Earlier this month, the European technical board of appeal published their decision on T1252/20. The decision tackled the question of “whether a material or object is a substance or composition or a device” in the context of second medical use claims.

What are second medical use claims?

Second medical use claims allow a substance or composition, which is already known for one medical use, to be patented for a use in a therapeutic, surgical or diagnostic method practised on the human or animal body, provided that the new use is novel and inventive. It is important to note that Article 54(4) and 54(5) EPC specifies that this novelty exception may only be used for a “substance or composition” and not a “device”.

T1252/20: 3-D Matrix Ltd’s patent application

In this case, the applicant, 3-D Matrix, Ltd., filed a patent wherein claim 1 was a second medical use. Claim 1 defined a composition for use in the treatment of various diseases wherein the composition forms at least a partial blockage in a blood vessel, such as a blood vessel connected to a tumour, and wherein the composition comprised “a solution comprising an amphiphilic peptide in an effective amount and in an effective concentration to form a hydrogel under physiological conditions…”.

The composition was known in the prior art. The applicant was therefore relying on the new use of this composition for novelty.

During prosecution of the patent application, the examining division deemed that the peptide solutions defined in claim 1 did not qualify as “substance or composition” in the sense of Article 54(5) EPC because their mode of action was purely mechanical and not chemical. The examining division argued that the composition formed a hydrogel which formed a physical blockage in the patient’s blood vessels. The examining division therefore deemed that the peptide solutions had to be considered a device and since the alleged “device” was known from the prior art and was suitable for the method defined in the claim, the claim was deemed to lack novelty.

There are a number of previous cases which have deemed products which would be typically seen as substances or compositions, such as collagen fillers, alginates or bone glue, to not actually be “substances or compositions” in the sense of Article 54(5) EPC since once they were inside the body they acted as a device. The examining division referenced this case law and stated that the therapeutic effect of the composition was based exclusively on the macroscopic 3D-structure formed by a composition once inside the body.

Appeal: a substance or composition vs a device

The applicant appealed the decision and stated that the chemical nature of the peptide solutions defined in the claims produced a hydrogel with better adhesion once assembled inside the body of the patient. The board of appeals acknowledged this argument and stated that it was actually much simpler than that. The board of appeal stated:

“The subject-matter to be protected is defined by the claims in terms of technical features of the invention… the independent claim defines a material in a liquid state… The claim does not define the material by any technical features which would be characteristic for a device, e.g. its shape…. thus, the material defined in the claim is evidently a “substance or composition”. It is a shapeless liquid mixture of chemical entities and, already for this reason alone, it is not a device.”

Whilst it was agreed that the peptide solution may form something which may be considered a device in use, the peptide solution before its actual use is not a device.

The board of appeal went on to say that there is no legal basis for defining a material as a substance or composition or alternatively a device by its mode of action. The decision of whether the composition was a device, or device-like, could therefore not be based on its physical interaction with the body, instead of a chemical interaction. More importantly, the claimed composition may behave differently to the material within the body, as is the case here; therefore, the mode of action should not determine whether the material of the claim is a substance/composition or a device.

In summary, the board confirmed that a material or an object as claimed, and not the mode of action, should be the basis of the question of whether the material is a substance or a composition or alternatively a device. If you have any questions about this decision please contact one of our attorneys.