Intellectual property of software in medical devices and what you can do to protect it

Innovations in medical devices are increasingly software-based. Software might run on the device itself, on an associated app, or ‘in the cloud’. But what are the best ways to protect such innovations?

This article was first published on Health Tech World.

A patent is often regarded as the ‘gold standard’ of protection. A granted patent can, for up to 20 years, provide strong protection against others wishing to exploit your invention, whether through copying or independent creation. By potentially excluding competitors, or licensing in exchange for royalties or access to other technologies, patents have the potential to add significant value to your business.

However, while granted patents can exclude others from using your invention, actually detecting infringement (and subsequently proving it) may not be straightforward, particularly with software-based inventions. Obtaining patent protection can also involve considerable expense, and there is of course no guarantee that a patent application will actually be granted.

The difficulties involved with patenting software inventions are somewhat notorious, but they are often exaggerated. It is certainly possible to patent a software invention, provided that it is shown to solve a technical problem in a technical way. The patent then protects the function of the software, i.e. what the software does, rather than the specific code itself. A patent attorney can help to draw out the technical features of your invention in order to improve the prospects for grant, but the patenting process for software inventions can still be unpredictable.

Trade secrets provide an alternative form of protection, which in some ways and for some inventions may be preferable to patents. First, trade secrets can protect subject-matter that it might not be possible to protect using patents. For example, so-called business methods or purely mathematical methods may be deemed to be excluded from patentability. Therefore, some software-based inventions which might have a relatively low chance of successfully being patented could be kept instead as a trade secret. Trade secrets may also be useful to protect software-based innovations for which infringement of a patent would not be easily detectable. Additionally, trade secrets have the potential to last forever, provided the secrecy is successfully maintained, whereas patents have a limited lifespan.

Unlike patents, which require filing, examination and registration, trade secrets exist automatically provided the relevant conditions (set out below) are met. Since there is no registration process, costs can be substantially lower than for patents, and timescales shorter. Trade secrets can thus provide a level of immediacy and flexibility that may be difficult to achieve with patents. However, unlike patents, trade secrets do not protect against competitors arriving at the invention independently or by reverse-engineering your commercially available product. If a competitor does manage to arrive at the invention, there is a risk that they might then try to patent it, and if they are successful this could severely impact your activities.

In the UK and many other countries, a trade secret is defined as information which (i) is secret, (ii) has commercial value because it is secret, and (iii) has been subject to reasonable steps to keep it secret by the person in control of the information. What constitutes ‘reasonable steps’ for software-based trade secrets is not certain under current case law, but might include: internal document security measures (including both physical and cyber security), limiting access to sensitive information, educating employees regarding trade secret issues, using appropriate confidentiality labels, and watermarking or metadata on sensitive documents. It is also important to properly document the measures that have been taken to ensure secrecy. If you cannot show that ‘reasonable steps’ were taken to keep the information secret, then your trade secret may be effectively unenforceable. Of course, once a secret is out, it is no longer a secret. Since any information breach can be fatal, the information (and access to it) must be managed carefully.

When deciding between patents and trade secrets for your software inventions, you should discuss the following questions with a patent attorney. How valuable is the invention to you? Is it worth the expense of seeking patent protection? How valuable might the invention be to third parties, such as your competitors or potential licensees or investors? Is a patent application likely to get granted in the territories that are important to you? If so, will the likely scope of protection of the patent be commercially useful? Would infringement of the patented invention be easily detected? How easy would it be to arrive at the invention by reverse-engineering the commercial product? Do you have the internal processes and infrastructure in place to maintain secrecy?

An optimal strategy may be to combine patents with trade secrets (and possibly other forms of IP). Patents can be used to protect your most valuable technical innovations and functionality, whilst trade secrets protect the more specific (and perhaps less patentable) algorithms that you use to realise your ideas.

We are a European firm and assist our clients to protect their IP rights in the UK, Europe and worldwide from our offices in the UK and The Netherlands and through our international network of trusted local attorneys. We enjoy looking after your ideas so you are free to do what matters most to you.