- A jury in the U.S. District Court for Delaware ruled that Edwards Lifesciences' Sapien 3 device infringed a transcatheter aortic valve replacement patent held by Boston Scientific, the companies said late Tuesday. The implementation of TAVR technologies can be an alternative to open-heart surgery for patients in need of a new aortic heart valve.
- The court simultaneously ruled that the Boston Scientific Lotus Aortic Valve System does not infringe a range of Edwards' patents.
- Edwards was ordered to pay roughly $35 million in infringement damages through the end of 2016, with further damages and interest incurred from sales in 2017 and 2018 to be determined by the court in post-trial motions. Edwards said it does not intend to pay the award, citing a more favorable finding from the U.S. Patent Office in March. The company also said it plans to appeal the decision on the Lotus infringement of its own patents.
The high stakes back and forth between Boston Scientific and Edwards Lifesciences, which also competes with Medtronic in the TAVR space, is indicative of the lucrative market opportunity recognized by both companies, which Edwards estimated last week to reach $10 billion by 2024.
After the U.S. Patent Office review found infringement claims against Sapien 3 invalid, conversely, a German court's injunction to Boston Scientific in October is keeping Sapien 3 out of the German market.
Edwards recently forecasted its own TAVR sales to grow 11% to 15% in 2019, which it said could reach $2.4-$2.7 billion. The predictions follow the company meeting those same projected TAVR growth margins in 2018.
Boston Scientific has also grown further into the TAVR space, acquiring the Sentinel embolic protection system this summer which prevents strokes during TAVR procedures. The company's Lotus Edge Aortic valve system is an investigational device in the U.S. and is pending CE Mark.
A CE Mark is also pending for its Acurate neo2 aortic valve system, the latest version of a system currently on the market in parts of Europe. Boston Scientific said it intends to commercialize this newer product during the first half of 2019.