How Will Patients Be Affected By Medtronic's TAVR Battle With Edwards?

A federal appeals court granted Medtronic a temporary stay on an injunction that would have prevented the device maker from selling its CoreValve Transcatheter Aortic Valve Replacement system in the U.S.

Some analysts have said that injunctions being issued in the U.S. preventing sale of products are a rare phenomenon. While it has a temporary reprieve, Medtronic now has to convince the Federal Circuit Court of Appeals that its products do not infringe upon the patent of rival Edwards Lifesciences and that the injunction was improperly issued. How does this legal case affect patients.

The Minnesota company only has a few months to persuade the court that the injunction was improperly issued. By Medtronic’s own request, the court has agreed to an expedited schedule. May 12 is the deadline by which Medtronic has to file its opening brief, followed by an opening brief from Edwards by June 12. June 19 is the deadline for a reply from Medtronic. Oral arguments could occur as soon as this summer, said Glenn Novarro, an analyst from RBC Capital Markets in a research note Monday, where he also speculated about possible scenarios regarding the outcome of the case.

One scenario is Medtronic loses the case and the injunction goes into effect. That would mean that Edwards would still be market leader in the TAVR space up until 2016. Edwards has sought extensions of the patent that it has so far successfully argued Medtronic has infringed. That patent originally expired in 2012 but Edwards has been getting annual extensions. The California company has requested a permanent extension till 2016. That would mean Medtronic’s CoreValve product would not be available for sale in the U.S., except in clinical trials, for another two years.

If Medtronic doesn't settle and the appeals court agrees with the lower court that Medtronic has wilfully infringed Edwards' patent - something that Edwards' CEO Michael Mussallem has said Medtronic did as soon as it acquired CoreValve in a recent letter to customers and partners - patients will be left with only one commercially available TAVR system.

That is Edwards' Sapien system and while the product is novel, safe and effective, it hasn't proved as Medtronic's CoreValve has done that it is clinically better than traditional open heart surgery for patients with severe aortic stenosis. Michael Weinstein, a JPMorgan Chase analyst reported in a recent analyst report that cardilogists were shocked by the initial news that a judge had ecided that Medtronic's device should not be sold in the U.S. market. 

Medtronic's loss,this time in the federal appeals court would ironically appear to be a loss for U.S. patients as well. 

However, not everyone sees it this way. An analyst who declined to be quoted on the record said that the CoreValve and Sapien are very similar and he doubts patients will be affected. 

"In head to head studies, Sapien has performed slightly better," he said in an email. 

That was likely a reference to a small, European study - CHOICE - which pitted Sapien's next-generation product of a lower profile against Medtronic's CoreValve.

In the short term, the courts may decide that only one company can sell a TAVR device in the U.S. and in doing so, make the choice for patients and physicians. From a clinical perspective, which is the better product is something that is more complicated.

"“Continued efforts at understanding the risks and benefits of TAVR particularly in relation to patient characteristics and long-term outcomes are imperative for continued progress and refinement of these revolutionary devices," said said Dr. E. Murat Tuczu and Samir Kapadia in an editorial in the Journal of the American Medical Association published earlier this month.  Additional rigorous randomized trials like the CHOICE trial will provide the quality of evidence necessary to ensure optimal use and optimal patient outcomes from TAVR.”

[Photo Credit: user THEPALMER]

 -- By Arundhati Parmar, Senior Editor, MD+DI



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