Burden of Changes in Generic Pill Appearance (Reply)

The authors counter the FDA’s concern that requiring generic drugs to resemble their brand-name counterparts would violate “trade dress” protections, arguing that Supreme Court precedent prohibits trade-dress rights for functional product features. They urge the FDA to formally acknowledge in a guidance document that bioequivalent generic drugs resembling their brand-name counterparts enhance patient safety, which would provide factual input guiding courts to find such appearance features functional and therefore unprotectable by trademark.