Boston Scientific, Edwards facing off in new TAVR battle

A new patent spat is being fought in Germany by Boston Scientific (NYSE:BSX), who alleges that Edwards Lifesciences (NYSE:EW) is infringing on a patent associated with its Lotus transcatheter heart valve.

Late last month, Boston Scientific filed the patent infringement in Dusseldorf, Germany, charging that Edwards Sapien 3 transcatheter aortic valve replacement is infringing on a European adaptive sealing technology patent, according to a correspondence between MDDIOnline and Boston Scientific spokesperson Thomas Keppler.

Keppler told MDDI that the Lotus Valve won CE Mark approval in the European Union in October 2013, featuring adaptive sealing technologies designed to reduce paravalvular leakage.

In January, 2014, Edwards won a CE Mark for its Sapien 3, which Keppler said “also uses an external seal which it claims significantly reduces PVL.”

“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. Our investments in developing the field of TAVR have been significant, encompassing more than 15 years of trailblazing work and greater than $1 billion dedicated to carefully nurturing the development of this therapy, training clinicians around the world and investing in the clinical research that guides the continuous improvement in patient outcomes,” Edwards said in a response statement, according to MDDI.

Edwards is no stranger to TAVR suits, having won a round in January last year in the longtime legal battle Medtronic (NYSE:MDT) over their respective transcatheter aortic valve implants when a Delaware jury ruled that Medtronic’s CoreValve device infringes a patent covering Edwards’ Sapien device.

Medtronic struck back in March, landing a major win against arch-rival Edwards when the European Patent Office revoked an Edwards patent at the heart of a contentious infringement lawsuit.

The EPO decision stymies Edwards’ efforts to keep Medtronic’s CoreValve transcatheter aortic valve implantation system off the market, but doesn’t affect Edwards’ own sales. The ruling is open for appeal and Edwards plans to pursue one, spokeswoman Sarah Huoh told MassDevice.com.

In April, Medtronic went to Federal Circuit Court of Appeals after a lower court ruled in favor of Edwards, banning U.S. sales of Medtronic’s CoreValve transcatheter aortic valve implantation system.

The Federal District Court of Delaware ruled last year that the CoreValve device infringes on Edwards’ patents, and the judge issued an order banning Medtronic from selling or offering to sell the CoreValve system in the U.S. At Medtronic’s request, the judge stayed the order for 7 business days to give the company time to “seek prompt relief” from a higher court.

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