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LOPID PATENT EXTENSION PROVISION IN SEN. DeCONCINI's PROCESS PATENT BILL

Executive Summary

LOPID PATENT EXTENSION PROVISION IN SEN. DeCONCINI's PROCESS PATENT BILL may meet some resistance from the House as it moves to House/Senate conference. The bill was approved on the Senate floor July 21 as part of the Omnibus Trade Bill. The amendment provides a five-year patent extension for Warner-Lambert's Lopid (gemfibrozil). The provision was not part of Rep. Moorhead's (D-Calif.) original process patent bill, which passed with the House trade legislation this spring. Rep. Kastenmeier (D-Wis.), a co-sponsor of the House process patent bill, reportedly opposes the Lopid amendment. The conference committee members have not been appointed to date and no meeting has been scheduled. The Lopid provision was added to DeConcini's bill with the understanding that it would not be viewed as a precedent for other products ("The Pink Sheet" June 8, T&G-1). Warner-Lambert's lipid-lowering agent is scheduled to go off patent July 4, 1989. The Senate version of the process patent legislation contains other provisions not included in the House measure. One relates to the sale by retailers or distributors of partially processed infringing products. Under the Senate bill, retailers or distributors may avoid penalties for partially manufactured products in transit or already in possession when notice of infringement is served. The loophole has been criticized by the Pharmaceutical Manufacturers Association as incentive for stockpiling. Unlike the House bill, the Senate version also contains requirements for disclosure of patent information to suspected infringers by patent holders. Both bills make it infringement to sell or use products made overseas by unauthorized use of a process patented in the U.S.
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