Major Reversal: Medtronic Overturns $106.5M Patent Infringement Verdict in TAVR Case

On July 18, 2025, the U.S. Federal Court of Appeals ruled in favor of medical technology giant Medtronic, overturning a 2023 patent infringement verdict. The original ruling had ordered Medtronic to pay substantial damages to Colibri Heart Valve, LLC.

Source: Reuters

The background of the case can be traced back to 2019, when Colibri Heart Valve, LLC accused Medtronic's CoreValve, CoreValve Evolut R, CoreValve Evolut Pro, and CoreValve Evolut Pro+ transcatheter aortic valve replacement (TAVR) products of infringing on its two patents.

Medtronic's CoreValve Evolut TAVR

Colibri Heart Valve, LLC, founded in 2010, is a private medical device company located near Boulder, Colorado. It is dedicated to the research and development of novel, patent-protected structural heart technologies. Leveraging Colibri’s proprietary tissue technology and valve design, the company has developed a pre-mounted, pre-crimped, and pre-loaded, ready-to-use balloon-expandable transcatheter aortic valve implantation (TAVI) system, known as the "Colibri TAVI System."

At the beginning of 2023, a jury of the Federal District Court for the Central District of California ruled that Medtronic's Evolut series of devices infringed on U.S. Patent No. 8,900,294 held by Colibri Heart Valve, LLC. The jury found that Medtronic failed to provide "clear and convincing evidence" to prove the patent invalid, and accordingly ordered Medtronic to pay Colibri $106.5 million (approximately RMB...RMB 760 million) in compensation. Medtronic immediately filed an appeal.

This week, the federal appellate court issued a final ruling, overturning the district court's decision. The panel of three judges determined that Medtronic is entitled to the judgment of non-infringement of Patent No. 294, thus reversing the district court’s rejection of the non-infringement determination. This ruling rendered the remaining issues in the appeal process automatically moot.

Original Judgment

The ruling by a panel of three judges stated that the judge in the previous court failed to determine whether Medtronic had indeed infringed upon Colibri's patent.

"We now conclude, based on Colibri's cancellation of the 'withdrawal' claim regarding partial deployment of the replacement valve, and Colibri's own acknowledgment of the close connection between the subject matter of the canceled and retained claims, that the doctrine of prosecution history estoppel bars the application of the doctrine of equivalents," the judge summarized. "Thus, we reverse the district court's denial of [judgment] as a matter of law on non-infringement. That is all the decision we need to resolve this expired patent dispute."