Genentech, Inc. v. Bowen
United States District Court for the District of Columbia
676 F. Supp. 301 (1987)
- Written by Alex Ruskell, JD
Facts
Genentech, Inc. (plaintiff) manufactured a synthetic growth hormone from cadavers that had a seven-year market exclusivity under the Orphan Drug Act. Before the seven-year period was up, the Food and Drug Administration approved a similar drug produced by Eli Lilly and Company as an orphan drug. Lilly’s drug treated the same conditions, but because it was synthetic, it did not have the same potential for disease-causing contamination as Genentech’s drug. In fact, because of contamination potential, the industry had pulled such drugs from the United States market. Genentech sued, arguing that the Food and Drug Administration violated the act by approving Lilly’s drug before the seven-year period was over.
Rule of Law
Issue
Holding and Reasoning (Harris, J.)
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