AI in Medical Devices: Patent Eligibility

AI is rapidly transforming the medical device industry, enabling smarter diagnostics, personalised treatment, and real-time intelligent health monitoring. From AI-powered imaging tools to predictive algorithms embedded in wearable devices, innovation is accelerating. UK patent law gives rise to unique challenges for protecting AI-driven medical inventions. This is particularly true when software and algorithms are involved.

In the UK, certain categories of inventions are excluded from patent protection, including “programs for a computer” and “mathematical methods.” However, these exclusions are not without qualification. When considering these exclusions, the Courts and the UKIPO apply the Aerotel test to determine, in essence, whether a software-based invention makes a ‘technical contribution’ to the art. For AI in medical devices, this means that the invention must go beyond abstract computation and demonstrate a real tangible technical effect. Simply processing patient data or making diagnostic recommendations may not be sufficient. To improve the prospects of patentability, it is important to integrate the AI into a system such that it improves performance, accuracy, or functionality in a measurable way. The following examples are inventions of the sort which may more easily be found to include the requisite ‘technical contribution’:

• Technology that enhances image resolution or processing in a diagnostic tool (e.g. MRI scans).
• Technology that controls hardware functions in robotic surgical systems.
• Inventions that optimise drug delivery mechanisms based on real-time physiological data.

UKIPO decisions from past few years show that there is a fine line between eligible and excluded subject matter and care must be taken when drafting a patent application to ensure that the invention is framed in such a way as to provide the necessary ‘technical contribution’. For example, a computer program that predicts disease progression based on patient data may be deemed unpatentable but where that program is embedded in a wearable monitoring device that can adjust treatments in real time, the wearable monitoring device may itself be patentable.

In light of the above, when seeking patent protection, inventors in the AI space would be wise to think carefully about how the AI interacts with hardware or improves a technical process. Further, it is sensible to avoid presenting the invention simply as a decision-support tool. Most importantly, it is vital to collaborate across legal and technical teams to craft claims which highlight the inventions real-world impact.

By taking these points into account, businesses can enhance the likelihood of securing patent protection for their AI-related inventions.  Indeed, it is notable that patents can and do get granted in this area all the time. For further information, please refer to section 2 (MedTech) of our 2023 AI Report.

Tom will be attending TechBio UK on 16 October 2025.