Troutman Pepper Locke
A district court issued a preliminary injunction against a competing generic to the cardiovascular drug Entresto last month after finding that the generic pill’s size, shape, and color were likely to violate Entrestro’s trade dress. The FDA recommends that generics and branded drugs have similar size, shape and other traits to promote patient safety and compliance with drug regimens. But these recommendations are at odds with trade dress laws, leaving generic manufacturers walking a regulatory tight rope and branded drug manufacturers seeking to protect their established goodwill in the market.
Here are some considerations for generic and branded manufacturers in light of this latest ruling.
Functionality
While the overall look and feel of a pill are potentially eligible for trade dress protection, this protection is only available for the pill’s nonfunctional features. This requirement is intended to prevent a single manufacturer from monopolizing an important pill feature in order to gain an unfair advantage. Functional features excluded from trade dress protection are those that are essential to the use or purpose of the drug or impact its cost or quality.
However, the functionality inquiry is a flexible one, and features such as size, shape, color, coating, and taste could either be nonfunctional or functional depending on the facts and circumstances of each particular case.
To the extent manufacturers wish to pursue trade dress protections for a drug, they should consider incorporating multiple nonfunctional features into their dosage designs. These features could include a combination of unique traits, such as shape and color.
Patient recognition of generic’s dosage form that is similar to the branded equivalent could improve patient drug regimen compliance and reduce medication errors. If patient recognition is functional, it could depend on a variety of factors, such as whether the target patient is more susceptible to pill errors (e.g., children, elderly) or if there is a need to distinguish doses (e.g., a typical regimen requires that the patient take multiple pills at varying doses each day). Whether patient recognition is functional could potentially depend on a multitude of factors, such as whether the target patient is more vulnerable to pill errors (e.g., children, elderly) or if there is a need to distinguish doses (e.g., a typical regimen requires the patient to take multiple pills of varying doses each day).
From a risk mitigation perspective, both branded and generic manufacturers should document and evaluate the functionality or nonfunctionality of all tablet or capsule features before they are incorporated into the applicable dosage form.
Secondary Meaning
In order for a brand drug manufacturer to claim trade dress protection, the pill’s trade dress must also have “secondary meaning.” This means the public must associate the tablet or capsule’s design, packaging, or overall appearance with a particular source or brand.
Size, shape, and color can contribute to secondary meaning, but are not always enough on their own. Additional factors that may contribute to the secondary meaning analysis, include:
Market Exclusivity.
Courts will often consider the length of use and exclusivity of trade dress when determining whether secondary meaning has been established. Branded pharmaceutical drugs from large companies may have an advantage in establishing this factor due to the length of regulatory exclusivity their products often have in the market
- . Consumer Surveys.
- Customer survey and testimony supporting the recognition of the drug could potentially provide direct evidence for secondary meaning. However, it’s important to consider that for purposes of secondary meaning, the ultimate “consumer” is generally a prescriber or pharmacy, not the patient.Promotional Efforts.
- Drug manufacturers’ use of a pill’s trade dress in their promotional efforts with prescribers is another factor that may be considered when evaluating whether the pill’s features have secondary meaning.Likelihood of ConfusionEven if the tablet or capsule features at issue are nonfunctional and secondary meaning of the trade dress is established, there is no trade dress infringement unless it is determined there is a likelihood that a prescriber will confuse the generic with its branded counterpart. Courts often use a multifactor test to evaluate this.
It is important to note that a court can also use the factors used to determine secondary meaning and functionality to evaluate likelihood of confusion. For example, a generic could argue that the similar traits are a function of FDA regulatory considerations, but if functionality is not ultimately established, a court could potentially attribute the generic’s intention to develop a similar dosage form appearance to an intent to copy — a factor considered in the likelihood of confusion analysis.
Conclusion
Navigating the complex interplay between FDA regulations and trade dress protections requires careful consideration and strategic planning. Generic manufacturers need to balance the need to adhere with regulatory guidelines and avoid potential trade dress infringement lawsuits. Branded drug manufacturers, on the other hand, must be vigilant in protecting the market position they have built and the goodwill that they have developed with their products. This includes any distinctive trade dress embodied within the tablet or capsule design.
