Edwards Lifesciences v. Medtronic Corevalve, Appeal Settles After AARP Legal Advocacy

Appeal Settles After AARP Files Brief Urging Access to Life-Saving Medical Device

Read AARP's (PDF) A medical-device patent dispute settles for more than $1 billion after AARP asks to keep a FDA-approved heart valve accessible to patients

Background br

Aortic stenosis (a narrowing of the aortic valve opening that does not allow normal blood flow) is a health problem affecting over 1.5 million people. Patients at high risk who are too sick to be candidates for open heart surgery may benefit from a less invasive transcatheter aortic valve replacement as an alternative. This less invasive procedure allows a new valve to be inserted within a diseased aortic valve and can save lives. Without any treatment, half of the people with severe aortic stenosis die within an average of two years. Edwards Lifesciences (Edwards) obtained a patent on transcatheter aortic valve replacement system. Edwards sued a competitor, Medtronic for manufacturing a similar device for infringing their patent and won. After Edwards’ patent expired Edwards secured an extension of their patent. In January 2014, Medtronic obtained FDA approval for alternative valve replacement therapy for patients who are not able to use Edwards’ valve technology. Edwards sought and obtained a new preliminary injunction blocking the sale of Medtronic’s Corevalve aortic heart valve replacement system despite clear differences between Edwards and Medtronic’s valve systems. Edwards argued that Medtronic’s recently approved system also infringed on its patent despite the differences in the two valve devices. Even though the district court found that there are patients who cannot be served by Edwards’ valve system who might benefit from Medtronic’s new Corevalve device, the court still enjoined the sale of Medtronic’s system as infringing on Edwards’ patent. The injunction provided that Edwards was entitled to approve which patients could use the Medtronic system. AARP Foundation Litigation attorneys filed AARP’s friend-of-the-court brief supporting the sale of Medtronic’s device and challenging the injunction. Injunctions are designed for situations where there is a substantial likelihood of success on the merits and irreparable harm. AARP’s brief pointed out that the only potential harm to Edwards is financial — which is reparable by a later monetary award should Edwards succeed on the merits — while the dangers of the injunction are literally life-threatening for patients who cannot use the Edwards system and are too frail for open heart surgery. While litigation was pending, patients in over 20 states do not have access to Medtronic’s aortic Corevalve device and AARP’s brief argued patients in all states should have access to the system if their physicians determine that Medtronic’s system is the best treatment for them. Medtronic and Edwards Lifesciences settled a medical-device patent dispute allowing two heart valve systems to be sold in the U.S. and around the world. The settlement gives physicians the option of choosing the best medical device.

What s at Stake

Seriously ill patients should not be denied life-saving medical care as a result of alleged patent infringement. Millions of people have aortic stenosis, a disease that typically occurs after age 60. A significant number of these patients cannot tolerate open-heart surgery and Medtronic’s Corevalve system has been proven to save lives.

Case Status

Edwards Lifesciences AG v. Medtronic Corevalve settled after briefs were filed in the U.S. Court of Appeals for the Federal Circuit.

Get Involved

Find Help

Cancel You are leaving AARP.org and going to the website of our trusted provider. The provider’s terms, conditions and policies apply. Please return to AARP.org to learn more about other benefits. Your email address is now confirmed. You'll start receiving the latest news, benefits, events, and programs related to AARP's mission to empower people to choose how they live as they age. You can also by updating your account at anytime. You will be asked to register or log in. Cancel Offer Details Disclosures

Close In the next 24 hours, you will receive an email to confirm your subscription to receive emails related to AARP volunteering. Once you confirm that subscription, you will regularly receive communications related to AARP volunteering. In the meantime, please feel free to search for ways to make a difference in your community at Javascript must be enabled to use this site. Please enable Javascript in your browser and try again.