Ever since the creation of Article 54(5) EPC, many cases have hinged on the interpretation of this article, and the rules regarding how second medical use claims must be formulated. Article 54(5) EPC reads:
“Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.”
While much of the discussion around Article 54(5) has focused on what can be considered a “substance or composition” (e.g. T 1252/20), additional questions arise when considering the second half of Article 54(5). Specifically, how is “for any specific use in a method referred to in Article 53(c)” to be interpreted? In particular, are device features capable of imparting limitations on a claim formatted in accordance with Article 54(5), particularly when the device feature does not impact the medical treatment?
Appeal case T 2749/18 considers this topic. In this case, the claims were formatted as a second medical use claim, and the patentee attempted to rely on a device feature, the gauge of the needle, to limit the claim. The Opposition Division had decided that T 51/93 supports the use of the needle gauge as a limiting feature, and indeed considered the needle gauge to be the only distinguishing feature. T 51/93 states “The mode of administration may be a critical factor in a medical treatment, and no reason can be seen for any a priori bar to relying on this difference when distinguishing over the prior art”, and the Opposition Division considered that the needle gauge was part of the mode of administration, and therefore it was limiting on the claim.
The contrary position is that the needle gauge should not be considered limiting because the case law provides no basis for allowing a feature that does not impact the medical treatment to be limiting on a second medical use claim and that previous cases such as T 51/93 only provide for a feature to be limiting if it impacts the medical treatment, and do not provide blanket approval to use device features to characterise a medical use claim.
The Board dismissed the appeal, finding all claim requests to lack inventive step, without directly considering this issue. However, as noted in the minutes of the oral proceedings, the Chair of the Board noted that the Board had “doubts” that the needle gauge feature was limiting on the claim. Further, the Board had noted when considering this issue in their preliminary opinion that the application as filed did not disclose that the gauge of the needle “has any direct influence on the effect of the claimed GLP-1 agonist composition … other than the mere delivery of the drug”, indicating that the Board considered this to be potentially relevant to the question of whether the feature has a limiting effect.
Thus, although no final decision was reached on the matter, applicants may wish to exercise caution when seeking to limit a second medical use claim in this way. It will be interesting to see whether the written decision contains any further comments on this issue, watch this space!
