Reversal: Medtronic Overturns $760 Million Verdict

Recently, the U.S. Federal Court of Appeals issued a ruling in favor of medical technology giant Medtronic, overturning a 2023 patent infringement verdict. The previous verdict had required Medtronic to pay substantial damages to Colibri Heart Valve.

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

Founded in 2010, Colibri Heart Valve is a privately held medical device company located near Boulder, Colorado. The company is dedicated to developing innovative, patented structural heart technologies. Leveraging Colibri’s proprietary tissue technology and valve design, Colibri 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 in the U.S. District Court for the Central District of California ruled that Medtronic's Evolut series devices infringed on U.S. Patent No. 8,900,294 held by Colibri. The jury determined that Medtronic failed to provide "clear and convincing evidence" that the patent is invalid, and accordingly ordered it to pay $106.5 million (approximately 760 million RMB) in damages to Colibri. Medtronic immediately filed an appeal.

This week, the Federal Court of Appeals rendered a final judgment, overturning the district court’s decision. The panel of three judges determined that Medtronic is legally entitled to the effect of a judgment of non-infringement of Patent No. 294, thereby reversing the district court’s denial of the non-infringement ruling. As a result of this decision, the remaining issues in the appeal automatically became moot.

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A panel of three judges ruled that the previous court's judge failed to determine whether Medtronic actually infringed on Colibri's patent.

“We now conclude that because Colibri has withdrawn the 'withdrawn' claims regarding partially deployed replacement valves, and due to Colibri's recognition of the close relationship between the canceled and retained claims, the doctrine of prosecution history estoppel precludes the application of the doctrine of equivalents,” the judge summarized. “Therefore, we reverse the district court's denial of the [legal judgment] of non-infringement. This concludes all necessary decisions to resolve this expired patent dispute.”