Medtronic, Inc.: Medtronic Settles Global Patent Litigation with Edwards
TAVI and Surgical Patent Cases Resolved
MINNEAPOLIS - May 20, 2014 - Medtronic, Inc. (NYSE: MDT) announced that it has
reached a global patent settlement agreement with Edwards Lifesciences
Under the terms of the cross-license settlement agreement, the parties will
dismiss all of the pending litigation matters and patent office actions
between them, and grant each other broad releases to patent litigation
claims. Medtronic will pay Edwards a one-time payment of $750 million, and
ongoing royalty payments through April 2022 based on a percentage of CoreValve
sales, in payments of no less than $40 million annually.
In addition to settling the pending lawsuits with cross-licenses, Medtronic
and Edwards have agreed that neither party will sue the other for patent
matters anywhere in the world for eight years in the field of aortic and all
other transcatheter heart valves.
"This agreement brings to an end years of disputes between our companies
related to TAVI patents, and allows both companies to make their respective
therapies available to physicians and patients around the world," said John
Liddicoat M.D., president of the Structural Heart business at Medtronic. "With
this resolution, we are pleased that Medtronic will be able to continue to
provide the CoreValve® System, as well as other products, to patients who need
them in the U.S. and abroad without the overhang of any potential injunction
or additional damages. "
In the agreement, neither Medtronic nor Edwards have admitted that their
products infringe any patents or that any patents are invalid.
The CoreValve System received approval from the FDA in January 2014. Based on
the strength of the clinical data, the FDA quickly reviewed and approved the
CoreValve System for patients at extreme risk for surgical valve replacement
in January. The CoreValve System is not yet approved in the U.S. for other
Data presented at the American College of Cardiology (ACC) annual meeting in
March 2014 and simultaneously published in The New England Journal of Medicine
showed that patient results with CoreValve System were superior to surgical
aortic valve replacement (SAVR) at one year in patients at increased risk for
surgery. This is the first time a prospective, randomized study has shown any
transcatheter aortic valve to be superior to surgery.
Upon reviewing the CoreValve Trial's results for high-risk patients, the FDA
determined it has sufficient information to evaluate the safety and efficacy
of the Medtronic CoreValve System for this patient group without the need for
an external expert panel. As such Medtronic anticipates FDA approval of the
CoreValve System for high-risk patients sometime this summer.
In collaboration with leading clinicians, researchers and scientists
worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias. The company strives to offer products and
services that deliver clinical and economic value to healthcare consumers and
providers around the world.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the
global leader in medical technology - alleviating pain, restoring health, and
extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities
and Exchange Commission. Actual results may differ materially from anticipated
This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf
of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for
the content, accuracy and originality of the information contained therein.
Source: Medtronic, Inc. via Globenewswire
Press spacebar to pause and continue. Press esc to stop.