EBR Systems Expands to 58 US Patents but Faces USPTO Extension Setback

Expanding Patent Protection

EBR Systems, the Silicon Valley-based innovator behind the WiSE wireless cardiac pacing system, has announced the grant of four new patents; three from the US Patent and Trademark Office and one from the Japan Patent Office. This latest development brings the company’s intellectual property portfolio to a robust 58 granted US patents, 9 granted non-US patents, and 13 pending applications. The patents cover a broad range of technological innovations integral to the WiSE system, including leadless cardiac pacing via ultrasound, sensor and transmitter designs, and delivery mechanisms.

Navigating Patent Term Extension Challenges

Despite this positive momentum, EBR faces a regulatory hurdle with a preliminary disallowance notice from the USPTO regarding its application for a patent term extension on one of its key US patents. The extension, which would have added approximately 4.5 years to a patent expiring in 2030, was filed just one day past the statutory 60-day deadline following FDA approval. The USPTO is currently seeking additional information from the FDA before issuing a final decision. EBR is actively consulting independent experts to explore possible recourse, underscoring the importance of this extension in maintaining competitive exclusivity.

Sustained Innovation and Market Position

EBR’s WiSE technology remains the only wireless, endocardial pacing system clinically used to stimulate the heart’s left ventricle, a position long sought after for its physiological advantages. The company’s ongoing research and development efforts continue to generate new patent applications, potentially extending the technology’s patent runway well beyond current expiry dates, some as far out as 2043. Furthermore, EBR highlights its extensive know-how and trade secrets as formidable barriers to entry for any emerging competitors, noting no direct rivals currently in development.

Strategic Implications

This update reinforces EBR’s commitment to protecting and advancing its proprietary technology in a niche but critical medical device sector. While the preliminary USPTO disallowance introduces some uncertainty, the company’s proactive approach to securing expert advice and continuing innovation suggests resilience. Investors and industry watchers will be keen to monitor the final outcome of the patent term extension appeal and the pace of new patent grants, both of which will influence EBR’s market exclusivity and long-term commercial prospects.