Over the coming decade, digital health devices are likely to transform our ability to monitor health, diagnose diseases and deliver healthcare to individuals. Digital health products are often best protected using a combination of IP rights, each covering different aspects of the product, Companies operating in this field therefore need to carefully consider their IP strategies. This article is the first in a series providing guidance on how to protect the IP in digital healthcare products. The focus of this article is patent protection.

What is digital health?

Digital health is a broad concept that describes the use of digital technologies for healthcare and related issues.

Emerging technologies in this field include both hardware and software solutions such as:

  • telemedicine – the distribution of health-related information via electronic and telecommunication technologies
  • wearable devices – smart devices worn by the user that detect, analyse and transmit health-related data
  • mobile health (or m-health) – the use of mobile communication devices, eg mobile phones to provide health and wellbeing monitoring and services including health and wellness behaviour modification tools
  • digitalised health record platforms
  • augmented reality technologies – the projection of digital information onto the real-life surroundings to assist in the diagnosis and treatment of disease, and to extend the skills of healthcare professionals
  • data analytics and intelligence including predictive modelling
  • bioinformatic tools
  • medical social media
  • patient-physician portals
  • imaging.

Patent protection for digital health products

What is a patent?

A patent is a territorial IP right that grants the inventor the right to stop others from making, using or selling the invention for a limited period in exchange for publishing an enabling disclosure of the invention. Patents can enable digital health companies to protect their core inventions and prevent competitors entering the space, as well as partner with other companies in sharing technology. They can also assist in fundraising efforts. However, in fast-moving areas of digital health such as app development, the benefits of patent protection need to be weighed up against the difficulty, length of time and costs involved in obtaining patent protection.

How can patent protection be obtained in the UK?

UK patent applications can be filed through the UK Intellectual Property Office (UKIPO), the European Patent Office (EPO) or via an international application under the Patent Cooperation Treaty (PCT) at the World Intellectual Property Office (WIPO).

Digital health companies may wish to conduct freedom-to-operate searches to determine whether their activities are likely to infringe any third-party patents. They may also consider conducting prior art searches to establish whether there are any existing publications relating to the same or similar inventions. This can assist in deciding whether to pursue patent applications.

What impact has Brexit had on patent protection in the UK?

Although the UK has left the EU, it is still a contracting state to the European Patent Convention (EPC), which is the international treaty instituting the EPO and the patent application process and which is not a treaty relating to the EU. The UK's departure from the EU has therefore had no impact on the patent application process in the UK or the validity of national and European patents in the UK.

What aspects of digital health products can patents be used to protect?

Digital health products will often encompass several distinct inventions, which may span different fields, for example a product may include apps, desktop applications (both types of software) and sensors (hardware). Patents can generally be used to protect inventions relating to the hardware and some inventions relating to the methods and protocols used in digital health products provided they meet the requirements for patentability (ie that they are new, involve an inventive step and are susceptible of industrial application). Although there are no new patentability requirements relating to digital health technologies, there are various exclusions and hurdles under UK and European patent law relating to both medical devices and software. Securing patent protection for digital health inventions at the interface of these disciplines can therefore present unique challenges.

Software exclusions

In the UK, neither mathematical methods, business methods nor programs for a computer are patentable pursuant to s1(2) of the Patents Act 1977. Likewise, under the EPC, neither computer programs, mathematical models nor business methods as such are patentable. However, despite these exclusions, both the UKIPO and EPO regularly grant patents for inventions that are either fully or partially implemented via computer software. The approaches taken to assess the patentability of such inventions is different, however there should be no significant difference in the result. Under the approach currently followed by the EPO, a claim directed to a computer program will not be excluded from patentability if it contains at least one feature with a technical character. A feature will be considered to have a "technical character" if it produces a "further technical effect" which is a technical effect going beyond the "normal" physical interactions between the program (software) and the computer hardware on which it is run. Examples of further technical effects include the control of a technical process; the internal functioning of the computer itself; or its interfaces. Claims directed to devices or methods implemented in a computer are therefore not excluded. The approach taken in the UK is broadly based on a four-step test set out in Aerotel v Telco and Macrossan’s Application, which was devised to assess whether the actual or alleged contribution of an invention is actually technical in nature.

It is worth noting that there are significant differences between the approach to patenting software-related inventions in Europe and the US, therefore digital health businesses applying for patents will need to take a carefully considered approach if they require protection in several jurisdictions. In particular, they need to think strategically about the requirements for patent protection in each jurisdiction. For example, as discussed, in Europe it is necessary to demonstrate that the software component of a digital health product has a technical effect, whilst in the US, a patent will not be granted if the claims relate to abstract ideas.

Medical exclusions

Methods of treatment of the human or animal body by surgery or therapy; and methods of diagnosis practised on the human or animal body are excluded from patent protection under both the Patents Act 1977 and the EPC, however, the EPC explicitly sets out that the exclusion does not apply to "products, in particular substances or compositions, for use in any of these methods" and in many cases patent protection is still available for devices developed for the diagnosis or treatment of disease. In particular, the device itself used to carry out the diagnosis or treatment may be patentable. Further, there may be aspects of the methods implemented by the device (such as those related to collection or processing of the data) that do not fall within the exclusions and are suitable for patenting. More difficulty may be encountered obtaining patents for pure methods of calculation or algorithms applied to measurements, which in themselves have no technical effect. For example, patenting an algorithm which estimates cardiovascular activity or oxygen consumption based on heart rate would fall within the exclusions.

The next article in this series will discuss how trade marks, registered designs and unregistered designs can be used to protect digital health products.