Xechem, Inc. v. Bristol-Myers Squibb Company

The Hatch-Waxman amendments to the Food and Drug Act entitle pharmaceutical companies that first bring a drug to market to a five-year period of exclusivity, even if the drug is unpatented. 21 U.S.C. §355. Bristol-Myers Squibb was first to market with paclitaxel, a compound derived from the bark of the yew tree and useful in combating some cancers. Bristol-Myers calls its formulation Taxol, which has been a commercial success. The exclusivity period was due to expire in July 1997, and many other drug producers geared up to sell generic paclitaxel once the market opened.