Boston Scientific Corporation, lobal medical technology leader, announced the UK Court of Appeal dismissed Edwards Lifesciences' appeal and upheld a prior court decision that Edwards' Sapien 3 device infringes Boston Scientific patent EP (UK) 2 926 766 and that all claims of that patent are valid.
"We are pleased with another positive ruling from the European courts which further substantiates our intellectual property," said Desiree Ralls-Morrison, senior vice president, general counsel and corporate secretary, Boston Scientific. "We see the U.K. court's decision as an important validation of our patents and supports our goal to bring differentiated solutions to patients suffering from severe and symptomatic aortic valve stenosis."
Separately, the company plans to appeal the US Patent Office's recent Inter Partes Review finding that certain claims of the Boston Scientific US patent 8,992,608 asserted against Edwards are invalid.
Boston Scientific currently offers the ACURATE neo Aortic Valve System in key European markets. The company is also seeking CE mark application for the next-generation valve system, the ACURATE neo2, and intends to commercialize the new valve later this year as well as begin a pivotal clinical study for US regulatory filing.
The ACURATE family of valve products is one of two valve systems in the Boston Scientific structural heart portfolio. The LOTUS Valve System features an adaptive seal, which creates an external seal to prevent leakage around the valve known as paravalvular leak or PVL, which is a proven predictor of mortality. The company continues to have a goal to return the LOTUS Valve to the European market and launch in the US in 2019, pending its ability to clear certain technical and regulatory hurdles.