Xechem, Inc. v. Bristol-Myers Squibb Company
372 F.3d 899, 71 U.S.P.Q.2d 1220, 2004.C07.0000291
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Publisher Description
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.