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Letters |2 December 2014

Burden of Changes in Generic Pill Appearance

Aaron S. Kesselheim, MD, JD; Niteesh K. Choudhry, MD, PhD; Jerry Avorn, MD

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We believe that Drs. Uhl and Peters' perception that brand-name manufacturers could successfully claim monopoly protection for the appearance of their pills as “trade dress” is not supported by current intellectual property law. Since a key 1982 decision, the U.S. Supreme Court has stated many times that no valid trade-dress rights can exist in a feature of a product that is functional, which is defined as something that is “essential to the use or purpose of the article or … affects the cost or quality of the article” (1). In 1998, the U.S. Trademark Act was amended to expressly prohibit registration any of “matter that, as a whole, is functional” (2). In 1 relevant case, the court ruled that the pink color of wall insulation was nonessential to the product's use (3). By contrast, the black color of a motorboat engine was found to be functional because it allowed easier coordination with other boat colors and reduced the apparent size of the engine to customers (4).
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Kesselheim AS, Choudhry NK, Avorn J. Burden of Changes in Generic Pill Appearance. Ann Intern Med. ;161:840. doi: 10.7326/L14-5028-3

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Published: Ann Intern Med. 2014;161(11):840.

DOI: 10.7326/L14-5028-3

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