German court: Boston Sci 2, Edwards 1 in heart-valve patent feud

The District Court of Düsseldorf found Edwards Lifesciences' Sapien 3 valve infringed upon two Boston Scientific patents for TAVR sealing technology. Image: Edwards Lifesciences

A German court ruled that Boston Scientific violated one Edwards Lifesciences patent, while Edwards infringed two Boston Scientific patents, the latest development in the pair’s international spat over patents for heart valve technology.

Boston Sci’s patents cover sealing technology used in transcatheter aortic valve replacements (TAVRs), designed to reduce leaking around the edges of implants after they’re placed. The Edwards patent is a “foundational patent for the invention” of TAVR, an Edwards spokeswoman said. The District Court of Düsseldorf found that Boston Sci did not infringe upon a second Edwards patent.

Edwards will promptly appeal and “believes the company will ultimately prevail,” the company said in a statement. It said the same a week ago when a U.K. patent court found the devicemaker infringed on one Boston Sci patent, but not the other.

Free Webinar

From Patient Adherence to Manufacturing Ease - Why Softgels Make Sense for Rx

Join Thermo Fisher Scientific’s upcoming webinar to learn why softgels offer numerous benefits for Rx drug development, including enhanced bioavailability, patient compliance and easy scale-up. Register Today.

The patents in question are Boston Sci’s '254 and '766 patents, and Edwards’ '762 and '550 patents. While the German court found Boston Sci violated Edwards’ ‘550 patent, the company “believes” the European Patent Office will throw that patent out, according to a statement.

The decision brings the dispute full circle—Boston Scientific first filed suit against Edwards in Düsseldorf in 2015, charging that Edwards’ Sapien 3 violated its patents for adaptive sealing tech. Edwards hit back, alleging that Boston Sci’s Lotus valve violates the company’s own patents.

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

While the German court ruled that Edwards had violated both of Boston Sci’s patents, last week, a U.K. patent court invalidated the ‘254 patent, but upheld the ‘766 patent, finding that Edwards infringed upon it.

Boston Sci took the feud stateside last April, 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.

While Boston Sci scored a CE mark for its Lotus valve in October 2013, a defect forced the company to recall both versions of the device last month. The devicemaker has downgraded its expectations for sales in its Structural Heart unit, which includes the Lotus products, according to EP Vantage.

The Sapien 3 earned a CE mark in January 2014, with FDA approval following in June 2015. The device helped drive a 38% increase in Edwards' 2016 transcatheter heart valve sales to $1.63 billion

Edwards is no stranger to TAVR lawsuits—in 2007, it sued Medtronic in Germany. In 2014, the duo announced Medtronic would fork out a one-time payment of $750 million in addition to ongoing royalty payments until 2022 to settle their TAVR-related lawsuits worldwide.

Suggested Articles

A COVID-19 antibody diagnostic developed through a joint venture between Mount Sinai Health System and RenalytixAI has been authorized by the FDA.

Researchers at Northwestern University have trained an AI algorithm to automatically detect the signs of COVID-19 on a basic X-ray of the lungs.

Polyphor is developing an inhaled version of murepavadin, which targets Pseudomonas aeruginosa infections, but is currently given intravenously.