As outlined in our article of November 25, 2015, EPO on device for medical use claims, novelty of a known substance or composition for a new medical use is exceptionally governed by Article 54(5) EPC and said exception does not extend to “medical devices”. A skilled person has no problem to understand that, for example, sildenafil sold under the “Viagra” trademark is a substance or composition and that a scalpel is a medical device, but there is also a lot of between that is questionable.

For example, according to the EPO’s Guidelines for Examination part G, chapter VI, item 6.1.1 under the heading “Products that may be claimed for a further medical use”, only a product that interacts chemically with the body qualifies as a “substance or composition”, and e.g. injected filler material mechanically shielding tissue from radiation is qualified as a “medical device” rather than a “substance or composition”.

The latter filler material example of a “medical device” from said EPO Guidelines is somewhat like that refused by the Examining Division in the European patent application EP 2 919 826, claiming a peptide solution which, when injected into a blood vessel, forms a hydrogel, and thereby blocks the blood supply to a tumour in a subject.  Referring to said EPO Guidelines, the Examining Division found that said peptide hydrogel used for embolization of blood vessels was merely a “device” and thus not novel, as the peptide solution and the hydrogel were already known from the cited prior art D1 and D2.

In subsequent appeal decision T 1251/20 of February 6, 2024, the Board of Appeal departed from said EPO Guidelines and relevant case law, including decision T 1758/15, to which said EPO Guidelines explicitly refer, by pointing out that there is no legal basis for using the (chemical) mode of action as the relevant criterion for judging whether it is a device or substance/composition, as the mechanism of action may not even be understood and the relevant novelty exception in Article 54(5) EPC does not even presuppose such an understanding.

Instead, the Board of Appeal considered that the lack of any “device-like features”, e.g. shape in case of a shapeless liquid peptide solution for administration, as in the present case, demonstrates that the product in question is not a medical device and can therefore be considered as a “substance or composition”. Therefore, the medical use claim for the peptide solution was considered as a true medical use claim and consequently found to be novel in view of the cited prior art D1 and D2 already disclosing said peptide solution and hydrogel as such.

In other words: shape matters.