US-based Medtronic has announced that the European Patent Office (EPO) has invalidated an Edwards’ patent (EP2055266) that was used to prevent Medtronic from selling its CoreValve transcatheter aortic valve in Germany.
In its ruling, the EPO in The Hague said the entire patent is invalid and therefore has revoked it.
Medtronic senior vice-president and president of the Medtronic structural heart business Dr John Liddicoat said: "Medtronic is very pleased with this ruling as it will ensure that patients across Europe who need aortic valve replacement will have access to this life-saving therapy."
In October 2013, the EPO issued a preliminary opinion that questioned the validity of Edwards Lifesciences’ patent, which led the higher German court to order the discontinuation of the injunction. Medtronic said that the latest ruling is subject to further appeal.
The CoreValve system was developed to serve the needs of the broadest range of patients with severe aortic stenosis.
The CoreValve system is suitable for patients with native valves of nearly all sizes and its self-expanding nitinol frame enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement.
In addition, the CoreValve system is available in the broadest range of sizes available, so patients who have smaller, larger or in-between sizes can be accommodated.
All valve sizes are delivered through the smallest (18Fr, or 6mm) TAVR delivery system available, making it possible to treat patients with difficult or small vasculature.
In January, a federal court jury in Delaware ruled that Medtronic’s CoreValve infringed on another Edwards patent, known as the Cribier patent.
The jury held Medtronic liable for $394m in damages. Edwards has said it will move to enforce the verdict and seek a permanent injunction against Medtronic and CoreValve.
The CoreValve system received the CE Mark approval in 2007 and has been implanted in more than 50,000 patients worldwide, excluding the US.
It also received US Food and Drug Administration (FDA) approval for patients at extreme risk for surgery in January 2014.
According to GlobalData estimates, the transcatheter heart valves market in the US was valued at $280m in 2012 and is expected to grow at a CAGR of 25.3% to reach $1.36bn by 2019.
Image: Medtronic world headquarters, Minneapolis, US. Photo: courtesy of Medtronic.