By Omar Ford, Staff Writer
The court determined one of Marlborough, Mass.-based Boston Scientific’s patents asserted against Edwards is valid and infringed. The court also ruled that a second patent related to the outer seals for the technology was found to be invalid.
Boston Scientific has developed the Lotus Valve for TAVR, which received approval in Europe back in 2013, but has yet to receive a nod from the FDA. Irvine, Calif.-based Edwards’ Sapien valves hold the distinction of being the first approved TAVR devices on the market. The company first received U.S. approval for its Sapien valve in 2011. (See Medical Device Daily, Nov. 4, 2011.) Edwards received European approval for Sapien 3 – the valve at the center of the patent disputes – back in 2014. The company managed to obtain FDA approval in 2015.
The lawsuit centers around Boston Scientific’s ’254 patent and its ’766 patent, which both cover sealing technology used on TAVRs, designed to reduce leaks around the edges of the devices.
Rick Wise, an analyst for Stiefel, said the “split decision seems to indicate that this will be a complicated, lengthy intellectual property battle that will see Edwards and Boston Scientific appeal and counter-appeal. This process will likely take time to work through.”
Edwards said on Friday it was already in the process of making plans for an appeal on specific aspects of the ruling. A spokeswoman for Edwards said “the court’s decision does not affect the commercial availability of Sapien 3.”
Boston Scientific took issue with part of the ruling and noted some claims of patent ’254 were found invalid, and not the entire patent.
“The judge also ruled that Edwards does not infringe any of the valid claims,” Kelly Leadam, a spokeswoman for Boston Scientific, told Medical Device Daily. “The judge’s finding on the invalidity of the claims [for patent '254] is contrary to the preliminary opinion of the European patent office and we will appeal this finding in the U.K.”
However, Germany is the next stop for both companies in the patent fight. In November 2015, Boston Scientific sued Edwards in the German courts regarding TAVR patent infringement, and a decision could come sometime this week.
Larry Biegelsen, an analyst with Wells Fargo said, “while [last week's ruling] is good news for Boston Scientific and negative for Edwards, we are not sure the U.K. ruling is a good read-through to Germany.”
Joshua Jennings, an analyst for Cowen and Co. noted the results in Germany are a wild card at this point. He noted that more than likely Edwards would not have its valve taken off the market.
“The possibility of the German court removing a highly valued lifesaving therapy from the market seems implausible to us,” Jennings said. “Further, Boston Scientific runs the risk of a public relations nightmare if interventional cardiologists and cardiothoracic surgeons are denied access to Sapien 3, particularly with Lotus now off the market for [about] six months.”
Last month, Boston Scientific had a voluntary recall for its Lotus technology in Europe following reports of problems with the products’ locking mechanisms. (See Medical Device Daily, Feb. 24, 2017.) This marked the second time Boston Scientific had issues with its TAVR product line. Last October, the company suspended implants of the next generation Lotus Edge valve in Europe, citing similar concerns. In January, Boston Scientific executives said the company found a fix for the October issue. (See Medical Device Daily, Jan. 11, 2017.)
During Boston Scientific’s most recent earnings call, the company went into more specifics of its solution for the Lotus Edge devices. PMA submission for Lotus could come in 4Q17 and U.S. launch by mid-2018, depending on regulatory review cycle times.
TAVR LITIGATION IS THE NORM FOR EDWARDS
About three years ago, Edwards saw its six-year TAVR patent war with Medtronic plc end. (See Medical Device Daily, May 21, 2014.) The Dublin-based company agreed to pay out $750 million, with at least $40 million a year in royalties until 2022, to Edwards, to settle the case.
While the outcome of the Edwards and Boston Scientific battle is hard to predict, Biegelsen said that both companies could ultimately come up with some type of settlement.
“We think the litigation between Boston Scientific and Edwards … could settle with some type of cross-licensing or royalty agreement between the two companies that allows them to market their valves,” Biegelsen said.
If Boston Scientific’s Lotus products can come out of these court battles unscathed and gain FDA approval, the company could end the TAVR “duopoly” held by both Medtronic plc and Edwards Lifesciences.
Medtronic picked up FDA approval for Corevalve about three years after Edwards TAVR entry into the U.S. (See Medical Device Daily, Jan. 21, 2014.)