Infringement of Neuromodulation Patents (2000-2024).

Abstract

Objectives: There has been a >20-fold increase in neurotechnology patent applications since 2000. These patents are a strong sign of industry growth, but the rights they confer also may be used to hinder innovation. We sought to identify US patent infringement lawsuits involving neuromodulation and assess the implications of litigation for innovation.

Materials and methods: Using the legal data base Lexis Advance® Quicklaw®, we conducted a search of US court pleadings filed since 2000 and identified initial complaints. We analyzed the data base for the basis of the complaint, type of neuromodulation, and requests of the court, and determined outcomes on the basis of the court judgments.

Results: We found 18 unique patent infringement complaints, 15 of which were filed after 2015. Lawsuits spanned various neuromodulation modalities: spinal cord stimulation (n = 6), transcranial magnetic stimulation (n = 5), sacral nerve stimulation (n = 3), transcutaneous electrical stimulation (n = 2), and vagus nerve stimulation (n = 2). Of the 14 disputes concluded by December 2024, eight caused dismissals; two caused findings of infringement; two caused findings of noninfringement, and two caused findings of patent invalidity that led to dismissals.

Conclusions: Inventors in neuromodulation may encounter proprietary barriers when they commercialize their products. The findings here underscore the need for balanced intellectual property policies that simultaneously foster innovation, preserve competition, and protect patient access to technologies.