UPDATED April 21, 2014, at 12:30 p.m. with comment from Medtronic.
UPDATED April 21, 2014, at 3:45 p.m. with comment from Edwards Lifesciences.
Edwards Lifesciences (NYSE:EW) urged a federal appeals court to ignore the alleged "scare tactics" put forward by Medtronic (NYSE:MDT) in an effort to forestall a pending ban on U.S. sales of Medtronic’s CoreValve replacement heart valve.
Earlier this month Judge Gregory Sleet of the U.S. District Court for Delaware granted a preliminary injunction to Edwards, limiting U.S. sales of the CoreValve transcatheter aortic heart implant to patients deemed unsuitable for Edwards’ rival Sapien device.
Medtronic promptly appealed the ban, slated to begin April 23, to the U.S. Court of Appeals for the Federal Circuit, drawing a rebuke from Sleet. In a statement released today, Medtronic said it doesn’t believe that Edwards "has met the standards needed for an injunction, particularly with respect to the impact it will have on the public health interest."
"It is highly unusual for an injunction to be enforced on a therapy that the patent-holder cannot replace, and it is virtually unheard of that an injunction would be enforced against a unique, life-saving therapy," structural heart president Dr. John Liddicoat said in prepared remarks.
Medtronic said it is "committed" to ensuring that patients get the valve implants they need.
"To date, Medtronic has made numerous offers to Edwards to ensure patients have continued access to this life-saving technology," according to the statement. "The company is striving for a near-term solution that addresses patient interest completely, but not one that selectively and arbitrarily controls who has access to a device they need and who does not, regardless of where they live in the United States."
In a letter to "our trusted clinical partners," Edwards CEO Mike Mussallem wrote that "clinicians and patients have been placed in the middle of the legal issues regarding CoreValve."
"In spite of the violations of our intellectual property, we are not seeking a total ban on CoreValve sales, because we understand the implications that could have for patients and physicians," Mussallem wrote. "In fact, we put forward multiple offers, in court and directly to Medtronic, that would allow patients to continue to be treated with CoreValve. But, unfortunately, they have refused these offers. We encourage Medtronic to accept our standing offer to enable use of CoreValve at U.S. hospitals where it is commercially available today."
Edwards last week called Medtronic’s claims of potential harm to patients "hyperbolic" and labeled them "scare tactics," according to court documents.
"Edwards’ commitment to patient care and the district court’s cautious order are a bulwark to ‘the calamity to public health’ that Medtronic direly predicts. All along, Edwards has unequivocally advocated for a carve out whereby any patient who can be safely treated only with a CoreValve device can receive that device. Edwards remains committed to that position," according to the documents. "Medtronic’s all or nothing approach – ‘all’ being that it gets to continue willfully infringing without repercussion (including expanding), and ‘nothing’ being an injunction that it argues must be stayed – is untenable. Medtronic’s hyperbolic claims of patient care are just the latest example of its disingenuous attempts to flout the patent laws."
Edwards also cited Medtronic for claiming that clinical trials show that the CoreValve implant is safer than the Sapien device.
"Medtronic’s scare tactics simply do not comport with the facts. It is undisputed that, together, Edwards’ Sapien and soon-to-be-approved Sapien XT devices can treat patients with an aortic annulus up to 27mm. Edwards has expressly stated that patients with an annulus of greater than 27mm may receive a CoreValve implant," according to the documents. "Recognizing this, Medtronic asserts without basis that the CoreValve device is ‘proven’ safer than Edwards’ [transcatheter heart valve]. Medtronic’s argument is based on the district court’s statement that CoreValve ‘may be to some degree the safer, better option for most patients.’ However, the district court acknowledged that Medtronic’s safety conclusions ‘were drawn from comparing the results of 1 study on the CoreValve Generation 3, the CoreValve pivotal trial, to the results of another study on the Sapien.’ Moreover, Medtronic’s own witness, Dr. [Michael] Deeb, acknowledged that no head-to-head study, adjudicated or otherwise, has ever concluded that the CoreValve device is superior to the Sapien devices." [emphasis theirs]
Edwards initially filed the infringement claim in 2008 against CoreValve, then an independent entity (Medtronic acquired CoreValve in 2009). A federal jury ruled in 2010 that the CoreValve device willfully infringes Edwards’ "Andersen" patent, also known as the ‘552 patent. The U.S. Court of Appeals affirmed that decision in 2012 and the Supreme Court last year refused to hear Medtronic’s appeal. Earlier this year the FDA approved the CoreValve system for sale in the U.S.
The legal battle is also happening overseas, where the European Patent Office in October 2013 issued a preliminary, non-binding ruling that an Edwards’ patent was invalid, allowing CoreValve back on the German market after a temporary ban. The EPO last month finalized that ruling, entirely invalidating and revoking the so-called "Spenser patent" at the heart of the overseas dispute.
Edwards earlier this year won a $393 million decision after a Delaware jury ruled that CoreValve infringes on Edwards’ "Cribier" patent.