Heart Pills are Red, Viagra is Blue… When Does Pill Color Become Functional? An Analysis of Utilitarian and Aesthetic Functionality and their Unintended Side Effects in the Pharmaceutical Industry

Signe H. Naeve, University of Washington School of Law

Abstract

Abstract: As consumers we often associate pill color and shape with particular medications. Should that trade dress be protected beyond the expiration of the patent? Legal scholars have recognized some of the tensions and inconsistencies in court opinions when it comes to trade dress protection for pill shape and color. This article focuses on the specific tensions between requiring secondary meaning and non-functionality, as well as the potential of “genericide” when generic pharmaceuticals enter the market. Ultimately this article makes some novel recommendations to assess functionality at the time of FDA approval for the pharmaceutical and to have the FDA responsible for determining when a shape and color should be an industry standard, creating an exception to trade dress protection. Some exceptions for allowing protection for pill shape and color could be for flavor and colors that indicate flavor, for medications that indicate dosage, for medications that are associated with a particular patient compliance or psychosomatic effect.