Patents in the age of digital twins

For those new to the term, a “digital twin” is a virtual replica of a physical object. The potential use in healthcare is enormous. For example, a cardiovascular digital twin may provide a virtual model of a patient’s heart and blood-flow dynamics and this can be used to simulate how different treatments (e.g. stent placement) might perform before surgery is undertaken. As another example, an orthopaedic implant twin may provide a digital replica of a hip or knee implant, personalised to the patient’s anatomy, and can be used to predict wear, alignment issues, or the likelihood of implant failure over time.

Digital twins have been used in the engineering (aerospace in particular) industry for some time now; it is more cost effective to test a simulation than a multi-million-pound asset. The use of digital twins in the healthcare/medical sector is predicted to be a huge growth area (indeed, the market is already reportedly valued at over $4 billion) and with it comes questions of patent law and monopoly rights. 

The nature of technological developments concerning digital twins (and therefore opportunities for patenting) is vast. However, many developments do not map neatly onto conventional patentable subject matter. This presents the first hurdle – the need for a “technical contribution” for patentability.

In the UK, in order to be patentable, computer-implemented inventions must provide a technical effect beyond e.g. an abstract piece of software, mathematical model or algorithm. This topic is explored in a previous article; in essence it is important for patentees to draft claims in such a way that avoids the invention being viewed as a “mathematical method”, “presentation of information” or “computer program as such”, all of which are unpatentable under the Patents Act 1977. This can be achieved, for example, by providing a clear-real world technical use such as device calibration, implant control, or generating clinically actionable outputs.

Moving to the second hurdle - digital twins patents may be susceptible to sufficiency and plausibility attacks. For example, a claim covering “a patient-specific cardiovascular digital twin” may be vulnerable to insufficiency arguments if the specification does not enable how the model is initialised, what physiological parameters are required, how real-world data updates the simulation, and/or if it otherwise fails to disclose the invention clearly and completely enough for it to be performed by a skilled reader of the patent.  It follows that patentees should seek specialist advice to ensure a fully enabled patent specification. In relation to plausibility, if the twin claims e.g. to forecast deterioration, detect anomalies, or recommend interventions, given the current state of the technology, competitors may seek to challenge whether the patent makes this plausible, and if not whether the patent can be challenged on that basis.

A third potential hurdle is infringement. Digital twins often operate as distributed systems whereby wearables may collect data in the UK, processing may occur on cloud servers abroad, and clinicians may interpret outputs locally. Accordingly, there is the potential for questions as to where potential acts of infringement take place; there may be issues concerning acts being split between jurisdictions and therefore where any claim for infringement can be brought. Moreover, there are also likely to be questions about who performs the infringing act as a patient, a clinician, a hospital trust, and a device manufacturer and/or a processing company may all be involved. All of these points should ideally be considered at the drafting stage when patent claims can be adapted as much as possible align potential claims with the commercial realities of where infringing acts are likely to happen.

Finally, a fourth potential issue for digital twins is claim construction and interpreting terms such as “model”, “simulation”, “virtual representation”, and “configured to predict”. Terms such as these are likely to be heavily debated by Courts dealing with digital twin patents.

Digital twin technology presents a legally complex area for those involved with MedTech patents. This technology blurs the boundaries between mathematical methods, medical devices, AI systems, and clinical workflows. For those working in MedTech it will be necessary to have careful, technically grounded patent drafting and specialised legal advice for when disputes arise.