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| Edwards Lifesciences CEO Mike Mussallem |
Edwards Lifesciences ($EW) is determined to have the last word in its ongoing patent feud with Medtronic ($MDT) over the companies' transcatheter aortic valve replacement (TAVR) products. CEO Mike Mussallem wrote a letter to customers and partners on Wednesday, offering the company's take on the recent legal proceedings and reassuring patients that they would still have access to life-saving therapies.
In the April 16 letter, Mussallem describes the history that led to last week's ruling by U.S. District Judge Gregory M. Sleet in Wilmington, DE, which found that Medtronic's CoreValve product infringed on Edwards' Andersen patents for its Sapien transcatheter heart valve. The court issued an injunction, limiting CoreValve's sales in the U.S. Medtronic then filed an emergency motion in a U.S. Circuit Court of Appeals to prevent the injunction from going into effect.
Medtronic was "well aware" of Edwards' Andersen patent, Mussallem said in the letter, as both companies invested in Percuntaneous Valve Technologies (PVT) in 2002--a company whose technology formed the backbone of Edwards' transcatheter valve. In 2008, Edwards filed a case against CoreValve, claiming that the company's transcatheter valve device infringed on its Andersen patent. Medtronic acquired CoreValve in 2009, and the following year, a jury decided that the company's TAVR device infringed on one of Edwards' patents and awarded the company $74 million. Earlier this year, a U.S. District Court jury ordered Medtronic to pay up $394 million in damages, allowing Edwards to grab a bigger piece of the TAVR pie.
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| Edwards Lifesciences' Sapien--Courtesy of Edwards |
"Even with this knowledge, Medtronic launched their infringing product in the U.S.," Mussallem claims in the letter. He quotes an April 15 written court opinion that said Medtronic "boldly continued to thumb its nose at the law by continuing its conduct even after being found to be a willful infringer." As a result, clinicians and patients have been put in the middle of the legal brawl, Mussallem said.
However, Edwards does not want to completely ban CoreValve sales in the U.S. In its recent ruling, the U.S. District Court acknowledged that the CoreValve System "is a safer device and that patients in whom it is implanted have better outcomes with a lower risk of death" Medtronic said in a statement, and that Edwards' competing product cannot serve patients with aortic annuli larger than 25 mm.
"According to the district court's findings, the injunction would leave no or an inferior treatment option for many patients on the verge of death due to malfunctioning aortic valves," Medtronic said in its U.S. Circuit Court of Appeals filings.
Mussallem said that Edwards "understands the implications" that banning CoreValve could have for patients and physicians, but that Medtronic has refused a standing offer for CoreValve to be used at U.S. hospitals where it is commercially available. He added that Edwards created a hotline for clinicians and patients to help provide access to therapy, and will "actively work" to refer them to TAVR programs.
"I personally want to assure you that Edwards is dedicated to protecting the interests of patients," Mussallem said in the letter. "There is a large body of clinical evidence demonstrating the safety and performance of the Edwards Sapien valves. In the countries around the world where both products are available, Sapien valves have proven to be the preferred choice for doctors treating their patients."