Why Edwards-Bos Sci Battle is Far from Over

A UK patent court issued a split decision in a case between Edwards Lifesciences and Boston Scientific, but the battle over the two companies' transcatheter heart valve patents is far from over, and could ultimately settle in a cross-licensing agreement.

Amanda Pedersen

A UK patent court ruled that one of Boston Scientific's patents related to outer seals for transcatheter heart valves, which was asserted against Edwards' Sapien 3 valve, is invalid, but that a second patent is valid and infringed. Edwards said it will appeal the latter part of the decision.

"Boston Scientific obtained patents long after Edwards completed many comprehensive clinical evaluations, advanced the therapy through multiple regulatory approval processes, supported the training of heart teams around the world, and ultimately established the market leadership of the Sapien 3 valve," Sarah Huoh, a spokesperson for Edwards Lifesciences, told Qmed.

Boston Scientific started the fight in November 2015 by filing suit against Edwards in Germany based on European patents related to the technology. Edwards fought back with a counter suit, alleging that Boston Scientific's Lotus valve infringed on Edwards' foundational patents for the technology. Subsequently, Edwards took the battle to the UK, which led to Friday's split decision.

The German patent ruling is expected to be handed down Thursday morning, according to Boston Scientific.

"While this is good news for [Boston Scientific] and negative for [Edwards], we are not sure the UK ruling is a good read-through to Germany," Larry Biegelsen, a medtech analyst with Wells Fargo Securities, said in a research note.

Edwards said the UK court's decision does not affect commercial availability of Sapien 3, and the company does not plan to change its financial guidance for the year.

Analysts expect this to be a complicated and lengthy patent battle that will likely included appeals and counter-appeals across Europe. Boston Scientific also filed a suit against Edwards in a U.S. federal court last year targeting the Sapien 3 valve.

"Clearly, both parties think they have valid IP on both sides of the table," said Rick Wise, a medtech analyst with Stifel. "We suspect that this specific battle will end as other recent medical device IP battles have concluded, with some type of royalty payments and/or some licenses."

Biegelsen agreed that Edwards and Boston Scientific have a long way to go, and that the case could settle with some type of cross-licensing or royalty agreement that would allow both companies to continue to sell their valves.

That is, after all, how Edwards' patent infringement saga with Medtronic ended in 2014. It's also similar to the way Phillips and Masimo eventually ended a seven-year patent fight over last year.

Amanda Pedersen is Qmed's news editor. Contact her at [email protected].

[Image courtesy of Pixabay]