Déjà vu? A federal jury determined that Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) device infringed on a patent owned by Edwards Lifesciences, a finding Medtronic indicated it would appeal. The jury awarded Edwards Lifesciences $394 million in damages.
This is not the first skirmish between the two companies over their competing TAVR products. Last year, a German court ruled that Medtronic infringed on an Edwards TAVR valve patent and ordered Medtronic to recall its CoreValve and CoreValve Evolut systems in Germany.
The CoreValve System received FDA approval for extreme risk TAVR patients two days after the U.S. infringement decision. Edwards’ Sapien TAVR device was approved by the FDA for use in inoperable patients with severe aortic stenosis in 2011 and for high-risk patients in 2012.
The patent under dispute in the U.S. is part of the Cribier family of patents, according to Edwards. It expires in December 2017. The case in Germany revolved around Edwards’ Spenser patent. At the time, Medtronic said it would appeal the ruling.
Neil Ayotte, vice president and Medtronic’s acting general counsel, predicted the U.S. jury decision would be overturned on appeal. “Medtronic has prevailed against Edwards in several legal actions related to a European counterpart to this patent and others, and believes the Federal Circuit Court of Appeals will find no merit to Edward's infringement claim,” he said in a release.
Edwards listed other legal challenges involving infringement between the two companies. It cited a 2010 federal jury decision against Medtronic CoreValve over the U.S. Andersen transcatheter heart valve patent. It said the finding was upheld on appeal, resulting in an initial payment of $84 million in 2013.
Edwards Lifesciences in based in Irvine, Calif., and Medtronic in Minneapolis.