PATENT ANALYSIS ON DIGITAL THERAPEUTICS IN THE UNITED STATES: A CROSS-SECTIONAL STUDY OF KEY DRIVERS

Abstract

Background: Digital therapeutics (DTx) represent an innovative integration of technology and healthcare, employing software and digital tools to enhance, complement, or directly deliver medical interventions, including disease prevention, diagnosis, and treatment. With recent approvals of prominent digital therapeutic solutions, such as anti-smoking programs and treatments for diabetes, major depressive disorder, and ADHD, there is a clear trajectory toward increased acceptance and regulatory approvals in this field. Consequently, patent activity related to DTx technologies is also anticipated to grow significantly, making it crucial to understand the underlying intellectual property trends and key technological drivers. Methodology: This study provides a comprehensive analysis of DTx-related patents filed in the United States, leveraging patent databases and the International Patent Classification (IPC) system. We focused specifically on patent applications incorporating applied technology and medical indications as primary drivers. To elucidate the most influential innovations, we conducted both patent application trend analyses and patent citation analyses. The latter included citation matrix analyses for prominent U.S. companies involved in digital therapeutics, offering insights into technological dominance and market growth potential based on the citation frequency and self-citation ratios of patents. Results: Our analysis identified several key technological drivers in the DTx space, notably within the realms of healthcare informatics and diagnostics. The patents predominantly focused on areas such as "Sensor," "Blood Vessel," "Medical Image," "Heart," "Central Nervous System," "Psychiatry," and "Application," underscoring a wide range of medical and technological foundations supporting DTx advancements. Furthermore, companies such as Akili and Welldoc emerged prominently, demonstrating significant patent activity and technological influence through customized cognitive training regimens and adaptive health assistant systems, respectively.