No copyright over simple colors and shapes used to annotate X-rays

Overjet, Inc. v. VideaHealth, Inc., 2024 WL 3480212, No. 24-cv-10446-ADB (D. Mass. Jul. 19, 2024)

The court denied Overjet’s request for a preliminary injunction on copyright and false advertising claims, concluding that Overjet’s selection of colors and shapes for annotating dental x-rays was unlikely to be protected by copyright and that the literally false statements identified by Overjet had been removed, thus preventing a finding of irreparable harm.

“Overjet uses AI to scan dental radiographic X-rays and detect dental diseases. Specifically, Overjet uses an approach called segmentation, which outlines exact borders and shows the extent to which pathologies, or diseases, exist.” Its software “annotates diseases and structures on dental X-rays,” which “allows clinicians to better detect diseases and devise treatment plans.” It’s presently the only dental AI company with FDA clearance for “performing dental detection and segmentation to outline exactly where pathologies exist.”

In fall 2023, Overjet launched its “Anatomical Structures Visualization Tool” for Overjet Caries Assist, which introduced the relevant coloring scheme and design. The tool uses “white to represent enamel, purple to denote the pulp of a tooth, bright green lines with circles at the ends to indicate measurements of bone levels, and red and translucency to mark areas of decay.” [Id. Overjet allegedly chose these colors and shapes in order to create a “contrast with the gray scale” of the X-rays and with the ultimate goal of assisting with “patient assessment, diagnosis, and treatment planning.” It also allegedly “selected the design and colors to help with brand identification; the purple, for example, complements Overjet’s purple brand color.” Example image showing use of red, white, purple, and green lines ending in dots: 

Videa is a competing dental AI company. In December 2023, the FDA cleared “Videa Dental AI,” for “identifying and localizing a range of dental findings and indications, including caries or cavities and periapical radiolucency, when analyzing bitewing, periapical, and panoramic X-rays taken from patients three years of age and older.” If the software detects any indications, it “returns a set of bounding boxes representing the suspect dental finding.” Unlike Overjet, VideaAI offers a Clinical View and Patient View; the former “uses boxes and lines with dots to quickly display … points of interest.” Patient View, at issue here, is designed to be a “communication tool for [ ] provider[s].” and offers “a version of the results that are ‘segmented’ and highlights the shape of the points of interest” by “show[ing] more than mere lines and boxes.”

 Example; patient view with red areas, blue, white, and greenish lines with circles:

Videa beat Overjet out of a lucrative partnership with a large dental client.

Copyright: Overjet’s copyright protected its source code, but there were no allegations of code copying. Instead, it alleged copying of its “coloring scheme, shades, and shape.” First, there were real questions about whether actual copying occurred, given the timeline, which I won’t get into, though those questions are related to the existence of protection for, e.g., selecting green as the color for healthy gum levels, yellow for some risk, orange for higher risk, and red for a “potential problem.” Videa argued that it chose this “stoplight” system because it was “intuitive for patients and clinicians.” Likewise, it argued that red boxes to indicate tooth decay was an “obvious color choice to indicate warning ... and commonly used across industries.” Videa further argued that it used white to indicate enamel and blue to demarcate pulp was made “because white is the color of enamel and blue provides contrast to render pulp more visible.”

Second, the color scheme, shades, and shapes were not sufficiently creative/concrete to get copyright protection. The court began with 17 U.S.C. § 102(b): “In no case does copyright protection for an original work of authorship extend to any idea, procedure, process, system, method of operation, concept, principle, or discovery, regardless of the form in which it is described, explained, illustrated, or embodied in such work.”

The court found that Overjet’s claim to shapes, colors, and shading defined the relevant “abstraction” for the infringement test. The next step was filtration: eliminating unprotectable elements. Functional elements are uncopyrightable. The scheme here seemed functional:

The underlying impetus of the color scheme and display is seemingly to aid clinicians in carrying out dental diagnostics.. Thus, although there may not be industry-standards or guidelines specifying what colors and shapes may be used on an X-ray, it nevertheless appears intuitive to use certain specific colors to indicate problem areas or create contrast in order to efficiently identify pathologies, suggesting that Overjet’s color, shape, and shading decisions were primarily driven by functionality.

Overjet’s own complaint indicated that the tool was “a tremendous aid in patient education …. Highlighting enamel and pulp allows for a richer understanding of the nature and severity of disease progression and a visual that matches dentists’ quantified AI finding.”

Relatedly, the individual colors and shades did not rise to the necessary low level of creativity. Although the “selection, coordination, and arrangement” of elements that are by themselves not protectable may nonetheless meet the originality requirement, that wasn’t the case here. It did not seem to the court that “countless artistic decisions” were possible, as they would be for turning a real animal into a stuffed toy. Overjet “organized and arranged only four colors (red, white, purple, and green) and two shapes (a line with circles at the end).”

False advertising:

Overjet challenged statements that allegedly falsely indicated that (1) “Videa’s software is safe and effective for various medical purposes,” even though it had not obtained the relevant FDA clearance, and (2) it had “reached a technological milestone in AI development before Overjet.”

For (1): In a now-deleted LinkedIn post from December 2023, Videa stated, “[h]ear from the clinicians who are experiencing firsthand VideaAI’s transformative power.” [The X-ray accompanying the statement allegedly implied that Videa had FDA clearance for segmentation when, in reality, the FDA had only cleared Videa’s “bounding box” approach. But “[b]ecause Videa is in fact an AI platform, the statement is not explicitly false. The Court cannot, however, without the benefit of the full LinkedIn post, assess the extent to which Videa’s statement, in light of the accompanying X-ray, is misleading, and refrains from evaluating Statement # 1 under the first prong of the Lanham Act at this juncture.”

In 2021, Videa represented that its AI software can “aid in the diagnosis and prediction of the progression of diseases such as caries or periodontitis.” But Videa has not been cleared for progression analysis. Video argued that it “merely provides this comparative tool to aid clinicians’ analyses.” The court found that the challenged statement emphasized the benefits of “AI within diagnostics and treatment planning,” [Ex. 27 at 2], and was neither false nor misleading. Its software localizes and identifies various dental indications in X-rays using bounding boxes. “In comparing these AI-generated annotated X-rays over time, clinicians can assess the extent to which certain conditions, including caries and periodontitis, have progressed.” Thus, the statement didn’t communicate that Videa provided progression analyses or that Videa had obtained FDA clearance for conducting such analyses. Similar analysis applied to Videa’s statement that its “artificial intelligence software ... helps gauge the caries level in carious lesions.” (The court also noted that, when the blog post was published, it contained an “investigational” disclaimer; that disclaimer was removed when Videa obtained the relevant FDA clearance.)

In 2024, Videa blogged that “[w]e suggest choosing an AI provider with the most FDA-cleared annotations.” According to Videa, annotations are “not equivalent to segmentation,” for which it’s not cleared, but rather refer to “a visual way of showing the results of AI analysis, which can take many forms, including a simple bounding box.” This wasn’t literally false, because Videa had just obtained FDA clearance for thirty plus indications. Nor was there a necessary implication that “annotation,” that is, labeling an X-ray, refers to FDA clearance for segmentation. That was too attenuated.

Overjet argued that the statement was misleading because the image right above the alleged misrepresentation is captioned “VideaAI’s patient view showing a segmented x-ray,” which could create an implied connection between “annotations” and “segmentations,” but there was no evidence of actual deception.

However, another ad, a segmentation view with the caption “[i]ntroducing the first FDA-cleared dental AI for patients aged 3 and up,” whose images were subsequently replaced, could lead a viewer to recognize the claim that Videa obtained FDA clearance for segmentation as “readily as if it had been explicitly stated” because of the combination of the image sand text.

Videa also stated that it is the “only dental AI company to spend time and money to retest and improve [caries] models.” Overjet argued that it had also done so, submitting a new iteration of its model after the FDA cleared it, and the court agreed that this rendered the statement literally false. Likewise, an initial statement that “[p]roviders can use VideaAI to help diagnose all patients, regardless of age” was literally false; it has been modified to “[p]roviders can use VideaAI to help diagnose all patients 3 years and older.” And another removed statement, “[t]he world’s first pediatric dental AI” was literally false because Overjet obtained clearance for pediatric patients—at least 12,efore Videa did, even though it was the first to receive clearance for patients 3 and older. “Pediatric care refers to the treatment of infants, children, adolescents, and young adults, and commonly encompasses all ages up to twenty-one years old.”

Another statement that VideaAI could “identify cysts” was potentially false, even though it was FDA-cleared for periapical radiolucency (“PRL”) detection, which includes cysts; identifying a PRL might not be the same thing as identifying a cyst. So too with a statement that Videa’s software “annotates 18+ months of historical images to help monitor and track progression of disease.” The software itself doesn’t track or quantify progression, but seeks to assist clinicians in assessing side by side comparisons of annotated X-rays. Although the statement was literally true, an image captioned “Current Visit” indicates that the subject tooth’s caries size has increased by 20% since the previous X-ray was taken. That image, coupled with the statement that Videa’s “AI annotates 18+ months of historical images to ... track progression of disease,” could suggest that the software—rather than the clinician—evaluates the progression.

Of the surviving statements, there was “scant” support for materiality. Statements focusing on the idea that Videa’s AI software can aid in the diagnosis and prediction of various diseases didn’t seem material. But references to VideaAI’s pediatric qualities were more plausibly material. Nonetheless, Videa sells to sophisticated customers such as dental practices and services, who “likely have the scientific and technological understanding to fully appreciate Videa’s product offering and its limitations.”

Online advertising and presentations during trade shows appear to be a starting point for potential purchases, but do not alone drive such decisions. It is reasonable to assume that, given the actors involved and the considerable monetary value of potential contracts, the sales process is thorough and lengthy, with a heavy focus on the software’s actual capabilities, including relevant FDA clearance.

What about bait and switch reasoning?

There was also no evidence of actual deception. “It seems reasonable that discussions surrounding relevant FDA clearance—and verification thereof—are a critical component of the sales process. A few promotional videos and blog posts, it appears, are unlikely to cause consumer deception among the relevant pool of potential consumers.”

Nor did Overjet show injury from the deception. This also prevented a showing of irreparable harm, especially as the literally false statements have been removed.