Broader definition of “substance or composition” in medical use claims
Before the European Patent Office, an invention shall be considered to be new if it does not form part of the state of the art. Articles 54(4) and (5) EPC define a novelty exception for substances or compositions that are already part of the state of the art. Substances or compositions may still be considered novel if claimed for use in a method for treatment by surgery or therapy or in vivo diagnosis: “Substance or composition X for use in surgery/therapy/in vivo diagnostics or as a medicament” or for any second or further use in these methods: “Substance or composition X for use in treating disease Y”
The novelty exception can only be invoked for substances or compositions but not for other products such as medical devices. Problems may arise for materials and products for which it is not always clear whether they qualify as a “substance or composition” in the context of a medical use claim or as a device. This applies for instance to organic nanoparticles, liposomes, quantum dots, polymeric crosslinkable biomaterials, dental fillings, cements, gels, etc.
Given the importance of the distinction between a substance or composition versus other products, the key question is how the European Patent Office looks at the interpretation of “substance or composition” in a medical use claim.
Based on Case Law, a product is said to qualify as a “substance or composition” if the product is the active agent or ingredient in the specific medical use and if the therapeutic effect can be ascribed to its chemical properties (G5/83, T2003/08, and T1758/15, GL EPO, Part G, VI, 6.1.1). A detailed overview of Case Law is provided here.
As an example, reference is made to a filler material which is injected between a first tissue targeted for radiation treatment and a second sensitive tissue which is desired to be protected from radiation. If the shielding effect of the filler material is achieved by a mere mechanical displacement of the sensitive tissue relative to the target tissue, e.g. due to the volume it occupies between the two tissues, the filler material qualifies as a “device” rather than a “substance or composition”. On the other hand, if the filler material produced a radiation-reducing effect on the sensitive tissue which could be attributed to its chemical properties, it would be considered as a “substance or composition” in the context of a medical use claim. The example shows that the same material may or may not be seen as a “substance or composition” for use in a medical method depending on its mode of action, namely how the material exerts its medical effect.
Technical Board of Appeal decision T 1252/20 relates to a decision of the Examining Division to refuse a European patent application (EP 2919826). Claim 1 of the application relates to a composition for use in reducing or eliminating cancerous cells in a subject by forming at least a partial blockage, … in a blood vessel to deprive a tumor in the subject of blood supply. The composition is defined as a peptide forming a hydrogel under physiological conditions, wherein the peptide has a defined amino acid sequence and concentration.
The Examining Division was of the view that the peptide solutions defined in the claim did not qualify as a “substance or composition” in the sense of Article 54(5) EPC since the effects were only due to the (macro)structure formed by the self-assembly process of the peptide. Thus, according to the Examining Division, the peptide did not qualify as a substance or composition but as a device. As such, the claim was considered as not including the intended medical use as a limiting feature and thus found to lack novelty over the prior art.
The applicant, in its statement setting out its grounds of appeal, brought forward various arguments emphasizing the chemical nature of the peptide solutions defined in the claims. While the Board considered at least some of the arguments to have merit, the Board found that the peptide solutions should be considered a “substance or composition” in the context of medical use claims for more fundamental reasons. According to the Board, there is no legal basis for the mode of action as a criterion for qualifying a material or object as a substance or composition under Article 54(5) EPC.
The Board further found the criterion of mode of action problematic for several reasons. First of all, the material acting inside the body may not be the same as the material the claim is directed to. Secondly, the mechanism of action may not be understood in detail or may later turn out to be wrong. Thirdly, a material may behave in different ways according to its mode of administration. Finally, the criterion based on the mode of action does not achieve the legislative purpose, namely to provide at least a complementary form of protection for an otherwise recognisably useful invention.
In T1252/20, the board decided on whether a product may be considered a “substance or composition” in a medical use claim on the basis of the claimed material or object as such. The Board expressed that a product may be considered a “substance or composition” in a second medical use claim if the claim defines the chemical composition of the product and/or does not define device-like features of the product such as its shape.
The Board further made clear that this interpretation based on the material or object as such did not apply to medical devices such as a pacemaker or surgical scalpel.
We welcome the Technical Board of Appeal decision T 1252/20 which provides hope for applicants seeking to protect material-related medical inventions defined by their use before the European Patent Office. The decision however deviates from existing case law on this topic. Hence, it remains to be seen how this decision will be considered by Examining and Opposition Divisions, as well as other Technical Boards of Appeal.
Our experienced team of European patent attorneys at De Clercq & Partners can assist you to select the most suitable ways to protect your inventions in the medical field. Please reach out to us at info@dcp-ip.com.