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Edwards vs. CoreValve

This article was originally published in The Gray Sheet

Executive Summary

Edwards Lifesciences files patent suit Feb. 12 against CoreValve in Delaware District court alleging CoreValve's ReValving percutaneous aortic valve replacement system infringes three Edwards' patents related to transcatheter heart valves. Edwards has filed similar litigation in Germany and the U.K. The latest suit is directed at CoreValve devices made in the United States and sold in Europe, where ReValving earned a CE mark in May 2007. Edwards recently launched its Sapien transcatheter aortic replacement heart valve in Europe and has begun the PARTNER pivotal trial of the device in the United States (1"The Gray Sheet" Sept. 10, 2007, In Brief)

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Edwards v. CoreValve in U.K.

CoreValve and Edwards Lifesciences each claimed victories Jan. 9 in patent infringement cases involving competing transcatheter valve technology. A U.K. court found the product design for CoreValve's ReValving system for transcatheter aortic valve replacement does not infringe on a patent held by Edwards. But the court also upheld the validity of Edwards' U.K. Andersen patent for transcatheter valve technology, dismissing a CoreValve suit. An Edwards lawsuit against CoreValve in the U.S., citing infringement against the U.S. patent for the same technology, is still pending (1"The Gray Sheet" Feb. 18, 2008, In Brief). The ReValving system is not available in the U.S

Edwards Lifesciences transcatheter heart valve gains European market go-ahead

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