The European Patent Office (EPO) has long followed a specific and sometimes restrictive approach to protecting innovations in the medical field. In particular, obtaining patent protection for new uses of known materials in medical methods of treatment or surgery has historically presented challenges under European law. The scope for overcoming the statutory exclusions relating to medical methods has been narrow, often limiting patent rights in this area.
However, more recently, developments in EPO case law – notably decision T 1252/20 – suggest a more flexible interpretation may be emerging. This could provide expanded opportunities for innovators seeking patent protection for uses of medical materials, even where those materials are not entirely new.
The Scope of Patentability
Under the European Patent Convention (EPC), methods of treatment of the human or animal body by surgery or therapy, and diagnostic methods practiced on the human or animal body, are excluded from patentability (Art. 53(c) EPC). These exclusions are intended to ensure that medical practitioners can freely apply their skills without concerns about patent infringement.
Nevertheless, products – including “substances or compositions” that are for use in these excluded methods remain patentable, provided they meet the standard criteria of novelty, inventive step, and industrial applicability. Notably, the EPC provides two important carve-outs from the standard novelty requirement:
- A ‘first medical use’ exception, allowing patents for the first use of a known substance or composition in a medical method (Art. 54(4) EPC); and
- A ‘second medical use’ exception, allowing patents for new, or more specific use of known substances or compositions (Art. 54(5) EPC).
The interpretation of what constitutes a “substance or composition” has previously been defined quite narrowly. In particular, decisions T 2003/08 and then T 1758/15 confirmed a relatively restrictive definition of this term as products that act as the active agent or ingredient in the specific medical use and further required the mode of action demonstrated to be ascribed to the chemical properties of the substance or composition in question. This definition has posed difficulties for applicants whose inventions rely on mechanical or physical effects to provide a therapeutic effect rather than direct chemical interaction.
Broadening the scope: developments in the case law
The decision in T 1252/20 reflects a potential shift in the EPO's approach.
In that case, the application related to the use of a peptide solution for blocking blood vessels to treat tumours. The peptide solution in question formed a hydrogel under physiological conditions, forming a physical blockage in blood vessels to restrict blood flow to the tumour. The Examining Division refused the application, finding that the peptide solution did not qualify as a “substance or composition” under Art. 54(4) and (5) EPC, because the mode of action of the solution was primarily mechanical, rather than chemical. As the peptide solution itself was already known, the Examining division found that the particular use proposed by the applicant was not patentable.
On appeal, however, the Board of Appeal overturned the refusal. Importantly, the Board decided that the earlier requirement for a chemical mode of action did not have clear legal basis. Instead, the Board held that a product could be considered a “substance or composition” if it is claimed in a way that defines its chemical composition and does not exhibit “device-like features”, regardless of whether its therapeutic effect relies on chemical or mechanical properties, or a combination of the two.
However, the decision left intact the distinction between "substances or compositions" and medical devices. Uses of products that exhibit “device-like features” remain outside the scope of the medical use exceptions according to the new definition proposed by the Board. For example, a novel medical use for a surgical tool made from a particular known alloy, would not be protectable under the medical use exceptions.
Current position and outlook
The decision in T 1252/20 appears to broaden the category of products eligible for protection via medical use claims and expands the options available for protecting new uses of known medical materials. For example, the use of materials that can be defined chemically but rely partly or wholly on a non-chemical mode of action for providing a therapeutic effect, such as resorbable sutures, hydrogels, and bioengineered scaffolds might benefit from this more permissive interpretation, even where their mode of action is primarily mechanical.
However, important uncertainties remain. The exclusion of “device-like features” has yet to be tested in subsequent case law, with no Board of Appeals referring to this decision so far. Furthermore, the EPO’s own Guidelines for Examination continue to reflect the more restrictive position taken in T 1758/15. It therefore remains to be seen whether future Boards will endorse or refine the more expansive view provided by T 1252/20.
Nevertheless, in the meantime, the decision in T 1252/20 offers helpful arguments for applicants seeking to protect innovations in medical materials and perhaps represents a shift in the EPO’s attitude that will be welcomed by innovators in the Medical Materials space. Careful claim drafting, with an emphasis on defining products in chemical rather than structural terms, may be critical in taking advantage of this developing line of authority.
This piece was co-authored by Max Bertrand and Isobel Stone.
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Isobel Stone
Isobel is an accomplished UK and European patent attorney whose technical expertise spans a wide range of technical fields in the mechanical engineering and materials engineering spaces. Her work extends across the full IP lifecycle: she has extensive experience in original drafting and patent prosecution work, as well as a keen interest in opposition and other contentious matters.
Email: Isobel.Stone@mewburn.com
