Tuesday, 11 June 2013

R 18/11 – Loss Of Control

This petition for review concerns decision T 7/07 (reported on this blog), in which Board of appeal 3.3.02 had revoked the opposed patent after the Opposition Division had rejected the opposition.

The Enlarged Board (EBA) found the petition not to be allowable.

[2] […] The EBA cannot share the view that in the proceedings before the board the petitioner was deprived of its right to be heard. Even after hearing the petitioner […] it sees no reason to change its provisional assessment of the case as set out in the annex to the summons.

In taking its decision the EBA must bear in mind that review proceedings under A 112a(2)(c) and (d) are confined to procedural defects so fundamental as to be intolerable for the legal system and overriding the principle that proceedings which have led to a final decision should not be reopened in the interest of legal certainty and that substantive issues are excluded (consistent case law since R 1/08 [2.1] and the travaux préparatoires there cited).

[2.1] The EBA continues to take the view that the decision objected to could have been formulated more clearly. However, the flaws do not constitute the fundamental procedural defect of denying a party the right to be heard (A 112a(2)(c)), as is clear from an analysis of the passages in point [3.3] of the decision cited by the petitioner in support of its allegation that its right to be heard was infringed.

[2.1.1] In said point [3.3] (first paragraph) the board begins by stating that the petitioner had not contested that clinical trials had been carried out before the priority date, and that the participants had not entered into confidentiality agreements and had been informed about all the active agents of the trial products, albeit not about the micronisation feature. The board continues by setting out (second paragraph) the criteria which, under established board of appeal case law, give rise to prior public use. According to the decision, these criteria are entirely consistent with what the petitioner indisputably conceded in the proceedings before the board. What this part of the decision may lack – an omission which however is made good at the end of point [3.3] – is a final conclusion that the facts not disputed by the petitioner already fulfil the criteria for public prior use under the boards’ case law (see point [2.1.3] below).

[2.1.2] In the next section of point [3.3] (fourth and fifth paragraphs) the board discusses the argument that decisions T 152/03 and T 906/01, cited by the petitioner in the appeal proceedings, had found that clinical trials were not public. But the board dismisses it because the trials underlying those decisions were conducted on clinic premises and involved devices implanted into a small number of patients. Under such circumstances, the trial devices could be assumed to have remained secret. Trials of that kind differed from the one in dispute in which a large number of participants without confidentiality agreements were given products to take home and did not return all the unused ones at the end.

[2.1.3] The board then sums up as follows: “Therefore, it appears that after having handed out the drugs the respondent effectively lost control over them as the participants in the clinical trial were in no way barred from disposing of the drugs as they wanted”. Point [3.3] ends by concluding that handing out the drugs to the participants made them publicly available.

[2.2] The EBA does not agree with the petitioner that the English formulation “Therefore, it appears” expresses a mere “assumption”. In its submission of 10 March 2009 […], the petitioner itself uses the phrase to make a firm assertion: “As it appears from page 21 to 22 of D43, the proprietor entered into confidentiality agreements …”. Here, the petitioner is not making a mere assumption, but stating what it regards as an incontrovertible fact. Even though the EBA concedes that “it appears” could also be read as meaning “it is assumed”, the interpretation “it is apparent” in the given context as analysed above is objectively the more likely one.

[2.3] Nor is the EBA convinced by the petitioner’s objection that its right to be heard was infringed because the board’s decision created new criteria for public availability – “loss of control” and “free disposal” – on which it had no opportunity to comment during the proceedings. The second paragraph of the decision’s point [3.3] begins “It is established board of appeal case law…”, leaving the reader in no doubt about the principles applicable under that case law on public prior use, namely “… that if a single member of the public … has the theoretical possibility to access particular information, this information is considered as being available to the public within the meaning of A 54(2)”. It does not mention “loss of control” and “free disposal”.

It does however make clear, to those familiar with board of appeal practice, that the criterion cited in the decision (point [3.3], second paragraph) as established case law, namely that even the theoretical possibility of access is novelty-destroying for an invention, sets higher confidentiality requirements than criteria such as “loss of control” and “free disposal”. The EBA regards these two concepts as sub-categories of the “theoretical possibility to access” which suffices under the boards’ consistent case law, and therefore does not consider them to be unexpected criteria on which the petitioner was unable to comment.

[2.4] It is true that the decision’s point [3.3] might have been more clearly structured. However, as shown above, these deficiencies did not constitute an infringement – let alone a “fundamental” one of the petitioner’s right to be heard.

[2.4.1] After all, the petitioner was legally represented. In the appeal proceedings it should therefore have been familiar with the boards’ established case law on the legal criteria for public prior use, including its implications for the pharmaceuticals field. Public prior use of the petitioner’s invention was a crucial issue in the appeal proceedings, in the light of the trials conducted in the United States, the US court judgment and the exchange of submissions. It was therefore a pressing task for the petitioner to address the issue in a comprehensive manner, and to raise any open questions itself. In view of the impartiality required of the boards in inter partes opposition appeal proceedings, it could not expect much in the way of helpful hints from the board.

[2.4.2] Under the boards’ established case law, there can be no doubt that an invention which reaches a third party without a confidentiality agreement has become public. As explained above, “loss of control” and “free disposal” are just ways of describing that. These formulations were therefore not decisive for the board’s decision.

[2.5] Consequently, there is no basis for assuming that the petitioner did not have sufficient opportunity to comment exhaustively on all aspects of public prior use which were relevant for the decision.

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

The file wrapper can be found here.