Edwards Lifesciences AG v. CoreValve, Inc.

Edwards Lifesciences AG and Edwards Lifesciences LLC (Edwards) (plaintiff) owned a patent for a transcatheter heart valve, a device for performing non-invasive open-heart surgery. Edwards sued CoreValve, Inc. and Medtronic CoreValve, LLC (CoreValve) (defendant) for infringement of the patent, seeking damages and a permanent injunction against further infringement. After trial, a jury concluded that CoreValve had infringed the patent. The jury awarded damages and a reasonable royalty. The district court denied Edwards’s request for an injunction, however, finding that Edwards would not suffer irreparable harm in the absence of an injunction because Edwards had already relinquished exclusivity of the patent when it licensed to another competitor. As a result, Edwards had already lost its market share prior to the alleged infringement. The district court also relied on CoreValve’s representation that it planned to move its manufacturing operations to Mexico, which would effectively terminate the infringement. Edwards appealed, contending that Edwards had not yet lost market share because the Food and Drug Administration had not yet authorized sales in the United States, and that Edwards had not, in fact, licensed the patent to another competitor. Edwards further contended that, despite CoreValve’s representation that all operations would be moved to Mexico, CoreValve had continued manufacturing the infringing valves in California.