The ongoing TAVR patent dispute between Boston Scientific and Edwards continues, with the former scoring a partial victory over the latter in the U.K. courts.

Omar Ford

March 28, 2018

2 Min Read
Boston Sci Triumphant in Latest TAVR Scuffle with Edwards
Succo/Pixabay

The ongoing transcatheter aortic valve replacement (TAVR) patent dispute between Boston Scientific and Edwards Lifesciences continues to heat up. This time Boston Scientific is coming out victorious as the U.K. Court of Appeal has ruled in the Marlborough, MA-based company’s favor. But it isn't a total victory for Boston Scientific, Edwards notes.

The U.K. dismissed Edwards’ appeal and upheld a prior court decision that the Irvine, CA-based company’s Sapien 3 valve infringes Boston Scientific’s patent EP (UK) 2 926 766. 

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"We are pleased with another positive ruling from the European courts which further substantiates our intellectual property," Desiree Ralls-Morrison, senior vice president, general counsel and corporate secretary, Boston Scientific, said in a release. "We see the U.K. court's decision as an important validation of our patents and supports our goal to bring differentiated solutions to patients suffering from severe and symptomatic aortic valve stenosis."

Edwards is noted as a pioneer of TAVR, having garnered FDA approval for its Sapien Valve in 2011.  A spokesperson for Edwards spoke on the ruling and noted there were a lot of moving parts in this patent litigation.

“The appeals court in the U.K. upheld the Patents Court decision from 2017, which found that one of Boston Scientific’s patents related to outer seals for transcatheter heart valves that was asserted against the Sapien 3 valve is invalid, while a second patent is valid and infringed,” a spokesperson for Edwards told MD+DI via email. “The validity of this second patent, regarding outer THV seals with “sacs,” is separately under review by the European Patent Office, which is expected to hold a hearing this summer. Today’s decision from the appeals court applies only within the U.K. and does not currently affect the availability of the Sapien 3 valve."

The U.K. Court of Appeal ruling comes a few short days after Edwards claimed victory over Boston Scientific in a patent spat in the U.S. In the case, the United States Patent and Trademark Office (USPTO) decided in Edwards’ favor in an Inter Partes Review of Boston Scientifics’ patent – 8,992,608. The USPTO determined that all claims of the patent Boston Scientific asserted against Edwards were invalid.

On Monday, a Boston Scientific spokesperson said the company has plans to appeal the USPTO’s findings.

This isn't Edwards first rodeo when it comes to TAVR litigation.  In 2014, Dublin-based Medtronic made a one-time $750 million payment to settle all TAVR patent litigation with Edwards. Medtronic develops CoreValve TAVR devices. 

The settlement also called for Medtronic to make quarterly royalty payments to Edwards based on a percentage of sales of its competing CoreValve product in an amount no less than $40 million per year, through 2022. The maximum amount Medtronic will pay annually, irrespective of CoreValve sales, is $60 million.

About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].

 

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