Boston Scientific takes its TAVR patent battle with Edwards stateside

Boston Scientific's Lotus TAVR--Courtesy of Boston Scientific

Boston Scientific ($BSX) and Edwards Lifesciences ($EW) have been scuffling over patents for heart valve replacement devices in Europe. Now, the legal battle is expanding to the U.S. as Boston Scientific vies for more market share.

Boston Scientific alleges in two separate lawsuits in the U.S. District Courts for the District of Delaware and the Central District of California that Edwards infringes on its patents for replacement heart valves and related products, Reuters reports.

Edwards, though, called Boston Scientific's suits "without merit," the company told FierceMedicalDevices in an emailed statement. Edwards has been around in TAVR longer than Boston Scientific and has made $1 billion in investments in the field, the company said. Therefore, it's "confident" in its case and is "obligated to defend it vigorously."

"We are disappointed that Boston Scientific, which does not have an FDA-approved transcatheter therapy in the U.S., has resorted to legal action in this matter, rather than sharing our focus on creating value through innovative therapies and enabling treatment for patients around the world," the company said. 

Boston Scientific's move comes months after it filed another patent infringement suit against Edwards in Europe. In November, Boston Scientific claimed in a German court that Edwards' Sapien 3 TAVR infringes its patents for adaptive sealing technology. Boston Scientific's Lotus TAVR, which is approved in Europe, also uses the technology.

Sapien 3 valve--Courtesy of Edwards Lifesciences

But Edwards isn't owning up to any misdoings. The company holds the "seminal patents" for TAVR, Edwards told FierceMedicalDevices at the time. "It is unfortunate that Boston Scientific, as a more recent entrant into the TAVR field, is seeking to capitalize on our long-term efforts and gain greater presence through the court system," the company said.

Edwards, which has a first-to-market advantage for its TAVR devices, is no stranger to patent litigation. In 2014, the company and archrival Medtronic ($MDT) squared off over patents for competing TAVR products. 

The companies ended up agreeing to settle the suit in May 2014. "Edwards has looked forward to resolving these cases for a long time, and more recent court activity prompted a productive dialogue that led to this agreement," CEO Mike Mussallem said at the time. "We are very pleased that we reached a settlement that recognizes our significant commitment to pioneering transcatheter heart valves for clinicians and their patients around the world."

- read the Reuters story