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Executive Summary

REP. BOUCHER's BIOTECH PATENTS BILL IS SET FOR HOUSE SUBCOMMITTEE HEARING scheduled for Sept. 25. At the hearing, the House Judiciary/Courts, Intellectual Property subcommittee has invited the Administration, Genentech, Amgen and Upjohn to testify on HR 3957. The bill was jointly introduced by Reps. Boucher (R-Va.) and Moorhead (R-Calif.) on Feb. 6. The Commerce Department has concerns with parts of the bill. For example, in a July 5 letter to Boucher, the department's General Counsel, Wendell Wilkie, commented that the bill's authorization of the International Trade Commission to bar importation of infringing biotech products is unnecessary ("The Pink Sheet" July 16, T&G-7). Wilkie maintained that the ITC is already authorized to bar products made abroad by a process patented in the U.S. The bill is designed to close what some biotech companies see as a loophole in current law that has allowed the importation of biotechnology products made by offshore companies through use of a U.S. patented compound. The legislation is supported by Genentech and Amgen, and opposed, at least in part, by Upjohn. If passed, the legislation would effectively bar importation of Chugai-Upjohn's Marogen (erythropoietin) from entry into this country. The ITC has dismissed a patent infringement claim by Amgen (currently the sole U.S. marketer of EPO) against Chugai-Upjohn for "lack of subject matter jurisdiction." The bill may also impact the entry into this country of a competitor to Genentech's tissue plasminogen activator, Activase, the only TPA approved in the U.S. Genentech has been involved in a patent dispute with Genetics Institute and Burroughs Wellcome over another version of TPA. The Industrial Biotechnology Association supports all provisions of the bill and is planning to submit written testimony to the subcommittee. The bill also would modify U.S. Patent & Trademark Office practice to ensure that a process would not be considered "obvious" if an "essential" material used in that process were in itself patentable, or "novel and nonobvious." The law would become effective on enactment but contains a transition clause allowing an importer to sell off infringing product after the date of enactment, if the product had been imported prior to enactment. While it has been argued that the effective date would unfairly prohibit continued importation of EPO from Japan, it is IBA's position that it is more inequitable to allow continued importation of EPO at the pioneer companies' "expense."

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