SmithKline Beecham v. Watson Pharmaceuticals, Inc.
United States Court of Appeals for the Second Circuit
211 F.3d 21 (2d Cir.2000)

- Written by Mary Phelan D'Isa, JD
Facts
SmithKline Beecham (plaintiff), the holder of patents on prescription and over-the-counter (OTC) nicotine gum, Nicorette, brought a copyright-infringement action against Watson Pharmaceuticals, Inc. (Watson) (defendant), a generic competitor of OTC Nicorette. Watson’s generic nicotine gum was packaged with a user guide and audio tape that were virtually identical to SmithKline’s. The district court, relying on a March 1999 Food and Drug Administration (FDA) letter that indicated that its same-labeling requirement did not require using an innovator’s identical materials and that generic sponsors could deviate their labeling to avoid copyright concerns, granted a preliminary injunction that stopped Watson from shipping or selling its product. Watson revised its guide and audio tape so they would be comparable but not identical to SmithKline’s, but the FDA then reversed course and rejected Watson’s revised materials, essentially advising Watson that it had to copy verbatim substantially all the text used in SmithKline’s materials. After that, the district court dissolved the preliminary injunction, noting Watson’s attempt to revise its materials and the public interest in a generic nicotine gum product. SmithKline appealed. Watson argued that because the FDA required the copying, it constituted fair use and was protected under 17 U.S.C. § 107. In its amicus brief, the United States argued that SmithKline gave the FDA an implied license to permit or require generic-drug applicants to copy SmithKline’s materials.
Rule of Law
Issue
Holding and Reasoning (Winter, C.J.)
What to do next…
Here's why 814,000 law students have relied on our case briefs:
- Written by law professors and practitioners, not other law students. 46,300 briefs, keyed to 988 casebooks. Top-notch customer support.
- The right amount of information, includes the facts, issues, rule of law, holding and reasoning, and any concurrences and dissents.
- Access in your classes, works on your mobile and tablet. Massive library of related video lessons and high quality multiple-choice questions.
- Easy to use, uniform format for every case brief. Written in plain English, not in legalese. Our briefs summarize and simplify; they don’t just repeat the court’s language.