The Federal Circuit Court of Appeals has affirmed the April 2010 jury verdict from the Federal District Court of Delaware that the CoreValve System infringed a single Andersen patent held by Edwards Lifesciences.
The Court of Appeals also remanded the case back to the District Court to consider a potential injunction. “While Medtronic respects the court’s ruling, we respectfully disagree with this conclusion and we are evaluating next steps,” stated Medtronic.
According to the company, these legal actions have no impact on the Medtronic CoreValve US pivotal trial, the Medtronic CoreValve SURTAVI trial, or any other clinical studies evaluating the CoreValve system. Due to its global manufacturing capabilities, Medtronic does not anticipate any interruption to the global supply of the Medtronic CoreValve system.
While Edwards has applied for a patent extension, there is no assurance an extension will be issued or what the impact or duration of that extension would be. These applications involve a review by two government agencies, and the process often can take between two and five years.