The market for products like watches, rings, belts and extended applications to provide a consumer-friendly overview and analysis of medically useful biometric data is steadily growing.
In 2023 it was valued at $81.15 billion. Recent technological advancements in wearable devices, the growing awareness towards prioritisation of health and physical performance as well as the increasing prevalence of chronic diseases and lifestyle-related disorders have all contributed to this notable development.
This growth is highly relevant for innovative companies in this sector, as is reflected in the increasing number of patent applications and related disputes. As more businesses enter the market and innovate, the competition for IP rights intensifies. Consequently, companies must be diligent in protecting their valuable assets, securing their related patents and preparing for potential litigation to maintain a competitive edge.
The global patent litigation concerning glucose-monitoring mobile devices between Dexcom and Abbott is a prominent example of the growing relevance of wearable medical electronic devices (WMEDs).
In this article, we discuss the wide range of wearable healthcare technology and how innovators must adapt traditional IP management strategies to keep up with the market's dynamic developments.
Benefits and Challenges of Wearables
Wearable devices are currently used in manifold ways, some of which are exemplified below:
Smartwatches and Fitness Trackers
Smartwatches and fitness trackers are able to monitor activity, sleep patterns, stress, heart rate and other fundamental health parameters. As technology advances and sensor sensitivity improves, some can also alert users about abnormalities and signs of atrial fibrillation. These wearables are specifically popular among the growing demographic of health-conscious consumers that aim to improve their habits and lifestyle choices.
Glucose Monitors
Devices to provide continuous glucose monitoring are currently mostly used as a tool for people with diabetes to track and manage blood sugar levels. Some devices are able to connect with insulin pumps to offer automated insulin delivery. However, glucose monitors can also be beneficial for a wider audience, especially people with prediabetes, obesity as well as certain glycogen storage disorders that can cause low blood sugar episodes. Furthermore, endurance athletes are also starting to lean towards glucose monitors as an extra tool to optimise nutrition and fueling strategies and therefore maximise performance.
Blood Pressure Monitors
Patients suffering from hypertension and other blood pressure deviations have to keep a continuous eye on this health metric. Unlike traditional arm cuffs, modern monitors make the use of such devices more comfortable as it is practically a cuffless technology, which can transfer the data directly to the user's phone or a health care provider. This manner of data tracking allows for a more specific analysis of how a person's habits and day-to-day choices can influence their blood pressure.
ECG Monitors
Wearable ECG monitors can be an important tool for cardiovascular patients. Besides accurately measuring electrocardiograms they can also detect arrhythmias. These wearable devices allow patients to capture their heart rhythm whenever they feel symptoms—something that wasn't possible at home just a couple of years ago. This makes diagnosis and treatment significantly easier.
IP Protection and Litigation
The growing amount of use cases of wearable devices opens several opportunities for both traditional medtech and pharmaceutical companies as well as startups to grow their business.
Patents play an essential role in this context from the drafting of appropriate patent applications and prosecuting and defending against challenges to litigating before the courts to defend valuable assets and market positions.
Prosecuting Patents
From a general perspective, patent filing seems straight forward. When it comes to filing patents, innovators and applicants follow well established routes, which is also confirmed by the Patent Index of the European Patent Office (EPO) showing a growth in patent applications relating to medical technology in its latest statistics. However, there are some hurdles.
While the pace of technology change is fast, innovators who want to stay ahead in this field must continuously file new patent applications to protect their latest developments. Even more, since wearable technology in the pharmaceutical industry often involves interdisciplinary innovations, combining aspects such as sensing technology in interaction with human body and software applications, protecting these multifaceted innovations can be complex and may require multiple patents covering different aspects of technology. This amounts to a large portfolio of patent applications, which, if filed at an early stage in development, secures own innovations and provides protection for later products.
In addition, besides patents on the hardware just discussed, patents on software and algorithms are to be considered. It must be kept in mind, however, that there are some pitfalls in related patents. For example, Article 52 of the European Patent Convention (EPC) excludes scientific theories and mathematical methods as well as programs for computers from patentability—but these issues can be overcome if there is an associated technical character or a further technical effect. Furthermore, Article 53(c) of the (EPC) states that European patents shall not be granted in respect of diagnostic methods practiced on the human or animal body. However, also these issues can be circumvented eg, by a purpose limited product claim.
Litigating Patents
It follows that that complex field of patent protection is also reflected in patent infringement proceedings and patent litigation.
The multinational patent litigation between Dexcom and the Abbott group in the US and Europe including Germany and the UK concerning glucose-monitoring mobile devices is a prominent example of litigation over wearable medical electronic devices (WMEDs). And proceedings were also brought before the newly established Unified Patent Court (UPC), where decisions may take effect in currently up to 18 European member states since the accession of Romania on September 1, 2024.
The fast pace of technology means that patentees active in the field of wearables are required to permanently monitor the market to detect potential patent infringement by competitors. When potential infringers are identified, the enforcement of patents requires a highly strategic approach and it is beneficial to rely on a broad patent portfolio for tailored litigation. The opening of the UPC provides additional opportunities besides national country-by-country litigation litigants should be aware of and consider. Patentees may also use their inventions to generate revenue by licensing patents for example to other companies. While this usually avoids patent disputes, it can be lucrative and could be used as leverage in negotiations and business deals.
Conclusion
Patents play a key role in the evolving market of wearable technology in the pharmaceutical industry, but it requires a long-term and overall perspective to navigate the topic and to benefit from the system. We anticipate that the role of patents will gain even greater significance over the next few years, as the technological field of wearables in healthcare is driven by continuous innovation and an expanding range of applications.
Also, more companies can be expected to enter the market of wearable medical electronic devices. Patent litigation may thus also become more important in this sector. For companies active in this field it seems thus advisable to implement comprehensive IP management practices, ranging from appropriate patent filing strategies, regular monitoring of the patent and product landscape as well as the establishment of suitable litigation strategies to maintain their competitive edge in the market.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
