United States: Color, Size and Shape Matter—For Pharmaceuticals That Is

In a recent case involving the validity of trade dress in drug configurations, the U.S. Court of Appeals for the Third Circuit held color, size and shape of certain medication was functional and that the manufacturer had, therefore, failed to demonstrate a likelihood of success on the merits of its trade dress claim. Shire U.S., Inc. v. Barr Laboratories, Inc., 329 F.3d 348, 2003 U.S. App. LEXIS 10363 (3rd Cir. 2003).

Shire has offered its ADDERALL brand ADHD medication in tablet form since 1996. The color (blue or orange/peach), size and shape (oval or round) of the tablets vary with dosage strengths. The tablets are also scored and stamped with the mark "AD" on one side and the dosage on the other. Barr, a competing pharmaceutical manufacturer, began offering a generic equivalent. Barr's tablets were offered in similar colors (blue or peach/light orange), sizes and shapes (oval) as Shire's. Shire brought suit for infringement of its unregistered trade dress, arguing that Barr's use of a similar trade dress for its nearly identical products was likely to cause consumer confusion.

The district court concluded that the allegedly infringed feature of Shire's trade dress is functional and, therefore, ineligible for trade dress protection. Specifically, the district court credited Barr's evidence that the variations in color, size and shape of Shire's ADDERALL drug are functional because they provide adult ADHD patients with the ability to recognize the identity and dosage of their medication with greater accuracy. The district court also noted that the coding facilitates the adjustment of dosages, which is common with ADHD drugs, and that many patients take multiple daily dosages of different strength tablets, and the coding decreases the likelihood of errors by patients and caregivers.

The Third Circuit agreed, but acknowledged that it had in the past made arguably contrary rulings. However, the court stressed that "it is inherent in the very nature of the deferential appellate review of findings of fact that a court of appeals can and, indeed, should, depending on the records before it, uphold arguably inconsistent outcomes." The district court's crediting of Barr's evidence that similarity in tablet appearance enhances patient safety by promoting psychological acceptance was not to be disturbed because Shire did not meet its burden of showing that determination to be clearly erroneous.

Practice Note: Trade dress cases involving medications sometimes reflect determinations about public health more than established law regarding intellectual property rights. Pharmaceutical manufacturers should be aware that some courts may be unwilling to extend trade dress protection to a drug's, for example, color and shape, based on a determination that doing so would render generic equivalents less acceptable to consumers.