The patent relates to injection devices notably to automatic or semi-automatic pen-type injectors where a rotary drive shaft driven by a torsion spring used for insulin injection.
Brief outline of the case
The opponent appealed the rejection of the opposition.
A late-filed alleged public prior use of an insulin injection pen named GensuPen labelled as D18 was submitted in reaction to the preliminary opinion of the OD was admitted in the opposition proceedings as prima facie relevant, but considered not sufficiently proven.
The opponent argued, inter alia that the proprietor’s reply to the appeal was not sufficiently substantiated but the board disagreed.
The board confirmed the decision of the OD to dismiss the alleged public prior use D18 as not sufficiently proven.
The board thus confirmed the rejection of the opposition.
The opponent’s position on the alleged public prior use
Standard to be applied
The opponent argued that the higher up to the hilt standard of proof was incorrectly applied by the OD to come to the conclusion that the alleged public prior use D18 was not sufficiently proven.
The opponent criticised that the OD only focused on the information of single pieces of evidence taken in isolation without duly evaluating any possible indirect evidence resulting from the information which could be gathered from all the available pieces of evidence when considered in combination.
Request to hear a witness before the board
During the opposition proceedings, the opponent produced a declaration of Ms Simon stating that on request a GensuPen of lot number 100804 was handed over to her for free.
Ms Simon, after having visited the consultation room of the Polimed Medical Center in Katowice, wrote on the same day a declaration. The board noted that this declaration was used more than six years later in the present opposition proceedings.
Being aware of the gaps objected to by the OD regarding the circumstances of the alleged public prior use, the opponent offered, for the first time with the statement of grounds of appeal, the testimony of Ms Marzena Nabrdalik.
The opponent explained that Ms Marzena Nabrdalik had been working for many years and was still working at the Polimed Medical Center in Katowice where the sample of the GensuPen belonging to lot number 100804 was obtained, inter alia, by Ms Simon. It was submitted that as she was the nurse responsible for this product over many years, she could confirm that the GensuPen was indeed freely distributed by the personnel of the medical centre to the patients on request and for many years.
The board’s position on the alleged public prior use
Standard to be applied
The board concurred with the proprietor that the contested decision applied the lower standard of proof and came to the same conclusion based on the balance of probabilities standard which, incidentally, is the correct one in the current case. It has to be taken into account that it cannot be asserted that all the relevant evidence, in particular the information on the effective date of availability of the GensuPen on the market, lay exclusively within the sphere of the opponent.
The board found that the OD correctly concluded that evidence D18 could not convincingly support the alleged public prior use of an insulin injection pen according to the sample D18.13 because they were not clearly linked to this product, meaning that the alleged public prior use was correctly assessed on the basis of the remaining evidence D18.10 to D18.14. No failure to consider all the information by the OD could be seen by the board.
Revision of facts by the board
The board found that its power to review appealed decisions is not limited to points of law but extends to points of facts. The board referred to T 1604/16. In the latter case, the witness statement was re-evaluated by the board which concluded that the public prior use did not belong to the prior art under Art 54(2). The patent was maintained as granted.
For the board, it is settled case law that a board is not obliged to take all the evidence anew and that parties do not have the right to have the taking of evidence repeated as a request before the board.
According to the principle of free evaluation of evidence, there are no firm rules on the probative value of the various types of evidence. The deciding body is entrusted with weighing up all the evidence and basing its decision on what it is then satisfied has been established, implies a degree of freedom comparable to the one referred to by the EBA in G 7/93, Reasons 2.6.
The board held that, it is wise to similarly respect this freedom, especially when taking into account that a board, except when only reviewing documentary evidence, does not have the same first-hand impression of the probative value of a means of evidence as a department of first instance that has itself heard a witness or expert or inspected an object.
Although the Board is not limited in its decision, it seems useful to apply the test set out in decision T 1418/17, Reasons 1.3.
Unless the law has been misapplied, e.g. by application of the wrong standard of proof, a BA should overrule a department of first instance’s evaluation of evidence and replace it with its own only if it is apparent from that department’s evaluation that it:
- disregarded essential points,
- also considered irrelevant matters or
- violated the laws of thought, for instance in the form of logical errors and contradictions in its reasoning.
The evaluation of evidence only refers to establishing whether an alleged fact has been proven to the satisfaction of the deciding body. The discretion-like freedom is restricted to this question and does not extend to the further question of how the established facts are to be interpreted and what the legal consequences are.
It could not be deduced from the declaration of Ms Simon whether she was a member of the public or whether this was possible for any member of the public and not only for a restricted number of patients undergoing, for example, an experimental treatment which, as such, would normally be subject to a confidentiality obligation.
The fact that this relevant information is completely missing indeed casts a shadow on the plausibility of the statement of Ms Simon and, in the board’s view, justifies the conclusion of the OD that the public prior use, even under the lower standard of proof of the balance of probabilities, was not sufficiently proven because the circumstances were not fully and clearly specified. This same applies for the same reasons to the declaration of Mr Lubawy presented as further evidence.
The request to hear a further witness
The board firstly observed that the evidence presented at the first-instance department in support of the alleged public prior use D18 was not provided at once, as is generally required when a public prior use is claimed, but bit by bit at three different times, none of them within the period of opposition.
Furthermore, doubts concerning the plausibility of the declaration of Ms Simon and objections against the precise circumstances underlying the alleged public prior use were raised by the proprietor during the written opposition proceedings.
Therefore, with its subsequent letter and, in any case, before the date of the oral proceedings, the opponent had the opportunity to attempt to fill the gaps objected to by the proprietor and hence to submit the request to hear Ms Marzena Nabrdalik as a witness, being aware that if the late-filed alleged prior use was admitted, the OD also had to decide on whether the circumstances underlying the alleged public prior use were sufficiently detailed and proven.
However, the opponent considered that the evidence already submitted was sufficient and legitimately, but deliberately, decided to rely only on it. In conclusion, in view of the circumstances of the first-instance proceedings summarised above, the board is convinced that the request to hear Ms Marzena Nabrdalik as a witness could and should have been submitted in the first-instance proceedings.
Thus, in exercise of the discretion provided by Article 12(4) RPBA07, the Board decided to disregard the request to hear the witness submitted by the opponent when entering appeal.
The case is interesting as it shows a certain parallelism between the use of the discretion of the OD when admitting late-filed submissions and the evaluation of facts.
A board will however only revise and overrule a discretionary decision of a first instance deciding body if the discretion has been exercised according to the wrong principles, or in an unreasonable way.
The present decision makes also clear that the evaluation of facts can be revised by a board. In T 1604/16, it led the board to refute the witness statement so that the patent was maintained as granted.
In the present case, the board refused to re-evaluate the facts leading the OD to consider the alleged public prior use and to hear a new witness. This was also the case in T 460/13.
One lesson to be learned is that evidence of an alleged public prior use has to be filed as early as possible and certainly within the opposition period. It is also preferable to file the documents allowing to establish the plausibility of an alleged public prior use all at once and not in a piecemeal approach.
Unless the first instance deciding body made a mistake leading to a substantial procedural violation with respect to the hearing of a witness, it appears pointless to request the hearing of a witness for the first time before a board. The RPBA20 are furthermore a good way for a board to fence off such late filed requests.