Medtronic ($MDT) is losing badly against Edwards Lifesciences ($EW) in the companies' U.S. battles over transcatheter heart valve patents. But the Minnesota device giant's fortunes in Europe in the bitter fight have taken a significant turn for the better.
The European Patent Office (EPO) has invalidated and revoked Edwards Lifesciences' entire Spenser patent concerning its market-leading Sapien transcatheter aortic heart valve, which has approval in the U.S., Europe and other countries. This is a big victory for Medtronic and its CoreValve system, which has had a CE mark since 2007 and gained FDA approval for patients at extreme risk for surgery just in January 2014.
Medtronic, in its announcement of the EPO decision, noted the Spenser patent formed the basis for an August injunction stopping Medtronic from selling its CoreValve device in Germany. The EPO issued a preliminary opinion in October rebuffing Edwards' claims regarding its Spenser patent, and a German appeals court officially lifted the sales injunction in November. This is the biggest European victory in the case so far for Medtronic.
"Medtronic is very pleased with this ruling as it will ensure that patients across Europe who need aortic valve replacement will have access to this life-saving therapy," Dr. John Liddicoat, senior vice president at Medtronic and head of its structural heart business, said in a statement.
It's too soon for Medtronic to be breaking out the bubbly, yet, however, for a number of reasons. First, as the company noted, the EPO ruling can be appealed (no word yet from Edwards whether this will happen, but that's likely). There's also the U.S. District Court jury in January that ordered Medtronic to pay Edwards at least $394 million in damages, in another Sapien vs. CoreValve patent battle. This verdict stems from Edwards' Cribier family of patents (which expire at the end of 2017), and Edwards has said it will move to enforce the verdict and seek a permanent injunction against Medtronic and CoreValve. What's more, the U.S. verdict found that Medtronic's CoreValve transcatheter aortic heart valve "willfully" infringes on Edwards' U.S. Cribier transcatheter heart valve patent for Sapien, enabling Edwards to seek triple damages plus attorneys' fees.
There's also the U.S. federal jury trial that Edwards won in 2010 that found Medtronic's CoreValve willfully infringed on Edwards' U.S. Andersen transcatheter heart valve patent, awarding damages. Medtronic forked over $83.6 million in the matter last March and even lost an appeal with the U.S. Supreme Court.
In other words, there's plenty of fight left for Medtronic and Edwards to pursue before there's a clear winner.
- read the Medtronic announcement