Smithkline Beecham Consumer Healthcare, makers of Nicorette gum, argued that the marketing of the new product violated its copyright. The case revolved around how the U.S. Food and Drug Administration's (FDA) regulations affect Smithkline's labeling copyrights.

In 1994, Watson Pharmaceuticals Inc. applied for FDA approval to sell a generic version of the gum. The FDA required Watson to submit evidence that its product, including a user's guide and audiotape, would be "the same as" Nicorette. The requirement is part of the Food, Drug and Cosmetics Act. In essence, the FDA told Watson that the labeling would have to be identical to Nicorette in order to win approval.

Smithkline's exclusive right to market an over-the-counter version of Nicorette gum expired in 1999, but the company filed in 1998 to obtain copyright protection for the product's labeling, which included the text of its user guide and audiotape.

In 1999, Watson received FDA approval and began marketing its generic gum. In response, Smithkline filed a copyright-infringement lawsuit.

But lower courts ruled that the copyright could not be enforced against a company required by the FDA to mimic Nicorette's labeling.

Smithkline appealed to the Supreme Court, claiming the lower courts misinterpreted a key provision of the federal Food, Drug and Cosmetics Act dealing with generic drugs.

Smithkline argued that the lower courts should have interpreted the federal law's "same as" language to mean that a generic drug maker must tell consumers all facts concerning safe and effective use "without copying the precise manner in which this information is expressed by the pioneer drug's copyrighted labeling."

The Supreme Court rejected Smithkline's appeal without comment.

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