European patent No. 2846857 (Patent) relates to an injection device (claim 1), and a method of assembly of an injection device (claim 11). O/A had filed opposition against the Patent on the grounds of insufficiency of disclosure and lack of novelty and inventive step. In their argumentation, O/A addressed, among other attacks, the alleged public prior use of an insuline injection device, referred to as the “GensuPen” (D18).
Although some of the evidence related to this pen was late-filed, the OD had admitted all the supporting evidence pieces D18.1 to D18.14 into the Opposition Proceedings as being prima facie relevant. Nevertheless, the OD concluded that the alleged public prior use was not sufficiently proven and therefore dismissed the attack.
The Patent was maintained as granted during opposition.
O/A contested the decision by the OD and argued (amongst other reasons) that the public prior use of the GensuPen was sufficiently proven. According to O/A, the OD would have 1) incorrectly applied the higher “up to the hilt” standard of proof to arrive to the conclusion that the alleged prior use was not sufficiently proven; and 2) 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.
Before addressing the details of the specific case, the Board commented on their role as a Board in reviewing the evaluation of evidence. A summary of reasons to overrule a department of first instance is provided in the catchwords of the decision, which have been cited above.
The Board concluded that in the present case it was not needed to reevaluate the evidence or overrule the OD because of the following reasons.
As a first argument, O/A had submitted that the lower standard of proof for proving the prior use applied, i.e., the balance of probabilities. The Board confirmed that this was indeed the case, but also found that the OD already had applied this standard. The OD had concluded that under this lower standard of proof, the public prior use was still not sufficiently proven.
The Board further found that the OD had correctly concluded that pieces of evidence D18.1 to D18.9 could not convincingly support the alleged public prior use of an insulin injection pen according to the sample D18.13 because D18.1 to D18.9 were not clearly linked to the product. These pieces of evidence mentioned the name “GensuPen” prior to the filing date, without specifying the lot number or other details of the device. The Board therefore considered it to be correct that the assessment of the public prior use by the OD was done only on the basis of the remaining evidence D18.10 to D18.14.
Regarding D18.10-D18.14, the Board shared the doubts raised by the OD on the factual circumstances of the alleged public prior use. Not all the circumstances were indicated by the submitted evidence. In particular, the circumstances around a witness statement by Ms Simon (D18.11 and D18.12 (translation)) – stating that she had received a GensuPen free of charge after asking a nurse in the Medical Center where she was working – were considered to be unconvincing because the statement did not confirm that Ms Simon was a member of the public. According to the OD and Board, Ms Simon could for instance have been under a confidentiality obligation. Moreover, the declaration was written six years ago and failed to explain why the declaration was written and signed in the first place. A similar reasoning applied to D18.10, which included a witness statement by Mr Lubawy.
According to the Board, the lack of a full and clear specification of the circumstances justified 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.
Regarding the second argument of O/A, i.e., the consideration of the pieces of evidence individually, rather than in combination, the Board was also not convinced. O/A attempted to argue that the missing circumstances would follow from the other pieces of evidence, in particular a news article of D18.4 that would provide the missing circumstances of Ms Simon and Mr Lubawy being test-buyers. The Board essentially agreed with the assessment by the OD that the argumentation provided in support of this was not convincing.
The Board therefore confirmed the decision by the OD that the public prior use was not sufficiently proven during the first instance proceedings.
With the grounds of appeal, O/A had offered a testimony of a new witness, Ms Nabrdalik, to fill the gaps objected to by the OD regarding the specification of circumstances. Ms Nabrdalik had worked at the medical center where Ms Simon obtained her GensuPen and could, according to O/A, confirm that the GensuPen had in fact been freely distributed by the personnel of the medical centre to the patients on request for many years.
The Respondent (R) requested that this request be dismissed for being late filed. O/A argued that it had not filed this request previously as it had been convinced that the evidence previously provided had been sufficient at least under the applicable lower standard of proof.
The Board considered the reasons that O/A provided for the late submissions not to be convincing. It had been clear to O/A throughout the first instance proceedings that the supplied evidence was possibly not sufficient. The additional witness statement and request for the summons of a witness therefore could and should have been provided already during the first instance proceedings before the OD. The Board therefore dismissed the request, resulting in their final conclusion that the alleged public prior use was not sufficiently proven.
In addition to the alleged public prior use, the Board dealt with some other novelty and inventive step attacks as provided by O/A. However, the Board concurred with the decision of the OD that all claims were novel and inventive. The appeal was therefore dismissed and the Patent maintained as granted.
Summary written by the NLO EPO Case Law Team