The patent relates to a food composition for prodromal dementia patients.
Brief outline of the case
The present decision is the second decision in the case. In T 694/16, the decision to revoke for lack of sufficiency was set aside and the file remitted to the OD for further prosecution on the basis of, at the time, AR 4.
The patent was maintained according said AR4 and opponent 2 appealed this decision of the OD.
The board confirmed maintenance according to AR4.
The case is interesting as it deals, in case of a claim according to Art 54(5), with two topics:
- once sufficiency has been decided, can IS nevertheless be discussed.
- the free evaluation of evidence, relying on the balance of probabilities.
Claim 1 at stake
Claim 1 of the MR is drafted in accordance with Art 54(5) and relates to a composition comprising omega-3 fatty acids, uridine derivatives, a methyl donor and other ingredients, for use in the prevention or delay of the onset of dementia in a person having “characteristics” of a prodromal dementia patient.
Since claim 1 is drafted under Ar 54(5), attaining the claimed therapeutic effect is a functional technical feature characterising the claim. Thus, the issue of whether the claimed therapeutic method can be carried out and the purported effect achieved is primarily relevant in the context of the assessment of sufficiency of disclosure.
Lack of IS or lack of sufficiency?
The opponent’s position
The opponent argued that D31=H. Soininen et al., The Lancet Neurology, vol. 16, 2017, pg. 965-975 (Not in ISR) and D47=Soininen et al., Alzheimer’s Dementia, 2020, pg. 1-12 (Not in ISR), filed after that remittal, provided evidence that the claimed composition neither prevented nor delayed the onset of dementia at the prodromal stage. No therapeutic effect was achieved in prodromal patients. In its opinion, this was relevant to formulating the technical problem underlying the invention and for assessing inventive step.
The proprietor’s position
The proprietor countered that in its earlier decision the board had already decided that the claimed composition was suitable for inducing the claimed effect and that the requirement of sufficiency of disclosure was fulfilled. According to G 1/03, point 2.5.2, the issue of whether an effect specified in a claim was achieved was relevant to assessing sufficiency of disclosure, rather than inventive step. Therefore, the appellant’s arguments reopened issues which had already been settled by the board. The objections based on D31 and D47 should thus not be admitted.
The board’s decision
The board did not agree with the proprietor. In its earlier decision T 694/16, after dealing with the issues of sufficiency of disclosure and novelty, the board remitted the case to the opposition division for further prosecution on the basis of current auxiliary request 4.
For the board, the EPC, and in particular Art 111(2), does not preclude the OD from taking into account facts which were not at the disposal of the board remitting a case for further prosecution. Furthermore, although the issue of whether an effect specified in the claim is achieved is relevant to assessing sufficiency of disclosure, in the present case it may also have an impact on how the problem is formulated when assessing inventive step. The opponent’s arguments based on D31 and D47 have thus to be taken into account in the context of its objection of lack of IS.
Free evaluation whether a technical effect is credible
In the opponent’s opinion, certain passages of D31 and D47 explicitly taught that the tested composition neither prevented nor delayed the onset of dementia in the treated group of prodromal patients. Therefore, D31 and D47 provided clear-cut evidence that the claimed composition was not suitable for inducing the claimed therapeutic effects.
These arguments were not found convincing by the board because the message which the opponent conveyed, focusing on the cited passages, is not a true representation of the teaching of D31 and D47. The entire content of these documents must be taken into account to understand the meaning and significance of these passages.
D31 and D47 do not convey to the skilled person the message that “the tested composition is unsuitable for preventing or delaying the onset of dementia in a prodromal patient”, but rather that “this effect was not detected, possibly because the clinical trial was not designed and adequately powered to do so”.
The crucial point which had to be decided is whether further evidence is available which makes it credible that the claimed composition is suitable for preventing or delaying the onset of dementia in a prodromal patient.
According to established case law, the principle of the free evaluation of evidence applies universally in proceedings before the EPO when assessing any means of evidence. There is no reason for diverging from this principle when deciding whether a compound or composition induces a therapeutic effect. The EPO deciding body decides on this issue in the light of its conviction, taking into account the evidence available in the proceedings and on the footing that one set of facts is more likely to be true than the other.
This approach does not correspond to that applied in other contexts, where conclusions are only drawn if there is a high grade of statistical confidence. In proceedings before the EPO it is not a prerequisite to perform a statistical analysis of the results and to determine a specific confidence interval, as it is most often required in biomedical research and by health authorities granting marketing authorisations for medicinal products.
Evaluation of D47
The results presented in D47 and the conclusions drawn by its authors leave no doubt that Fortasyn Connect, a composition according to the invention, induces a beneficial and unprecedented effect in prodromal Alzheimer’s disease patients.
The board concluded that the results described in D47 make it credible that the claimed composition prevents or delays the onset of dementia in the patient identified in claim 1. Furthermore, that patients at the earliest stage of prodromal disease benefit the most from the treatment.
Evaluation of D48
D48 is an expert declaration by L.M. Broersen, filed by the proprietor with its reply to the grounds of appeal. D 48 was admitted in the procedure.
The board agreed with the proprietor that the tests carried out in the APP/PS1 mouse described in D48 make it credible that omega-3 fatty acids are not, alone, as effective in preventing degenerative processes associated with dementia as the claimed composition.
The opponent criticized the tests in D48, arguing that only incremental effects on neurodegeneration were measured, not the onset of dementia. Furthermore, that the mice were sacrificed at six months, although memory deficit typically only appears at ten months.
The board’s decision
The opponent’s arguments were not found convincing by the board. Dementia is a disease induced by a progressive degeneration of the brain cells. Thus, the neurodegenerative process which is already observed in young APP/PS1 mice at six months is suitable for reproducing the processes accompanying the development of dementia in prodromal patients.
For these reasons, it is credible that a composition combining the specifically claimed ingredients is more suitable for preventing or delaying dementia in the patients defined in claim 1 than a composition comprising only omega-3 fatty acids.
Comments
Before G 2/21, the term “plausible” would have been used. Since G 2/21, this term is replaced by “credible“. It does however boil down to the same concept.
The present decision shows first, that once sufficiency has been decided for the subject-matter of a claim pursuant Art 54(5), IS can still be decided separately, especially when new facts and evidence are filed after the decision on sufficiency was taken by a board. Further to G 1/03, it is also possible to quote T 2001/12, see the catchword.
The present decision shows also when it comes to a claim pursuant Art 54(5), that the standard to be applied is not necessarily the standard required in biomedical research and by health authorities granting marketing authorisations for medicinal products.
Demonstration that, on the balance of probabilities, an effect is potentially achievable is sufficient. There is no need for a vast amount of statistical data. It is enough if the effect is credible. This is also in line with existing case law in case of second medical use
https://www.epo.org/en/boards-of-appeal/decisions/t212036eu1
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