In April 2026, a complaint alleging “one of the most egregious examples of piracy in the medical technology industry” landed on the docket of the U.S. District Court for the Eastern District of Texas.
The 180-page patent infringement lawsuit by Heartflow, Inc.—a California-based medical company that advances coronary care through artificial intelligence (AI)-powered three-dimensional models of a patient’s heart—alleges that a former Heartflow consultant founded a rival company, Cleerly, Inc., using Heartflow’s “revolutionary cardiovascular diagnostic technology, trade secrets, and confidential business information” while still bound by contractual obligations.
“By this action, Heartflow seeks to protect the extraordinary investment—measured in hundreds of millions of dollars, decades of research protected by hundreds of patents, and the contributions of countless scientists, engineers, and physicians—that created the world’s first AI-powered, non-invasive cardiac diagnostic platform, as recognized by the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS),” the Heartflow complaint states.
Cleerly issued a statement on April 17, calling the filing a “lawsuit to limit competition.”
“We strongly disagree with the allegations and will vigorously defend against these baseless claims,” Cleerly wrote. The company’s answer is due July 8, 2026.
We discuss this patent infringement case in further detail below.
Background
According to the complaint, Heartflow’s history reaches back to 1978, when a future co-founder of the company, then a teenager, suffered a ruptured appendix and resolved to become a doctor. By the 1990s, Dr. Charles Taylor’s research interests expanded to include using computers to simulate blood flow in arteries and medical image analysis.
In 2010, Heartflow’s leaders hired Dr. James K. Min, who signed a nondisclosure agreement and who agreed to assign to Heartflow “all right, title, and interest in and to any invention, improvement…trade secret, or other intellectual property, made, conceived, developed, or first reduced to practice by him[.]” Without informing Heartflow, Min allegedly founded Cleerly in 2016, while still bound by “his confidentiality obligations, his non-compete restrictions, and his invention assignment obligations,” the complaint alleges.
Heartflow claims that Min spent the ensuing years “using its Confidential Information to develop Cleerly’s competing products” while “simultaneously working to undermine Heartflow’s business at his own institution[.]” Cleerly also hired Heartflow’s former chief commercial officer, “who had full access to Heartflow’s clinical, technical, and business activities and who was bound by confidentiality obligations[.]”
The Patents at Issue
The Heartflow cardiac diagnostic platform is allegedly protected by more than 600 patents, including six that are the subject of the complaint. Specifically, Heartflow alleges direct and induced infringement of the following patents relating to AI-powered cardiac imaging analysis, which Cleerly allegedly cited to for its own patents:
- U.S. Patent No. 11,288, 813 (Ex. 7): “Systems and methods for anatomic structure segmentation in image analysis”;
- U.S. Patent No. 11,382, 569 (Ex.8): “Systems and methods for estimating blood flow characteristics from vessel geometry and physiology”;
- U.S. Patent No. 9,770,303 (Ex. 9): “Systems and methods for predicting coronary plaque vulnerability from patient-specific anatomic image data”;
- U.S. Patent No. 9,839,399 (Ex. 10): “Systems and methods for numerically evaluating vasculature”;
- U.S. Patent No. 9,607,386 (Ex. 11): “Systems and methods for correction of artificial deformation in anatomic modeling”; and
- U.S. Patent No. 11,013,425 (Ex. 12): “Systems and methods for analyzing and processing digital images to estimate vessel characteristics.”
“[E]ach of the Asserted Patents and the claimed inventions thereof are directed to ‘novel,’ ‘groundbreaking,’ ‘disruptive,’ ‘innovative,’ and ‘new’ technologies that did not have a predicate device,’ the complaint alleges. “These innovations and distinctions over routine and conventional techniques were recognized by the FDA, CMS, Cleerly’s founder and CEO, and many others in the industry.”
Heartflow further claims that Cleerly has and continues to induce others, including health care providers and hospitals, to directly infringe the patents via instructional videos, training, webinars, demonstrations, and the like.
Analysis
The complaint asserts that its “pioneering” AI-powered non-invasive cardiac diagnostic platform has been recognized as “novel,” with FDA granting de novo clearance on November 26, 2014, for a first-of-its-kind device; CMS assigning a “New Technology” Ambulatory Payment Classification; industry praising Heartflow’s technology; and industry publications recognizing Heartflow through extensive citations as being the most utilized AI-based technology in the United States. These facts bolster Section 101 eligibility and inventive concept arguments for AI/machine learning medical imaging claims, often a pivotal early merits issue.
The pleading also ties Cleerly’s workflows (including determining a center point of the anatomic structure; using trained convolutional neural networks to perform lumen wall evaluation and vessel contour determination; quantifying atherosclerosis in a particular way; and determining the likely presence or absence of ischemia) to the six patents, including concrete algorithmic steps and specific outputs, increasing the likelihood of establishing infringement. The patents are alleged to be foundational and heavily cited, including by Cleerly’s own patents.
Takeaways
The Heartflow lawsuit seeks actual and consequential damages, including lost profits in a highly concentrated market. It further seeks injunctive relief, treble damages, pre-judgment interest, expenses, costs, attorneys’ fees, and other relief as the court deems just and proper.
To protect against patent infringement lawsuits in the context of AI-powered medical technology, businesses should adopt the following strategies:
- Obtain a Freedom to Operate (FTO) opinion before launching any AI-related product or service. An FTO opinion assesses the risk of infringing existing patents and can serve as evidence to counter claims of willful or induced infringement in later litigation.
- Develop a robust patent portfolio. Businesses should create a patent portfolio that covers key aspects of their technology and potentially overlaps with competitors' products or processes. A strong portfolio serves as a deterrent against infringement suits because it raises the possibility of counterclaims. If a competitor sues for infringement, the business may have patents the competitor is infringing, providing leverage for cross-licensing negotiations or defensive counterclaims.
- Include indemnification provisions in agreements: When licensing AI intellectual property from third parties, businesses should negotiate indemnification provisions to allocate liability effectively.
- Create clear corporate patent policies: Establishing a clear corporate policy that prohibits infringement of third-party patents demonstrates good faith and compliance with patent laws.
- Conduct thorough pre-suit investigations. In the event of potential litigation, businesses should perform detailed investigations to understand the nature of disputed AI systems. This includes reviewing source code, conducting discovery, and preparing expert analyses to mount a strong defense or negotiate settlements.
If you have questions, please reach out to the author.
Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.
