December 12, 2018 — A jury in the U.S. District Court for the District of Delaware determined Dec. 11 that the Boston Scientific U.S. patent 8,992,608 is valid and that Edwards Lifesciences' Sapien 3 Aortic Valve infringes this patent. The court ruled that Edwards owes Boston Scientific $35 million in infringement damages through the end of 2016. Additional damages and interest incurred from 2017-2018 will be determined by the court in post-trial motions.
The jury also found that the Boston Scientific Lotus Aortic Valve System does not infringe Edwards' Spenser patents U.S. 7,510,575, U.S. 9,168,133, or U.S. 9,339,383.
In a statement, Edwards said it does not expect to pay the jury award since “earlier this year, the U.S. Patent and Trademark office determined that all asserted claims of the '608 patent were invalid.” Edwards plans to appeal the jury’s ruling on the Spenser valve patents.
The Lotus system features an adaptive sealing technology, which creates an external seal to prevent leakage around the valve known as paravalvular leak (PVL), which is a proven predictor of mortality.i,ii,iii The company anticipates the Lotus Edge Valve System will be commercialized in CE mark countries in Q1 2019 and in the U.S. in mid-2019, pending U.S. Food and Drug Administration (FDA) regulatory approval timelines.
The Lotus valve is one of two valve systems in the Boston Scientific structural heart portfolio. Boston Scientific currently offers the Acurate neo Aortic Valve System in key European markets and is also seeking a CE mark application for the next-generation valve system, the Acurate neo2, which it intends to commercialize during the first half of 2019.
UPDATE: On Jan. 15, 2019, Edwards and Boston Scientific reached an agreement to settle all outstanding patent disputes between the companies in all venues around the world. All pending cases or appeals in courts and patent offices between the two companies will be dismissed, and the parties will not litigate patent disputes related to current portfolios of transcatheter aortic valves, certain mitral valve repair devices and left atrial appendage closure devices. Any injunctions currently in place will be lifted.
Under the terms of the agreement, Edwards has made a one-time payment to Boston Scientific of $180 million. No further royalties will be owed by either party under the agreement. All other terms remained confidential.
For more information: www.bostonscientific.com, www.edwards.com
iii. Abdel-Wahab M., et al. Aortic Regurgitation After Transcatheter Aortic Valve Implantation: Incidence and Early Outcome. Results from the German Transcatheter Aortic Valve Implantation Registry. Heart 2011;97:899-906.