Evaluation of Intellectual Property Strategies in Digital Therapeutics

Overview

This study analyzed patent and design right strategies across 30 digital therapeutics (DTx) products, revealing distinct intellectual property (IP) approaches based on product architecture. App-based DTx often lacked patents, while app + device-based and entertainment-based DTx showed more extensive patent protection; design rights were rarely utilized.

Background

Digital therapeutics (DTx) deliver evidence-based interventions via digital platforms to treat or prevent diseases and are gaining prominence in healthcare, especially post-COVID-19. Strategic IP protection, including patents and design rights, is essential to support development costs and foster innovation in this emerging field. However, little is known about how IP strategies vary among different DTx product types. This study addresses this gap by examining patent and design right usage across app-based, app + device-based, and entertainment-based DTx products.

Data Highlights

Key Findings

• Half of app-based DTx products lacked patent applications, often relying on platform technologies rather than novel inventions.
• All app + device-based DTx products had patents covering programs, biometric acquisition, and platform technologies.
• Entertainment-based DTx exhibited the highest average number of patent applications, reflecting their novelty and divergence from conventional treatments.
• Only 5 of the 30 DTx products were protected by design rights, which were limited in scope and practical utility.
• Distinct differences in patenting approaches exist among DTx types, indicating that IP strategies should be tailored to product architecture.

Clinical Implications

Understanding the variation in IP strategies among different DTx types can guide developers and healthcare stakeholders in protecting innovations effectively. For app-based DTx, focusing on platform technologies may suffice, whereas app + device-based and entertainment-based DTx require comprehensive patent protection. Limited use of design rights suggests that patents remain the primary IP tool to secure competitive advantage and support sustainable innovation in digital therapeutics.

Conclusion

This study highlights that intellectual property strategies in digital therapeutics differ significantly by product type, with patents playing a central role and design rights used sparingly. Tailoring IP approaches to the specific architecture of DTx products is essential to promote innovation and ensure sustainable development in this evolving healthcare sector.

References

1. Digital Therapeutics Alliance 2023 -- Product Library
2. US FDA 2023 -- Approved Augmented and Virtual Reality Products