Medtronic asks ITC to wade into Axonics patent spat, filing request for exclusion order

As Medtronic and Axonics’ legal battle over alleged similarities between their sacral neuromodulation devices drags on, Medtronic is getting the U.S. International Trade Commission involved.

The medtech giant announced Thursday that it has filed a complaint asking the ITC to investigate whether Axonics’ U.S. sales of neuromodulation implants violate Medtronic’s patent rights. The company has requested that the ITC levy an exclusion order and cease-and-desist order on Axonics that would stop it from selling devices that Medtronic claims infringe on its patents.

Medtronic said it has also filed a parallel action in U.S. District Court in Delaware.

The ITC confirmed it has received Medtronic’s complaint in a notice (PDF) of its own, in which the agency also said it’s seeking information within the next week about any “public interest issues” that may arise if it were to heed Medtronic’s request.

The request focuses specifically on two Medtronic patents related to the neurostim devices’ MRI compatibility.

“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 Medtronic’s pelvic health business, said in the company’s announcement. “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 didn’t immediately respond to Fierce Medtech’s request for comment.

The legal spat dates back to late 2019 when Medtronic first filed suit against Axonics, claiming that certain aspects of the company’s sacral neuromodulation implants infringe on seven patents protecting Medtronic’s own InterStim devices.

In response, Axonics filed for inter partes review, which effectively paused the litigation as the U.S. Patent and Trademark Office was tasked with reviewing whether the technologies in question could be patented at all.

By September 2021, per a Medtronic release at the time, the office’s Patent Trial and Appeal Board (PTAB) had issued rulings on all seven patents—affirming most of Medtronic’s claims within the patents, but invalidating a handful of them—after which the company requested that the legal proceedings continue.

In back-to-back rulings last summer, however, Axonics scored a win of its own as a federal appeals court reportedly determined that the PTAB had erred in the process of making its patentability decisions on a total of four of Medtronic’s patents by failing to consider evidence that Axonics had filed in response.

That appeals court ruling has further delayed the litigation between the two companies, as it tasked the PTAB with starting over in its consideration of the technologies’ patentability, taking into account all of Axonics’ responses to Medtronic’s claims, as well as any new evidence brought by Medtronic. The PTAB has yet to release its revised decision.