LOPID PATENT EXTENSION SEPARATE BILL SET FOR HOUSE CONSIDERATION: MARKUP JAN. 27

Executive Summary

Rep. Kastenmeier's (D-Wisc.) House Judiciary/Courts Subcommittee, has tentatively scheduled a markup of a separate Lopid patent extension bill for Jan. 27. The scheduling of the markup, only two days after the House returns from the congressional recess, could give the Lopid measure a quick boost in this year's limited Congressional session. The election-year effectively will shorten the legislative calendar. Rep. Derrick's (D-S.C.) HR 3074 would extend the patent for W-L's gemfibrozil, the lipid-lowering agent, by five years through 1994. The patent is currently scheduled to expire July 4, 1989. No amendments to the bill are expected at the markup. The firm was "pleased" with the outcome of an Oct. 8 subcommittee hearing on the bill, at which W-L Chairman Joseph Williams said the firm is willing to commit to five years of price stability for Lopid if the patent extension is granted ("The Pink Sheet" Oct. 12, p. 6). The Lopid extension is based on the premise that Warner-Lambert lost 5-7 years of exclusive marketing under a broader indication in order to conduct a large-scale study in Finland on the effect of Lopid on mortality rates (the Helsinki Heart Study). Lopid was approved in 1981 for a restricted triglyceride-lowering indication. Identical legislation for Lopid has already passed the Senate as an amendment to the omnibus trade bill (HR 3) and is pending before a House/Senate conference committee. As an alternative to passage by the House as an individual bill, Lopid legislation could also pass the House through the conference process. However, the legislation's progress as an individual bill may be quicker: the conference committee has not yet scheduled consideration of the Lopid provision.