Smithkline Beecham Consumer Healthcare, L.P. v. Watson Pharmaceuticals, Inc.

WINTER, Chief Judge:

This appeal arises out of a copyright action alleging infringement of appellant’s copyright in a user’s guide and audiotape developed for its Nicorette-brand gum. Appellees, in obtaining approval to sell a competing generic nicotine gum product, were directed by the Food and Drug Administration (“FDA”) to use labeling almost identical to appellant’s copyrighted guide and tape. The FDA acted pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (“FFDCA”), see Drug Price Competition *23and Patent Term Restoration Act of 1984 § 101, 21 U.S.C. § 355©…