Abstract
Advances in digital technology and the coronavirus disease (COVID-19) pandemic have accelerated the digital transformation of healthcare. Digital therapeutics (DTx), which deliver evidence-based interventions through digital means to treat or prevent diseases, are expected to generate significant value in modern healthcare. Strategic intellectual property (IP) protection for DTx is essential to support development costs, including clinical trials, and to ensure sustainable innovation. This study analyzed patent and design right strategies across different categories of DTx. We examined 25 DTx products registered with the Digital Therapeutics Alliance in the United States and five U.S. Food and Drug Administration-approved augmented and virtual reality products as of April 2023, classifying them into three categories: app-based, app + device-based, and entertainment-based DTx. Patent data were collected from the Derwent Innovation Index, and design rights were identified using the Patent Public Search. A case study of one representative product from each category was conducted to contextualize these findings. The results revealed that half of app-based DTx lacked patent applications, often relying on platform technologies, while all app + device-based DTx had patents covering programs, biometric acquisition, and platform technology. Entertainment-based DTx exhibited the highest average number of patent applications, possibly due to their novelty and divergence from conventional treatments. Only five of the 30 products were protected by design rights, which appeared limited in scope and practical utility. Overall, distinct differences in patenting approaches were observed among DTx types, with design rights used sparingly. These findings suggest that optimal IP strategies vary by product architecture and that understanding such distinctions is essential for promoting innovation in digital therapeutics.