Boston Scientific Prevails in German Edwards Lifesciences Litigation

Boston Scientific Corporation announced the District Court of Dusseldorf, Germany has determined that Edwards Lifesciences Corporation’s Sapien 3 Ultra device infringed a patent—established by Symetis SA, a subsidiary of Boston Scientific—specific to the fabric used on the valve seal, specifically the German part of European Patent (EP) 2 949 292 B1. The Dusseldorf Court ruled in preliminary injunction proceedings that Boston Scientific has the right to enjoin Edwards and its German subsidiary from offering and selling Sapien 3 Ultra in Germany. The infringement and injunction decision can be appealed by Edwards.
 
In 2017, Edwards’ currently-available Sapien 3 device was found to infringe two Boston Scientific patents (EP 2 749 254 B1 and EP 2 926 766 B1) by the same Court. Those rulings, which have been appealed by Edwards, enable Boston Scientific to enjoin Sapien 3 from the German market. The company has not yet exercised that option. 
 
“We are pleased with the steady cadence of European court rulings which uphold and validate our TAVR intellectual property against competitive encroachment,” said Desiree Ralls-Morrison, senior vice president, general counsel and corporate secretary, Boston Scientific. “Defending our patents is a core necessity which allows us to continue to innovate and offer differentiated technologies to hospitals, physicians and their patients.”
 
Boston Scientific currently offers the ACURATE neo Transcatheter Aortic Valve System in key European markets and is seeking a CE mark for the next generation system—ACURATE neo2 Transcatheter Aortic Valve System—which it intends to commercialize during the first half of 2019. The company expects to begin a pivotal clinical study of the ACURATE neo2 system in the U.S. later this year.
 
The ACURATE family of valve products is one of two TAVI valve systems in the Boston Scientific structural heart portfolio. The company anticipates the LOTUS Edge Valve System will be commercialized in CE mark countries in Q1 2019 and FDA approval to be secured in mid-2019, pending regulatory approval timelines.