UK Court of Appeal dismisses Edwards Lifesciences’ appeal against Sapien 3 infringement ruling

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Acurate neo

Boston Scientific has 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.

Desiree Ralls-Morrison, senior vice president, general counsel and corporate secretary, Boston Scientific, comments: “We are pleased with another positive ruling from the European courts which further substantiates our intellectual property. We see the UK 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.”

According to a press release, Boston Scientific currently offers the Acurate neo transcatheter aortic valve implantation (TAVI) 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 commercialise the new valve later this year as well as begin a pivotal clinical study for US regulatory filing.

However,  in a separate ruling, the US Patent and Trademark Office (USPTO) decided in Edwards’ favour in an Inter Partes Review (IPR) of Boston Scientific’s US transcatheter heart valve patent, number 8,992,608 (the ‘608 patent). The USPTO determined that all claims of the ‘608 patent that have been asserted against Edwards are invalid. According to a press release from Edwards Lifesciences, Edwards asserted three of its own foundational transcatheter heart valve patents against Boston Scientific. The press release states that the Edwards patent claims are unaffected by the USPTO’s ruling and will continue to trial, which is expected later in 2018.

In the Boston Scientific release about the UK Court of Appeal decision, the company claims it plans to the USPTO’s decision.

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