Medtronic
(NYSE: MDT)
announced today that the U.S. Patent and Trademark Office upheld many of its claims around two of its patents in its battle with Axonics (Nasdaq:AXNX).
The office’s Patent Trial and Appeal Board (PTAB) affirmed the validity of many of the claims in two of Medtronic’s patents in the latest development in a long-running spat between the two companies. It means the PTAB has now upheld the validity of five of the company’s patents at issue in its lawsuit against Axonics.
Medtronic in November 2019 filed a lawsuit against Axonics alleging patent infringements over sacral neuromodulation (SNM) technologies. Since then, the battle has gone back and forth, with the medtech giant most recently asking the U.S. International Trade Commission (ITC) to block the sales of certain Axonics devices. (The complaint to the ITC runs parallel to action in the U.S. District Court for the District of Delaware.)
Medtronic now wants to ask the federal court in the Central District of California to lift its stay on the lawsuit. This would mean a jury trial over the five valid and affirmed patents in the suit.
“It’s now past time for Axonics to stand up in a court of law and take responsibility for its unauthorized use and infringement of Medtronic’s intellectual property,” said Mira Sahney, president of the Pelvic Health business in the Neuroscience portfolio at Medtronic. “We respect the intellectual property of innovators, and our patent system exists to benefit society by encouraging the kind of innovation that Medtronic invests in.
“We are pleased with the PTAB’s decision, and we are confident that the evidence at trial will show that Axonics improperly used and profited from Medtronic’s patented technology.”
Axonics’ response to the latest update
The PTAB’s decision revolved around Patent Nos. 8,626,314 (“the ‘314 patent”) and 8,036,756 (“the ‘756 patent”). Medtronic asserted the patents, which expired in 2021 and 2022, against Axonics’ tined lead design.
Axonics issued a press release highlighting the fact that the PTAB invalidated 10 of 15 challenged claims in Medtronic’s ‘314 patent. It declined to invalidate challenged claims in the ‘756 patent over one administrative patent judge’s dissenting opinion.
The district court case remains stayed based on the inner partes reviews (IPRs), Axonics said. It plans to seek a review of the PTAB’s finding that the remaining claims were not unpatentable.
“We are pleased with the PTAB’s decision finding numerous claims of the ‘314 patent unpatentable,” said Raymond W. Cohen, CEO. “Axonics will continue to vigorously defend itself against Medtronic’s claims while we remain focused on fulfilling our mission of changing the lives of patients suffering from bladder and bowel dysfunction.”
The analysts’ view
Wells Fargo analysts Larry Biegelsen, Nathan Treybeck, Vik Chopra, Lei Huang, Simran Kaur and Dean Weinstock said in a report that their patent consultant believes the PTAB’s argument “is really weak and the patents are still vulnerable.”
The analysts expect more appeals, with the original case remaining stayed as those appeals play out. They said the consultant expects reluctance from the district court to restart the underlying patent case
According to Wells Fargo, there’s a high chance of the invalidation of Medtronic’s patents on appeal.
As such, our consultant still expects the patents to be invalidated, though we have to wait for yet another appeal to the Federal Circuit. Our consultant expects the appeal to the Federal Circuit will take roughly 8-12 months. In the meantime, we are still waiting for yet two more IPR decisions, recently delayed to May 31.”
More on the background of the Medtronic-Axonics battle
Irvine, California-based Axonics develops neuromodulation systems for treating urinary and bowel dysfunction. Its fourth-generation R20 rechargeable SNM system received FDA approval over a year ago. Axonics also launched the recharge-free F15 SNM system in mid-2022. Boston Scientific announced a deal to acquire Axonics for $3.7 billion in January.
Axonics’ r-SNM platform has rivaled Medtronic’s Interstim system in the neuromodulation space since its initial FDA approval in 2019, when Medtronic first filed its lawsuit.
In 2020, the the U.S. Patent Trial and Appeal Board (PTAB) handed down a decision to reject one of Axonics’ claims to invalidate a Medtronic patent. Then, in 2021, PTAB rejected Axonics’ attempt to invalidate three Medtronic patents in its IP infringement lawsuit related to the InterStim neuromodulation device family.
Axonics maintains that Medtronic aims to stifle competition with its lawsuit. The company alleged in the past that this limits choices for physicians and patients and protects its leading market position.
Cohen said last month: “Axonics refuses to be intimidated by Medtronic and intends to defend itself vigorously In the meantime, we remain focused on innovation for improving the lives of patients with incontinence and continuing on our path to market leadership.”
