T 2036/21 concerns compositions for use in the prevention or delay of the onset of dementia in a person having characteristics (biomarkers) of a prodromal dementia patient. The opponent asserted that post-filing clinical trial data provided evidence that the claimed composition neither prevented nor delayed onset of dementia at the prodromal stage.

The Technical Board of Appeal pointed out that the clinical trial data did 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”. In particular, the board highlighted that the crucial point which has 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. Even if the tests aimed at assessing an endpoint of a clinical trial do not yield a statistically significant outcome, other results may still be taken into account to evaluate the efficacy of a treatment. In some cases, these may provide valuable information in relation to the endpoint for which no significant results were observed.

The board confirmed that the established case law principle of the free evaluation of evidence applies universally in proceedings before the EPO when assessing any means of evidence and there are no reasons not to apply this principle when deciding whether it is credible that a compound or composition induces a therapeutic effect. Moreover, following G3/97, the board emphasised that 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. This contrasts to the requirements of biomedical research and of health authorities granting marketing authorisations for medicinal products, where conclusions are only drawn if there is a high degree of statistical confidence.

In T 1863/21 the claims at issue were medical use claims which broadly relate to enhancing oral tolerance against dietary proteins using non-digestible oligosaccharides which enhance the oral tolerance-inducing effect of the partially hydrolysed proteins. The examples in the description used a specific blend of three non-digestible oligosaccharides. To support its assertions that the invention was sufficiently disclosed over the whole scope, the proprietor filed further experimental data using a combination of two non-digestible oligosaccharides. The opponent late-filed a statistical analysis of the post-filing data and asserted that no statistically relevant results could be drawn.

The EPO did not admit the late-filed analysis and the board went on to state that statistical significance is not and should not be the sole criterion for considering experimental results, let alone for excluding them from consideration. Moreover, the board confirmed the principle discussed in T 2036/21 that it is not a prerequisite to perform a statistical analysis of the results and to determine a specific confidence interval in order to consider a certain piece of evidence convincing, as is most often required in biomedical research and by health authorities granting marketing authorisations for medicinal products. In particular, statistical significance quantifies the probability that an observed difference in data is not a random occurrence, hence the lack of statistical significance does not in itself prove the null hypothesis. The board concluded that the lack of statistical significance does not automatically render a demonstrated effect implausible for the purposes of a legal assessment.

Key takeaway

The EPO recognises that the standard for supporting data for patents and patent applications does not need to be as rigorous as that required by regulatory authorities or peer-reviewed journals. 

Case details at a glance

Jurisdiction: EPO
Decision level: Technical Board of Appeal
Parties: NV Nutricia (applicant) and Fresenius Kabi Deutschland GmbH; Société des Produits Nestlé SA
Citation: T 2036/21
Date: 24 October 2023
Decision: dycip.com/epo-t2036-21

Jurisdiction: EPO
Decision level: Technical Board of Appeal
Parties: NV Nutricia (applicant) and Société des Produits Nestlé SA
Citation: T 1863/21
Date: 29 April 2024
Decision: dycip.com/epo-t1863-21