US District Court for the District of Delaware rules that Sapien 3 infringes a Boston Scientific patent

Acurate neo

A jury in the US District Court for the District of Delaware determined that the Boston Scientific US patent 8,992,608 is valid and that Sapien 3 transcatheter aortic valve implantation (TAVI) device infringes this patent and that Edwards owes Boston Scientific infringement damages through the end of 2016. A press release reports that additional damages and interest incurred from 2017–2018 will be determined by the court in post-trial motions.

According to the press release, the jury also found that the Boston Scientific Lotus TAVI device does not infringe Edwards’ Spenser patents US 7,510,575, US 9,168,133, or US 9,339,383. At present, Boston Scientific does not have a TAVI device on the US market, but the press release states that the company Lotus Edge will be commercialised in CE mark countries in Q1 2019 and in the USA in mid-2019, pending FDA regulatory approval timelines. Additionally, it is seeking a CE mark application for the next-generation valve system, the Acurate neo2, which it intends to commercialise during the first half of 2019 (the first-generation Acurate neo is already on the European market).

Desiree Ralls-Morrison, senior vice president, general counsel and corporate secretary, Boston Scientific, comments: “We continue to be encouraged by the sustained record of positive legal rulings, first in European courts and now in the USA, which upholds our company’s intellectual property.”

However, in a statement responding to the ruling, Edwards Lifesciences said it not expect to pay the jury award since “earlier this year, the US Patent and Trademark office determined that all asserted claims of the ‘608 patent were invalid”. It adds that although the its Spenser Patents for transcatheter heart valves “are valid, but not infringed by the Lotus devices”, it plans to appeal. Furthermore, in the statement, Edwards Lifesciences notes “Boston Scientific initiated litigation that now involves multiple patents in multiple venues, and will likely yield court actions over an extended period of time”.


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