This series explores which inventions in the medical field can and cannot be patented in Europe. Part two below looks at surgical inventions.
- Part one of the series looks at diagnostic inventions
The European Patent Convention excludes from patentability “methods for treatment of the human or animal body by surgery”. 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 patent infringement.
While at first sight this exclusion appears to rule out obtaining any patent protection within the surgical field, with careful patent drafting many inventions within the field can still be protected.
Inventions can be broadly split into products (i.e. physical entities) and methods (i.e. activities). This brief guide aims to clarify which surgical products and methods can and cannot currently be patented in Europe.
What cannot be patented
As mentioned above, European patent law excludes from patentability “methods for treatment of the human or animal body by surgery”.
The European Patent Office (EPO) defines these as “substantial physical interventions on the body which require professional medical expertise to be carried out and which entail a substantial health risk even when carried out with the required professional care and expertise”.
All surgical methods are assessed on a case-by-case basis considering numerous factors including the level of medical expertise and training required, the associated health risk, the degree of invasiveness and the complexity of the procedure. The injection of a contrast agent into the heart, catheterisation and endoscopy are each listed by the EPO as procedures which are likely to be excluded from patentability on these grounds.
Surgical methods can be excluded from patentability regardless of the purpose of the procedure. For example, a surgical procedure performed for cosmetic purposes can still be excluded along with procedures performed for purely medical reasons.
Another factor which is ignored when determining whether a surgical procedure can be patented is whether it is performed manually or whether it involves any level of computer-assistance.
Finally, it is important to note that multi-step processes are still excluded from patentability if just one of the steps is deemed to be of a surgical nature.
What can be patented
Products for use in surgical methods
The exclusion of surgical methods does not apply to products intended for use in such methods. 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 surgical methods, e.g. an anaesthetic compound or a composition comprising an anaesthetic, can be patented in two primary ways. Firstly, if the substance or composition is novel, it can be patented without reference to its proposed surgical use which gives broader protection. However, even if the substance or composition is already known, it can still be patented by specifying a novel surgical use.
In contrast, other types of products used in surgery such as endoscopes, surgical instruments and robotic surgical systems, must be novel themselves regardless of their proposed use.
Minor interventions
As discussed above, surgical methods are assessed on a number of factors including the level of medical expertise and training required, the associated health risk, the degree of invasiveness and the complexity of the procedure.
It follows that more minor interventions on the body requiring less medical expertise and having a lower health risk can be patented whether these are of a medical or non-medical nature.
With regards to minor non-medical procedures, the EPO states that the exclusion does not apply to “invasive techniques of a routine character which are performed on uncritical body parts and generally carried out in a non-medical, commercial environment”. This includes tattooing, piercing, hair removal by optical radiation and micro-abrasion of the skin.
An example of a medical procedure which is considered sufficiently minor to be patentable is retraction of the gums around a tooth in order to take an impression for a dental crown.
Post-mortem methods
It is worth noting that the exclusion only applies to methods performed on living human and animal bodies. Methods for post-mortem organ extraction, for example, are therefore patentable.
Further Advice
Please get in touch with your Appleyard Lees contact, or contact us here, if you require any further advice about protecting your surgical inventions, or to discuss how we can help secure your intellectual property.
Bibliography
- Article 53(c) of the European Patent Convention
- Article 54(4) & (5) of the European Patent Convention
- EPO Guidelines for Examination G-II 4.2
- EPO Guidelines for Examination G-II 4.2.1
- EPO Guidelines for Examination G-II 4.2.1.1
