Medtronic fined $106M in trial over TAVR device patent infringement

Medtronic was found guilty this week of infringing a patent concerning transcatheter aortic valve replacement (TAVR) systems that was awarded to Colibri Heart Valve in 2014.

In a lawsuit filed in a California district court in 2020, the Colorado-based company accused Medtronic and its CoreValve subsidiary of violating Colibri’s patent rights in the development of its TAVR devices, which include those sold under the CoreValve and Evolut names. Medtronic argued in turn that the patent claims were invalid.

Nearly three years later, on Wednesday, a jury ruled in Colibri’s favor. It found that Medtronic had “actively induced infringement” of three claims in Colibri’s patent and had failed to disprove the validity of the patent claims.

The jury determined Medtronic should pay damages of $106,489,000 to compensate Colibri for the infringement.

“Medtronic strongly disagrees with the ruling and will continue to vigorously defend against these allegations at the appellate level,” a Medtronic spokesperson said in a statement sent to Fierce Medtech.

“In the meantime, Colibri’s patent has no impact on ongoing operations, as the patent expired in January 2022,” the statement continued. “As a pioneer in healthcare technology, Medtronic has always been at the forefront of advancing cardiovascular treatment for patients around the world and this decision does not diminish our commitment to our mission of alleviating pain, restoring health and extending life.”

Colibri didn’t respond to a request for comment.

TAVR systems are used to treat aortic stenosis, in which the valve between the heart’s lower left chamber and the aorta is unable to open fully, weakening the regular flow of blood to the body. In a minimally invasive TAVR procedure, an implant is put in place via catheter then expands to hold open the faulty valve.

According to Colibri’s complaint, the delivery system for Medtronic’s CoreValve products violates the controlled-release mechanism detailed in its 2014 patent. Under Colibri’s method, a collapsible replacement valve is loaded into the movable sheath of a catheter then sent through the lumen of a blood vessel until it reaches the proper location. Once there, the doctor uses a “pusher member” on the catheter to slowly release the implant—rather than allowing it to immediately pop into place—so it can be readjusted or more easily removed if necessary.

Colibri claimed that several of Medtronic’s TAVR delivery systems mimic its own, equipped with pusher members and movable sheaths that allow for a more controlled release of the implants than other systems. The company also said that its CEO had given a presentation about Colibri’s TAVR system to a marketing director and senior clinical program manager from Medtronic in 2014. Then, a few months later, the CEO participated in a conference call about Colibri’s patents with a Medtronic patent attorney and business development employee.

The original complaint included allegations that Medtronic had also violated a second of Colibri’s TAVR patents—this one related to the construction of the replacement valve itself—but those claims were thrown out by the time the trial officially began.