U.S. Patent Office Completes Review of Medtronic Patents, Rejects More Axonics Challenges

DUBLIN, Sept. 22, 2021 /PRNewswire/ -- Medtronic (NYSE:MDT), the global leader in medical technology, today announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has affirmed an additional three patents in a dispute with Axonics over intellectual property for its sacral neuromodulation (SNM) device family, the InterStimtm systems. Today's decisions complete the review process initiated by Axonics to challenge the validity of the seven total patents involved in the IP infringement case brought by Medtronic. Cumulatively, the PTAB has now affirmed claims in all seven of the Medtronic patents.

The PTAB's latest decisions today affirmed all claims at issue in Medtronic's U.S. Patent Nos. 8,457,758 ('758) and 8,738,148 ('148); and affirmed claims 1-7, 16-18 and 22 of Medtronic's U.S. Patent No. 9,821,112 ('112), while invalidating claims 9-13 and 20. These patents relate to recharging technology. Medtronic is weighing its legal options with regard to the handful of invalidated patent claims in the '112 patent. The '758 patent and the '148 patent expire in April 2025, the '112 patent expires in April 2024.

Now that the IPR is complete ? including the PTAB's decision in September 2020 to reject without hearing the challenge to Medtronic U.S. patent No. 9,463,324 ('324) ? Medtronic will request that the U.S. District Court in the Central District of California lift the stay on the IP infringement case and resume proceedings. The decision on the '324 patent is final and not appealable. The '324 patent expires in April 2024.

All Medtronic patents affirmed by the PTAB have been in force for every sale Axonics has made to-date.

"Medtronic appreciates the Patent Trial and Appeal Board's efforts in this matter," said Brett Wall, executive vice president and president of the Neuroscience Portfolio at Medtronic. "We are pleased with the outcome of the review process and look forward to our day in court to protect the proprietary technology that brings SNM therapy to patients around the world."

About the IP Infringement Case Against Axonics
Medtronic filed suit against Axonics in November 2019, asserting claims for infringement of seven patents related to Medtronic's minimally invasive sacral neuromodulation lead placement procedure and implant recharging technologies. In response, Axonics filed Inter Partes Review (IPR) in March 2020 on all seven patents and the litigation was stayed pending the outcome at the PTAB.

In September 2020, the PTAB rejected without hearing the challenge to Medtronic's U.S. Patent No. 9,463,324 and found that Axonics' arguments lacked merit. That decision by the PTAB is final and not appealable.

Last week, the PTAB affirmed the additional Medtronic U.S. Patent Nos. 8,036,756 and 8,626,314, which protects technology related to its tined leads; and it upheld 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's decision on the '069 patent also found claims 5, 6, 8 and 9 invalid, while claims 1-4 and 10-13 were not challenged by Axonics. These decisions are subject to appeal, and Medtronic is weighing its legal options in regard to the invalidated claims of the '069 patent.

About Medtronic InterStimtm Systems
Medtronic has the world's smallest rechargeable bladder/bowel control system and the fastest battery recharge available and is the only company that offers patients the choice of a rechargeable or recharge-free sacral neuromodulation device. With 25-years' experience of innovation, investment and pioneering therapy, Medtronic is the only company with five-year data demonstrating the safety and efficacy of its sacral neuromodulation systems.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies ? alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

SOURCE Medtronic plc