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 providing guidance on how to protect the IP in (digital) healthcare products, focusing – as a first step - on trade marks.
What is a trade mark?
A trade mark is a sign that distinguishes the goods and/or services of one undertaking from those of others. Most trade marks consist of names (such as company, trading, brand and product/service names) or logos. However, it is also possible to protect other distinguishing features of products and/or services such as shapes, colours, patterns, sounds and motions. The owner of a validly registered trade mark has the right to prevent others using identical or similar signs in trade if certain conditions are met. Ideally, key trade marks should be protected by registration since this gives the owner a greater scope of protection. Without such protection, it might not be possible to stop others from using a conflicting mark.
Brand loyalty can be built through connection with a name that becomes trusted and registration of that name gives the trade mark owner rights to prevent others from 'piggybacking' on their brand loyalty.
How can trade mark protection be obtained?
Registered trade mark protection can be obtained on a country-by-country basis, e.g. in Germany by filing an application at the German Patent and Trademark Office (Deutsches Patent- und Markenamt DPMA). It is also possible to obtain protection for the whole of the EU by applying for an EU trade mark (EUTM) at the European Union Intellectual Property Office (EUIPO). A benefit of the EUTM is that it can give indefinite protection in all 27 EU Member States without having to use the mark in all of them. It is also cheaper than filing on a country-by-country basis in each EU member state. As UK is no longer member of the EU, trade mark protection must be obtained by filing an application at the UK Intellectual Property Office (UKIPO). If registered protection is required in several countries/regions worldwide, it can be more cost-effective and easier to file an international application through the World Intellectual Property Organization (WIPO) - sometimes called a Madrid filing - as opposed to filing separately in each country/region.
Trade marks are registered for specific goods and/or services split into classes. Medical devices would most likely be registered in class 10 (a.o. “surgical, medical, dental and veterinary apparatus and instruments”), some are covered by class 5 (medical preparations and articles), digital health products and services in class 9 (a.o. “apparatus and instruments for recording, transmitting, reproducing or processing sound, images or data”), class 41 (“education; providing of training; entertainment; sporting and cultural activities) and/or class 42 (“scientific and technological services and research and design relating thereto; industrial analysis and industrial research services; design and development of computer hardware and software”). It is important to get the application right as a registration in one area of use will not necessarily protect against third party use in other areas. Registration of a trade mark can potentially last indefinitely, provided the mark is put to use and the registration is renewed.
The registration of a trade mark can be challenged or refused on the basis of a number of grounds, for example that the mark is not distinctive enough or there is a conflicting prior right. It is often possible to overcome any objection with careful argument. It is therefore important to check (preferably before launch) the availability of a trade mark in all markets where the product will be distributed. Otherwise, there is a risk that the mark will infringe someone else's rights and the brand owner for the medical device or digital health product may need to re-brand (potentially globally) because of an issue in one country or territory.
What considerations are there when filing trade marks for medical devices or digital health products?
In addition to word and logo trade marks, digital health companies may seek protection for so-called non-traditional marks such as shape, colour, pattern, sound or motion marks. If, for example, a wearable device has a unique shape or colour, consumers may see this as an indication of the origin of the product – a role more commonly associated with logos or words. Non-traditional trade marks can be powerful rights because they can deter competitors from using similar shapes or colours. Since a trade mark registration can potentially last indefinitely, the advantages of obtaining this kind of protection for digital health products are obvious. The same applies for (non-digital) medical devices and the registration practice of the EUIPO in relation to the latter can be seen as indicator for shape marks for digital health products.
However, obtaining non-traditional marks can be challenging.
Shape marks, for example, will be objected to if they are purely functional or decorative (rather than a badge of origin). The registration practice of the EUIPO with regard to shape marks for (non-digital) medical devices proves this as the Office has rejected numerous applications for shape marks for inhalers because of lack of distinctiveness (see, for example, the refusal of application no. 018363104, a shape mark for an inhaler, filed by Novartis AG). This practice illustrates the difficulty in maintaining registered trade mark protection for medical devices, and the same will apply for digital health products.
Registration of colour marks is also often refused for lack of distinctive character. Again, the registration practice with regard to medical devices show the difficulties: the General Court, for example, held that a colour mark filed for a shade of purple in respect of inhalers was not registrable because it was devoid of distinctive character given that, for a proportion of the relevant public, the colour did not function as an indicator of origin (T-187/19, Glaxo Group Ltd v EUIPO). These cases highlight the challenges companies are likely to face securing and maintaining non-traditional trade marks for their devices.
Some medical devices as well as some digital health products however, including several wearable devices, have been successfully registered as shape marks. Educating the consumer that aspects of the product – such as its shape or colour – are indicators of origin can help in securing protection. This will involve a global branding strategy to achieve the necessary level of consumer recognition in all markets, but one that will then help with brand enforcement.
The digital health field is rapidly expanding. Therefore companies need to be mindful of the need to monitor for potential infringements, track competing products, and proactively manage their trade mark portfolio, particularly if they operate in several jurisdictions.
Companies can also consider registered design protection as another, sometimes more appropriate form of IP protection for the shape of medical devices or digital health products. Design protection has a few advantages compared to trade mark protection: registration is quite easy, there is a 12-month novelty grace period and a substantial deferment of publication which maintains confidentiality. We will be happy to advise you on which protection is best suited to your products and services.
