Third, pharmaceutical trade dress may not be as significant an impediment to the use of generics as the commentators presume. To the extent that pill color and size are used by consumers to identify dosage strength or other non-source identifying information about a medication, those color and size features are functional and therefore already non-protectable under current U.S. trade dress law. Indeed, the name-brand drug manufacturers have a fairly steep hurdle to establish trade dress protection in their pills' shape and color. As noted above, as a prerequisite for trade dress protection, the manufacturers must show that patients use the color and shape to identify the source of the pharmaceutical. Typically, this is only successful with unique and eye-catching color combinations or unusual pill shapes that have been highlighted for consumers in the branded drugs' advertising.

Fourth, there is a question as to whether the benefits of the placebo effect are sufficiently great to outweigh the benefits of trade dress protection for pharmaceuticals. The beneficial placebo effect is likely to be most pronounced in the treatment of conditions with a psychosomatic component (such as anxiety, depression, impotence, etc.). This fairly small portion of the pharmacopoeia may be insufficient to justify the total elimination of pharmaceutical trade dress protection. Further, the placebo effect may not be attributable to pill shape and color at all, but may instead derive from the perceived quality of the medical care and/or the high cost of the name-brand prescription. If the patient is aware of the generic switch, and believes that the generic is a lower-quality product, a continuation of color and shape may not preserve the beneficial placebo effect.

Fifth, the legitimacy of adopting a public policy to foster a "beneficial" placebo effect may be philosophically suspect. The placebo effect occurs when patients' conditions improve merely because they believe that they are taking a helpful drug (whether it actually is helpful or not). However, the same "positive effect" could be felt by any consumer of counterfeit goods in other fields. The fashion-conscious consumer could look and feel better when they believe they are wearing a Rolex watch or sporting a Gucci handbag, even if the watch and handbag are fakes. Clearly, these sorts of psychological benefits to the consumers of counterfeit goods do not justify the illegal actions of counterfeiters outside the pharmaceutical field. Should our health policy aim to preserve a similarly psychological placebo effect by purposefully clouding the source of a pharmaceutical product in the mind of the patient?

Given the rise of patient-directed advertising, combined with the rise of FDA-approved generics, the issue of pharmaceutical trade dress is likely to become an increasingly important and contentious issue for the near future. Indeed, there is a general expectation that generics companies will seize on this debate in an attempt to defeat trade dress protection for brand-name pharmaceutical products whose U.S. patents are set to expire soon.

With respect to the public policy debate, it is imperative that brand-name drug manufacturers: A) educate the public about the importance of trade dress to the industry; and B) publicly question the assumptions underlying the arguments for the elimination of pharmaceutical trade dress. While the debate about promoting the use of generic drugs is a healthy one, it should not be hijacked by generic manufacturers as a justification for a wholesale attack on pharmaceutical trade dress rights.

As a practical matter, drug name manufacturers desiring trade dress protection for their products must carefully select and cultivate that trade dress. The combination of physical attributes comprising the trade dress must be unique and not commonly found in the field. It must not serve a functional purpose or affect the performance of the drug in any way. Further, once a unique combination of non-functional physical attributes is selected, the drug manufacturer must launch a campaign aimed at linking this trade dress exclusively with the manufacturer in the minds of consumers. While developing a protectable pharmaceutical trade dress may require a great deal of planning and effort, it may be a very effective tool to boost consumer recognition and desire for the product.

B. Brett Heavner is a Partner at Finnegan Henderson, Farabow, Garrett & Dunner. He can be reached at b.brett.heavner@finnegan.com