July 12th, 2013

Medtronic Faces Removal of CoreValve Transcatheter Heart Valve from German Market

In the wake of a major patent decision, Medtronic will be forced to remove its CoreValve transcatheter heart valve from the German market. Edwards Lifesciences said today that a German Court had found that Medtronic infringed a key patent, known as the Spenser patent, and granted an injunction prohibiting the sale of CoreValve and CoreValve Evolut systems in Germany.

Medtronic said it would appeal the decision and that the action “will limit options for physicians and their patients who need transcatheter aortic valve procedures, which Medtronic believes is contrary to sound health policy.”

It should be noted that although the court found that Medtronic had infringed the Spenser patent, the validity of the patent itself is being contested. (In Germany the validity and infringement of patents are contested separately.) “Ultimately,” Medtronic said, it “believes that Edwards’ patent claims will be found to be invalid, which will negate today’s ruling of patent infringement.”

But the court decision today means that Medtronic will be forced to withdraw from the German market after Edwards posts a bond.  Edwards noted that the Spenser patent is also in place in France, Italy, Spain, and other countries, raising the possibility that Medtronic may be forced to withdraw from additional markets in the future. The German ruling does not affect the status of other Medtronic products in Germany such as the Engager device, which is used for transapical procedures, and the MelodyPulmonic Transcatheter Valve.

Edwards and Medtronic are also engaged in litigation in the U.S. over a different Edwards patent, known as the Andersen patent. If Edwards prevails in the U.S., Medtronic might not be able to enter the U.S. market until 2016, according to Wells Fargo analyst Larry Biegelsen.


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