Heartflow sued Elucid on October 22, alleging patent infringement and trade secret theft in the market for AI analysis of coronary CT angiography.
It is the second such suit this year. Heartflow went after Cleerly in April on similar grounds, claiming the rival used insider knowledge to build competing plaque analysis software.
The Elucid complaint leans on four patents, including No. 9,770,303. At the centre of the case is a regulatory detail: when Elucid filed its 510(k) for FFR-IQ, it named Heartflow’s FFRct as the sole predicate device and described its indications as “same as predicate.”
The regulator as evidence
Predicate-based clearance is routine at the FDA, and naming a competitor’s product is not itself wrongdoing. But Heartflow is using the filing to argue that Elucid defined its own device by reference to Heartflow’s, which makes the infringement claim easier to tell to a jury than a pure software patent fight.
Elucid chief executive Kelly Huang said the Boston company is confident in the independent development of its technology and has spent over a decade building an intellectual property portfolio. It will defend the claims through the courts.
What is really at stake
Software patents are notoriously hard to enforce, so the trade secret count may carry more weight than the patent claims. A Heartflow win would hand it effective control of a segment where several well-funded companies now compete.
Neither company has disclosed damages sought. No trial date has been set.
