The Court issued the preliminary injunction on Friday preventing Medtronic from selling its CoreValve System in the United States following a patent battle beginning in 2008, according to a Forbes report. In 2010, a federal jury ruled Medtronic infringed on Edwards’ patent for a transcatheter aortic valve replacement.
The U.S. Food and Drug Administration approved the CoreValve System for use in January without requiring an independent device advisory panel review due to the device demonstrating “exceptional clinical performance.”
The Court, too, noted CoreValve’s superior outcome rate, but said public interest in patent rights still override.
“The Court is…convinced that the CoreValve Generation 3 is a safer device and that patients in whom it is implanted have better outcomes with a lower risk of death. At the same time, the Court cannot downplay the strong public interest favoring enforcement of patent rights,” the judge said when delivering the decision.
The judge ordered Medtronic and Edwards Lifesciences to settle upon an arrangement for physicians trained on the CoreValve system to decide which device to implant in a way that does not violate the injunction.
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