Dive Brief:
- Medtronic has filed a complaint with the U.S. International Trade Commission (ITC) to stop Axonics from importing and selling products the medtech firm claims infringe on two of its patents related to the compatibility of implantable devices with MRI machines.
- Axonics, which Boston Scientific announced plans in January to buy for $3.7 billion, sells sacral neuromodulation (SNM) implants that compete with Medtronic’s Interstim products for bladder and bowel dysfunction markets.
- Medtronic filed a complaint in 2019 in the U.S. District Court for the Central District of California alleging Axonics’ rechargeable SNM system infringes its patents. The case is continuing, after a federal appeals court ruled in Axonics’ favor twice, and will now advance in parallel to a push for the ITC to block the sale of the devices.
Dive Insight:
Medtronic received premarket approval for its first Interstim device in 1997 and had the market to itself for years. The Food and Drug Administration approved Axonics’ r-SNM device in 2019. Axonics’ devices are designed to last 15 to 20 years, compared with seven to 10 for Medtronic’s Interstim X. The company’s SNM products have gained traction on the market, generating $291.8 million in sales last year, up 31% year over year.
Within weeks of Axonics winning approval, Medtronic filed a lawsuit alleging the device infringed three of its patents. The company later expanded the complaint to cover three more patents. With that case continuing, Medtronic has opened another front in its dispute with Axonics.
“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,” Mira Sahney, president of the pelvic health business in Medtronic’s neuroscience portfolio, said in a Thursday statement.
Medtronic has filed a complaint with the ITC and a parallel action in the U.S. District Court for the District of Delaware. The goal is to block the sale of Axonics devices that Medtronic claims infringe two patents related to MRI compatibility. MRI compatibility has been a feature of Axonics’ devices since the 2019 approval, which covered an implant that can remain in place during full-body scans.
The ITC responded to the complaint with a call for comments on the case. In particular, the ITC wants more information on how the devices are used in the U.S., the implications of blocking their sale and the ability of competitors to increase output to offset the impact of an import ban.
Axonics CEO Raymond Cohen slammed Medtronic’s allegations in a Thursday statement, claiming the company is attempting to stifle competition and protect its market position.
“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,” Cohen said. “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.”