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 nonfunctionality, 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, or for medications that are associated with a particular patient compliance or psychosomatic effect.Naeve writes
Imagine a world without the little blue pill or the purple pill. For pharmaceuticals, colors and shapes not only signify the type of medication to a consumer, they can also represent the source of each medication. Most consumers would identify a shiny, round, brown pill not just as an anti-inflammatory medication or even as Ibuprofen, but as Advil. "The purple pill" is Nexium and the light blue angular pill, Viagra. Relying on trade dress to protect the pill color and shape after the patent term has expired enables the manufacturer to extend its market power via another form of intellectual property protection. Like most medications, however, trade dress protection can have unintended side effects.
To obtain trade dress protection for shape and color, the design cannot be functional and the owner must demonstrate that it has acquired secondary meaning in the minds of consumers. A problem arises because, as the brand owner develops secondary meaning in the trade dress, the color and shape can begin to cross the line into functionality, which would then exclude it from protection. "The purple pill" not only signifies the brand Nexium, but it also identifies the pill for acid reflux. In other cases, a shape or color may become associated with a particular dosage, efficacy, result or soothing effect.
Sometimes an element of the medication that was not "functional" in its original design begins to serve a purpose over time and the manufacturer is now potentially a victim of its own success. Additionally, a form of trade dress "genericide" has the potential of occurring to allow generic drugs to enter the market.
This article will first briefly explain the history of trademark and trade dress protection for color and shape. Second, it will introduce the functionality limitations that have arisen in relation to pill shape and color and introduce the concept of aesthetic functionality. Third, it will consider public interest considerations that justify allowing or disallowing protection. Fourth, it will examine more deeply the protection that has been afforded pill shape and color and assess whether trade dress protection is being preempted in the pharmaceutical context due to functionality, aesthetic functionality, and genericness concerns.
Ultimately, this article will argue that color and shape should not become functional or be subject to genericide as a result of creating secondary meaning; that substitution for generic drugs should not be a reason to find that a color and/or shape are functional or generic; that functionality could be determined when the color and/or shape are adopted, not at the time of assessing secondary meaning; that using color and/or shape to indicate a general type of medication should not be considered functional, unless they are industry-regulated by the FDA; that using industry-accepted color and/or shape to indicate dosage is an acceptable functionality limitation, but it too should be regulated by the FDA; and finally that flavor and colors that indicate flavors should be considered functional due to scarcity concerns. …
"Unlike in other industries, several courts have denied protection where it can be demonstrated that the product design serves any useful purpose to the doctor or patient-including the ability to distinguish the product from others in the marketplace." This useful purpose is being called a functional feature, even when it does not fit the traditional notions ofutilitarian or aesthetic functionality.
My proposed solution is to clearly separate secondary meaning and genericide from functionality so that they serve complementary rather than opposing purposes. Accordingly, one possible solution is to assess functionality at the time when the color/shape is adopted, not at the time of assessing secondary meaning. In addition, if generic drug companies or other competitors are allowed to use the same trade dress as the pioneer company, then this determination should be made by the FDA, not the courts or the USPTO. The FDA could also determine industry standards for a particular medication rather than a determination of genericide by the courts. In addition, the FDA could make decisions regarding industry standards regarding acceptable trade dress for dosage specifications.
Ultimately, a pill's shape or color should be determined to be functional because it meets traditional definitions of utilitarian and aesthetic functionality, not because a court determines that it is functional as a result of the effort expended to create secondary meaning or that there is an "industry standard" because the second comers have intentionally copied the pioneer.