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UNIFORM INTERNATL. PATENT POLICIES SHOULD BE SOUGHT

Executive Summary

UNIFORM INTERNATL. PATENT POLICIES SHOULD BE SOUGHT by the federal govt., the Commerce Dept. maintained in a report on the internatl. competitiveness of the U.S. drug industry. Noting that "some countries, notably Germany, do not issue composition of matter patents" but only allow process claims, and that the goal of pharmaceutical research "is to find compositions of matter" that are useful, the report states: "The U.S. might accelerate negotiations with its trading partners to achieve greater uniformity of internatl. patent policies and practices utilizing the already established internatl. patent conventions." Calling pharmaceuticals a form of intellectual property, Commerce also recommended that the govt. "give greater consideration to ways of providing greater protection to the legitimate intellectual property rights of U.S. drug companies." For example, in cases where counterfeit or pirated drugs reach the U.S. market from foreign countries, the govt. should pursue further remedies such as the Generalized System of Preferences Renewal Act, which authorizes the President to deny preference "benefits to any country that does not take adequate steps to prevent illegal counterfeiting or theft of U.S. goods or intellectual property rights, including patents, trademarks, and copyrights." Titled A Competitive Assessment of the U.S. Pharmaceutical Industry and prepared by the department's Industry Analysis Div., the recently released report predicts that the domestic industry's competitiveness in the internatl. marketplace should remain strong. Copies of the report are available from the U.S. Commerce Dept., Internatl. Trade Administration, Washington, D.C. 20230. The report predicts that FDA's regulatory strength will prove an advantage for U.S.-based firms as therapies that emerge raise moral and social, as well as safety, concerns. "While there are some forces at work to reduce the level of govt. regulation over drug development and marketing" in order to get new drugs approved more quickly and enhance return on R&D investment, "the convergence of concerns related to the safety and efficacy of new classes of drugs as they come on the scene will increase the pressures for more, rather than less, govt. regulation," the department said. Such products will "touch on the most personal and sensitive aspects of an individual's life and being (e.g. mental functions, reproductive systems, etc.) and hence raise special concerns for safety," the report predicts. In addition, some products "will raise moral and societal issues that may be more far-reaching than current arguments concerning safety and efficacy." For example, the report states, questions will be raised about the use of drugs to influence a child's "skin color, facial features, and body build . . . intelligence, ambition, aggressiveness, persistance, creativity, and artistic qualities."
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