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Medical Devices / Regulatory Affairs / Research and Development

European Patent Office Rules for Medtronic in Spat with Edwards

March 10, 2014

The European Patent Office Thursday invalidated and revoked Edwards Lifesciences’ EP2055266 Spenser patent, the basis for the Sapien transcatheter heart valve and source of an injunction against sales of Medtronic’s CoreValve system in Germany.

Medtronic lauded the ruling, saying it will ensure that European patients have access to aortic valve replacement therapy.

Edwards spokeswoman Sarah Huoh said the company will appeal the decision. She stressed that the decision has “no impact on Edwards’ ability to offer the Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valves.”

Thursday’s ruling follows a preliminary ruling by the EPO in October and a November order by Germany’s Higher Regional Court in Karlsruhe to discontinue a lower court injunction against CoreValve. — Lena Freund

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