Edwards Lifesciences has obtained a preliminary injunction from the Federal District Court of Delaware to prevent Medtronic from selling its CoreValve transcatheter aortic valve implantation system in the US.
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The preliminary order will become effective in seven business days. Medtronic is currently appealing the court’s injunction, and intends to ask the Federal Circuit Court of Appeals to prevent it from going into effect until it determines if the injunction was properly issued.
At the conclusion of the hearing, the court ordered Edwards Lifesciences and Medtronic to enter discussions immediately to agree on a mechanism that will enable physicians at facilities currently trained on CoreValve to make clinical judgments on the appropriate device to implant (CoreValve or the Edwards’ SAPIEN valves) in patients, free from limitations of the injunction.
This case was initiated by Edwards in 2008. In 2010, a federal jury found that Medtronic CoreValve LLC willfully infringed on Edwards patent, the US Andersen transcatheter heart valve patent, and awarded damages to the company.
In November 2012, the US Court of Appeals for the Federal Circuit affirmed the jury decision; in October 2013, the US Supreme Court declined to hear Medtronic’s appeal.
The patent involved in this suit is part of the Andersen family of patents. The US Andersen patent was issued in 1995. A petition has been filed with the US Patent and Trademark Office to extend this patent into early 2016.
Edwards also won a similar case regarding the Cribier patent in January 2014 aganist Medtronic.
The CoreValve system received US Food and Drug Administration (FDA) approval in January for patients at extreme risk for surgical valve replacement.
Before then, CoreValve therapy was available to extreme risk patients who were eligible to participate in the US clinical trial. The CoreValve system is not yet approved in the US for other patient groups.
Medtronic said that this ruling has no impact on the sale or marketing of CoreValve outside of the US or the use of CoreValve in the current US clinical trials.
Image: Medtronic world headquarters, Minneapolis, US. Photo: courtesy of Medtronic.
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Find the right pricing strategy for your medical device
- A proprietary algorithm that leverages numerous pricing sources, with an emphasis on real-world data
- Estimates of the likely spread of selling prices per brand and manufacturer, as well as 3-year forecasts for prices
- Medical device pricing data that can be tracked by market, company, and brand
- Additional categories that can be built on a custom basis