WaveForm Technologies Inc. is a developer of novel products for continuous glucose monitoring and a wholly owned subsidiary of AgaMatrix Holdings LLC. Today they announced that the Patent Trial and Appeal Board has ruled two early patents held by WaveForm are not invalid, based on challenges brought by Dexcom, Inc. (NASDAQ:DXCM).
In its final written decisions last week, the PTAB found that three claims from WaveForm’s U.S. Patent No. 7,146,202 and all challenged claims from its U.S. Patent No. 8,187,433, are not invalid. Dexcom’s validity challenge before the PTAB on a third WaveForm patent remains pending.
The patented technology in WaveForm’s sensor design and methodology used in their Continuous Glucose Monitoring System (CGMS) allows the use of small, flexible, sensor wires. This unique sensor design enables a reduced diameter, which may aid day-one performance, reduced warm up time, and reduced wound diameter for significantly less pain and faster healing. WaveForm Technologies anticipates the features of its CGMS, clinical performance, and cost profile to be competitive compared to currently available CGMS options.
The two patents addressed in the recent PTAB rulings are part of ongoing litigation respecting three of WaveForm’s patents. In the lawsuit filed in the US District Court for the District of Oregon in 2016, WaveForm Technologies has asserted that all of Dexcom’s G4 and G5 CGM products sold in the US since 2012 willfully infringe on three WaveForm patents. According to SEC filings, Dexcom’s sales of products accused of infringement in that case are approximately $2 billion. The case has been on hold pending the PTAB decisions since March 2017.
On February 27, in an action brought by Dexcom against AgaMatrix, Inc., a separate wholly owned subsidiary of AgaMatrix Holdings LLC, in the Central District of California, the court ruled in AgaMatrix’s favor by granting Final Judgment of non-infringement of a patent that Dexcom had asserted against AgaMatrix in that case.
WaveForm and AgaMatrix believe that these recent legal victories support the value of its intellectual property and confirm the merits of its Oregon patent suit against Dexcom.
WaveForm Technologies is conducting human clinical studies for their CGMS, and expects to file for CE mark approval for the product in 2018. The WaveForm CGMS will offer several potential advantages as compared to currently marketed systems, including easy and virtually painless on-body sensor insertion, limited interferences (for example, for patients taking acetaminophen), rapid, one hour sensor warm up time, and potentially longer sensor wear life (14 days). The WaveForm system is designed to work with leading smartphone platforms and utilizes Bluetooth® wireless technology to transfer glucose data more frequently, with up to the minute glucose readings viewable directly on a patient’s smartphone without the need for an additional receiver.