Medtronic
(NYSE: MDT)
today announced that it filed a complaint to the U.S. International Trade Commission (ITC) to block the sales of certain Axonics (Nasdaq:AXNX) devices.
The complaint to the ITC runs parallel to action in the U.S. District Court for the District of Delaware. Medtronic wants to block Axonics from “improperly importing and selling products that infringe two of its patents related to the MRI compatibility of implantable medical devices.”
Medtronic wants the ITC to investigate and exclude the importation of Axonics products believed by the company to infringe its patents. The company has a separate infringement suit pending in the U.S. District Court for the Central District of California as well. That suit asserts that Axonics infringed additional technologies developed by and belonging to Medtronic.
“Medtronic is continuing our efforts to stop Axonics from profiting off of their unauthorized use of our innovations and intellectual property,” Mira Sahney, president of the medtech giant’s pelvic health business in the neuroscience portfolio, said in a news release. “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.”
Axonics has described Medtronic’s legal actions as intimidation.
Irvine, California-based Axonics develops neuromodulation systems for treating urinary and bowel dysfunction. Its fourth-generation R20 rechargeable sacral neuromodulation (SNM) system received FDA approval around a year ago. Axonics also launched the recharge-free F15 SNM system in mid-2022. Boston Scientific announced a deal to acquire Axonics for $3.7 billion last month.
Axonics says the dispute is about stifling competition
In a news release posted this evening, Axonics CEO Raymond W. Cohen said Medtronic, through its legal complaints, was seeking to stifle competition, limit choices for physicians and patients, and protect its incumbent 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. 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.”
History behind the Medtronic-Axonics spat
Axonics’ r-SNM platform has rivaled Medtronic’s Interstim in the neuromodulation space since its initial FDA approval in 2019. The companies have since battled over IP on this front in the years that followed.
Medtronic in November 2019 filed a lawsuit against Axonics in the U.S. District Court for the Central District of California. It alleged infringements of four patents for Medtronic’s SNM technologies indicated for bowel and bladder conditions.
In 2020, the the U.S. Patent Trial and Appeal Board (PTAB) handed down a decision to reject one of Axonics’ claims to invalidate a Medtronic patent. Then, in 2021, PTAB rejected Axonics’ attempt to invalidate three Medtronic patents in its IP infringement lawsuit related to the InterStim neuromodulation device family. That PTAB decision upheld all claims in Medtronic’s U.S. Patent Nos. 8,036,756 and 8,626,314, which protects technology related to its tined leads; and upholds claim 7 in Medtronic’s U.S. Patent No. 7,774,069 (‘069 patent), which protects technology related to its recharge power control.
The PTAB then affirmed an additional three patents shortly after that decision, again siding with Medtronic. That completed the review process initiated by Axonics to challenge the validity of the seven Medtronic patents.
Medtronic and Axonics continue to battle the patent spat out in court.
