Medtronic Turns Tables on Edwards in Heart Valve Saga

Medtronic scored a badly needed point in its heart valve struggles with rival Edwards Lifesciences when the European Patent Office (EPO; The Hague) ruled that Edwards' so-called Spenser patent was invalid in its entirety. The decision has no effect on Edwards' Sapien series of transcatheter heart valves, but scuttles their efforts to keep Medtronic's CoreValve competition out of the market.

The two companies have been fighting a seesaw battle over the German heart valve market since last summer. In August, Edwards won an injunction against Medtronic's CoreValve transcatheter aortic valve implantation (TAVI) system in a Mannheim court. After the EPO issued a preliminary opinion in October questioning the validity of Edwards' patent, the Higher Regional Court in Karlsruhe ordered the discontinuation of the Mannheim court ruling and Medtronic could once again sell its CoreValve technology in Germany.

Yesterday's ruling, while subject to further appeal, effectively finalizes that preliminary opinion and invalidates the Edwards patent in Europe. Edwards reportedly does indeed intend to appeal.

Medtronic is no doubt pleased with this win. Reports from the European Society of Cardiology Congress held in Munich in 2012 indicate that German doctors have adopted TAVI faster than those of any other country. About half of all elderly patients over 75 in Germany are said to receive transcatheter aortic valve replacement therapy.

Still there remains the bigger fight in the United States, where Medtronic has not been faring so well. The U.S. court cases have centered around Edwards' Cribier patents, and here Edwards has been winning. In January, a U.S. District Court jury ordered Medtronic to pay Edwards at least $394 million in damages in a verdict centering around the Cribier patents. What's more, the jury found this infringement to be willful, enabling Edwards to seek triple damages plus attorneys' fees. In other words, Medtronic's exposure in this case could top $1 billion. Edwards has said it will move to enforce the verdict and seek a permanent injunction against Medtronic and CoreValve.

And a year ago, Medtronic lost an appeal at the U.S. Supreme Court stemming from a jury trial that Edwards won in 2010. That jury had found willful infringement by Medtronic's CoreValve of Edwards' Andersen transcatheter heart valve patent, and awarded damages of $83.6 million.

Stephen Levy is a contributor to Qmed and MPMN.