The US Court of Appeals has overturned a $106.5m ruling wherein a California court jury found that Medtronic infringed on a heart valve replacement method developed by Colibri Heart Valve.

Colibri sued Medtronic in 2020, alleging that the medtech giant’s Evolut transcatheter aortic valve replacement (TAVR) systems for treating severe aortic stenosis infringed on its patented method for controlled release of replacement heart valves.

The Colorado-based company’s filing with a California court alleged that Medtronic’s systems infringed on its patented method (No. 8,900,294) of partially deploying a replacement valve from the delivery apparatus and recapturing the valve within the delivery apparatus before full deployment if it looks like the positioning will be off.

Colibri’s lawsuit asserted that Medtronic learned about its patented methods in a 2014 conference call and during a presentation given by Colibri CEO Joseph Horn about its technology to Medtronic’s marketing director and senior clinical programme manager.

The patent claimed the ‘do-over’ method of partial deployment could involve pushing out the valve from an outer sheath of the delivery apparatus or retracting the outer sheath to expose the valve.

The case went to trial in 2023, with Medtronic attesting that the accused's use of its product involved partial deployment by retracting, not pushing.

During the trial, Colibri dropped its initial assertion of ‘literal’ infringement and relied solely on the doctrine of equivalents to establish patent infringement using the accused method.

Medtronic sought judgment as a matter of law (JMOL) to get this change rejected, deeming the entire premise of the lawsuit invalid; however, the invalidity challenge was rejected. Medtronic was subsequently found to have ‘induced infringement’, with Colibri awarded $106.5m in damages.

The overrule from the US Court of Appeals read: “We now conclude that prosecution history estoppel, based on Colibri’s cancelling of a claim to “retraction” for partial deployment of the replacement valve and Colibri’s own recognition of the close linkage of the subject matter of the cancelled and retained claims, bars application of the doctrine of equivalents. We therefore reverse the district court’s denial of JMOL of noninfringement.”

A Medtronic spokesperson told Reuters that the court outcome “affirms our longstanding position that Colibri’s patent infringement claims lacked merit".

Medical Device Network has reached out to Colibri for comment.