Protecting your Digital Medical Device and Software Inventions

In the rapidly advancing landscape of healthcare technology, digital medical devices and software have become integral in the diagnosis and treatment of disease, and in providing patient care. Obtaining patents is crucial for companies seeking to maintain a competitive edge and obtain investment. Patents not only foster innovation by encouraging investment in research and development but also play a pivotal role in shaping the future of healthcare.

What is patentable?

Patent applications in the healthcare space (including software-related inventions) must meet the same requirements as applications in all other fields of technology; that is, the invention must be new, inventive, and capable of industrial application.

It is important to remember that your patent application should be filed before the invention is disclosed to the public.

Some examples of potentially patentable subject matter include:

Medical Devices

  • Diagnostic devices, such as imaging equipment, biosensors, and monitoring devices.
  • Surgical instruments or robotic systems designed to improve medical procedures.
  • Smart wearable devices for health monitoring and data collection.

Medical Imaging and Analysis

  • Advanced medical imaging technologies, such as MRI, CT scans, and ultrasound devices.
  • Image processing algorithms for the enhancement or analysis of medical images.
  • Three-dimensional modelling and virtual reality applications for medical visualisation.

Prosthetics and Assistive Devices:

  • Prosthetic devices, orthopaedic implants, or assistive technologies for individuals with disabilities.
  • Adaptive technologies designed to enhance the quality of life for patients with chronic conditions.

If the medical device is an apparatus or piece of equipment, then the device itself can be protected. However, it is not possible to protect a method of using the device on a patient (a method of surgery or treatment practised on the human body) in at least the UK and Europe, although this is possible in the US and Australia, for example.

What should be considered when looking to protect software and AI-based technologies?

Firstly, it is important to remember that it is possible to patent software and AI-based inventions in the UK, Europe, US and many other key jurisdictions. It is a common misconception that it is not possible to patent such technologies, and whilst there are some additional considerations, we would recommend discussing any invention with your patent attorney to determine what could be protected.

A strong indicator of whether your software or AI-based technology could be patent-eligible is if it makes an impact on something outside of the processor. For example, the computer program may control an external system, such as a component of a manufacturing apparatus, or may function to enhance an image or scan.

Whilst the UK, European and US patent offices each follow a different approach to assessment of patent eligibility, they are all considering similar points in their assessment (e.g., what is the contribution beyond simply running a program on a computer?). Therefore, they should all reach the same conclusion.

If, following discussion with an IP professional, it is decided that patents are not the right approach to protect your technology, other forms of IP may be useful, including copyright and trade secrets.

How about training AI models?

Regarding inventions relating to methods of training AI, a recent landmark legal decision has made protecting such innovation in the UK more favourable to applicants. The situation is in-flux, but a good approach to protecting an AI invention in the healthcare space may therefore be to consider initially filing a UK patent application, and follow up with filings in other commercially important jurisdictions.

Appleyard Lees IP LLP has a number of patent attorneys who specialise in protecting medical devices and medical technology more broadly. Please contact [email protected] or [email protected] or visit https://www.appleyardlees.com to find out how we can help secure protection for your innovation.