Medtronic has reported that it would appeal the $73.5m jury verdict returned in the US District Court in Delaware deciding that the CoreValve transcatheter aortic valve system infringes a valid US Andersen patent owned by Edwards Lifesciences.
The jury verdict has no bearing on Medtronic’s ability to sell CoreValve products internationally or to conduct clinical trials in the US. It pertains to an Andersen patent that is currently scheduled to expire before CoreValve products are expected to be approved by the FDA. In the event of a US injunction, Medtronic has manufacturing capabilities for CoreValve products outside the US to ensure continued supply world wide.
Medtronic said that it would also oppose any effort by Edwards to seek an injunction of the CoreValve product in the US. For several reasons, the most significant of which is the public interest in keeping the CoreValve product available to patients with aortic stenosis who need it, Medtronic contends that an injunction in this case is not justified.
The CoreValve transcatheter aortic valve system is designed to enable replacement of a diseased aortic valve without open-heart surgery and without surgical removal of the diseased valve. The replacement valve is delivered through a catheter inserted into a small opening in an artery in the patient’s leg.
As the replacement valve is deployed, the diseased valve is pushed aside, replaced by the new valve, which begins working immediately to improve blood flow from the heart to the rest of the body. The CoreValve System is not currently available in the US for clinical trials or for sale.
Scott Ward, senior vice president and president of the CardioVascular business, at Medtronic said: “Medtronic is disappointed that the jury in this case reached a different conclusion than courts in England and Germany, where the CoreValve product was found not to infringe related European Andersen patents owned by Edwards. We will file appropriate motions and appeals to challenge the jury verdict.”
Medtronic said that its CardioVascular business is committed to advancing the treatment of coronary, peripheral, aortic and structural heart disease through collaboration with leading clinicians, researchers and scientists worldwide.