T 1252/20 - Board of Appeal Revises Interpretation of 'Substance or Composition' for Medical Use Claims

Case Law | 22.05.2024

London partner Adam Lacy, and Italian and European Patent Attorney Arianna Bartolini review a recent decision of the EPO Board of Appeal making it easier for patentees to obtain protection for medical use claims.

T 1252/20 provides patentee-friendly guidance on the distinction between “substances and compositions” and “devices” in the context of medical use claims. This is highly relevant, since Articles 54(4)/(5) EPC suggest that it is only “substances and compositions” which qualify for protection as medical use claims.

G 05/83 explained that a "substance or composition" in Article 54 EPC should be understood to mean an "active agent" providing a therapeutic effect in a medicament. Previous decisions have interpreted G 05/83 to mean that only if the interaction with the body is of a chemical type can it be considered a substance or composition in accordance with Article 54(4)/(5) EPC. See e.g. T 1758/15 where a gel for which the only effect was given by the 3D structure once inside the body was considered a device and thus not a “substance or composition” according to Article 54(4)/(5) EPC. 
 
This existing practice has been overturned in T 1252/20, where the claim defined a peptide forming a hydrogel. Despite the patentee arguing that the chemical interaction between the molecules gave the 3D structure, the examining division concluded that the peptide had a physical mode of action and was thus a device, not a substance or composition. The Board reversed this decision, and at reason 9.2.3 did not consider G 05/83 to provide any legal basis for using the mode of action of a product as the relevant criterion for judging whether the product is a substance or composition: 

"if the substance itself is the key element in the therapeutic, surgical, or diagnostic method, the ratio decidendi of G 05/83 is applicable to such substances, irrespective of their mode of action.

Instead, the Board found the lack of any "device-like features" of the product, e.g., shape, as demonstrating that the product was not a device (reason 7). A product may therefore be considered a "substance or composition" in a medical use claim if the claim a) defines the chemical composition of the product and/or b) does not define device-like features of the product (e.g., shape). The peptide was defined by its chemical composition, in the form of its amino acid sequence, and was a shapeless liquid without any device-like features. It was considered to be entitled to protection as a medical use claim.
 
Patentees will welcome this decision as it removes the complex issue of the mechanism of action from the equation, making it easier to obtain medical use claims. 

retour