James Bell, of counsel, Finnegan and Darren Jiron, partner, Finnegan outline the considerations to be made for wearable medical electronic devices.
shutterstock / Jackie Niam
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Wearables and digital health concept
In 2022, the market for wearable medical electronic devices (WMEDs) was $27 billion in the U.S. alone, and according to Future Market Insights this market is expected to grow at a compound annualised rate of over 28% between 2023 and 2032. Sales relating to WMEDs include hardware-based products such as watches, rings, belts, etc., but also extend to associated applications configured to provide monitoring, diagnostics, analysis, and reporting of medically useful biometric data to medical practitioners. Revenue streams further rely upon “server” based applications and communication between such servers (e.g., smartphones, cloud devices, etc.) and wearable units. Such a multi-faceted eco system presents significant opportunities for companies to build corporate value through a strategically developed, diversified international patent portfolio designed to protect the underlying features and innovations of its WMEDs.
Why patents?
Granted patents provide a territory-specific, exclusive right to exclude others from practicing an invention claimed in the patent. Claims that impact competitors can generate huge value as tools for offense (e.g., litigation, licensing) and/or defence (e.g., deterrents to litigation or market entry). Regardless of company size, strong, international patents can support an array of corporate interests, from enhanced investment opportunities to leverage over competitors.
Considerations when patenting WMEDs
1) Therapeutic claims
Choosing where to patent typically depends on factors such as competitor activity, market size, location of R&D activities, etc. Patenting WMEDs raises additional considerations. For example, various jurisdictions have different rules regarding the availability of claims directed to therapeutic and diagnostic methods carried out on human or animal bodies. The United States and Australia are two of the few jurisdictions not explicitly prohibiting patent claims directed to such methods. Indeed, patent regulations in China, Japan, and even Europe expressly prohibit such method claims, while permitting patenting of devices carrying out such methods.
In view of such variation, patents applications for WMEDs should include different types of claim sets tailored to a particular jurisdiction. Claims should focus on WMED products configured to execute therapeutic and/or diagnostic methods and/or any corresponding server devices configured to cooperate with the WMED. Patentees should also consider claims in at least the U.S. directed to diagnostic and/or therapeutic methods.
2) Hardware and/or software claims
Claims focused on hardware should be the first to consider, especially as infringement of such claims does not require actual use of the product. Merely manufacturing or selling of products can constitute infringement.
But what about the software that drives the WMED features? While claims directed to software per se may be problematic from patentability and detectability perspectives, claims directed to software-driven techniques for collecting, analysing, and presenting data, including how the device interacts with a user, are often patentable and can be highly valuable. Here, a proper definition of claim scope within the context of the device performing the innovative techniques, as well as a statement of a resulting technical effect within the description are key factors to consider.
Further, WMEDs may cooperate with a server device to perform operations, and claims focused on this relationship should be considered. For example, system features may be claimed from the perspective of the WMED or the server device and may include combinations of the WMED with the server device. This strategy may provide options for enforcement, while remaining within claim limits set by various patent jurisdictions.
3) Timing
Patent applications protecting developed IP should be filed as early as possible, and before discussions with third parties. Most patent jurisdictions follow a “first-to-file” system, and with rapid innovation in the WMED space, there is elevated risk that another party may win the race while others hesitate.
Conclusion
As the WMED market grows, so too does the number of companies competing in this space. Those with strategically developed patent portfolios may earn and maintain their seat at the table, while those without proper IP protection may be relegated to the side lines.
