Tandem Diabetes Care (Nasdaq:TNDM) recently filed an SEC Form 8-K announcing its entry into a patent litigation settlement with Roche.
The two companies entered into a settlement, mutual release and cross-license agreement. It resolves all actual or potential patent disputes as of May 21.
According to the SEC filing, the settlement relates to Tandem’s t:slim X2 insulin pump and EP Patent No. 2 196 231 B1 (the ’231 patent) and EP Patent No. 1 970 677 B1 (the ‘677 patent). It includes pending patent infringement actions, revocation actions, counterclaims for revocation and non-infringement declarations.
All relate to claims filed in the Unified Patent Court in Paris and Germany. Tandem filed a revocation action and action for a declaration of non-infringement against Roche in November 2023. In return, in February 2024, Roche filed an infringement action against Tandem in Germany.
By the end of 2024, the UPC Paris held a hearing on Tandem’s action to revoke claims of the ‘231 patent and upheld the patent. The UPC court in Hamburg, Germany had a hearing on invalidity and non-infringement scheduled for June 12, 2025.
Pursuant to the settlement agreement, though, the companies agreed to terminate pending actions. They also provided releases and waivers of claims relating to their disputes and respective licensed patents. Tandem and Roche included covenants not to sue, effective upon payment of an initial payment made by Tandem.
The San Diego-based insulin pump maker agreed to pay Roche $36 million over a five-year period. It agreed to provide an initial payment of $8 million, paying off the remaining balance in four equal annual installments thereafter.
Effective upon payment of the initial $8 million, the companies granted each other non-exclusive, non-sublicensable, non-royalty-bearing, non-transferrable and irrevocable licenses to all their respective patents and patent applications related to insulin delivery systems for a period of 10 years.