SMITHKLINE BEECHAM v. WATSON PHARMACEUTICALS

Docket No. 99-9501.

211 F.3d 21 (2000)

SMITHKLINE BEECHAM CONSUMER HEALTHCARE, L.P., Plaintiff-Appellant, v. WATSON PHARMACEUTICALS, INC., Watson Laboratories, Inc., and Circa Pharmaceuticals, Inc., Defendants-Appellees.

United States Court of Appeals, Second Circuit.

Decided April 4, 2000.


Attorney(s) appearing for the Case

Helene D. Jaffe, Weil, Gotshal & Manges LLP (Bruce S. Meyer, Jonathan Bloom, Elizabeth R. Forminard, and Randi S. Singer, of counsel), New York, New York, for Plaintiff-Appellant.

Joseph P. Lavelle, Howrey & Simon, Washington, D.C. (Matthew J. Moore, Howrey & Simon; Barry S. White and James K. Stronski, Frommer Lawrence & Haug LLP, New York, New York, of counsel), for Defendants-Appellees.

Mary Jo White, United States Attorney for the Southern District of New York, New York, New York (Heidi A. Wendel and Gideon A. Schor, Assistant United States Attorneys; David W. Ogden, Acting Assistant Attorney General; William B. Schultz, Deputy Assistant Attorney General; Douglas N. Letter and H. Thomas Byron III, Attorneys, Appellate Staff, Civil Division, Department of Justice, Washington, D.C., of counsel), filed a brief amicus curiae, on behalf of the United States of America.

Gary L. Yingling, McKenna & Cuneo, L.L.P. (Rebecca L. Dandeker, of counsel), Washington, D.C., filed a brief amicus curiae, on behalf of the National Pharmaceutical Alliance.

Professor William F. Patry, Benjamin N. Cardozo School of Law, New York, New York, filed a brief amicus curiae, on behalf of Pharmacia and Upjohn, Inc.

Before: WINTER, Chief Judge, JACOBS, and KATZMANN, Circuit Judges.


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...

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