According to a news release, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) rejected Axonics’ attempt to invalidate three Medtronic patents in its IP infringement lawsuit related to Medtronic’s InterStim neuromodulation device family. Nearly one year ago, the PTAB handed down a decision to reject one of Axonics’ claims to invalidate a Medtronic patent and has now added three more.
Axonics develops the r-SNM sacral neuromodulation system, which it touts as the first of its kind approved for sale in the U.S., Europe, Canada and Australia and the only SNM device approved for full-body MRI scans without needing the device explanted.
The company, a direct competitor of Medtronic in the space, has rivaled the medtech giant with multiple regulatory nods for its technology, including winning FDA pre-market approval in November 2019 for the treatment of overactive bladder and urinary retention, which followed the FDA approval that r-SNM won in September for fecal incontinence.
In November 2019, Medtronic (NYSE:MDT) filed a lawsuit against Axonics in the U.S. District Court for the Central District of California, alleging infringements of four patents for Medtronic’s SNM technologies indicated for bowel and bladder conditions.
Axonics, in response, filed seven claims over the ‘069 patent, which concerns charging an implantable medical device having a battery. PTAB determined that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition,” and instituted an inter partes review related to six of the Axonics claims.
Last year, the PTAB rejected without hearing the challenge to Medtronic’s 324 patent and found that Axonics’ arguments lacked merit, with that decision final and not appealable, Medtronic said.
The latest PTAB decisions uphold 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.
“Medtronic is pleased with the PTAB’s decisions today,” Medtronic EVP & president of the neuroscience portfolio Brett Wall said in the release. “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.”
On the third patent (‘069) the PTAB invalidated four of the five claims that Axonics challenged. Axonics plans to appeal the PTAB’s decisions on the claims it declined to invalidate, claiming in a news release that the decision relates only to the issue of invalidity or patentability of Medtronic’s patents and does not mean that Axonics infringes on any of the patents in question.
“We are quite pleased with the PTAB’s decision to invalidate four of the five key claims of the ‘069 Patent, which reflects the merit of the compelling arguments we presented and represents a significant victory for Axonics,” Axonics CEO Raymond W. Cohen said in the release. “We respectfully disagree with the PTAB’s decision on the claims it declined to invalidate, and we intend to appeal. It’s also important to understand that the PTAB rulings are not related to the notion of infringement – they are simply addressing whether or not the claims in these patents are valid as a starting point. We are confident that we will ultimately prevail on all of the patent claims Medtronic has asserted against us.”
This article, originally published on September 14, was updated with additional information from Axonics on September 15.