This article in the series follows our first article on the oral proceedings for case T 2749/18, which looked at whether it is possible for device features to limit second medical use claims. The Board has now issued the full written decision on this case, which contains further clues as to how the EPO will assess future attempts to characterise second medical use claims with device features.
This topic is likely to be of interest to applicants, as limiting a second medical use claim with device features might improve the validity position of the claims. In this case, it is notable that the device claim had been found to lack novelty at first instance, while the second medical use claim was found to lack inventive step, as the Opposition Division accepted that the needle gauge was limiting on the claim. This case therefore demonstrates that in the right circumstances such a second medical use claim could be very valuable, and thus the question of whether formulating claims in this way is permissible is a relevant question.
In T 2749/18, the Board considered whether the gauge of a needle could limit a claim directed to a substance or composition within the meaning of Article 54(5) EPC. While the case did not turn on this point, and so no full discussion of the issue was held, the Board still noted in section four of the reasons for the decision that:
“The Board has doubts that a device-related technical feature, in the current case the “injection device comprising a tube having a needle gauge of 28 or greater”, can be taken into consideration as a feature of the claimed subject-matter if it has not been convincingly shown that this feature directly interacts with the substance or composition (in the current case, the glucagon-like peptide agonist composition) in a manner that alters the treatment (in this case, the treatment of type 1 diabetes, type 2 diabetes, obesity or hyperglycaemia) as such.”
Thus, the Board was sceptical of the reasoning of the Opposition Division that T 51/93 provides justification for a device feature related to administration of a medicament, to be limiting per se on claims formatted in accordance with Article 54(5) EPC. It may be the case that because T 51/93 related to a new injection location, rather than a device feature, the Board did not consider the findings of that case to be applicable to the feature of the needle gauge.
It is also notable that the Board use the phrase “convincingly shown”. This suggests that Board 3.3.04 would consider the burden of proof to be on the applicant to demonstrate that a device feature alters the treatment before that feature is considered limiting, rather than on an Examining Division/Opponent to show that the feature does not alter the treatment. The use of data may aid applicants in this regard, to back up arguments that the device feature alters the treatment.
Additionally, the phrase “interacts with the substance or composition in a manner that alters the treatment as such” appears open to interpretation. It remains to be seen whether this is to be interpreted as stating that the device feature’s interaction with the substance must lead to a different outcome in the treatment, or whether it suffices for some stage of the treatment to be different, even if the final outcome of the treatment is substantially the same.
It will be interesting to see whether other Boards follow this approach, and whether further clarification is provided when a case is brought before the Boards of Appeal which turns on the question of whether a device feature can limit a second medical use claim. In the meantime, it would appear advisable for applicants wishing to limit their claims in this way to provide evidence in their application to show that the device feature interacts with the substance or composition in a manner that alters the treatment.
