A federal jury has awarded damages to Boston Scientific for patent infringement by Edwards Lifesciences’ Sapien 3 transcatheter aortic valve, both companies announced Tuesday, December 11, 2018.
The jury also found that Boston Scientific’s Lotus transcatheter aortic valve does not infringe on Edwards’ U.S. Spenser patents.
“We continue to be encouraged by the sustained record of positive legal rulings, first in European courts and now in the U.S., which upholds our company's intellectual property,” said Desiree Ralls-Morrison, Boston Scientific’s senior vice president, general counsel and corporate secretary, in a news release.
A jury in the U.S. District Court for the District of Delaware determined that Edwards Lifesciences’ infringement entitles Boston Scientific to damages through the end of 2016, according to Boston Scientific, which added that additional damages from 2017-2018 will be determined by the court at a later date.
Edwards Lifesciences issued a brief statement acknowledging the jury’s decision, which it said awarded $35 million in damages to Boston Scientific.
However, the statement added, “Edwards does not expect to pay the jury award since, earlier this year, the U.S. Patent and Trademark office determined that all asserted claims of the ’608 patent were invalid.”
The ’608 patent refers to the last 3 digits of Boston Scientific’s U.S. patent number, 8,992,608.
Edwards also said in its statement that it plans to appeal the court’s finding that Boston Scientific did not infringe on Edwards’ transcatheter heart valve patents.
Boston Scientific’s Lotus system features an adaptive sealing technology, which creates an external seal to prevent leakage around the valve known as paravalvular leak, which is a proven predictor of mortality, according to the company. The company anticipates that the Lotus Edge Valve System will be commercialized in CE mark countries in the first quarter of 2019 and in the U.S. in mid-2019, pending Food and Drug Administration regulatory approval timelines. Currently, Lotus Edge is an investigational device in the U.S., and a CE Mark is pending.
Boston Scientific recalled the Lotus and Lotus Edge systems in February 2017, saying then that a pin in the tool that deploys the valve may get disconnected before the operator is ready to release the device. In November 2017, Kevin Ballinger, the company’s executive vice president and president of interventional cardiology, stressed that the valve itself was operating as it should, but that a mechanical attachment between the delivery system and the valve still had problems.
In announcing the company’s third-quarter 2018 results in October, Boston Scientific said it had submitted the premarket approval application for Lotus Edge.
Edwards Lifesciences announced in November 2018 that its Sapien 3 Ultra transcatheter aortic valve system received the CE Mark.
Sapien 3 Ultra features enhancements to the valve, and a new delivery system and sheath, according to Edwards. The valve features a heightened outer skirt designed to eliminate paravalvular leak. The valve’s delivery system, which consists of a new low-profile 14-French Axela expandable sheath, introduces an “on balloon” design, removing the need for valve alignment during the procedure, the company said.
Sapien 3 Ultra is not approved in the U.S., but Edwards previously said it anticipates receiving FDA approval by the end of 2018. The FDA approved Sapien 3 in June 2017 and Sapien XT in October 2015.