21 June 2022
Digital Health – 2 of 8 Insights
This article, which focuses on trade marks and design rights is the second article in a series exploring IP protection for digital health products. The first article in this series on patent protection for digital health products can be accessed here.
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. The Fitbit® is one digital wellness product brand that has built a loyal following and is regulated as a medical device. For guidance in distinguishing between wellness devices and medical devices, see our recent article on the topic.
Registered trade mark protection can be obtained on a country-by-country basis, eg in the UK by filing an application at the UK Intellectual Property Office (UKIPO). 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. 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. 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 digital health product may need to re-brand (potentially globally) because of an issue in one country or territory.
EUTMs no longer cover the UK. However, EUTMs that were registered before 1 January 2021 have been automatically re-registered in the UK and have substantially the same legal status as registered UK trade marks. These re-registered marks are called 'comparable UK trade marks'. Applicants with pending EUTMs that were filed (but not registered) before 1 January 2021 were given a nine month window to file a corresponding UK application if they wanted to retain the same filing/priority date as the corresponding EUTM. Post-1 January 2021, UK citizens and entities can still file EUTMs but the geographical scope of EUTMs is now limited to the 27 EU Member States.
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.
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). In Glenmark Pharmaceuticals v Boehringer Ingelheim (C-37137), the EUIPO's Cancellation Division declared Boehringer's shape trade mark for its HandiHaler (a chronic obstructive pulmonary disease inhaler) invalid on the basis that the essential characteristics of the mark performed a technical function. In T-187/19, the General Court held that a colour mark filed by Glaxo Group Ltd 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. These cases highlight the challenges digital health companies are likely to face securing and maintaining non-traditional trade marks for their devices.
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. In 2013, the UK-based company Fitbug lost a suit alleging trade mark infringement in Northern California against Fitbit because it had waited too long to enforce its rights.
Digital health companies often spend time and money designing products which are sleek, fashionable and desirable to consumers. Designs therefore play an important role in protecting the appearance of these products.
As a result of Brexit, there are now five forms of design right which cover the UK. The most important as far as digital health products are concerned are UK Registered Designs and Supplementary Unregistered Designs. Both protect the appearance of the whole or part of a product resulting from such features as the lines, contours, colours, shape, texture and/or materials of the product and/or its packaging. 2D and 3D designs can be protected, as can logos and ornamentation. Designs which are purely functional or internal to a product cannot be protected. Protection is given for the design itself – the design is protected for all products, not just the product in which it is incorporated. Any digital health product that incorporates a design feature that is new and has individual character (compared to designs that have gone before it) can potentially be protected as a design provided the design is not dictated by its technical function.
Registration confers a longer term of protection (25 years as opposed to three years). There is also no need to show copying for infringement of a registered design. In contrast, the unregistered form is only infringed if a third party produces an article by copying the design.
The UK also protects another form of unregistered design called the design right. To be protected, the design must comprise the shape or configuration (whether internal or external) of the whole or part of an article. Protection lasts for 15 years.
There are also two forms of pan-EU designs available: registered Community designs (RCDs) and unregistered Community designs (UCDs). These are comparable to the UK Registered Designs and Supplementary Unregistered Designs mentioned above, but cover all 27 EU Member States.
UK Registered Designs can be obtained by filing an application at the Designs Registry, which is a part of the UKIPO. RCDs can be obtained by filing an application with the EUIPO. Supplementary Unregistered Designs and UCDs both come into existence automatically upon first disclosure of the design (in the UK and EU respectively). There is debate about whether the same design can benefit from both a Supplementary Unregistered Design and UCD – simultaneous disclosure in the UK and EU would be required and the law in this area is untested. UK Design Rights come into existence automatically upon the design being recorded in a design document or article.
RCDs and UCDs no longer cover the UK. However, RCDs that were registered prior to 1 January 2021 were automatically re-registered in the UK, called re-registered UK designs. For pending EU RCDs that were filed (but not registered) prior to 1 January 2021, applicants were given a nine month window to file corresponding UK applications if they wanted to retain the same filing/priority date as the corresponding EU application. UCDs in existence prior to 1 January 2021 also continue to be protected in the UK for the life of the right. These are called Continuing UK Unregistered Designs. UK citizens/entities can still obtain RCDs and, provided they make the first disclosure of designs in an EU country, they can also obtain EU UCDs. These rights now cover the remaining 27 EU Member States only.
Quite a number of digital health products have been registered as designs, including various wearable devices, baby monitors, blood pressure monitors, thermometers, mobile health devices and more complex medical devices. It is worth being aware that, where a design has functional elements or the design freedom is highly constrained by technical considerations, obtaining and enforcing designs might be more difficult. In Pulseon OY v Garmin, PulseOn claimed a large proportion of Garmin's heart-rate monitoring devices infringed its designs. The High Court rejected the claim on the basis that the EU RCDs in issue were afforded a relatively narrow scope of protection in light of their highly functional nature. PulseOn's appeal was dismissed. Nonetheless, since obtaining registration for designs is cost-effective and straightforward – and can ward off potential competitors – it is well worth considering in appropriate cases.
The final article in this series will explore the use of copyright, database rights and confidentiality to protect digital health products.
16 June 2022
14 June 2022
9 June 2022
1 June 2022
25 May 2022