What is the best practice for obtaining patent protection for functionally defined medical devices before the European Patent Office?<\/p>\n
The European Patent Office is responsible for granting European patent rights in respect of a multitude of inventions, including medical devices. Generally, a European patent cannot be granted in respect of methods of treatment of the human or animal body, either by surgery or therapy [1]. However, the law stipulates that this exception to patentability does not apply to products, particularly substances or compositions, for use in such methods [2]. The function of this patentability exclusion is to provide medical and veterinary practitioners the freedom to use the best available treatments without being inhibited by a worry that such a treatment might be covered by a patent [3].<\/p>\n
A recent decision of the Board of Appeal [4] has cast doubt on how this exclusion is applied in practice. In this case, the patent under review related to a device for desynchronising neuronal brain activity. The patent included a single independent claim, specifically directed to a device for the treatment of Parkinson\u2019s disease, essential tremor, dystonia, or the like. This group of neurological conditions is characterised by an undesirable synchronisation of activity in two neural subpopulations in the brain. In order to treat such conditions, the device included two electrodes and a controller, the controller arranged to control the electrodes to stimulate the subpopulations of so as to desynchronise them. In essence, independent claim 1 of the patent functionally defined that the device includes a controller to emit a stimulus to the brain via electrodes, thereby causing activity in the brain to desynchronise between two subregions.<\/p>\n
An opposition was subsequently filed after grant, which was initially dismissed by the European Patent Office, a decision which was appealed by the Opponent. In the appeal proceedings, the Board of Appeal reviewed the decision and decided that the device, despite being novel, was excluded from patentability as a method of treatment by surgery. The patent was revoked.<\/p>\n
In discussing their decision, the Board noted that \u201cthe claimed device was inevitably implanted by a non-patentable surgical step, otherwise the distinguishing feature [i.e. the control means for emitting stimuli via the electrodes] would not be able to be implemented\u201d. As such, since implantation into the brain represents a method of treatment by surgery, the subject-matter was considered as excluded.<\/p>\n
The decision is interesting in that it suggests that a functionally defined device, which requires a surgical step to implement its function within the body, is excluded from patentability, despite not relating to a method per se. Interestingly, this appears contrary to the established view in the \u201cCase Law of the Boards of Appeal\u201d text [5], which notes that \u201cThe fact that some features of the claimed apparatus were functionally defined in relation to the body of the patient did not, in itself, transform the apparatus claim into a method claim<\/em>\u201d.<\/p>\n However, whilst this case does cause some uncertainty, there are steps that can be taken to avoid such objections, or at least provide possible solutions, from the outset.<\/p>\n In summary, the above decision brings some uncertainty in this particular area of European patent law. However, it serves as a useful reminder to include both functional and structural \u201cclaim-like\u201d statements in the application as filed, in order to provide suitable auxiliary positions in prosecution and opposition proceedings whilst avoiding unnecessary limitations in the claims.<\/p>\n <\/p>\n\n
Final comments<\/h4>\n