Judging a Pill by its Cover

Mar 01, 2012
By Pharmaceutical Executive Editors

B. Brett Heavner
The expense of public healthcare has given rise to a policy debate regarding whether the public would benefit by increased use of less-expensive generic pharmaceuticals rather than brand-name pharmaceuticals. One proposal to decrease physician and patient preference for brand-name pharmaceuticals would be to eliminate trade dress protection for pill shapes and colors. Historically, drug companies have been accorded exclusive rights to their pharmaceutical "trade dress"—the unique, eye-catching pill colors and shapes that consumers use to identify the brand of the pharmaceutical product. Pharmaceutical trade dress protects both the drug manufacturer and the public by preventing: A) the surreptitious substitution of a similar, but not identical, drug for the one being prescribed; and B) the accidental substitution of one drug for a completely different drug when the two happen to look alike.

Some recent commentators allege that pharmaceutical trade dress protection deters use of FDA-approved generic drugs due to fears of medication errors, decreased patient adherence, and the loss of the beneficial placebo effect. Specifically, these commentators argue that patients who rely on pill color and shape to identify their medications may stop taking the medication or become confused if their switch to a generic is accompanied by a change in the color or shape. Further, they assert that effectiveness of all drugs can, in part, be ascribed to a beneficial placebo effect. This placebo effect may be reduced if patients have less faith in the generic medication due to use of a different color and shape from the original name-brand drug. Despite the vigor of the criticism aimed at pharmaceutical trade dress, there has been little factual analysis of whether pharmaceutical trade dress is actually an impediment to the use of generic drugs or whether there are potential adverse consequences of scrapping pharmaceutical trade dress in its entirety.

What is Trade Dress?

Trade dress is the overall look and feel of a product, including the physical attributes of the product's design and/or its packaging. Product-design trade dress may include color, size, shape, aroma, and even flavor. To secure trade dress protection, the drug manufacturer must demonstrate that the consumer has come to associate the particular combination of physical attributes (color, size, shape, flavor, etc.) with the drug manufacturer. Marketing and advertising typically play a central and critical role in this process. Further, the physical attributes of the drug must not be "functional." That is, they must not be essential to the use or purpose of the drug, and must not affect the cost or quality or performance of the drug. If the product design is found to be legally functional, protection is not available. Over the past 30 years or so, the U.S. courts have been judicious in granting trade dress protection when the combinations of a pill's physical attributes are shown to identify the source of the product, and also in denying such protection when those same physical attributes serve another purpose, such as making the pills more palatable and digestible, or making it easier for consumers to determine the pills' strength.

Elimination: Good or Even Necessary?

Proponents of the recent attacks on pharmaceutical trade dress have failed to address a number of theoretical and practical issues that would arise should trade dress protection be eliminated in the pharmaceutical field.

First, the debate so far has focused solely on FDA-approved generic drugs that are bioequivalent to the brand-name drug. However, pharmaceutical trade dress serves a very important function in preventing infringers from marketing non-generic and non-bioequivalent "look-alike" drugs with significantly different active ingredients and/or effectiveness. It is unclear how a world without pharmaceutical trade dress would effectively combat such look-alike problems absent significantly increased FDA supervision.

Second, there has been no discussion of accidental medication errors when two completely different pharmaceutical products by happenstance share similar but uncommon physical attributes. While patients may double-check medications that consist of commonly used physical attributes (such as plain white tablets or clear capsules), they may be less likely to do so when the pharmaceuticals have an unusual shape or color combination. So pharmaceutical trade dress protection may reduce the risk of a medication error by assuring that unusual combinations of physical attributes are not displayed on multiple drugs. Preventing accidental medication errors from look-alikes may be particularly important to over-the-counter drug or vitamin manufacturers who may not have the benefit of strict FDA regulatory review.

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