Pepcid 252-day Waxman/Hatch extension created by court has no statutory basis -- GPIA appeal brief.

Executive Summary

PEPCID 252-DAY WAXMAN/HATCH EXTENSION UNDER COURT RULING CHALLENGED by the Generic Pharmaceutical Industry Association in a brief submitted in the appeal of the consolidated case of Merck, Schering-Plough, Bracco and Roche v. FDA and the Patent & Trademark Office. Merck's Pepcid (famotidine) patent is one of 12 specifically at issue in the case, which seeks to overturn the PTO/FDA position that sponsors cannot add existing Waxman/Hatch patent extensions to the new 20-year-from-filing terms created by the General Agreement on Tariffs & Trade. The plaintiffs won the first round in the case when the Alexandria, Va. federal court ordered FDA to publish expiration dates as submitted by NDA holders ("The Pink Sheet" Oct. 23, 1995, T&G-1).