Medical technology, referred to as MedTech, is a sector which relates to the application of technology towards improvements in human health and quality of life. It is a very broad term, covering simple products such as wound dressings, glasses, or walking aids, but also goes as far as covering hi-tech software-driven services and products, pharmaceuticals, and in vivo implants.
Innovators in the MedTech sector can therefore find it difficult to obtain good guidance about how to approach an IP strategy for their business. There are, however, some guiding principles which can be followed.
As with any business, establishing commercial priorities for IP for a MedTech start-up will be crucial to long-term growth. In an industry with lots of big players with deep pockets, it is essential to build up a robust IP portfolio early on. Without IP, the ability to licence innovative technology becomes undermined.
In an R&D-driven industry, patents can be vital to securing inward investment and commercial partnerships. This means that you need to put in place good systems for ensuring that patentable material is assessed. Protocols should be put in place for:
- Invention capture – ensuring that R&D staff are recording crucial developments for posterity;
- Invention review – determining whether new ideas are worth protecting via a patent application – usually in conjunction with a patent attorney; and
- Confidentiality – ensuring that there is no rush to publicise new ideas before the invention review stage has been completed.
With regards to trade marks, almost every business will want to register their company name or trading style; it’s just good commercial sense. You want to be able to keep your goodwill yours.
Whether product names should be protected via trade mark registrations may be more dependent on the business strategy. If a MedTech firm is looking to licence their technology out, it may be more likely that a business partner will want to apply their own branding, making a large trade mark portfolio less valuable. On the other hand, medical device businesses, manufacturing and/or selling products in a market, will want to ensure that their brand names are locked into place with prompt trade mark registrations. Similar logic applies to design registrations. These will be more powerful for medical device companies where direct plagiarism of the appearance of products will occur, more so than for businesses following a licencing-based approach.
MedTech filings at the EPO over the past decade – based on EPO annual reports. MedTech has significantly increased in patent application filing volume over this period.
Since the MedTech industry provides fertile ground for innovations, patent protection would seem to be the obvious way forward. However, there are lots of excluded subject-matter issues that must be navigated:
- Diagnostic/surgical/therapeutic methods – the purpose of the patent system is to provide a time-limited monopoly for innovative concepts as a reward for the effort put in to R&D. That said, it is not intended to actively impede the actions of a physician, and therefore methods of providing care to a patient, in whatever form, are largely excluded from patentability.
- No such restrictions apply to the devices, systems, or apparatuses which are used to perform the methods. In other words, you can protect a diagnostic tool, but not the overarching method of diagnosis.
- Computer programs – the increased use of digital technology, and particularly machine learning and artificial intelligence, in the MedTech sector, offers lots of potential improvements to the patient experience. However, a computer program alone is excluded from patentability. This is just deemed not to be an invention due to a lack of technical character; a computer program is just series of instructions for a computer to follow after all.
- That is not to say computer-implemented inventions are not protectable. It just needs to be demonstrated that the steps being performed by the computer are themselves novel and inventive, and have a tangible technical output in the real world.
- Presentation of information – one of the goals of MedTech is to improve the patient experience. Sometimes, this may involve presenting information to a patient in a different, more accessible manner. This is not technical in nature, and therefore non-patentable.
- By-and-large, presentations of information would be protectable under design or copyright law, so a patent is probably not appropriate unless there was an additional technical step associated with the presentation of information.
Overall, there are seemingly lots of obstacles in the way for the protection of MedTech concepts, but with careful characterisation of the inventive concepts which are realised, this does not mean that patent protection is out of reach.
MedTech filings at the EPO in 2021 by territorial origin – based on EPO annual reports. Unsurprisingly, the US is the ‘big beast’ in this sector, more than ten times the size of the UK’s output.
Even where protectable innovations exist, the intertwined nature of the MedTech sector often means that there are thorny entitlement issues to resolve. For MedTech innovators, there are a few specific issues which should be reviewed:
- University/Hospital links – medics are often prime innovators in the MedTech sector. However, often clinicians will have contracts in place with their place of employment, often academic institutes or medical research bodies. There may well be contractual requirements or provisions within grant funding agreements which require intellectual property to be assigned away from the inventor. Any prior agreements should be reviewed to ensure that there are no contractual breaches in applying for registered intellectual property.
- External contractors – it is relatively common for medical devices to be designed in tandem with private enterprise, such as product designers, who might work in conjunction with a clinical lead. The chain of entitlement for patent rights generates from the inventor, potentially to their employer, but does not necessarily result in rights being assigned to a commissioning party. This is a major point to be aware of for MedTech innovators working with contractors.
- Confidential data – patient data may well be used in the development of many types of MedTech product and service. Making sure that there are agreements in place to ensure that data is used in a compliant manner from a data protection perspective is critical, but so is the need to make sure that any crucial intellectual property rights in the data, particularly database rights, are held in the business in a manner which will not undermine future activities.
Ongoing IP Strategy
For many MedTech innovators, the world of intellectual property might seem to be a minefield. However, many of the main principles of IP protection apply regardless of what sector you are working in. Having a workable IP strategy in place, early on in the development cycle, will ensure that you have long-lived and valuable rights which can get a business off to a flying start.
- Record potential inventions for review.
- Keep critical information confidential prior to patent filing.
- Determine how best to work around excluded subject-matter provisions in the MedTech sector.
- Check any ownership minefields for your ideas.