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Valve Wars, Part II: Edwards vs. Medtronic
European Patent Office Invalidates Edwards' Spenser Patient
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Medtronic, Inc.

Medtronic's CoreValve
Medtronic's CoreValve
March 6, 2014 -- Last summer the District Court of Mannheim issued an injunction prohibiting Medtronic from selling its CoreValve and CoreValve Evolut transcatheter valves in Germany. The injunction was based on the Spenser patent.

In November, the German courts lifted the injuction, due to a preliminary ruling by the European Patent Office (EPO) that the Spenser patent was not valid.

Today Medtronic announced that the European Patent Office has finalized its opinion and has revoked the Spenser patent in its entirety. This outcome is a big win for Medtronic in Europe, although the ruling is subject to appeal by Edwards.

In the U.S. Edwards has sued Medtronic, claiming that the CoreValve design infringes on its Cribier patent, a different claim than was rejected in Germany. Although this lawsuit currently does not involve an injunction against Medtronic's U.S. sales of the CoreValve, which was just approved by the FDA in January, the company is obviously hoping for an outcome similar to today's.

This morning's press release from Medtronic, Inc. follows:

Medtronic Wins European Patent Office Ruling

March 6, 2014 -- Minneapolis -- Medtronic, Inc. (NYSE: MDT) today announced that the European Patent Office (EPO) has invalidated, in its entirety, the Edwards Lifesciences EP2055266 Spenser patent which was the basis for the Aug. 26, 2013 injunction prohibiting sales of the CoreValve® System in Germany.

In its ruling, the EPO in The Hague said the entire patent is invalid and therefore revoked.

"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," said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart Business.

In October, the EPO issued a preliminary opinion that questioned the validity of this patent, and this led the Higher Regional Court Karlsruhe to order the discontinuation of the prior court ruling that prohibited Medtronic from commercially marketing or selling the CoreValve System in Germany. Today's ruling is subject to further appeal.

The CoreValve System was designed specifically to overcome the challenges of a broad range of TAVR patients. The device has a small 18Fr profile for all four valve sizes, which minimizes trauma at implant, and allows physicians to treat patients with small or calcified vasculature. Its Nitinol frame is designed to prevent unwanted leakage and optimize blood flow. In addition, the CoreValve System is available in the broadest range of sizes available, so patients who have smaller, larger or in-between sizes can be accommodated.

The CoreValve System received CE Mark in 2007, and received U.S. Food and Drug Administration (FDA) approval for patients at extreme risk for surgery in January 2014.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic
Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Reported by Burt Cohen, March 6, 2014