March 9, 2017 — Boston Scientific announced the German District Court of Düsseldorf has determined that Edwards Lifesciences and its German subsidiary's Sapien 3 device infringed two patents of Boston Scientific Scimed Inc. related to the seals for transcatheter heart valves. The seals help prevent paravalvular leak around the valve after it is implanted, which is a feature of both the Boston Scientific Lotus transcatheter aortic valve replacement (TAVR) system and the Edwards Sapien 3 TAVR system.
The court said the two patents violated by Edwards are the German parts of EP 2 749 254 B1 and EP 2 926 766 B1.
Boston Scientific and its German subsidiary were also found not to infringe upon Edwards' German part of EP 1 441 672 B1. However, the court did find Boston infringed upon Edwards' German part of EP 2 399 550 B1. Boston Scientific said its believes the '550 patent will be revoked by the European Patent Office (EPO). Edwards said it will promptly request an appeal the decision.
The Lotus Valve System is designed for aortic valve replacement in patients with severe aortic stenosis who are considered at high risk for surgical valve replacement. Instead of open heart surgery, the replacement valve is delivered via transcatheter percutaneous delivery. The Lotus Valve Adaptive Seal is a technology that creates an external seal to prevent leakage around the valve known as paravalvular leak or PVL, which is a proven predictor of mortality.[1,2,3]
Edwards Lifesciences and Boston Scientific can appeal each of the four decisions as far as the District Court of Düsseldorf has decided against them. Each company has opposed the other's patents in the EPO.
This decision in Germany follows the March 3, 2017, ruling from the Patents Court of the High Court of Justice in England, which also ruled in favor of Boston Scientific Scimed Inc., finding that Edwards' Sapien 3 device infringes Boston Scientific patent EP (UK) 2 926 766 and that all claims of that patent were valid. Edwards has stated that it will try to appeal this judgment.
"We will continue to protect our intellectual property to ensure we can continue to bring forward innovative technologies that make a meaningful difference in the lives of patients," said Tim Pratt, executive vice president, chief administrative officer, general counsel and secretary, Boston Scientific. "We are pleased with the progress we are making with litigation in Europe, and believe the strength of our intellectual property will also be upheld in U.S. cases involving the same patents."
1. Kodali SK et al. “Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement.” N Engl J Med 2012; 366:1686-1695
2. Tamburino C et al. “Incidence and Predictors of Early and Late Mortality After Transcatheter Aortic Valve Implantation in 663 Patients With Severe Aortic Stenosis.” Circ. 2011;123:299.
3. Abdel-Wahab M et al. “Aortic Regurgitation After Transcatheter Aortic Valve Implantation: Incidence and Early Outcome. Results from the German Transcatheter Aortic Valve Implantation Registry.” Heart 2011;97:899-906.