1212/97 [4] the board expressed the view that “written notes made at the lecture by at least two members of the audience can usually be regarded as sufficient” for that purpose.

[38] However, a fact also alluded to by the board in case T 1212/97 [4] is that the amount of evidence necessary to establish the content of an oral presentation beyond reasonable doubt is to be judged on a case to case basis, i.e. it depends on the quality of the evidence in each case. In the present board’s view decision T 1212/97 cannot therefore be interpreted as setting an absolute standard for the amount of evidence necessary to prove the contents of an oral disclosure.

[39] In the present case the Opposition Division (OD) found that the evidence available to it – documents E1, E2, E3 – did not prove beyond reasonable doubt that the subject-matter of claim 1 was made available during Dr Wallukat’s lecture.

[39.1] Document E3, an article published in a book (according to the bibliographic data on page 3 of document E3: Proceedings of the International Symposium on “The Role of Immune Mechanisms in Cardiovascular Disease”), disclosed all the features of claim 1, but was published after the priority date. There was no supplementary evidence to establish that the relevant contents of document E3 had in fact been made available to the public at the lecture. Document E24, aimed at proving that document E3 had been written shortly after the conference, was not admitted by the OD into the proceedings due to its late filing and lack of prima facie relevance. This document was re-filed in appeal proceedings and the board has – by agreement between the parties – admitted it into the proceedings […].

[39.2] Documents E1 and E2 are each a so-called “Eidesstattliche Versicherung” (i.e. a declaration made in lieu of an oath, hereinafter “declaration”), declaration E1 being that of the lecturer himself, Dr Wallukat, and declaration E2 that of a member of the audience, Dr Kunze. Neither of the two declarations was supported by contemporary notes. The OD therefore concluded that these declarations did not satisfy the criteria in decision T 1212/97 for establishing the contents of an oral disclosure beyond reasonable doubt. Further, the objectivity of the contents of declaration E2 could be questioned in view of a later professional cooperation of Dr Kunze and Dr Wallukat. Moreover, in view of the nature of the written evidence E1 and E2 the OD declined in the light of decision T 1212/97 to hear Dr Wallukat and Dr Kunze as witnesses because their oral testimony would not make good the “deficiencies” of their declarations.

[40] The board shares the OD’s view on the evidential quality of document E3. It cannot automatically be assumed that a written publication, although it appears in a book referred to as “proceedings” of a conference, identically reproduces the lectures.

[41] As the OD, but for different reasons, the board comes to the conclusion that documents E1 and E2 per se are not of a quality to put the contents of an oral disclosure beyond reasonable doubt.

First, the long lapse of time between the event to be recalled and the writing of the declarations – around 10 years – together with the absence of contemporary notes sheds prima facie doubt on the correctness of the recollection of Dr Wallukat and Dr Kunze, as does the possibility that their recollection was tainted by the contents of document E3, later publications or information gained from their subsequent professional relationship. Second, relations with the appellant-opponent’s company could possibly have influenced Dr Wallukat’s and Dr Kunze’s objectivity.

[42] As noted above […], the board is not convinced that decision T 1212/97 is the last word on the quantum of proof for prior disclosures during lectures. The board considers that there may be circumstances where evidence from the lecturer and only one member of the audience is convincing enough to reach the standard of proof - i.e. beyond reasonable doubt.

Oral testimony of Dr Wallukat and Dr Kunze

[43] The board felt that its reservations concerning declarations E1 and E2 and document E3 could possibly be dispelled by hearing the authors of declarations E1 and E2 themselves. In contrast to the OD the board therefore considered it appropriate to hear Dr Wallukat and Dr Kunze as witnesses because their testimony could affect the outcome of the proceedings.

[44] The following is a selection of statements made by Dr Wallukat and Dr Kunze during their testimonies. […]

General details about the conference

[44.1] Dr Wallukat remembered who the organizer was, that he had been invited by him, the venue and date of the conference, that many American colleagues participated, that he had seen Dr Kunze in the auditorium during his lecture and that he had not presented a poster […]. Also Dr Kunze recalled who the organizer was, the venue and date, that the conference “came quickly” – it took place six weeks after the announcement, that he had heard about it, but that he had additionally received an invitation, and that he went there for two days as evidenced from parking tickets […].

Both Dr Wallukat and Dr Kunze could not remember whether poster sessions took place during the conference […], whether Dr Wallukat’s lecture was held in the morning or in the afternoon […] and who introduced the speakers […].

The lecture


[44.2.1] Whereas Dr Kunze remembered that the lecture room was the great ballroom of the hotel in which the conference was held, Dr Wallukat only remembered that it was one of the bigger lecture rooms of this hotel […]. Dr Kunze remembered Dr Wallukat’s presentation, but could not remember any other presentation without recourse to document E3 […].

Both Dr Wallukat and Dr Kunze agree in their recollection that during Dr Wallukat’s presentation the room was not really full […].


[44.2.2] Dr Wallukat said that he had shown slides of all the figures disclosed in document E3 plus those in an envelope which he brought with him to the witness hearing plus possibly two or three more […].

Dr Kunze said that Dr Wallukat had shown 8 to 10 slides which were all in Dr Wallukat’s envelope […].

Contents of the lecture

[44.2.3] Dr Wallukat said that the data presented at the lecture were “brand new”. Dr Kunze said that he did not need to make notes because he knew what was said.

Dr Wallukat stated that the gist of his lecture was that he and Dr Müller had noticed that the relevant antibodies decreased in the course of the healing process in a patient with myocarditis and that at the same time the patient’s heart function improved […].

Dr Kunze said that during the lecture Dr Wallukat reported on a patient with myocarditis, by whom in the course of the healing process, the antibodies disappeared […] and that this had given him the idea to reduce antibodies in patients suffering from DCM – for which there was no cure […] and that the take-home message was: if you reduce the antibodies, then this improves the function of the heart and its anatomy […].

Patient identification

[44.2.4] Dr Kunze stated that Dr Wallukat had identified the myocarditis-patient by initials […], whereas Dr Wallukat said that he had not identified the patient by any means […].

Extent of the reduction of immunoglobulin

[44.2.5] Dr Wallukat stated that he had not disclosed during the lecture any details of the extent to which the immunglobulin portion in the patient’s blood was reduced.

Dr Kunze said that Dr Wallukat had disclosed that the level of immunoglobulins was decreased to the extent of 80%. That this was a good value had not been known at the time […].

Discussion after the lecture

[44.2.6] Dr Wallukat was not sure about the intensity of the discussion immediately after his lecture and whether the “bridge-to-transplant” issue had been discussed […]. He recalled that in later personal conversations at the symposium other participants, in particular Prof. Maisch, had expressed appreciation of the new method presented by him […].

Dr Kunze appeared not to be sure that there had been a discussion immediately after Dr Wallukat’s presentation ([…] “Frage: Aber nach den Vorträgen gibt es eine Fragerunde. Antwort: Ja, das ist dann normalerweise die Podiumsrunde ...”), but he remembered that he participated as listener at the “Podiumsrunde” where the participants expressed surprise about the new treatment […]. Dr Kunze also said that the “bridge-to-tranplant” issue had been mentioned at the “Podiumsrunde” (war “auf dem Podium”) […].

Collaboration between Dr Wallukat and Dr Kunze before the lecture

[44.3] Dr Wallukat said that he had not worked directly with Dr Kunze on aspects of DCM in the days, weeks or months preceding the presentation and that Dr Kunze had not been involved in the studies that led to the data presented at the presentation […]. They only cooperated later in the context of the firm “Affina” where they tried to develop new adsorbers, also with the aim of using them for the treatment of DCM […].

Dr Kunze said that he had often had discussions with Dr Wallukat about DCM or immunoaphereses before his presentation […] and that he himself, Dr Wallukat and Dr Müller had together determined the regimen to reduce the level of immunoglobulins by 80% […]. Dr Kunze said that after the presentation the collaboration was intensified. He said that he and Dr Wallukat developed new adsorbers in the context of the firm “Affina” which had been founded in 1999 […].

Declarations E1 and E2

[44.4] Dr Wallukat and Dr Kunze both stated that they had written the declarations themselves […], but neither of them spontaneously recalled when exactly this happened […].

Dr Wallukat said that he had not used anything to refresh his memory when he wrote the declaration. Dr Kunze said that he had used document E3 and his memory; moreover, he knew the publications of Dr Wallukat and Dr Borda and he could of course not at the time of his oral testimony distinguish precisely between what he knew in 1995 and the knowledge he had acquired later […].

Conformity of the contents of document E3 with those of the lecture

[44.5] Dr Wallukat and Dr Kunze both remembered that Figure 3 of document E3 had been shown as a slide at the lecture.

Dr Wallukat could not remember whether he had shown a slide with the data of Table 1 of document E3 […] whereas Dr Kunze said that such a slide had been presented […].

Dr Wallukat remembered that he had said more during the lecture than what was disclosed in document E3, in particular that he had shown slides with data of patients treated at the “Charité” hospital […]. Dr Kunze said that the contents of document E3 were an accurate reproduction of what Dr Wallukat had said […] and that the only point that was additionally mentioned in the lecture was how to measure the antibodies […].

Relationship to the appellant-opponent

[…] Dr Kunze said that he had been working for the last five years as medical advisor for the appellant-opponent’s company […] and Dr Wallukat said that he never had any relations with this company […].

[45] The board appreciates that both witnesses were honest and open in their testimony and appeared genuinely to be trying to assist the board. The board draws the following conclusions after hearing the oral testimony:
  • It appears that any relation of Dr Wallukat and Dr Kunze to the appellant-opponent at the time of writing the declarations, i.e. the party in whose support the declarations were made, can be excluded, so that any influence on their evidence for that reason can be eliminated.
  • It is accepted that attention plays a key role in storing information in the human brain. This is why, for example, emotionally charged events are better and longer remembered. The board did however not gain the impression that the lecture was perceived by Dr Wallukat as an outstanding and therefore easily memorisable event. For example, Dr Wallukat could not remember the lecture room, or the time of the day when he gave the lecture.
  • Both Dr Wallukat and Dr Kunze do not have a recollection of all details of the conference and the lecture. It would in fact be surprising if they had – human memory fades with the passage of time. In many aspects the witnesses have recollections, but they are diverging – the extent of their collaboration in the period before and shortly after the lecture, the information that was disclosed (or not) during the lecture and the identity of the contents of the lecture and document E3 are particularly noteworthy. The board cannot exclude that the divergence in recollection is due to mixing up knowledge from the lecture and knowledge gained from later collaboration and joint publications. In other aspects Dr Wallukat’s and Dr Kunze’s recollection is uniform, in particular about Dr Wallukat’s disclosure at the lecture that patients with DCM had been treated by immunoapheresis. The board is not sure whether the recollection of details falling in this category is spontaneous, i.e. whether it has been made independently of written information, such as for example the declarations or document E3.
[46] In toto, the oral testimony of Dr Wallukat and Dr Kunze could not dispel the board’s doubts that, during Dr Wallukat’s presentation, what is stated in declarations E1 and E2 as having been said was in fact actually said, that a slide with the contents of Figure 3 of document E3 was actually shown, or even that the complete contents of document E3 were actually disclosed.

Document E24

[47] As to the post-published document E3 as evidence of what was said during Dr Wallukat’s lecture, document E24 does not add anything to prove how much of the contents of document E3 was made available at the lecture. Document E24 appears to be a standard letter sent to all speakers at the conference (otherwise the writers would not have expressed the hope that Dr Wallukat, who lives in Berlin as they must have known, had “einen angenehmen Aufenthalt in Berlin”).

Document E24 does not contain anything from which it could be concluded that the document had to be an accurate reproduction of the lecture. The indication of the maximum amount of pages and figures suggests that shortening may be necessary, but it does not indicate that nothing of relevance can be added.

[48] Taking together all the evidence before it, the board is not in a position to conclude that it has been established beyond reasonable doubt that Dr Wallukat disclosed during his lecture subject-matter falling within claim 1. Hence, the novelty-objection based on the oral disclosure fails for this reason.

Should you wish to download the whole decision, just click here.

The file wrapper can be found here.


Raoul said...

The decision is not only interesting in that it deals for a good part with the hearind of wittnesses and the appreciation of testimonies before the Boards of Appeal, which is a quite rare occurrence.

It is also interesting as it does not allow to merely delete the last method step of re-injection into the patient in porder to overcome the prohibition of the Art 52(4), now Art 53,c).

As second medical use claims are not any longer applicable, the corresponding considerations are not to be considered, and the refusal of a referral is quite understandable.