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Valve Wars, Part III: Edwards vs. Medtronic
Federal Court Orders Injunction on U.S. Sales of Medtronic's CoreValve
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Medtronic and Edwards logos
April 14, 2014 -- Another volley across the bow in the ongoing heart valve wars was served up Friday, when the U.S. District Court for the District of Delaware granted Edwards Lifesciences (NYSE: EW), the manufacturer of the Sapien transcatheter aortic valve, a preliminary injunction that will limit Medtronic's (NYSE: NDT) sales of its competing CoreValve system in the United States. Barring further rulings, the injunction will go into effect on April 23.

The seven-business-day delay before the ruling takes effect was requested by Medtronic to give the company time to seek relief from the Federal Circuit Court of Appeals.

This setback for Medtronic comes only three months since the CoreValve received FDA approval and just weeks since a major study, presented at the American College of Cardiology meeting, showed significantly improved outcomes with the CoreValve as compared to surgery in an expanded patient population. At the close of the stock market today, Edwards Lifesciences was up a whopping 11%; Medtronic was down 1.89%, rebounding from 5+% down at the market open.

This latest development began from legal actions started a half-dozen years ago and is the direct result of a 2010 federal jury that found Medtronic had willfully infringed Edwards' Andersen patent. It is also just one more chapter in the ongoing courtroom saga that we at Angioplasty.Org have dubbed the "Valve Wars."

A Legal Not a Medical Battle
Unlike the "Stent Wars" that were fought a decade ago between the various manufacturers of drug-eluting stents, the Medtronic-Edwards battles are not about which device is better, but is a strictly legal battle about patents: Cribier, Andersen, Spenser, and so on. A number of presentations at the recent American College of Cardiology meeting pointed up the value of both valves which have shown greatly improved outcomes for patients too sick to undergo open heart valve replacement surgery. Approved for years in Europe, the Sapien and CoreValve became available relatively recently in the U.S.: the Sapien at the end of 2011 and the CoreValve just three months ago.

Injunction in Germany Overturned
In the summer of 2013, Edwards obtained a similar injunction against Medtronic in Germany for violating the Spenser patent. In November, a German court overturned the injunction, citing questions about the validity of the Spenser patent. This ruling resulted in Medtronic being able to sell its CoreValve system again in Germany. Last month, in a finale to this particular dispute, the European Patent Office invalidated the Spenser patent in its entirety, handing a big win to Medtronic.

Battlefield America
With the recent January FDA approval of the CoreValve, the legal battle has shifted to the United States. Friday's injunction is the first that could prevent the CoreValve from being used in U.S. patients, a fact which presented a difficulty to the Court. There are a number of hospitals where the surgeons and cardiologists have been trained on and are more familiar with the CoreValve, and are less-experienced with the competing Sapien. Additionally there are patients whose clinical characteristics may make them better candidates for one valve or the other.

Therefore, to protect and ensure that patients receive the best care, the Court ordered the two device manufacturers to enter immediately into discussions and agree on a protocol whereby physicians can make a clinical judgment as to which device to implant. Presumably, this protocol would allow physicians to use the CoreValve, even though the device technically would be prohibited for sale under the injunction. In fact, in a statement somewhat odd, since it was part of the judge's ruling to place an injunction against Medtronic, the Court said that the CoreValve is a "safer device, and that patients in whom it is implanted have better outcomes with a lower risk of death."

Needless to say, more news on this matter will be forthcoming. Duelling press releases from both Edwards and Medtronic, Inc. follow:

Federal Court Orders Preliminary Injunction on U.S. Sales of Medtronic's Infringing Transcatheter Valve

April 11, 2014 -- Irvine, CA -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that the U.S. District Court for the District of Delaware today granted a preliminary injunction limiting the sale of Medtronic's CoreValve system in the United States. The court ordered the injunction to go into effect in seven business days. Today's hearing related to a federal jury decision in 2010 that CoreValve willfully infringes Edwards' U.S. Andersen transcatheter aortic valve replacement patent.

At the conclusion of the hearing, Chief Judge Gregory Sleet ordered Edwards and Medtronic to confer on what instances the CoreValve device could continue to be used in the treatment of U.S. patients at centers currently trained on CoreValve. There is a large body of evidence demonstrating the safety and performance of the Edwards SAPIEN valves, and the remains committed to ensuring patients have appropriate access to transcatheter therapy.

Background
This case was initiated by Edwards in 2008. On April 1, 2010, a federal jury found Medtronic willfully infringed Edwards' U.S. Andersen patent and awarded damages. In Nov. 2012, the U.S. Court of Appeals for the Federal Circuit affirmed the jury decision; in Oct. 2013, the U.S. Supreme Court declined to hear Medtronic's appeal.

The patent involved in this suit is part of the Andersen family of patents. The U.S. Andersen patent was issued in 1995. A petition has been filed with the U.S. Patent and Trademark Office to extend this patent into early 2016.

In a separate case, a federal jury in January found that Medtronic CoreValve had willfully infringed Edwards' U.S. Cribier transcatheter heart valve patent, and awarded damages to Edwards in that trial.

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, enabling them to save and enhance lives. Additional company information can be found at www.edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo and SAPIEN are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Source: Edwards Lifesciences

Medtronic to Appeal Federal District Court Ruling

April 11, 2014 -- Minneapolis -- The Federal District Court of Delaware today granted in part Edwards Lifesciences' motion for a preliminary injunction that prevents Medtronic, Inc. (NYSE: MDT) from selling or offering to sell its CoreValve System in the United States. Today's ruling has no impact on the sale or marketing of CoreValve outside of the United States or the use of CoreValve in the current U.S. clinical trials.

At Medtronic's request, the Federal District Court agreed to postpone the implementation of the order for seven business days to allow Medtronic to seek prompt relief from the Federal Circuit Court of Appeals. Medtronic is appealing the Court's injunction, and intends to ask the Federal Circuit Court of Appeals to prevent it from going into effect until it determines if the injunction was properly issued.

In addition the Court ordered Medtronic and Edwards Lifesciences to enter into discussions immediately to agree on a mechanism that will enable physicians at facilities currently trained on CoreValve to make a clinical judgment as to which device to implant (CoreValve or the Edwards device) free from the limitations of the injunction. The Court stated that CoreValve is a 'safer device, and that patients in whom it is implanted have better outcomes with a lower risk of death.' The Court also found that the public interest favors enforcement of patent rights.

The CoreValve System received approval from the U.S. Food and Drug Administration (FDA) in January for patients at extreme risk for surgical valve replacement. Prior to that date, CoreValve therapy was available to extreme risk patients who were eligible to participate in the U.S. clinical trial. The CoreValve System is not yet approved in the U.S. for other patient groups.

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.

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, April 14, 2014
(correction 4-21-14: Original article stated injunction would go into effect on April 22. It's actually after April 22.)