A brief guide to patenting diagnostic inventions in Europe
At first sight this exclusion appears to rule out obtaining any patent protection within the diagnostics field. However, with careful patent drafting many inventions within this field can still be protected.
The European Patent Convention excludes “diagnostic methods practised on the human or animal body” [1] from patent protection. The intention behind this exclusion is to leave medical and veterinary practitioners free to act in the best interests of their human or animal patients without fear of infringing granted patents.
Inventions can be broadly split into products (i.e. physical entities) and methods (i.e. activities). This brief guide aims to clarify which diagnostic products and methods can and cannot currently be patented in Europe.
What cannot be patented
As mentioned above, European patent law excludes from patentability “diagnostic methods practised on the human or animal body”. Methods only fall within this exclusion if they include at least the following four steps:
1. the collection of data,
2. the comparison of these data with standard values,
3. the finding of a significant deviation during the comparison, and
4. the attribution of the deviation to a particular clinical picture [2].
Furthermore, methods only fall within the exclusion if the collection of data step is practised on the human or animal body [2]. Direct physical contact with the body is not necessary as long as the presence of the body is required [2]. For example, a step involving imaging a body without physical contact would still fall within the exclusion. However, it is worth noting that this requirement relates to living bodies and so diagnostic methods which are performed post-mortem or in vitro are patentable [5].
The amount of medical or veterinary expertise required to perform a diagnostic method is irrelevant to this exclusion [2].
What can be patented?
Products for use in diagnostic methods
The exclusion of diagnostic methods does not apply to products intended for use in such methods [1]. There is, however, a distinction between the protection that can be obtained for substances and compositions as opposed to other types of products such as devices, instruments and computer programs.
Substances and compositions intended for use in diagnostic methods, e.g. an antibody for detecting a disease biomarker or a composition comprising such an antibody, can be patented in two primary ways. Firstly, if a substance or composition is novel, it can be patented per se without reference to a proposed diagnostic use.
Otherwise, if a substance or composition is already known, it can still be patented by specifying a novel diagnostic use [3-4].
In contrast, other types of products which may be used in diagnostic methods such as devices, instruments and computer programs, must be novel per se regardless of their proposed diagnostic use.
Methods of collecting and/or analysing data
As discussed above, methods only fall within the exclusion if they involve each of the steps from the collection of data up to the diagnosis of a particular clinical picture. It follows that methods which omit at least one of these steps are not excluded from patentability.
Methods of collecting and/or analysing data from a human or animal subject which do not directly enable a diagnosis are therefore patentable. Such methods can include medical imaging techniques and methods of measuring parameters such as blood pressure.
Methods which include a diagnosis step while omitting one or more of the earlier steps may still be excluded if those earlier steps are judged to be essential or implicit to the diagnosis [2].
Software and AI/machine learning algorithms for analysing patient data may also be patentable as long as the algorithm or machine learning contributes to the “technical character” of the invention.
In vitro testing
As discussed above, diagnostic methods are only excluded if the collection of data step is practised on the human or animal body.
This means that diagnostic methods involving in vitro testing of samples are eligible for patent protection [5]. For example, a diagnostic method involving detecting a biomarker in a blood sample can be patented.
Further advice
Please get in touch with your Appleyard Lees contact, or contact us here, if you require any further advice about protecting your diagnostic inventions, or to discuss how we can help secure your intellectual property.
References
1. Article 53(c) of the European Patent Convention
2. EPO Guidelines for Examination G-II 4.2.1.3
3. Article 54(4) & (5) of the European Patent Convention
4. EPO Guidelines for Examination G-II 4.2
5. EPO Guidelines for Examination G-II 4.2.1