Heartflow has filed a lawsuit against Cleerly, alleging that three of the Texas-based company’s artificial intelligence (AI)-based tools for coronary artery disease (CAD) evaluation infringe on six of its patents.

Filed on 13 April in the US District Court for the Eastern District of Texas, Heartflow’s complaint seeks “permanent injunctive relief and damages” arising from what the company claims is Cleerly’s “unauthorised and continued use” of Heartflow’s patented technology. 

Heartflow states that its lawsuit has arisen from “one of the most egregious examples of piracy” in the medical technology industry, putting Cleerly CEO Dr James Min in the lawsuit’s crosshairs. Min served as a consultant to Heartflow from 2012 to 2017.

Outlining the lawsuit’s rationale, Heartflow said it is seeking to protect the “extraordinary investment” that led to its creation of “the world’s first AI-powered, non-invasive cardiac diagnostic platform”.

The three technologies in the scope of Heartflow’s lawsuit are Cleerly’s Ischemia, Plaque Analysis, and Compare products. These AI-based products are used to determine inadequate blood supply (ischaemia), the extent of coronary plaque buildup (atherosclerosis) in the coronary arteries, and to provide longitudinal disease evaluation so clinicians can assess changes in CAD progression, respectively.

The key allegation within Heartflow’s lawsuit is that the trio of Cleerly products infringe on patents “with priority dates from 2012 to 2018”.

Heartflow CEO John Farquhar commented: "We take seriously our responsibility to protect the intellectual property that supports this field and the clinicians and patients it serves."

The lawsuit alleges that without informing his colleagues at Heartflow, Min launched a competing enterprise “built upon Heartflow’s pioneering innovations” after gaining access to Heartflow’s technology, trade secrets, and confidential business information.

Cleerly has refuted Heartflow’s allegations. In written comments provided to Medical Device Network, Min stated that Cleerly is “confident” in its “extensive and well-established intellectual property portfolio” and the “originality” of its technology.

Min continued: “Cleerly has published landmark clinical science that has redefined how cardiovascular disease is understood and treated, which has formed the basis of our novel technologies that provide physicians with actionable insights into their patients’ heart health.”