Colibri Heart Valve claimed in 2019 that Medtronic violated its patents for replacement heart valves. The lawsuit alleged infringement of two patents with the Medtronic CoreValve, CoreValve Evolut R, CoreValve Evolut Pro, and CoreValve Evolut Pro+.
CoreValve Evolut transcatheter aortic valve implant (TAVI) products first received FDA approval in 2014. They rival Edwards Lifesciences’ (NYSE:EW) implants, which had the market to themselves for two years before the CoreValve products received the FDA nod.
Edwards and Medtronic reached a $750 million settlement over heart valve implant patents in 2014. Medtronic agreed to pay royalties through April 2022 of at least $40 million annually. Neither company admitted to any infringement as part of the settlement.
Colibri’s website says its TAVI implant is a low-profile transcatheter aortic heart valve that uses dry tissue technology. This allows for a pre-mounted, pre-crimped and pre-loaded heart valve that comes sterilized and ready for use.
The company’s CEO Joseph Horn met with Medtronic managers under a non-disclosure agreement in May 2014. They discussed the successful implementation of Colibri’s TAVI System in a patient. A conference call between the companies followed in July 2014, according to the lawsuit.
The jury in federal court in Central California concluded that the Evolut devices violated Colibri’s U.S. Patent No. 8,900,294. It determined that Medtronic failed to “prove by clear and convincing evidence” that Colibri’s claims were invalid.
According to the Star Tribune of Minneapolis, Medtronic plans to appeal the case.
“Medtronic strongly disagrees with the ruling and will continue to vigorously defend against these allegations at the appellate level,” the company said in a statement to the newspaper. “In the meantime, Colibri’s patent has no impact on ongoing operations, as the patent expired in January 2022.”
