Quarterly Journal Volume 53, Issue 4 November 2025

DMC-AI: AN ANTIVENOM 

COMPOUNDED DRUGS: AN UPRISE OF TRADEMARK INFRINGEMENT LAWSUITS CALLING FOR MORE FDA REGULATION

Demand for GLP-1 medications has surged, driven by their use in diabetes treatment and off-label weight loss. With increasing demand, manufacturers of the Food and Drug Administration (“FDA”) approved drugs Ozempic, Wegovy, Mounjaro, and Zepbound have had a hard time producing enough medicine to meet consumer demand. Supply shortages prompted the FDA to allow compounding pharmacies to produce copies of these drugs, which are not FDA-approved, meaning they lack safety, quality, and efficacy testing. The rise in compounded drugs has sparked trademark infringement and false advertising claims by original manufacturers, like Novo Nordisk and Eli Lilly, who allege that affiliation with the compounded drugs harm their brands. This Note discusses the need for enhanced regulatory measures to better control the advertising and labeling of compounded drugs, proposing that the FDA is given more authority to expand on its current regulation and require clear disclaimers to protect consumers and trademark rights.

DOMESTIC INDUSTRY: WHY THE ANALYSIS SHOULD CHANGE WITH THE TIMES 

The modern American industrial landscape is vastly different from when the Smoot-Hawley Tariff Act of 1930 first established Section 337 investigations. In the years since 1930, ITC Commissioners have disagreed over whether the economic prong of the domestic industry analysis should adapt to the modern economic landscape. Recent cases at the ITC and the Federal Circuit have shown that it is time for the Commission to once again reckon with this question. This note suggests that the ITC should fully adopt the Federal Circuit's recent ruling in Lashify, Inc. and implement the holistic "as-a-whole" analysis for domestic industry. This would include expenses centered on non-traditional industries such as sales and marketing, bringing American intellectual property rights enforcement into the modern age.

JUST A GENERATIVE AI USER, STANDING IN FRONT OF A COPYRIGHT TROLL, ASKING IT TO LOVE HER: GENERATIVE AI, COPYRIGHT TROLLS, AND THE STATUTORY DAMAGES REGIME

Copyright trolls have been on the rise for the last few decades, capitalizing on the statutory damages scheme offered in the Copyright Act. While the main arena for copyright trolls has generally been within peer-to-peer file sharing, the inception and popularization of generative artificial intelligence (“Generative AI”) may present a new frontier for copyright trolls. With the massive amounts of data contained in training sets for Generative AI models, some degree of copyright infringement in both the input and output of these engines is all but assured. End-users may not know it, but their actions in using Generative AI may open them up to the predatory litigation tactics of these trolls. The solution can be found in taking away the monetary incentive for copyright trolls to behave as they do; by applying a presumption of innocent infringement, end-users of generative artificial intelligence may be better shielded from forced settlements, while willful infringers can still be held accountable.

QJ Volume 53 Article and Author Index