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BIOTECHNOLOGY PATENT BILL CLEARS SENATE WITH PROSPECTIVE IMPORT RESTRICTIONS

Executive Summary

A revised version of Sen. DeConcini's (D-Ariz.) biotechnology patent bill cleared the Senate Sept. 18 by a voice vote. S 654, which has eight cosponsors, would establish patent safeguards for a production process when the starter material is patentable. The amended bill, offered by DeConcini, contains two key changes from the measure that cleared the Senate Judiciary Committee last November. The changes specify that the bill applies only to biotechnology processes and establishes certain import protections. The first change addresses concerns raised by the electronics industry that it might be adversely affected by S 654. The amended bill defines a biotechnology process as "any method of making or using living organisms or parts thereof, for the purpose of making or modifying products. Such term includes recombinant DNA, recombinant RNA, cell fusion including hybridoma techniques and other processes involving site specific manipulation of genetic material." The trade restrictions would bar the importation of finished products using U.S.-patented starter materials such as host cells. Amgen first had sought an import restriction due to concern that Genetics Institute licensee Chugai could import recombinant erythropoietin despite Amgen's court victory in a patent fight over the product. The committee, in its March report on the bill, indicated it would try to work out a compromise on the import issue ("The Pink Sheet" March 23, T&G-2). Reflecting the compromise effort, the import provision would take effect six months after the bill's enactment and would not affect products in "substantial and continuous sale" in the U.S. prior to the enactment date or for which there had been "substantial preparation" for such sale, "to the extent equitable for the protection of commercial investment made or business commenced" before the enactment date. The Senate vote provides a platform for action next year unless the House acts quickly. The House Judiciary/Intellectual Property Subcommittee has not marked up the House biotech patent bill (HR 1417) sponsored by Reps. Boucher (D-Va.), Moorhead (R- Calif.) and others. House sponsors are still optimistic that the issue will be considered this year -- perhaps by bringing up S 654 as a floor amendment.
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