Yesterday, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office affirmed an additional three patents in a long-term dispute between the companies over intellectual property for Medtronic’s Interstim sacral neuromodulation (SNM) system, completing the review process initiated by Axonics to challenge the validity of the seven total patents in the case brought by Medtronic, according to a news release.
“Medtronic appreciates the Patent Trial and Appeal Board’s efforts in this matter,” Medtronic EVP & president of the neuroscience portfolio Brett Wall said in the release. “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.”
Following the PTAB inter partes review (IPR) ruling, Medtronic said it 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.
In a news release, Axonics noted that either party may appeal the IPR decisions to the Director of the Patent & Trademark Office and to the U.S. Court of Appeals for the Federal Circuit. The company expects the stay on legal proceedings in the U.S. District Court in the Central District of California to continue until the appeals process is complete.
“First and foremost, it is important to understand that the PTAB rulings as to whether the claims in the Medtronic patents are valid or not do not mean that anyone has ‘won’ anything,” Axonics CEO Raymond W. Cohen said in the release. “When one party suggests that another party is infringing, the other party often asks the PTAB to determine if the claims in the patents are actually valid. This is what Axonics has done and for Medtronic to claim ‘victory’ is purely posturing. The fact that the PTAB decided to invalidate several claims in Medtronic’s ‘112 patent is a net positive for Axonics.
“Moreover, we believe the PTAB’s narrow construction of the claims in the ‘758 patent and ‘148 patent strengthens our non-infringement argument. Axonics remains confident that it does not infringe any Medtronic patents – valid or invalid – and that we will ultimately prevail on the patent claims asserted against us.”
Earlier this month, PTAB rejected Axonics’ attempt to invalidate three Medtronic patents in its IP infringement lawsuit related to the InterStim neuromodulation device family. That PTAB decision upheld 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.
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. Nearly one year ago, the PTAB handed down a decision to reject one of Axonics’ claims to invalidate a Medtronic patent.
The legal spat has been ongoing since November 2019 when Medtronic 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’ r-SNM platform has rivaled Medtronic’s Interstim in the space, 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.