Boston Sci wins one, loses one against Edwards in heart-valve patent fight

gavel auction
Boston Scientific first sued Edwards for patent infringement in Germany and filed subsequent suits in France, the U.K. and the U.S.

Boston Scientific and Edwards Lifesciences have been battling over their heart valve tech on two continents for nearly a year. Now, a U.K. patent court has invalidated one Boston Sci patent, but called Edwards out for infringement on another.

The patents cover sealing technology used on transcatheter aortic valve replacements (TAVRs), designed to reduce leaks around the edges of the devices after they're installed.

Edwards will immediately appeal and “believes the company will ultimately prevail,” the company said in a statement. Its Sapien 3 valve will still be available in the U.K., despite the court ruling, the company said.


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The two companies are fighting over a market that's important to their respective bottom lines—and one where Boston Sci's Lotus product line recently hit a snag. Sapien 3, launched in 2015, helped drive a 38% increase in Edwards' 2016 transcatheter heart valve sales to $1.63 billion. On the other hand, Boston Sci has downgraded its expectations for sales in the franchise that includes its Lotus products because of a worldwide recall, according to EP Vantage.

The two patents at issue in the U.K. case are Boston Sci's '254 patent and its '766 patent. The court invalidated some of the claims in the first, while upholding the second.

“The 254 Patent is invalid on the ground that it lacks inventive step. Had it been valid, it would have been infringed,” said Judge Richard Hacon, the presiding judge of the U.K.’s Intellectual Property Enterprise Court, in his decision.

The court not only upheld the '766 patent, but also determined that Edwards' product infringed on it.

Boston Scientific pointed out that some of the '254 patent's claims were upheld as well, though the court determined that Edwards' product didn't infringe on those remaining claims. The company plans to file its own appeal in the case.

“The judge’s finding on the invalidity of the claims is contrary to the preliminary opinion of the European patent office and we will appeal this finding in the U.K.,"  said Boston Scientific spokeswoman Kelly Leadem.

Boston Scientific first sued Edwards in October 2015. Filed in Dusseldorf, Germany, the suit alleged that Edwards’ Sapien 3 TAVR  violated a European patent relating to Boston Sci’s adaptive sealing tech. Edwards countersued, charging that Boston Sci's Lotus valve infringes on the company’s own patents.

Boston Sci earned a CE mark for its Lotus valve in October 2013, while Edwards’ Sapien valve got the EU nod in January the following year. Boston Sci’s valve is not yet approved in the U.S., but Edwards’ Sapien 3 scored an FDA OK in June 2015.

Boston Sci has taken the patent spat stateside as well, arguing in U.S. District Courts in Delaware and the Central District of California that Edwards’ replacement valves and related products infringe Boston Scientific patents. Those lawsuits are still pending. Edwards previously told FierceMedicalDevices that its rivals' U.S. claims are “without merit."

This isn’t Edwards’ first TAVR patent rodeo—it sued device giant Medtronic in 2007 in Germany. In 2014, the pair announced Medtronic would hand over a one-time payment of $750 million as well as ongoing royalty payments until 2022 to settle all of their TAVR-related lawsuits worldwide.

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