A generic drug maker was not liable for labeling that appeared to infringe the labeling of the brand name drug because the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (“FFDCA”) require generic drug makers to use the “same labeling,” the 2d U.S. Circuit Court of Appeals held April 4 (SmithKline Beecham Consumer Healthcare LP v. Watson Pharmaceuticals Inc., 2d Cir., No. 99-9501, 4/4/00).
In an unusual move, the court directed the dismissal of the copyright infringement suit brought by SmithKline against manufacturers of generic versions of its nicotine gum. The court found that this case fell within an “exception” to the general rule that an appellate court may not delve further into the merits than necessary to resolve issues presented in an interlocutory appeal because an examination of the record revealed that the case was “entirely void of merit.”
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