Neurotech patents in Europe: Part 1 - Methods, Medical Devices, and the EPC Exclusion

There are a number of challenges associated with patenting neurotech inventions. Whilst not unique to this technical field, they may be unfamiliar to those coming from an engineering background. Over the next few weeks, I will present a few brief articles discussing these challenges and offering my thoughts on solutions, or at least how the challenges can be mitigated.

To kick off, let’s consider the European prohibition against the patenting of methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body (EPC Article 53(c)). To those unfamiliar with patent laws, at first glance this seems pretty draconian. However, it is important to consider what is not covered by this exclusion, namely apparatus, systems including software, and software resulting in a technical effect. In the US, it is possible to patent methods of treatment. However, this series focuses on EU case law and patentability requirements.

While methods of surgery are not patentable, it is possible to patent features of a surgical tool which enable it to perform surgery or have a technical effect which is not related to treatment. It is also possible to patent a device which is suitable for implantation. As an example, it would be possible to patent a novel and inventive material which is biocompatible. It would also be possible to patent implants coated in that material, and a method of coating the implants. However, if a new surgical technique was required to successfully implant a coated device, it would not be possible to patent the surgical technique itself in Europe.

This exclusion is intended to ensure that medical professionals can freely choose the most appropriate method of treatment without threat of infringement proceedings. Assuming that a medical professional can procure a patented device, since it is not possible to patent a method of using the device, such use including surgical implantation cannot be an infringing act. It is important to note that it is not possible to circumvent this exclusion by claiming a method implemented by a computer or robot in place of a human, since Article 53(c) does not depend on the person carrying out the method.

In September 2024 Neuralink™ were granted a European patent for a method of configuring a robot to perform surgery. During prosecution, the European Examiner objected to the “method for robotic surgical implantation of an electrode” on the basis that it was a surgical method. Neuralink™ argued that the application related to preparing an insertion needle for surgery rather than the step of implanting the needle. However, it was eventually necessary to explicitly direct the claims to the configuration (rather than operation) of a robot to convince the European Examiner that the Article 53(c) exclusion did not apply.

It is possible to patent a method of operating a device if there is no functional link between the method and the effects produced on the body. One example from European case law is a flow measurement method for an implant which administers controlled volumes of drugs. The Board identified the technical contribution as relating to the miniaturisation of a system for detecting small volumes of liquid. The miniaturised system could be incorporated into the drug delivery device and used to check its operation. The method was not directed to treatment of the human body, but a method for determining whether a medical device was in working order.

A carefully constructed set of claims may enable applicants to protect methods of using their medical devices, but only where that use is not directly performed on the human body. However, a novel and inventive medical device is not, itself, subject to any exclusions. Applicants may wish to focus on protecting their devices for the most straightforward path to grant. In my next article I will explore the requirements and possible challenges associated with protecting the devices themselves.