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Edwards and Medtronic: "Valve Wars"
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January 15, 2014 -- A decade ago it was "stent wars"; now it's "valve wars." Percutaneous transcatheter aortic valve replacements to be exact: also called TAVR or TAVI. With these new devices, an aortic valve replacement (or implantation) can be accomplished using catheter-based techniques similar to coronary angioplasty, and without the need for open surgery.
Although there are several transcatheter valves available in Europe and other parts of the world, only one is currently available in the United States: the first generation Sapien valve, manufactured by Edwards Lifesciences.
Medtronic, Edwards' closest potential competitor in the U.S. market, is hoping for an FDA approval of its CoreValve sometime in the first part of this year. This estimate is based on very positive one-year results from its pivotal U.S. study.
And when the competition is fierce, the patent suits appear: today a federal jury handed a victory to Edwards, finding "willful infringement" by Medtronic of Edwards' Cribier patent, and awarding $394 million in damages (or $392.5 million, depending on whose press release you read). Medtronic immediately announced that it would appeal the verdict.
A previous battle, although over a different patent infringement, recently took place in Germany, where Edwards was able to obtain an injunction against Medtronic's sales of the CoreValve. On appeal to a higher court, the German injunction was discontinued due to the court decision that the patent claims by Edwards were invalid.
Although no injunction against Medtronic is part of this latest U.S. lawsuit, obviously Medtronic is hoping for a similar outcome to their appeal.
This morning's press releases from both Edwards and Medtronic, Inc. follow:
Federal Jury Finds Medtronic CoreValve Willfully Infringes Edwards' Transcatheter Valve Patent
January 15, 2014 -- Irvine, CA -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that a federal jury today found that Edwards' United States Cribier transcatheter heart valve patent is valid and that Medtronic CoreValve LLC willfully infringes it. Edwards will move to enforce this verdict and intends to seek a permanent injunction. The jury also awarded Edwards $394 million in damages, and the willfulness finding allows Edwards to seek increased damages of up to three times that amount, in addition to attorneys' fees.
"As the long-time leader and innovator in heart valves, Edwards invests in promising early technologies. As a result, Edwards holds a number of important patents in transcatheter valve technology, and we intend to continue to defend this intellectual property when it is used by others without permission. We are proud of our long-standing relationship with Prof. Cribier and other key innovators in transcatheter heart valves, and we continue to work with them today as we develop new transcatheter therapies for patients suffering from heart valve disease," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves.
The patent involved in this suit is part of the Cribier family of patents and expires in December 2017. This case was tried in the U.S. District Court for the District of Delaware and is directed at the manufacture and sale of the CoreValve ReValving System in the U.S., as well as the worldwide sales of valves assembled in Medtronic's Tijuana, Mexico facility using U.S. made components.
In 2010, a federal jury found that Medtronic CoreValve LLC willfully infringes on another Edwards patent, the U.S. Andersen transcatheter heart valve patent, and awarded damages to Edwards. That finding was upheld on appeal and an initial payment of $84 million was made by Medtronic to Edwards in 2013. A decision on Edwards' request to enjoin Medtronic's entrance into the U.S. market and additional damages is still pending. Because some of the sales have been found to infringe both the Andersen and Cribier patents, a portion of the damages awarded in the Cribier case could be reduced.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at www.edwards.com.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, Mr. Wood's statements and statements regarding the potential for enhanced damages, duplicative damages, attorneys' fees, and a permanent injunction. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unanticipated outcomes from future appeals and legal proceedings. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2012.
Edwards, Edwards Lifesciences, and the stylized E logo are trademarks of Edwards Lifesciences Corporation.
Source: Edwards Lifesciences
Medtronic to Appeal Federal District Court Verdict
January 15, 2014 -- Minneapolis -- A jury in the Federal District Court of Delaware today decided in favor of Edwards Lifesciences, ruling that the Medtronic (NYSE:MDT) CoreValve® System infringed on Edward's Cribier patent (US Pat. No. 8,002,825). Medtronic intends to appeal.
"While we are disappointed in the jury's verdict, we continue to believe that this decision will be overturned on appeal," said Neil Ayotte, vice president and acting general counsel at Medtronic. "Medtronic has prevailed against Edwards in several legal actions related to a European counterpart to this patent and others, and believes the Federal Circuit Court of Appeals will find no merit to Edward's infringement claim. Today's jury verdict does not impose an injunction, and Medtronic will oppose any requests for an injunction by Edwards. "
The jury found willful infringement and awarded Edwards total damages in the amount of $392.5 million. Medtronic anticipates U.S. regulatory approval of the CoreValve System for extreme risk patients by the end of its fiscal year 2014, and intends to begin selling the device in the U.S. at that time.
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.
About Medtronic
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 results.
Source: Medtronic,
Inc.
Reported by Burt Cohen, January 15, 2014
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