PATENTS | Board of Appeal on the definition of “substance or composition” under Articles 54(4)(5) EPC

In its decision (“Decision”) in the appeal case T 1252/20 (“Case”), the EPO’s Board of Appeal (“BA”) addresses the issue of the definition of “substance or composition” in second medical use claims. The appeal stems from the decision of the EPO’s Examining Division (“ED”) to reject a patent application claiming assembling peptides used in the treatment of various diseases due to the lack of novelty since the peptide solutions defined in the claim did not qualify as a “substance or composition” under Article 54(4) (5) of the EPC. Indeed, established EPO case law states that if a therapeutic effect is based exclusively on the macroscopic 3D-structure formed by a composition once inside the body, such a composition should not be considered a “substance or composition” but rather a device. In its Decision the BA found that the current interpretation lacks legal basis, providing that a product may be defined as a “substance or composition” “on the basis of the claimed material or object as such”. Moreover, it highlighted that “if this analysis leads to the conclusion that indeed a substance or composition is present, this requirement (…) is fulfilled”. According to the BA, this requirement was satisfied in the case at hand and therefore, it remitted the Case to the ED for further prosecution.

Newsletter n. 94 – March 2024