BIOCRAFT INITIATES FIRST PATENT CERTIFICATION PROCEDURE

Executive Summary

BIOCRAFT INITIATES FIRST PATENT CERTIFICATION PROCEDURE under the Waxman/Hatch Law in filing a post-1962 ANDA for a generic version of Merck's still-patented Moduretic. In an Oct. 21 press release, Biocraft announced that its ANDA, submitted to FDA on Oct. 15, included a certification that it believes Merck's composition and use patents for the amiloride HCl/hydrochlorothiazide combination product are invalid. "As part of its ANDA, Biocraft has certified to FDA that it believes Merck's patent for Moduretic is invalid," the generic firm said. "Biocraft has notified Merck of its position," as required by the year-old-law, the firm added. Under the Waxman/Hatch legislation, Merck has 45 days to respond to the patent challenge by requesting a declaratory judgment in federal court. If the litigation is not resolved after 30 months, Biocraft would have the option to begin marketing its product at risk. the ANDA/patent law provides Biocraft, if its patent challenge prevails, with six months of exclusivity as the sole generic mfr. of the product. In the negotiations on the Waxman/Hatch bill last year, Biocraft President Harold Snyder was one of the strongest proponents of the provision granting six months exclusivity for a successful patent challenge.