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U.S. Patent and Trademark Office Rejects Axonics' Challenge to Medtronic Patents

MDT | September 13, 2021

DUBLIN, Sept. 13, 2021 /PRNewswire/ --Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has won three additional important victories in a dispute over its intellectual property (IP) for its sacral neuromodulation device family, the InterStim™ systems. The Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office rejected Axonics' (NASDAQ:AXNX) attempt to invalidate three Medtronic patents in its IP infringement lawsuit.

Significantly, this victory is in addition to the PTAB's affirmation of Medtronic's U.S. Patent No. 9,463,324 ('324 patent) in September 2020, which protects key technology related to implant recharging and temperature control. As soon as the PTAB completes its review of the remaining three challenged patents (U.S. Patent Nos. 8,457,758, 8,738,148, and 9,821,112), due within days, the company will return its attention to the infringement lawsuit against Axonics and request that the U.S. District Court in the Central District of California lift the stay and resume proceedings.

"Medtronic is pleased with the PTAB's decisions today," said Brett Wall, executive vice president and president of the Neuroscience Portfolio at Medtronic. "We believe competition drives innovation and is good for the industry and for patients. We also believe that protecting our proprietary technology and intellectual property is vital to our business."

The PTAB's latest decisions uphold all the 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'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.

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) on all seven patents and the litigation was stayed pending the outcome at the PTAB. Last year, the PTAB rejected without hearing the challenge to Medtronic's '324 patent and found that Axonics' arguments lacked merit. That decision by the PTAB is final and not appealable.

About Medtronic InterStim™ 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.