The key litigated issue in Edwards Lifesciences AG v. CoreValve, Inc. was whether the lower court properly denied the plaintiff's request for injunctive relief in this patent infringement action in light of traditional principles of equity as set out in eBay Inc. v. MercExchange, L.L.C.

The plaintiffs in this case, Edwards Lifesciences AG and Edwards Lifesciences LLC (collectively, Edwards), sued the defendants in the US District Court for the District of Delaware for infringement of Edwards' US Patent No. 5,411,552 ('552 patent) claiming a transcatheter heart valve, a prosthetic device designed as a substitute for open heart surgery.

A jury found that the '552 patent was valid and willfully infringed. The district court entered judgment on this verdict but declined to issue Edwards's requested injunction against future infringement by defendant Medtronic CoreValve, LLC because CoreValve represented that, if enjoined, it would move its manufacturing operations to Mexico. Edwards appealed this ruling to the US Court of Appeals for the Federal Circuit.

Edwards argued on appeal that, despite the defendants' representation, CoreValve continued to manufacture its infringing device in California. CoreValve did not dispute this fact.

In its November 13, 2012 opinion, the Federal Circuit vacated the district court's denial of Edwards's requested injunction and remanded the case for reconsideration of whether an injunction should issue in view of Edwards's disclosure of changed circumstances.

Edwards argued that the court should issue an injunction because, among other reasons, CoreValve was its direct competitor and, without patent exclusivity, Edwards would lose first-mover advantage, market share and reputation. The district court rejected this argument, responding that Edwards already lost these advantages. However, Edwards argued on appeal that this finding was incorrect because the Food and Drug Administration had not yet authorized any US sales of its or the defendants' product and this precluded both parties from establishing, or losing, a first-mover advantage.

In considering the district court's denial of the injunction, the Federal Circuit expanded on the US Supreme Court's decision in eBay. In particular, regarding Edwards's exclusive patent rights, the Federal Circuit emphasized that the eBay decision in no way negated or qualified a patent holder's fundamental right to enforce the exclusive rights accorded by its patent. However, the court also noted that eBay counsels that the decision whether to direct or deny injunctive relief rests within the district court's equitable discretion, which it must exercise consistent with the traditional principles of equity.

Citing the need for the district court to fully explore the record to consider, among other things, the changed circumstances noted by Edwards, the Federal Circuit vacated the lower court's denial of Edwards's request for injunctive relief and remanded the case for reconsideration of this request in light of the changed circumstances and other relevant factors.

Parties to patent infringement disputes should note that: