Medtronic Asks ITC to Halt Sales of Axonics Neuromodulation Devices

Medtronic has filed a complaint with the U.S. International Trade Commission (ITC), as well as another action in the U.S. Court for the District of Delaware, aiming to cease Axonics from improper import and sale of products that infringe on two Medtronic patents.
 
Medtronic’s complaint alleges violations due to sale for importation and the U.S. of “certain medical programmers with printed circuit boards.” The patents in dispute are associated with the MRI compatibility of certain implantable medical devices.
 
Medtronic has asked the ITC to investigate the offending Axonics products. The company is seeking an exclusion order, cease and desist orders, and imposition of a bond from Axonics.
 
“Medtronic is continuing our efforts to stop Axonics from profiting off of their unauthorized use of our innovations and intellectual property,” said Mira Sahney, president of Medtronic’s pelvic health business. “The pattern is clear: Axonics uses Medtronic technologies to improperly compete in the market. It is time for Axonics to be held accountable for these unlawful acts.”
 
The company also has a separate infringement suit pending in the U.S. District Court for the Central District of California that alleges that Axonics has infringed further Medtronic technologies. Medtronic sued Axonics in 2019 for infringing seven patents related to sacral neurostimulation. In July 2023, after two failed attempts by Axonics tried to show that some of Medtronic’s claims were unpatentable, Axonics won an appeals court ruling that the board erred by refusing to consider reply arguments and evidence.

Axonics develops neurostimulation systems to treat urinary and bowel dysfunction. The company’s fourth generation R20 sacral neuromodulation system earned U.S. Food and Drug Administration (FDA) approval in January 2023. Boston Scientific began a deal to acquire Axonics earlier last month, as well.

Axonics issued a response to Medtronic shortly after it made the complaint public: 

“We believe Medtronic’s claims are designed to stifle competition, limit patient and physician choice, and protect the incumbent’s market position,” said Raymond W. Cohen, Axonics CEO. “For over 20 years, Medtronic took advantage of its monopoly position in this category and chose not to innovate, develop full-body MRI compatible sacral neuromodulation devices or invest in creating public awareness of advanced therapies for people with incontinence. Axonics took a different path and created a renaissance in sacral neuromodulation therapy by developing long-lived implantable devices and introducing full-body MRI compatibility in this category for the first time. Axonics refuses to be intimidated by Medtronic and intends to defend itself vigorously. In the meantime, we remain focused on innovation for improving the lives of patients with incontinence and continuing on our path to market leadership.”