Boston Scientific Sues Edwards Again over TAVR

Nancy Crotti

April 22, 2016

3 Min Read
Boston Scientific Sues Edwards Again over TAVR

Previous patent infringement suits were filed in Europe. Now Boston Sci is taking on the California company in the United States.

Nancy Crotti

In its continued efforts to muscle in on Edwards Lifesciences' pioneering transcatheter valve business, Boston Scientific has filed two patent infringement lawsuits in federal courts in Delaware and central California.

The Delaware suit targets the Edwards Sapien 3 TAVR, introduced in the U.S. in 2015. The suit filed in California aims at a handful of Edwards' catheter delivery systems and a crimping tool used with the Sapien 3.

"We maintain that Edwards' Sapien 3 device and its delivery systems infringe several of Boston Scientific's patents," Boston Sci said spokesman Thomas Keppeler said in an email statement. "We plan to protect our company's innovative and original approaches to advancing medical technology."

Edwards, which says it has invested more than $1 billion in TAVR, would prefer to keep its battle in the marketplace.

"It is unfortunate that Boston Scientific, as a more recent entrant into the TAVR field, is seeking to capitalize on our long-term efforts and gain greater presence through the court system," the company said in an email statement. "We will continue to protect our innovations, and are in the process of filing our responses to these suits, as well as challenging the validity of Boston Scientific's patent and asserting our own patents."

Boston Sci already has patent infringement lawsuits pending against Edwards in the U.K., France, and Germany. The German lawsuit, filed in Dusseldorf on October 30, 2015,  charges that Sapien 3, the next-generation TAVR valve from Edwards, infringes on a European patent related to the company's adaptive sealing technology, the company said.

BostonSci's competing product, the Lotus transcatheter heart valve, is approved in Europe. In 2015, the company predicted the device would bring in as much as $200 million by this year.

Much of Edwards' continued success comes from its success with transcatheter aortic valve replacement. The Irvine, CA, company was the first in the United States to launch TAVR technology and has been able to maintain market share with the U.S. launch of its Sapien 3 valve in July 2015.  Transcatheter heart valves sales in 2015 were up 38%, to $1.2 billion, and Edwards has raised its 2016 transcatheter heart valves sales guidance by $100 million, to the $1.3 billion to $1.5 billion range. Edwards is scheduled to report first-quarter earnings on April 26, after market close.

TAVR technology has proven fertile ground for patent claims. Medtronic and Edwards ended a drawn-out legal battle in 2014.Medtronic agreed to pay royalties of at least $750 million to Edwards to put the patent infringement saga of claims and counterclaims behind them. 

Nancy Crotti is a contributor to Qmed and MPMN.

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About the Author(s)

Nancy Crotti

Nancy Crotti is a frequent contributor to MD+DI. Reach her at [email protected].

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