Earlier this year, the European Patent Office (EPO) issued decision T 1252/20, which marks a significant departure from the existing European case law surrounding the patentability of known products for use in new methods of treatment by surgery or therapy and diagnostic methods.
In a welcome development for patentees, if this decision is followed then it will allow a much broader range of products to be eligible for medical-use patent protection in Europe.
In this article, we provide practice points for those seeking to obtain protection for known products in the medical field and highlight the key points to take away from T 1252/20.
Key points
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The new decision suggests that the EPO may allow medical use claims for any product that is capable of being defined as a substance or composition, regardless of its mechanism of action.
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This is a significant departure from established law where claims previously were only considered use-limited (as opposed to suitable for use) when a substance of composition provided its mechanism of action through chemical means (rather than by physical means).
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The product must, however, be a ‘substance or composition’; it is not possible to patent a new medical use of a known device.
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SPCs provide term extension to protect authorized medicinal products. T 1252/20 could allow a wider range of products to be eligible for SPC protection.
Practice points
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Include medical use claims for products that previously might have been considered medical devices when drafting – for more details on the appropriate format of these claims see our earlier article here.
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It remains to be seen whether this new decision will be followed in the future. Therefore, where possible, the product should still be described in the patent application as delivering its mechanism of action by chemical means.
Patenting medical uses in Europe
In Europe, methods for treatment by surgery or therapy and diagnostic methods practised on the human or animal body are excluded from patentability (Article 53(c) EPC). However, this exclusion does not apply to ‘substances or compositions’ for use in such methods.
The interpretation of a ‘substance or composition’ in Articles 54(4) and (5) EPC has been thoroughly debated over the years.
In T 2003/08, the opposed patent was directed to the “use of a specific ligand for human immunoglobulin in the manufacture of a column having said ligand coupled thereto for the treatment of a patient suffering from dilated cardiomyopathy”. The Board in T 2003/08 introduced the following criteria for determining whether a product qualifies as a ‘substance or composition’ – the product must be an “active agent” in the method and the following must be determined:
“(a) the means by which the therapeutic effect is achieved” and
“(b) whether that which achieves the therapeutic effect is a chemical entity or composition of chemical entities”.
The ligand in T 2003/08 was considered to be a chemical entity responsible for the therapeutic effect and therefore was found to be a ‘substance or composition’ within the meaning of Articles 54(4) and (5) EPC.
The criteria of T 2003/08 were applied in T 1758/15 and the Board in this case considered the product in question – a biological filler material injected into the body to create a 3D structure for spacing apart two tissues – to qualify as a device rather than a ‘substance or composition’, because the therapeutic effect was a result of the physical action of the biological filler. A similar approach was taken in T 2136/15, where the product in this application did not meet the criteria to qualify as a ‘substance or composition’ because it comprised a liquid that was injected into the heart to create 3D structures and it was the shape of these 3D structures, as opposed to the chemical composition of the initial liquid being injected, that brought about the therapeutic effect.
The application in T 0264/17 related to a known lubricant (consisting of at least one perfluoropolyether) for use as a synovial fluid replacement for a diseased natural joint of a human or animal body. The application was refused by the Examining Division because the perfluorinated polyethers were considered not to act by pharmacological, immunological and/or metabolic means, but exclusively by physical mechanisms. The Board disagreed and held that the lubricating effect of perfluoropolyethers is based on their omniphobic properties, i.e. on the fact that they are repellent to both hydrophobic and hydrophilic liquids and that these material properties are caused by the chemical structure of the polyethers. Therefore, the lubricants were regarded as a ‘substance or composition’ under Article 54(5) EPC and the application was allowed.
In summary, the earlier case law suggested that for something to qualify as a ‘substance or composition’ within the meaning of Articles 54(4) and (5) EPC, it must have a chemical mechanism of action rather than a physical one.
What is the new approach for defining a ‘substance or composition’?
Claim 1 of the application in question in T 1252/20 related to a “composition for use in reducing or eliminating cancerous cells in a subject by forming at least a partial blockage, lodging, occlusion or embolism in a blood vessel to deprive a tumor in the subject of blood supply, or in the treatment of patent ductus arteriosus (PDA) or major aortopulmonary collateral artery (MAPCA) in a subject…”, where the composition comprised “a solution comprising an amphiphilic peptide”, which was defined by its amino acid sequence.
Whilst the claimed peptide solution forms a hydrogel which performs its function based on its 3D structure by physically blocking a blood vessel, the Board adopted an entirely different approach to the Examining Division (who found claim 1 to lack novelty in line with T 1758/15) and considered that claim 1 defines a material in a liquid state and does not define the material by any technical features which would be characteristic for a device, e. g. its shape. While the peptide solution will, once used as defined in the present claim, transform itself into something which may act as if it were a device, the Board saw no good reason to consider the peptide solution before administration as a device.
Of particular note, the Board went further and argued that there is no legal basis (e.g. in G 5/83) for using the mode of action of a material as a criterion for qualifying that a material is a ‘substance or composition’ under Article 54(5) EPC. The Board also identified potential problems that could arise from using the mode of action in this way, namely that:
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it is not always the administered product that carries out the mode of action / brings about the therapeutic effect, for example in the case of prodrugs,
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a product may have an unknown mode of action or may have a different mode of action when in different environments,
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the legislative purpose of Articles 54(4) and (5) EPC was not to restrict but rather facilitate the patenting of inventions which are commercially desirable but would otherwise be excluded from patentability.
The Board held that it is not justified to apply the criteria from T 2003/08 to cases where the “substance-or-composition-like nature” of a product is “immediately apparent”, but acknowledged that these criteria can still be useful in cases that are “not straightforward”.
T 1252/20 will be a very welcome decision for those seeking protection for medical use claims in previously borderline cases. Whilst it remains to be seen whether this decision is followed, it would provide a more lenient and sensible approach than has previously been adopted when assessing whether a product falls within the definition of a ‘substance or composition’ in the context of Articles 54(4) and (5) EPC.
Get in touch
If you have any questions or would like to discuss the potential impact on your cases, please contact Jessica Smart, Annalise Hamblin, or your usual Kilburn & Strode advisor.