[Software] Esmé Swindells Q&A: the future of medical software patenting

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Patenting a piece of software can be a pain. The UK Patents Act rules that ‘software as such’ cannot be patented unless certain criteria are met, while the European Patent Convention states that software can be patented only if it achieves a technical contribution to the ‘prior art’ – all of the publicly available information before a given date that might be relevant to the patent’s claims of originality.

Essentially, software as such is not patentable unless the developer can robustly demonstrate a technical effect associated with it. But what does this mean for medical software patenting? Medical Device Network catches up with Potter Clarkson senior associate patent attorney Esmé Swindells about the impact of the pandemic on medical software patenting, the difficulties with in silico data and why patenting is so important for digital health companies.

Chloe Kent: Why is medical software patenting so difficult?

Esmé Swindells: European practice is that you can’t necessarily patent software per se, it needs to have some kind of technical effect associated with it. In theory it shouldn’t be too difficult to patent your software in the medical field, as it’s not actually too difficult to find a technical effect associated with your software. I think the issue is typically with working out how to draft your claims, making sure you hit that technical aspect that’s required by patent officers.

CK: How can a digital health company ensure that its technology is patentable?

ES: Work very closely with patent attorneys. For some of our clients we’ll have quarterly meetings and we’ll run through all of their current portfolios to see where their projects are at, but also importantly talk through other research programmes. Obviously patent attorneys know the law better, so they’ll pick up on things that might be patentable, bits of data that sound interesting.

It’s a case of making sure, before you file your application, that you assess what the technical feature is and have data that supports this. It wouldn’t be enough in the application to just say ‘look, we’ve used this AI algorithm’, you need to demonstrate the medical technical effect.

Data is key for getting patents through in the medical field. Something that’s obviously come out of AI is the in silico data, where algorithms are used in the drug discovery phase to target a particular disease. At the moment it’s a fine line between when you file your patent application based on in silico data and when you’re going to get in vivo data. We typically say to applicants not to solely rely on in silico data, and we try and get in vivo data before filing the main application. If you’ve got in vivo data in your application, the patent is very likely to go through to grant, whereas in silico data is unlikely to hit the sufficiency requirements at the moment.