BIOTECHNOLOGY PATENT BILL REPRISED IN 103rd CONGRESS

BIOTECHNOLOGY PATENT BILL REPRISED IN 103rd CONGRESS with the introduction on Feb. 4 of HR 760 by Reps. Boucher (D-Va.), Moorhead (R-Calif.) and five cosponsors and S 268 by Sens. DeConcini (D-Ariz.), Hatch (R-Utah) and eight cosponsors. The companion bills would provide patent protection to a product process when the starter material is patentable. The legislation is described as identical to the biotech patent bill that passed the Senate last September ("The Pink Sheet" Sept. 28, 1992, p. 10). Two changes added by the Senate to last year's bill, and included in the current proposals, would make the bill applicable to biotechnology processes only and would make it a patent infringement to import products using U.S.- patented intermediate materials such as host cells. Versions of the latter provision -- sometimes dubbed the "Amgen amendment" because it arose initially from Amgen's patent dispute with Upjohn-Chugai over Epogen -- had been included in some of Boucher's earlier process patent proposals but not in his HR 1417 of last year. The import restrictions would be prospective -- that is, not applicable to Epogen. Senate sponsors are hoping for expedited passage of the bill, particularly in view of passage last year of the same measure. As before, the hold-up may come in the House, which did not take up the legislation in the last session. House Judiciary/Intellectual Property Subcommittee Chairman Hughes (D-N.J.) became the panel's chairman in the last Congress. He did not take a firm position on the bill last year but also did not schedule any hearings or markups. In a floor statement on the bill's introduction, Rep. Boucher remarked: "After three hearings and volumes of analysis, there is no question that there is a need for a legislative response." Both the pharmaceutical and biotechnology industries have supported the measure.