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LOPID 3-1/2 YEAR PATENT EXTENSION IS PROVIDED IN COMPROMISE LEGISLATION REDRAFTED AS PRIVATE BILL; WARNER-LAMBERT WINS EXTENSION TO AT LEAST JANUARY 1993

Executive Summary

A 3-1/2 year patent extension for Warner-Lambert's Lopid (gemfibrozil) is provided in a compromise measure drafted by House and Senate trade bill conferees during the week ending March 19. The extension is conditioned on FDA approval of a second indication -- heart attack prevention -- for the lipid-lowering drug. The provision will prolong Lopid's patent to at least January 1993, assuming FDA approves the second indication by July 4, 1989, the patent's current expiration date. If approval comes after that date, the extension may go beyond January 1993. That seems unlikely, however, given the volume of data from the Helsinki Heart Study in support of the heart attack prevention claim. W-L says its application with FDA for the indication is "imminent." The tentative agreement was reached during the joint conference committee's consideration of the omnibus trade bill (HR 3), which is expected to complete the conference process and go to a vote shortly after Congress returns April 11 from the Easter recess. The Lopid bill is part of HR 3. As part of the compromise, the patent extension is 1-1/2 years less than what was proposed in the original version of the legislation. The measure has also been redrafted as a private bill to ensure that it will not be viewed as a precedent for other drugs. As a private bill, the measure provides relief to Warner-Lambert without amending Title 35 of federal patent law, as public legislation would have done. The Lopid bill was supported among conferees from the Senate, but had met some opposition from House members. The bill originated as an amendment to Sen. DeConcini's (R-Ariz.) process patent legislation. However, Rep. Kastenmeier (D-Wis.) had objected to the fact that the bill reached the conference stage without being considered in the House. He also expressed concern over its potential as a precedent-setting measure. The patent restoration project has been a high priority for Warner-Lambert because Lopid is the company's only currently marketed Rx drug with patent protection. The company's extensive lobbying efforts have apparently obtained sufficient support for a patent extension, including the backing of one of the firm's home state congressmen, Rep. Rodino (D-NJ), the conference chairman. Company efforts also resulted in the introduction of an identical bill in the House to provide an alternative route to enactment. The House bill was introduced by Rep. Derrick (D-SC). W-L participated in a hearing on that bill before Kastenmeier's Judiciary/Courts Subcommittee. At the subcommittee hearing last fall, Warner-Lambert Chairman and CEO Joseph Williams promised that the firm would continue to market Lopid at an inflation-adjusted stable price for at least the duration of the patent extension, if one were 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 the Helsinki Heart Study, a large-scale study in Finland on the effect of Lopid on mortality rates. Lopid was approved in 1981 for a restricted triglyceride-lowering indication.
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