Schering PTO patent extension proposal

Executive Summary

Schering's proposal that would extend the patent for the allergy drug Claritin and other "pipeline" products has not been included in omnibus appropriations bill. The measure is said to have been originally supported by Sen. Mack (R-Fla.) but later championed by Sen. Lautenberg (D-N.J.). The Clinton Administration is said to oppose a three-year patent extension proposal being pushed by Schering-Plough following an Oct. 9 letter from Sens. Durbin (D-Ill.) and Leahy (D-Vt.) to White House Chief of Staff Erskine Bowles. Senate Majority Leader Lott (R-Miss.) is also understood to oppose the measure, under which the U.S. Patent & Trademark Office would review applications for an extension of up to three years for "pipeline" drugs that were already submitted to FDA when Waxman-Hatch passed, but for which approval was delayed. Products under an IND when Waxman-Hatch was signed into law were limited to two-year patent extensions. The proposal would affect seven drugs