Medtronic has made fresh new patent infringement accusations against Axonics.

Amanda Pedersen

March 4, 2024

3 Min Read
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Medtronic is going after Axonics once again, this time with accusations that its competitor in sacral neuromodulation is illegally using Medtronic’s MRI compatibility technology.

The accusations come as Boston Scientific is in the process of acquiring Axonics. It also comes as a critical ruling from the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office related to the companies' previous patent spat is expected imminently.

“The pattern is clear: Axonics uses Medtronic technologies to improperly compete in the market,” said Mira Sahney, president of the pelvic health business at Medtronic. “It is time for Axonics to be held accountable for these unlawful acts.”

The Dublin, Ireland-based medtech giant filed a complaint with the U.S. International Trade Commission (ITC), along with a parallel lawsuit in U.S. District Court for the District of Delaware. These actions are an attempt to block Irvine, CA-based Axonics from importing and selling products that, according to Medtronic, infringe two of its patents related to the MRI compatibility of implantable medical devices.

Axonics is standing its ground in similar fashion to past accusations from the large competitor.

“Axonics refuses to be intimidated by Medtronic and intends to defend itself vigorously,” Cohen said.

Related:Boston Scientific Bids on a Medtronic Foe

He also reiterated his earlier position regarding the sacral neuromodulation market incumbent by noting that Medtronic held a monopoly for more than 20 years 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, as Cohen puts it, “created a renaissance in sacral neuromodulation therapy."

He argues that Medtronic's claims are designed to stifle competition, limit patient and physician choice, and protect Medtronic's market position in sacral neuromodulation (SNM).

Axonics vs. Medtronic: A medtech feud for the ages

Here are the key points to know about the contentious history between Medtronic and Axonics.

  • Medtronic pioneered the SNM market more than 20 years ago with its InterStim device, used to treat various bladder and bowel conditions.

  • Along came Axonics Modulation Technologies with FDA approval in 2019 for a rechargeable version of a similar device.

  • The market incumbent almost immediately filed a lawsuit against Axonics, alleging infringement on certain claims in seven patents related to Medtronic's SNM lead placement procedure and implant recharging technologies.

  • Axonics filed seven petitions with the U.S. Patent and Trademark Office requesting an inter partes review of each of the Medtronic patents in question.

  • In September 2020, the Patent Trial and Review Board (PTAB) decided to review the validity of six of the seven Medtronic patents in question. However, the PTAB decided not to institute a review of one of the patents — (U.S. Patent No. 9,463,324 ('324 patent) — because there was not a reasonable likelihood that any of the claims in that particular patent would be found to be invalid. According to Medtronic, the '324 patent protects key technology related to implant recharging and temperature control and is central to the infringement case against Axonics.

  • In September 2021, the PTAB upheld three of the patents Axonics challenged.

  • In February 2022, FDA approved InterStim X, the next generation of Medtronic's recharge-free device.

  • In March 2022, FDA approved Axonics' recharge-free sacral neuromodulation implantable neurostimulator, called F15.

  • In January 2023, FDA approved the latest version of the Axonics R20 SNM system.

  • In August 2023, a federal judge ruled that the PTAB had errored in Medtronic's favor by refusing to consider new arguments from Axonics after the board adopted an interpretation of the patents' terms that Medtronic submitted. The court also reopened Axonics' challenges to two other Medtronic patents at a U.S. Patent and Trademark Office tribunal in July 2023.

  • A critical PTAB ruling related to the ongoing case is expected imminently.

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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